ATTD 2017 Invited Speaker Abstracts A-1

ATTD 2017 Oral Abstracts A-10

ATTD 2017 E-Poster Discussion Abstracts A-36

ATTD 2017 E-Poster Viewing Abstracts A-45

ATTD 2017 Read By Title A-127

ATTD 2017 Abstract Author Index A-134

DIABETES TECHNOLOGY & THERAPEUTICS
Volume 19, Supplement 1, 2017
Mary Ann Liebert, Inc.
DOI: 10.1089/dia.2017.2525.abstracts
ATTD 2017 ABSTRACTS
ATTD 2017 Invited Speaker Abstracts
001
MOVING TO A DYNAMIC VIEW OF DIABETES:
A CORNERSTONE ON THE ROAD TOWARD
GLUCOSE CONTROL
E. Renard1
1 regimen in any inpatient setting. This study evaluated the effec-
Montpellier University Hospital, Department of
Endocrinology, Diabetes, Nutrition, Montpellier cedex 5,
France
Blood glucose is a biological parameter which is influenced by
almost all physiological body regulators and unlimited envi-
ronmental impacts. In contrast to this eminently moving element,
from the discovery of insulin and its therapeutic use in diabetes, a
paradoxical mode of insulin management has been followed.
Punctual measurements of glucose initially in urine and since the
1970s in blood have been used to decide which iterative doses of
insulin had to be delivered. Hence most of time blood glucose
levels fluctuate above or below the physiological glucose range
and it can be considered as a miracle that patients may obtain an
acceptable life in these conditions.
During the two last decades, the technology has made available
tools that fully change this paradigm. Insulin infusion from minia-
turized pumps has first allowed dynamic, prospective or corrective
adjustments of insulin delivery. Using this dynamic mode of insulin
therapy based upon static iterative measurements of blood glucose is
however just like driving a car with only distant occasions to see the
road. The availability of continuous glucose monitoring has pro-
vided the instrument to see the road. Moreover, the combination of
continuous adjustable insulin delivery and permanent monitoring of
glucose level has opened the way to efficient prediction and antici-
pation. Glucose control can then be switched from human brain to
control closed-loop algorithms. Hence targeted diabetes control is no
more having a good HbA1c but keeping blood glucose as much time
as possible in a close-to-normal range. Because blood glucose is a
dynamic parameter, a dynamic view of glucose status and a dynamic
management of insulin therapy are needed. Today, the request of
patients with diabetes to the health insurances can copy Winston
Churchills request to the US allies during WW2: Give us the tools,
and we will do the job!
002
COMPUTERIZED SOFTWARE USING
POC GLUCOSE IN THE HOSPITAL
AND OUTPATIENT SETTING
B. Bode1
1
Atlanta Diabetes Associates, Endocrinology & Metabolism,
Atlanta, USA
A-1
The importance of inpatient glycemic control on outcomes not
only applies to patients managed with IV insulin in critical care
areas but also patients on general surgical and medical wards. In
such patients, hyperglycemia is associated with increased length
of stay, infection, mortality, and readmissions. Time to target
glucose is important for success of a subcutaneous (SubQ) insulin
tiveness of an Electronic Glycemic Management System (eGMS)
to achieve prescribed glucose target ranges on SubQ insulin
therapy while measuring incidence and severity of hypoglycemia.
Methods: This retrospective study evaluated 5,718 hypergly-
cemic patients who required SubQ insulin. They were admitted to
one of 7 hospital systems over 45 months from 02/2013 to 11/
2016. Insulin regimens were targeted to glucose ranges of 100-
140, 120-160 or 140-180 mg/dL using the eGMS SubQ program
GM. Primary outcome measure was mean Time-To-Target (TTT).
Secondary measures included: average initial BG (SD), daily BG
average, time on eGMS, hypoglycemia <40 & <70 mg/dL, and
percent of BG readings and patient days in target once target was
reached.
Results: Patients reached their prescribed target in 0.8 days.
Average initial BG was 261.7 mg/dL (SD+/-129.2), average time
on eGMS was 4.56 days with 67.9% of BG readings and 68.5% of
patient day values remaining 70-180 mg/dL once prescribed tar-
get was reached. Hypoglycemia was <40 = 0.0011% & <70 mg/
dL = 0.013%.
Conclusion: These results suggest that eGMS can achieve a
prescribed target range quickly with limited mild or severe hy-
poglycemia.
003
CHALLENGES AND PROBLEMS IN INTRODUCING
NEW TECHNOLOGIES INTO CLINICAL PRACTICE
G. Grunberger1
1
Grunberger Diabetes Institute, N/A, Bloomfield Hills, USA
Diabetes technology has come a long way. From the initial use of
continuous subcutaneous insulin infusion via insulin pumps in late
1970s and capillary glucose monitoring introduced in early 1980s
we are now contemplating use of automated insulin delivery devices
(also known as artificial pancreas to bionic pancreas systems)
in clinical practice within the next year. Tremendous progress has
been made by investigators, clinicians and patients on all fronts to
enable this discussion. Insulin delivery devices have shrunk in size
and grew in complexity and flexibility while blood glucose monitors
have allowed faster, more accurate and convenient acquisition of
glucose concentration by patients. Introduction of continuous glu-
cose monitoring systems measuring glucose concentration in the
A-2
interstitial fluid brought in the next stage necessary for automation
of insulin delivery and eventual freeing up of patients from constant
need for finger sticks, carbohydrate counting, manual adjustments
of insulin pump delivery and fear of nocturnal hypoglycemia. While
these exciting developments had been taking place, discussions had
started about eventual deployment of these technological advances
into clinical practice beyond the research setting. Relevant stake-
holders have been asking essential questions: Is the technology
ready for implementation in the real world? If so, how will it be 005
done? Will any clinician be allowed to introduce it in his/her
practice setting? If not, who, when and how will train and certify the
practitioner in his/her proficiency? How will their performance be
monitored and acted on? Who will select the appropriate patients for
this technology to optimize its promise of better glycemic control
while minimizing risks of intensive insulin therapy? How, when and
by whom will the patients be trained? How will their progress be
monitored and judged? What is and will be the role of experts and
professional societies? How will their recommendations influence
the marketplace? And, most importantly, how will be the new
technology paid for? Who and by what parameters will decide on
reimbursement levels for the professionals, practice settings and
patients? It is not too early to start getting correct answers so the
advances in diabetes technology can be enjoyed by our patients.
004
HARVARDS PID APPROACH
G. Steil1
1 studies suggest that these approaches are misdirected, that insulin
Boston Childrens Hospital, Division of Medicine Critical
Care, Boston, USA
Different Proportional Integral Derivative (PID) control de-
signs have produced substantially different results. In many
cases, the differences can be attributed to improvements in the
PID algorithm that are effected as new data become available, or
to improvements in the continuous glucose monitor (CGM) used
by the controller. In other cases, changes in the PID design have
resulted in a worsening of control performance. In these latter
cases, it is often difficult to assess whether the decrease in per-
formance is due to a change in the PID design per se, a change in
CGM performance, or a change in any number of indeterminate
factors inherent in all cross-study comparisons e.g., differ-
ences in the subjects studied, differences in the types or size of
meals consumed, presence or absence of manual meal insulin
dosing, or difference in the allowed activity level all of which
can be reasonably expected to affect Artificial Pancreas (AP)
control performance. One approach to assess the impact of these
factors is through the use of model identification and simulation.
In this approach - used extensively at Boston Childrens Hos-
pital (BCH) to effect improvements in PID control design and
open-loop pump therapy - CGM and insulin delivery data are
combined with meal and exercise data to identify time varying
changes in insulin sensitivity and other metabolic parameters
characterizing insulins effect to lower blood glucose. Once
these parameters have been obtained, and the underlying met-
abolic model shown to predict the glucose profile observed in
the study in question without error (statistical runs test), the PID-
controller used in the study showing poor performance is re-
placed with a previously studied PID controller to assess if the
degradation in performance is related to a difference in the
control design. Once this step is completed, the controller is
optimized to address the problems in observed in the most recent
study while at the same time not degrade the performance pre-
ATTD 2017 INVITED SPEAKER ABSTRACTS
dicted for prior studies. As each new study becomes available,
the process becomes increasing difficult as the controller needs
to effect acceptable control over all prior studies. The BCH-
approach is compared to alternate approaches that have achieved
broad use within the AP community.
THE MOLECULAR BASIS FOR THE REMISSION
OF TYPE 2 DIABETES AND OPPORTUNITIES
FOR DRUG DEVELOPMENT
W. Pories1
1
Metabolic Surgery Research Group, Surgery, Brody School of
Medicine, East Carolina University, Greenbille, USA
Bariatric surgery has forced a re-examination of type 2 dia-
betes (T2D). It is no longer an incurable disease that ends, twenty
years after diagnosis, with renal failure, blindness and amputa-
tions. Operations that d.ecrease contact between food and the gut,
if done early enough, can produce long-term cures with decreases
in mortality by 80%. Further, the procedures do not only reverse
T2D but also produce full and durable remission of other ex-
pressions of the metabolic syndrome such as dyslipidemias,
hypertension, severe obesity and polycystic ovary syndrome.
Current therapies for advancing T2D are directed at over-
coming insulin resistance by decreasing insulin resistance, in-
creasing insulin secretion or the administration of insulin. Our
resistance may not be an appropriate target and that interfering
with gut signaling offers additional, so far overlooked, oppor-
tunities for drug development.
006
INSULIN PUMP THERAPY IN TYPE 2 DIABETES:
AN INDIVIDUAL PATIENT DATA META-ANALYSIS
J. Pickup1
1
Kings College London, Diabetes & Nutritional Sciences,
London, United Kingdom
Insulin pump therapy (CSII) has an established place in the
treatment of selected people with type 1 diabetes but its role in
the management of type 2 diabetes is less certain. There has been
equivocal evidence from some randomized controlled trials
(RCTs) for the effectiveness of CSII vs. MDI in type 2 diabetes,
but a recent large-scale, multicenter RCT indicates that and some
patients who remain poorly controlled after a period of optimized
MDI may benefit from a switch to insulin pump therapy.
In order to test the hypothesis that HbA1c is improved on CSII
vs. MDI in type 2 diabetes, and to identify those patients with
type 2 diabetes who benefit the most from CSII, we performed an
individual patient data meta-analysis of published RCTs in this
group. We searched for trials that met the inclusion criteria in
several data bases including Cochrane, Medline and Google. We
used Bayesian meta-regression models to identify determinants
of final HbA1c and insulin dose.
Five RCTs met the selection criteria, with 287 patients ran-
domized to MDI and 303 to CSII. Data from all individual patients
were available. Meta-regression models and recommendations for
patients with type 2 diabetes best treated by CSII will be presented.
ATTD 2017 INVITED SPEAKER ABSTRACTS
007
CGM IN TYPE 2 DIABETES: IS IT A REALISTIC
TECHNOLOGY?
I.B. Hirsch1
1 of elevated BP also occurs in *75%, dyslipidemia in *66%, and
University of Washington, Seattle, USA
Continuous glucose monitoring (CGM) is not nearly as mature
in its development in type 2 diabetes (T2D) as it is in type 1
diabetes (T1D). In fact, after a decade of CGM there are only a
few studies addressing its utility in T2D. Reasons for this in-
cludes a wide heterogeneity of patients, particularly in terms of
medication use. While it could be argued one of the mechanisms
of CGM success is behavioral modification no matter the type of
diabetes, for those not receiving insulin these alterations in
lifestyle are often the primary mechanism glucose control can
improve. Besides classifying patients on insulin-requiring or not,
CGM can also be divided as masked (professional) or real-
time (personal). Furthermore, the newer Flash Glucose Mon-
itoring (FGM) needs to be viewed separately from CGM since
alarms do not notify the patient about extremes in glycemia.
Studies to date, particularly randomized controlled studies for
CGM or FGM in T2D are sparse. Nine studies of professional
CGM observed for 12 to 24 weeks have shown HbA1c reductions
generally between 0.4 to 0.6%. However, only 3 of these trials were
RCTs. There also appears to be a CGM-behavioral memory in Joslin Diabetes Center, Pediatrics, Boston, USA
some with T2D. For example, in a separate 40-week study (after 12
weeks of intermittent CGM) of patients with T2D not receiving
prandial insulin there was a 0.8% reduction in HbA1c compared to
0.2% in those receiving conventional finger stick blood glucose
testing (Diabetes Care 2012; 35:32-38). Other shorter studies using
CGM for 12 weeks have shown similar improvements in HbA1c.
For FGM, a 26-week RCT reported in 2016 no improvement of
HbA1c but significant reductions in hypoglycemia exposure.
In conclusion, experience in CGM and FGM in T2D is
growing but not nearly what it is in T1D. The heterogeneity of the
populations studied makes it difficult to compare studies. More
research is required to better define the utility of this technology
in T2D and in particular which T2D patients would most benefit.
Finally, robust cost effectiveness studies will be required to show
benefit before widespread use can be adopted.
008
PROS AND CONS OF BARIATRIC SURGERY
IN ADOLESCENTS WITH OBESITY AND T2DM
M. Sperling1
1
New York, USA
The world-wide epidemic of obesity involves children and
adolescents who manifest several endocrine (PCOS, early or
delayed puberty, abnormal thyroid function) and biochemical
disturbances including metabolic syndrome and T2DM, both of
which are increasing in prevalence and are associated with
morbidity, earlier mortality and decreased quality of life mea-
sures. Medical treatment options, including lifestyle interven-
tions, are limited in effectiveness.
The seriousness of the problem has spawned surgical inter-
vention(s) via bariatric surgery procedures, the 2 most common
being gastric sleeve and Roux en Y gastric bypass.
A-3
In several reported studies, age at surgery is *16 years (range
14-20 years), mean body mass index is >50, and females pre-
dominate (75%).Weight loss ranges from 20%-30%, remission of
T2DM occurs in *95% in those who have this condition at
baseline, and remits in *75% in those with pre-diabetes; remission
significant improvement in weight-related quality of life is reported
by most. I discuss possible mechanisms for the rapid improve-
ments seen before significant weight loss occurs. Complications
include deficiency of essential micronutrients which occurs in
*50% and 10%-20% require one or more additional procedures.
Contra-indications for surgery include an unstable home environ-
ment, history of recidivism, drug or alcohol abuse, established
psychiatric disorders and emotional immaturity.
To date, follow up studies have been of short duration so
longer follow up is essential before widespread application of
these surgical techniques for a medical problem.
009
OPPORTUNITIES TO ENHANCE TECHNOLOGY USE
IN PEDIATRIC PATIENTS WITH T1D
L. Laffel1
1
Intensive insulin therapy and use of advanced diabetes tech-
nologies for type 1 diabetes (T1D) management offer opportu-
nities to optimize glycemic control in children, adolescents, and
young adults. Despite these treatment tools, the majority of
young patients do not achieve the recommended HbA1c targets
of <7.5% (58 mmol/mol) for patients <18 years old and <7% (53
mmol/mol) for those 18 and older; only *1/4 youth <18 reach
target and only *1/5 aged 18-25 achieve target. To enhance
uptake and sustain use of diabetes technologies, there is need to
understand potential barriers and burdens associated with use as
well as a need to demonstrate and promote potential benefits of
use. Understanding and articulating the balance between barriers
and benefits will become increasingly important in the era of
automated glucose control with the impending availability of the
first commercial hybrid closed loop system in 2017.
There is likely a bidirectional interaction between psychoso-
cial factors and technology. Devices such as CGM can add
burdens to care due to the need for repeated insertions, pain/
discomfort with insertions, site care, potential skin reactions,
daily calibrations, concerns with accuracy, need to carry multiple
devices, and alert/alarm fatigue, which should be counter-
balanced by the benefits of real-time glucose data to guide
management and provide timely alerts to patients (and family
members connected remotely) regarding out-of-range glucose
levels.
Pediatric patients are particularly burdened by technologies as
past experience has shown regarding CGM; young persons may
initiate CGM, but many fail to sustain consistent and durable
CGM use. Understanding burdens as well as benefits will be
particularly important with automated glucose control systems in
order to promote use and to yield glycemic benefits for youth. In
order to enhance technology use in pediatric patients with T1D, it
will be important to ensure provision of realistic expectations,
including review of patient/family efforts required to use such
systems and the limitations of device performance as well as the
need for ongoing support and education regarding system use.
A-4
010
MAKING THE MOST OF DIABETES TECHNOLOGY
K. Barnard1
1 commended by their health care professionals. They describe
Bournemouth University, Faculty of Health & Social Science,
Bournemouth, United Kingdom
Diabetes technologies represent some of the most advanced
pieces of engineering ever created. Devices including insulin
pumps (CSII), continuous glucose monitors (CGM) and automated
insulin delivery or closed loop (CL) systems, as well as self-
monitoring of blood glucose (SMBG) devices with varying levels
of functionality, are associated with improved glycaemic control
and psychosocial benefits. It is also often reported that such devices
contribute to relief from diabetes self-management in terms of
flexibility, freedom, greater awareness of glycaemic information
for both individuals with T1D and their families / significant others
for example with shared CGM data now possible.
Both disease and disease management contribute to subopti-
mal quality of life however, with the burden of managing tech-
nologies also reported to have a negative impact on quality of
life. SMBG, insulin pump therapy and CGMs have all been as-
sociated with increased burden of disease management in the
literature, with mixed reports of the psychosocial impact of CL
systems. Commonly believed to reduce time spent thinking about
diabetes, the STAR3 trial reported that CSII was associated with
more time spent on diabetes care than multiple daily injection
therapy. The amount of data provided by CGMs has been re-
ported to be overwhelming, with mixed impact on psychosocial
functioning of users.
Technology in itself is insufficient to effect long-term im-
provements in diabetes outcomes, as can be seen in successive
national diabetes audits. Optimal diabetes outcomes require timely
education and ongoing support of personalised use of devices.
Ensuring robust, consistent and effective assessment of psycho-
social factors associated with diabetes technologies is crucial to
understanding the barriers and facilitators of uptake and continued
successful use for each individual in the context of their daily lives
both bio-medically and psychologically.
011
ENHANCING AWARENESS OF HYPOGLYCAEMIA -
WHERE TO GO WHEN TECHNOLOGY FAILS!
S. Amiel1
1
Kings College Hospital, London, United Kingdom
Impaired awareness of hypoglycaemia (IAH), associated with
extensive defects in the physiological counterregulatory re-
sponses to hypoglycaemia, increases risk of severe hypogly-
caemia 6- (in type 1 diabetes) to 17- (in insulin-treated type 2)
fold. Awareness of hypoglycaemia can be restored by strict
avoidance of exposure to plasma glucose less than 3 mmol/l,
54 mg/dl, but this can be difficult to achieve and sustain, espe-
cially while maintaining target concentrations of glycated hae-
moglobin (HbA1c). For adults with type 1 diabetes, structured
education in flexible intensive insulin therapy can lower HbA1c,
reduce rates of severe hypoglycaemia and, in at least one pro-
gramme, restore awareness of hypoglycaemia to about 40% of
people entering the programme with impaired awareness. Insulin
pump therapy, and sensor-augmented pump therapy also reduce
severe hypoglycaemia rates but have not, to date, been able to
restore awareness. Neuroimaging has shown abnormal activation
ATTD 2017 INVITED SPEAKER ABSTRACTS
of dopaminergic pathways associated with motivation and re-
ward, as well as of brain regions involved in stress responses,
arousal and vigilance, in adults with type 1 diabetes and IAH and
people with IAH are less likely to follow treatment plans re-
unhelpful health beliefs that may act as barriers to their en-
gagement with hypoglycaemia avoidance. Anecdotally, these
may be associated with use of technology further to lower
glucose or avoidance of technological solutions. Nearly 1 in 10
adults with type 1 diabetes may be at high risk of severe hy-
poglycaemia but express relatively low concern about it. A pilot
study of a group intervention, delivered by trained diabetes
educators supported by clinical psychology, and using psy-
chotherapeutic techniques of motivational interviewing and
cognitive behavioural theory specifically targeting the de-
scribed health beliefs of IAH, has shown great promise in
helping people with treatment-resistant IAH regain awareness
and avoid severe hypoglycaemia. The programme is now the
subject of a formal randomized controlled trial.
012
18 MONTHS USE OF CLOSED-LOOP
AT HOME STUDY
S. Garg1
1
Barbara Davis Center for Diabetes, University of Colorado
Denver, Department of Medicine and Pediatrics, Aurora, USA
Several new technologies have emerged in the past 15 years to
improve diabetes outcomes as it relates to hypoglycemia (safety)
and improving glucose control (A1c values). Improvements in
continuous glucose monitoring (CGM) devices have consistently
shown reduction in HbA1c without increasing hypoglycemia in
insulin requiring patients with diabetes. These improvements
have been shown to be consistent in patients using insulin pump
or multiple daily injections a day (MDI). However, when CGM
is used alone without automatic feedback to the insulin delivery
system, the subjects have to intervene to take the necessary steps
of either have a snack to avoid hypoglycemia or take additional
insulin to avoid impending hyperglycemia.
With continued improvements in the CGM technology
(MARD now consistently less than 10%) and in the new insulin
delivery systems (pumps), several studies have now incorporated
the two technologies together to reduce diabetes burden in pa-
tients with type 1 diabetes. Several studies on closed-loop systems
have shown significant reduction in nocturnal hypoglycemia,
significant increase in time in range with a reduction of hyper-
glycemic glucose excursions. Most of these studies have been
short term lasting from a few days to three months. We report the
first large real-life unsupervised at-home use of the hybrid closed-
loop system (HCL) in subjects with type 1 diabetes.
The original cohort of 124 adolescent and adult subjects with
type 1 diabetes (single-arm) after two weeks of run-in phase
clearly showed the HCL system to be safe in reducing hypo-
glycemia and improving glucose control. The study results were
recently reported in JAMA 2016 (Bergenstal, Garg, et al., JAMA
2016). More than 85% of the subjects chose to continue with the
HCL system which was allowed by the FDA and the sponsor. To
everyones surprise in September 2016 the FDA approved the
first artificial pancreas (HCL) and making it an historic landmark
in use of technology for subjects with type 1 diabetes. It is likely
to be available in the US early spring of 2017.
In this study, we report results of 18 subjects out of the 24 who
participated in the original study reported above from the Barbara
ATTD 2017 INVITED SPEAKER ABSTRACTS
Davis Center for Diabetes. The data clearly indicates continued
benefits to both adolescents and adults in improving glucose con-
trol and reducing hypoglycemia. All subjects have been satisfied
with the use of HCL and are hoping not to give up the system next
spring. The detailed data will be presented at the ATTD 2017.
013
IMPLANTABLE AP: BENEFITS AND CHALLENGES
OF IP-IP AP
E. Dassau1
1 015
Harvard University, Harvard John A. Paulson School
of Engineering and Applied Sciences, Cambridge, USA
Automated insulin delivery (AID) systems have shown to be
superior to sensor augmented pump (SAP) and continuous sub-
cutaneous insulin infusion (CSII) in multiple clinical studies.
However, the first generation of subcutaneous automated insulin
delivery systems such as the Medtronic 670G will most likely
have limited capability and will be highly dependent on user
involvement. One of the main limitations of the first generation
of AIDs is current insulins and the delivery methods.
In this presentation, the benefits and challenges for an im-
plantable AID will be discussed, presenting the case for the next
generation of AID. Designed to be user centric and with superior
ability to reject disturbances such as meals and exercises.
014
MULTIPLE MODEL PROBABILISTIC PREDICTIVE
CONTROL: IS A PRE-MEAL BOLUS NECESSARY?
D. Maahs1, F. Cameron2, L. Trang3, B. Buckingham3, C. Levy3,
G. Forlenza4, D. Lam3, P. Clinton1, L. Messer4, E. Westfall4,
C. Levister3, Y.Y. Xie3, N. Baysal2, D. Howsmon2, S.D. Patek5,
W. Bequette2
1
Stanford University, Pediatric Endocrinology, Stanford, USA
2
Rensselaer Polytechnic Institute, Engineering, New York, USA
3
Icahn School of Medicine at Mount Sinai, Endocrinology,
New York, USA
4
Barbara Davis Center, Pediatrics, Aurora, USA
5
University of Virginia, USA
Background: Due to the action time of current insulin for-
mulations, closed loop systems require a pre-meal bolus to re-
duce post-prandial hyperglycemia. However, systems that
eliminate patients need to bolus insulin for meals may be de-
sirable. We report preliminary data assessing initial safety and
efficacy from a fully closed-loop insulin-only system that does
not require announcement of meals or activity.
Research Design and Methods: The multiple model proba-
bilistic predictive controller (MMPPC) anticipates meals when
the patient is awake. The system (UVa DiAs, Roche Spirit
Combo insulin pump, Dexcom G4 CGM) was tested at two sites
on 10 participants in a 30-hour inpatient study followed by 15
participants at three sites in a 54 hour supervised hotel study with
exercise and unannounced meals challenges.
Results: The mean overall (24-hour) and nighttime (11 pm7
am) CGM values were 142 and 125 mg/dl for the inpatient study.
Tuning adjustments to reduce daytime aggressiveness made
before the hotel study resulted in mean overall (24-hour) and
A-5
nighttime CGM values of 152 and 142 mg/dl for the hotel study.
The tuning change reduced hypoglycemia from 1.6 to 0.85
events/patient/day.
Conclusions: The MMPPC system achieved a mean glucose
equivalent to an estimated HbA1c of 7% and may be particularly
helpful for people who have an elevated HbA1c as a result of
frequent missed meal boluses. The current MMPPC algorithm
may have a higher risk for hypoglycemia when compared to
algorithms using meal announcement. More research is required
to develop a fully closed loop system.
MULTI-WEEK OUTPATIENT STUDIES
WITH ADAPTATION
F.J. Doyle1
1
Harvard, School of Engineering & Applied Sciences,
Cambridge, USA
In this talk, I will report on a multi-site clinical trial that
studied the performance of an automated glucose control system
in home settings for subjects with type 1 diabetes. We investi-
gated an enhanced version of zone model predictive control,
which included run-to-run optimizations of basal rates (BR) and
insulin to carbohydrate ratios (CR). Specifically, the protocol
included algorithmic adjustment of CRs prior to closed-loop
initiation, and continued BR and CR algorithmic optimization
during closed-loop use for a longer duration. The system was
evaluated for 15 weeks at 3 different sites (William Sansum
Diabetes Center, University of Virginia, and Mayo Clinic,
Rochester, MN). Thirty-two subjects (17 F) were enrolled and 29
subjects completed the protocol. The primary outcome measure
was the change in Hemoglobin A1c (HbA1c) (%) from baseline
(week 2) to the end of week 15 (end of study), with A1c measured
at weeks 7 and 11 as well for repeated measures.
016
ADD-ON THERAPIES IN OBESE PRE-DIABETIC
WOMEN WITH POLYCYSTIC OVARY SYNDROME
A. Janez1, M. Jensterle2
1
Univerzitetni klinicni center Ljubljana, KO za endokrinologijo-
diabetes in bolezni presnove, Ljubljana, Slovenia
2
University Medical center Ljubljana, Dept of Endocrinology-
Diabetes and Metabolic Diseases, Ljubljana, Slovenia
Obesity is frequently present in women with polycystic
ovary syndrome (PCOS). It aggravates the adverse features of
the syndrome and increases the metabolic risk in this popula-
tion. Weight management by lifestyle intervention often re-
mains unsatisfactory and Glucagon like peptide 1 receptor
agonists (GLP1RA) are a class of glucose-lowering drugs
which act through the GLP-1 receptors. Through approved for
use in type 2 diabetes, the ubiquitous distribution of GLP-1
receptors suggests that these molecules can be utilized to
benefit persons with other conditions, including endocrine and
metabolic dysfunctionnon-sustainable. GLP1RA liraglutide is
currently approved as anti-obesity agents, yet the experience
with their use in PCOS-related obesity and insulin resistance is
still limited Short-term 12 week randomized combined
A-6
treatment with liraglutide 1.2 mg QD s.c. alone or in combi-
nation with metformin 1000 mg BID was associated with sig-
nificantly greater weight loss in obese women with PCOS who
had been previously poor responders regarding weight reduc-
tion on lifestyle intervention and metformin when compared to
metformin monotherapy. The reported mean weight losses
were 6.5 kg with liraglutide plus metformin, 3.8 kg with lir-
aglutide alone and 1.2 kg with metformin alone. Furthermore,
treatment with liraglutide was associated with significantly
greater weight loss in a subset of obese patients with newly
diagnosed PCOS and higher metabolic risk profile when com-
pared to metformin and lifestyle intervention. Recognizing that
the weight reducing effects of GLP-1 RAs are mediated through
GLP-1 receptor its genetic variability could be hypothetically
associated with the inter-individually different response to
weight lowering potential of liraglutide in metabolically bal-
anced and BMI matched obese population. We have demon-
strated that some GLP1-R polymorphisms were associated with
inter-individual differences in response to liraglutide regarding
weight reduction in phenotypically and metabolically homo-
geneous cohort of obese women with PCOS.The novel phar-
macological treatment concept in obesity and obesity related
conditions should focus on distinct regulatory mechanisms of
energy homeostasis and eating behaviour. Agents mediating
through GLP-1 effects in combination with lifestyle interven-
tion and metformin could potentially improve treatment out-
comes in obese PCOS via co-targeting multifactorial origin of
obesity and concomitant abnormalities intrinsically related to
PCOS. Larger and longer randomized studies are needed to
establish the metabolic, reproductive, and cardiovascular risk
reduction and to assess the sustainability and safety profile of
weight reduction achieved by this potential new treatment
strategies.
017
NEW INSULINS IN TYPE 1 DIABETES: GETTING
BETTER ALL THE TIME?
C. Mathieu1
1
Laboratory and Clinic of Experimental Medicine and
Endocrinology, University Hospital Leuven- Catholic
University of Leuven, Leuven, Belgium
Therapy of people with type 1 diabetes consists of external
replacement of all functions of the beta-cell aimed at achieving
glucose levels as close to normal as possible. This demands re-
placing glucose sensing and achieving insulin levels that mimic the
physiological insulin profiles, with basal coverage and meal time
excursions. Patient education and training is crucial to achieve
good glycaemic control, but having insulin preparations at hand
that have profiles that provide stable basal insulin coverage and
appropriate mealtime insulin peaks helps patients with type 1 di-
abetes live active lives without sacrificing tight glucose control.
The availability of insulin analogues, with profiles that allow
better coverage of mealtime glucose excursions and give a
more stable basal insulin coverage than the human insulins have
allowed many people with type 1 diabetes to achieve tighter
glucose control, with less hypoglycaemia risk. Still, the first
generation rapid-acting and long-acting insulin analogues do not
provide the perfect fit for insulin demands and novel analogues
(long-acting: insulin degludec and U300 insulin glargine) as well
as rapid-acting insulin analogues (faster insulin aspart) are be-
coming available and will allow yet another step towards good
glycemic control in patients with type 1 diabetes. However, even
ATTD 2017 INVITED SPEAKER ABSTRACTS
these analogues do not solve the major issue of insulin therapy:
weight gain and risk of hypoglycaemia. Next generation insulins,
like smart insulins or hepato-preferred insulins, might bring a
solution.
018
CLOSED LOOP AND PHYSICAL ACTIVITY - A DREAM
OR ALREADY REALITY?
N. Bratina1, K. Dovc2, T. Battelino2
1
Lubljana University Medical Centre, Department of
Endocrinology- Diabetes and Metabolism, Lubljana, Slovenia
2
University Childrens Hospital Ljubljana, Department of
Endocrinology, Diabetes and Metabolic Diseases, Ljubljana,
Slovenia
Physical activity is important for children and adults and es-
pecially for people with chronic diseases. It helps to reduce stress
in everyday life, keeps body in good physical condition, it can
help to slow down atherosclerotic diseases, improves HDL
cholesterol level, it can delay osteoporosis.
Athletes with diabetes can participate in recreational sports or
be a part of the competitive teams. Physical activity is always a
challenge to the athlete with diabetes, as well as for members of
the medical teams who care for them on long term basis. We must
be aware that different sports and exercise intensity have their
own effects on diabetes. Many factors can significantly affect
blood glucose levels such as the level of hydration, the secretion
of counter regulatory hormones, timing of meals and the level of
active insulin. If talking physical activity in childhood next to
diabetes, growth, injuries, sudden heart death syndrome, and
doping problems, protein overload and unhealthy eating patterns
must be discussed.
Diabetic athlete must exactly plan how much aerobic and
anaerobic exercise will be a part of the training, the intensity,
duration and timing of the exercise, but also the risk of hypo-
glycemia and injuries are a concern. Most frequently athletes
learn to manage their diabetes during exercise by trial and error
or with sharing personal experiences with other athletes. Fear of
hypoglycaemia can be a big burden for many active people.
Nowadays technological development gives us new possibil-
ities for diabetes treatment modern insulins, insulin pumps and
sensors. Closed-loop systems combines glucose monitoring
system and a modern insulin pump with a computer algorithm
that regulates insulin delivery according to glucose oscillations.
Closed loop would be an important tool improving metabolic
control during physical activity. By the time data from studies on
closed loop and physical activity are modest.
We performed an open label, in-hospital, randomized, cross-
over designed trial with two different, 40 minutes protocols on a
cycle ergometer: moderate intensity (55% VO2max) physical
activity, and moderate activity with incorporated high intensity
(80% VO2max) sprints either with close or open loop use. The
results are promising, showing that closed loop system increased the
proportion of time within the target glucose range 70 180 mg/dl.
The proportion of time in hypoglycemia below 60 mg/dl was 0.00 %
for both groups.
Further studies are needed, including competitive and duration
sports.
References
Robertson K, Riddell MC, Guinhouya BC, Adolfsson P, Ha-
nas R. Exercise in children and adolescents with diabetes: Ex-
ercise. Pediatr Diabetes 2014;15(S20):20323.
ATTD 2017 INVITED SPEAKER ABSTRACTS
Adolfsson P, Nilsson S, Albertsson-Wikland K, Lindblad B.
Hormonal response during physical exercise of different inten-
sities in adolescents with type 1 diabetes and healthy controls.
Pediatr Diabetes. 2012;13(8):58796.
Wilson DM, Calhoun PM, Maahs DM, Chase HP, Messer L,
Buckingham BA, et al. Factors associated with nocturnal hypo-
glycemia in at-risk adolescents and young adults with type 1
diabetes. Diabetes Technol Ther 2015;17(6):38591.
Phillip M, Battelino T, Atlas E, Kordonouri O, Bratina N,
Miller S, et al. Nocturnal glucose control with an artifi-
cial pancreas at a diabetes camp. N Engl J Med 2013;368(9):
82433.
019
CONTINUOUS AND FLASH GLUCOSE MONITORING
IN YOUTH WITH TYPE 1 DIABETES HIKING GORGES
IN GREECE AND VOLCANOES IN ICLAND
O. Kordonouri1
1 management protocol was purposely built for a safe dive and
Kinder- and Jugandkrankenhaus AUF DER BULT, Diabetes
Center for Children and Adolescents, Hannover, Germany
Aim: To demonstrate that well-educated young patients using
modern insulin treatments are able to perform successfully even
extraordinary physical challenges without limitations because of
their diabetes.
Patients and Methods: Two challenges, a 4-days trekking in
Crete, Greece (2015) and a 5-days trekking in Iceland (2016) have
taken place so far. In total, 21 adolescents and young adults with
T1D [13 male, 8 female; age 18.0 years (16-25), BMI 22.4 kg/m2
(19.5-26.2), diabetes duration 7.3 years (1-17), HbA1c 7.2% (5.8-
8.5); median (range)] from 17 countries worldwide have suc-
cessfully participated. Ten youngsters (47.6%) were on CSII,
eleven on MDI. During the first trekking in Crete, participants
were wearing a continuous glucose monitoring system (CSII:
Paradigm Veo or 640G, Medtronic; MDI: DexCom G4 Platinum,
DexCom), while during the second challenge in Iceland they were
using a Flash glucose system (Freestyle libre). The glycemic
targets during the challenge were defined as 80-180 mg/dl (4.4-
10 mmol/l).
Results: All participants completed the challenge. In total,
the groups walked 54.5 km and 88.5 km under varying cli-
mate conditions, respectively. Insulin requirements decreased
significantly compared to baseline: total daily insulin by
31.5 17.6% (p
Conclusion: Despite of very challenging physical, climate
and cultural conditions, the youth succeeded reaching the sum-
mits while maintaining very good glycemic control and without
any acute complication. Intensive glucose management using
Continuous and Flash Glucose Monitoring systems, flexible
insulin treatment and food management guaranteed the excel-
lent performance of the young people.
020
CSII, CGM, AND SCUBA DIVING IN PEDIATRICS
1
R. Schiaffini
1 1
Bambino Gesu, Hospital, Pediatric Diabetology, Rome, Italy
Scuba diving is usually prohibited in children and adolescents
with Type 1 Diabetes, especially due to the particular risk of
hypoglycemia.
A-7
Nevertheless, recently it was recognized that with proper and
careful management, children and adolescents with Diabetes can
dive safely.
Practical guidelines are needed for diabetic patients and their
caregivers, in order to decrease the extra-risk during diving and
consequently prevent hypoglycemia and hyperglycemic peaks.
Continuous Subcutaneous Insulin Infusion (CSII), Continuous
Glucose Monitoring (CGM) and remote monitoring in case of
Multi Daily Injections (MDI) seem to be valid options to manage
children with diabetes approaching to diving. During the last ten
years some papers demonstrated that pump technology and ac-
curacy of glucose sensors are still valid even in a such extreme
condition as scuba diving.
Recently a CGM System (CGMS) has been developed to real-
time monitor glucose profiles during diving and allow a specific
control of glycemia and prevention of hypos.
Ten adolescents, 12 to 18 years old, with Type 1 Diabetes,
intensively insulin treated with both, CSII or MDI schemes, were
involved in a Project named Sweet Abyss, in order to evaluate
the accuracy and utility of a diving suited CGMS. A detailed
favorable results in terms of hypoglycemia prevention and glu-
cose control have been obtained. Further studies are needed to
fully evaluate the accuracy of glucose monitoring during pres-
sure changes.
021
THE INTERNET OF THINGS, DIABETES
MANAGEMENT AND AUTOMATED INSULIN
MANAGEMENT
E. Dassau1
1
Harvard University, Harvard John A. Paulson School
of Engineering and Applied Sciences, Cambridge, USA
Automated insulin delivery (AID) and decision support (DS)
systems can be considered as the first implementation of the
internet of things in health. With smart-electronics that can es-
tablish local body network and remote communication to cloud
services and other stakeholders. These smart insulin pumps and
glucose sensors are just the first step toward wearable medical
devices. The introduction of other on-body sensors provides
endless opportunities to improve diabetes management for pa-
tients with type 1 diabetes mellitus. The Benefit to glycemic
control has been proven, however this amazing technology has
opened the door to the integration of IOT as well as the need for
better cybersecurity, privacy of data, and human interaction. In
this talk I will discuss the integration of wearable IOT with AID
and DS systems.
022
NOVEL APPROACHES TO CYBER SECURITY
H. Goldman1
The MITRE Corporation, Center for National Security,
Bedford, USA
Medical devices are increasingly exposed through network-
ing. Consequently, their security posture is degrading as the
A-8
attack surface and cyber threats increase. They were originally
built for functionality, not security, at a time when cyber threats
were not what they are today. Practitioners and many device
manufacturers do not understand the number of, or extent of
commodity and proprietary embedded components. They are
also typically unaware of the amount of hardware and software
reuse that, if vulnerable, could result in pervasive compromise
across technologies and devices and cause systemic failures and
cascading effects. More importantly, many cybersecurity coun-
termeasures designed for traditional information systems may
not be useful or appropriate given embedded system constraints,
environmental and user considerations, and compromise impact
to safety, medical efficacy, or loss of life.
We will describe cybersecurity challenges unique to embed-
ded systems including system constraints and operating trends
that affect cybersecurity risk. We will also identify inherent
embedded systems characteristics to leverage that help mitigate
vulnerabilities and reduce consequences. Finally we will offer
approaches to address embedded systems threats, risk manage-
ment, secure resilient architectures, and countermeasure cost
effectiveness.
023
AUTOMATED GLYCEMIC REGULATION WITH A
DUAL-HORMONE (INSULIN AND GLUCAGON)
ARTIFICIAL PANCREAS: THE MONTREAL
APPROACH
1
A. Haidar
1
McGill University, Biomedical Engineering, Montreal,
Canada
The artificial pancreas is a long-awaited goal for the manage-
ment of type 1 diabetes and its development was recently trig-
gered by advances in continuous glucose sensors. Two
configurations of the artificial pancreas have been proposed: one
that infuses insulin (single-hormone) and one that infuses insulin
and glucagon (dual-hormone). We review two potential usages of
glucagon in the artificial pancreas: to reduce hypoglycemia and to
allow more aggressive insulin delivery, with discussion of the
potential benefits and drawbacks of each approach. We review
results from our inpatient and outpatient studies that assess the
ability of the dual-hormone artificial pancreas to reduce the risk of
hypoglycemia compared to the single-hormone artificial pancreas
and conventional pump therapy. Advances in novel insulin ana-
logs and non-insulin adjunctive therapies are also discussed in the
context of dual-hormone artificial pancreas systems.
024
AMYLIN PLUS INSULIN
S. Weinzimer1
1
Yale University School of Medicine, Pediatric Endocrinology,
New Haven, USA
Amylin is a naturally-occurring polypeptide co-secreted with
insulin from beta cells in response to food ingestion, and like
insulin, is deficient in people with type 1 diabetes (T1D). Amylin
improves post-prandial glucose control by inhibiting glucagon
ATTD 2017 INVITED SPEAKER ABSTRACTS
secretion, delaying gastric emptying, and inducing satiety.
Pramlintide, a synthetic amylin analog, is used as an adjunct to
insulin in the treatment of T1D and has been shown to effectively
lower A1c, primarily through blunting of post-prandial glycemic
excursions. Because most closed-loop (CL) insulin delivery
systems rely on manual meal bolusing to control post-prandial
glucose levels, we hypothesized that pramlintide may be an ef-
fective adjunctive therapy and eliminate the need for manual
insulin dosing during CL. In two studies of adolescents and
young adults with T1D, pre-meal injections of 30-60mcg doses
of pramlintide mitigated post-prandial glycemic excursions and
lowered overall mean glucose levels during CL control. These
improvements were achieved with lower insulin requirements,
due to the blunting of endogenous glucagon secretion after
meals. We conducted similar CL studies with adjunctive lir-
aglutide, a synthetic glucagon-like peptide-1 (GLP-1) receptor
agonist that also acts to suppress endogenous glucagon secretion,
and found comparable reductions in prandial glycemic excur-
sions and reduction in insulin requirements, although glucagon
suppression was inferior. Other groups have demonstrated that
exenatide, another synthetic GLP-1 agonist, may have even
greater suppression of endogenous glucagon during CL control.
Amylin and GLP-1 agonists show potential to mitigate prandial
glucose excursions during CL control but their effectiveness,
safety, and tolerability during longer ambulatory CL use needs
further characterization.
025
ISSUES RELATED TO INFUSION OF GLUCAGON
OR AMYLIN
R. Rabasa-Lhoret1
1
Institut de recherches cliniques de Montreal, Metabolic
diseases, Montreal, Canada
Single-hormone closed-loop systems using insulin only have
been shown to significantly improve overall glucose control. To
better reproduce physiology and bypass limitations of current
subcutaneous insulin pharmacokinetic and pharmacodynamics,
multi-hormonal closed-loop systems are under investigation.
Aims are to further improve mean glucose, reduce hyperglyce-
mic risk (by mainly targeting postprandial glucose excursions),
further reduce hypoglycemic and/or simplify meal insulin dos-
ing. Up to now, short-term data with two hormones have been
reported: 1) Glucagon has been shown to further reduce hypo-
glycemic risk and/or to allow more aggressive insulin infusion
without increasing the risk of hypoglycemia risk; 2) Pramlintide,
an amylin analogue, has been shown to improve postpran-
dial glucose excursions. Along with these significant potential
benefits, moving to multi-hormonal closed-loop systems raise
important challenges. By essence, these systems will be more
complex necessitating technological improvements (e.g. multi-
chamber pumps and specific algorithms), new indications (e.g.
glucagon for hypoglycemia prevention rather than to treat severe
hypoglycemia), and new pharmacological formulation (e.g.
stable glucagon). In addition, compliance issues will need to be
addressed if Pramlintide still needs to be injected subcutaneously
with a pen rather than with a pump. These hormones could by
themselves lead to additional costs, specific side effects (e.g.
nausea and vomiting with Pramlintide), and issues for hypogly-
cemia treatment or specific situations (e.g. glycogen depletion
with low carbohydrate diet). Though some data is available for
ATTD 2017 INVITED SPEAKER ABSTRACTS
Pramlintide, no long-term safety data is available for chronic
glucagon usage. Available data are reassuring but in order to
determine if such addition is worth, longer trials will have to
confirm benefits, investigate potential issues and finally assess
the risk-to-benefit ratio.
026
LACTOCOCCUS AS A DELIVERY SYSTEM
FOR IMMUNOTHERAPY
C. Mathieu1, C. Gysemans2
1
Laboratory and Clinic of Experimental Medicine and
Endocrinology, University Hospital Leuven- Catholic
University of Leuven, Leuven, Belgium
2
KULeuven, Experimental and clinical endocrinology, Leuven,
Belgium
Prevention of type 1 diabetes or arrest of the autoimmune
destruction of the beta-cell after onset of hyperglycemia remain
an elusive goal. Interventions with immune modulators have
proven to be able to arrest the progression of beta-cell destruction
for a short time, but despite doses being used at the edge of
acceptable side effects, like for anti-CD3 monoclonal antibodies,
no long lasting protection of the beta-cell was observed.
Combining immune modulation with antigen-specific tolerance
(re-)induction offers an attractive path for intervention.
The Lactococcus lactis (L. lactis) platform offers an elegant
tool to introduce beta cell auto-antigens in combination with
immune modulating agents like cytokines via the gut has been
demonstrated to be a promising approach for diabetes reversal in
NOD mice, when combined with a short course (5days) of low
doses of anti-CD3 antibodies. A combination of a 5 day course of
low-dose anti-CD3 with a 6 week treatment with clinical-grade
self-containing L. lactis appropriate for human application se-
creting human pro-insulin and IL10 cured 66% of new-onset
diabetic mice, comparable to plasmid-driven L. lactis. Initial
blood glucose concentrations (<350 mg/dl) and insulin autoan-
tibody positivity were predictors of stable reversal of hypergly-
cemia and decline in IAA positivity was an immune biomarker of
therapeutic outcome. Assessment of the immune changes in-
duced by the L. lactis-based therapy revealed elevated fre-
quencies of CD4+Foxp3+ T cells in the pancreatic draining
A-9
lymph nodes, pancreas, and peripheral blood of all treated mice,
independent of metabolic outcome. Neutralization of CTLA4
and TGF-b partially abrogated the suppressive function of
therapy-induced Tregs. Ablation or functional impairment of
Foxp3+ Tregs in vivo at start or stop of therapy impaired im-
mune tolerance, highlighting the dependence of the therapy-
induced tolerance in new-onset diabetic mice on the presence
and functionality of CD4+Foxp3+ T cells.
Other antigens have been introduced into the platform (GAD,
IA2) with similar results. Other cytokines have been introduced
as well, some of which allow the elimination of the anti-CD3
induction therapy.
027
ANTIGEN-BASED VACCINE THERAPY FOR T1D
M. Peakman1
1
Kings College London, London, United Kingdom
The main focus of my research has been the role of T lym-
phocytes in the aetiology of Type 1 diabetes, a chronic autoim-
mune disease. In particular, we have defined the critical targets
for T cells that appear to have a role in the destruction of insulin-
producing cells, and key immunological pathways through
which this damage is mediated. These findings represent the
fundamental breakdown in immunological self-tolerance that
underlies type 1 diabetes, and identify it as a major barrier to
preventive and curative therapies. Work in preclinical models
has highlighted the potential for restoration of tolerance through
various manipulations, including administration of antigens - so
called antigen-specific immunotherapy (ASI). ASI has given
mixed results in human trials to date, probably reflecting the
importance of selection of route of administration, timing and the
nature of the antigen. Work in our laboratory has led to the
definition of target antigenic peptides enabling the design of a
novel approach to ASI. This strategy, termed peptide immu-
notherapy is the first of its kind in diabetes. We have reported
proof-of-concept studies in different disease stages and further
phases of this programme are now progressing. In the future, a
better understanding of the role of the immune response in Type
1 diabetes will promote the further development of these novel
therapeutics into the clinical setting.
ATTD 2017 Oral Abstracts
028
REPLACE-BG: A RANDOMIZED TRIAL COMPARING
CONTINUOUS GLUCOSE MONITORING WITH
AND WITHOUT ROUTINE BLOOD GLUCOSE
MONITORING IN ADULTS WITH TYPE 1
DIABETES
G. Aleppo1, T. Riddlesworth2, R. Beck3, K. Ruedy3, E. Eyth4,
R. Bergenstal5
1
Northwestern University, Medicine Endocrinology,
Chicago, USA
2
Jaeb Center for Health Research, REPLACE-BG,
Tampa, USA
3
Jaeb Center for Health Research, REPLACE-BG Study,
Tampa, USA
4
University of South Florida, USF Diabetes Center,
Tampa, USA
5
International Diabetes Center Park Nicollet, Endocrinology,
Minneapolis, USA
Background and Aims: To determine whether the use of
continuous glucose monitoring (CGM) without confirmatory
blood glucose measurements (BGM) is as safe and effective
as using CGM as an adjunct to BGM in adults with type 1
diabetes (T1D).
Methods: Multicenter, randomized non-inferiority clinical
trial conducted by the T1D Exchange Clinic Network. Parti-
cipants were 25 years (mean 44 14 years), had T1D for 1
year (mean duration 24 12 years), were being treated with
an insulin pump, and had HbA1c 9.0% (mean 7.0 0.7%);
47% were CGM users and 53% were not using CGM when
enrolled. Each participant was randomly assigned 2:1 to ei-
ther the CGM-only (N = 149) or CGM+BGM Group (N = 77).
The primary outcome was time 70-180 mg/dl over the 6
months of the trial, with a pre-specified non-inferiority limit
of 7.5%.
Results: CGM use averaged 6.6 0.6 days/week in each
group over the 26 weeks of the trial. BGM tests/day (including
the 2 required daily BGM tests) averaged 2.8 0.8 in the CGM-
only Group and 5.4 1.4 in the CGM+BGM Group (P < 0.001).
Mean time 70-180 mg/dL was 63 13% at both baseline and 26
weeks in the CGM-only Group and 65 12% and 65 11%,
respectively in the CGM+BGM Group (adjusted difference = 0%;
one-sided 95% confidence interval 1%). Mean change in HbA1c
was 0.0% in each group (P = 0.40). One severe hypoglycemic
event occurred in the CGM+BGM Group and none in the CGM-
only Group.
Conclusions: Use of CGM without regular use of confirma-
tory BGM is as safe and effective as using CGM with BGM in
adults with T1D.
029
DETECTION OF UNANNOUNCED MEAL AND
ANOMALIES OF CONTINUOUS GLUCOSE MONITORS
USING SENSOR REDUNDANCY AND THE
UNSCENTED KALMAN FILTER
Z. Mahmoudi1, K. Nrgaard2, N. Kjlstad Poulsen1,
H. Madsen1, J. Bagterp Jrgensen1
1
Technical university of Denmark, Applied Mathematics
and Computer Science, Lyngby, Denmark
2
Copenhagen University Hospital Hvidovre, Department
of Endocrinology, Copenhagen, Denmark
Background and Aims: In an artificial pancreas (AP), it is
critically important to detect the faults of the continuous glucose
monitoring (CGM) sensor in order to e.g. avoid dosing insulin in
response to an erroneous high glucose signal. We developed a
method for detecting CGM anomalies as well as detecting un-
announced meals for the AP.
Methods: The module consists of two CGM sensors, two fault
detectors, a fault isolator, and an adaptive unscented Kalman filter
(UKF). Each of the fault detectors has a local UKF that works as a
residual generator. Each of the fault detectors detects drift and
compression artifacts associated with one of the sensors. When a
fault is detected, the fault detectors tune the noise covariance of the
adaptive UKF. By applying a set of rules on the filter-predicted
CGM measurements, the meal detector is a fault isolator differ-
entiating between a sensor fault and an unannounced meal.
Results: The drift detection sensitivity, specificity, and pre-
cision are 80.9%, 100.0%, and 100.0%, respectively. The sensi-
tivity, specificity, and precision of detecting compression artifacts
are 63.2%, 99.2%, and 95.2%, respectively. The fault detectors
detect 100% of the simulated drifts and 97% of the compression
artifacts. The fault isolator detects 100% of the unannounced
meals, without any false positive. The average change in glucose
between the meals and detection points is 62.8 [mg/dL].
Conclusions: The adaptive UKF compensates the effect
of drift and compression artifact on the CGM data, and
compared to a non-adaptive UKF, reduces the deviation of
the CGM measurements from their paired blood glucose
concentrations.
A-10
ATTD 2017 ORAL ABSTRACTS
030
PATIENTS WITH TYPE 2 DIABETES USING
MULTIPLE DAILY INSULIN INJECTIONS HAVE
HIGH ADHERENCE AND BENEFIT FROM CGM: A
PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL
R. Bergenstal1, T. Riddlesworth2, K. Ruedy2, C. Kollman2,
D. Price3, R. Beck2
1
Park Nicollet Institute - International Diabetes Center, n/a,
St. Louis Park, USA
2
Jaeb Center for Health Research, n/a, Tampa, USA
3
Dexcom Inc., n/a, San Diego, USA
Background and Aims: To determine the effectiveness of
CGM in adults with type 2 diabetes (T2D) using multiple daily
injections (MDI)
Methods: In a randomized trial conducted at 25 clinics in the
US and Canada, 158 adults (mean age 60 + 10, range 35-79 years)
with T2D (mean duration 18 + 9 years) using MDI and with
HbA1c 7.5%-9.9% (mean 8.5% +0.6%) were randomly assigned
to CGM (Dexcom G4 Platinum CGM System with software
505, N = 79) or Control Group, N = 79. The primary outcome was
HbA1c at 24 weeks.
Results: Mean HbA1c decreased from 8.5 + 0.6% at baseline to
7.7 + 0.7% at 24 weeks in the CGM Group and from 8.5 + 0.7% to
8.0 + 0.9% in the Control Group (adjusted difference = -0.3%, 95%
confidence interval -0.5% to -0.0%, P = 0.02). The CGM Group
averaged 6.7 + 0.9 days/week of CGM use and reported a high degree
of satisfaction with CGM. Benefits were similar across age groups,
educational level, and numeracy skills. There was minimal hypo-
glycemia at baseline and during the study. Mean CGM-measured
time in the range (TIR) of 70-180 mg/dL increased by about an hour
more per day in the CGM Group than the Control Group.
Conclusions: A high percentage of adults with T2D being
treated with MDI used CGM on a daily or near-daily basis for
24 weeks with a high degree of satisfaction and a significant
reduction in HbA1c and increased TIR compared with the con-
trol group. Since few MDI-treated patients with T2D currently
are using CGM, the study results support an additional man-
agement modality that may be beneficial for these patients.
031
BETTER OUTCOMES IN TYPE 2 DIABETES
MANAGEMENT WITH A USER FRIENDLY FLASH
GLUCOSE MONITORING SYSTEM: FREESTYLE
LIBRE PRO
J. Kesavadev1, G. Krishnan1, B. Saboo2, A. Shankar1,
A.D. Ashok1, G. Sanal1, L. Ramachandran1, S. Jothydev1
1 J. Bolinder1, R. Antuna2, P. Geelhoed-Duijvestijn33,
Jothydevs Diabetes Research Centre, Diabetes,
Thiruvanathapuram, India
2 1
Dia Care & Hormone Clinic, Diabetes, Ahmedabad, India
Background and Aims: Continuous Glucose Monitoring
(CGM) provides more distinct glycaemic patterns thereby al-
lowing appropriate therapeutic interventions to pursue glycaemic
targets safely. FreeStyle Libre Pro (FSLP) Flash Glucose Mon-
itoring (FGM) was launched in India with several unique fea-
tures over CGM. With an intention to reach better glycemic goals,
T2DM patients were deployed FSLP sensor for 14 days and im-
provements in HbA1C, FBS and BMI were assessed.
A-11
Methods: FSLP-FGM was done in T2DM patients (n = 388,
Age = 55.42 13.05 yrs., Diabetes duration- 14.17 8.37 yrs.,
70.62 % Male, 29.38 % Female). Our multi-disciplinary team
analysed the Ambulatory Glucose Profiles (AGP) generated by
FSLP and advised patients on therapeutic and lifestyle inter-
ventions. Improvements in health status in terms of HbA1C, BMI
and FBS after 6 months of undergoing FSLP- FGM were eval-
uated by comparing them to previously reported values.
Results: A mean wear time of 12.69 2.53 days was achieved
with FSLP. Statistically significant reductions in HbA1C
(p < 0.0001), FBS (p < 0.0001) and BMI (p = 0.0226) levels
(Figure 1) were noted among patients after 6 months of un-
dergoing FSLP-FGM.
Conclusions: FSLP generated collated AGP visualizes ac-
tual glycemic exposure patterns beyond HbA1c, discloses
persistent and significant hypo- and/or hyperglycemia, as well
as considerable glycemic variability. It also increases the fea-
sibility of a productive interactive session among patients and
health management team which facilitates better treatment
outcomes.Newer technologies with advantages such as pre-
calibrated mode which avoids frequent finger-pricks, increased
wear time, larger volume of data available for analysis, lower
MARD etc. are likely to eventually replace glucosemeters and
conventional CGMs.
032
NOVEL FLASH GLUCOSE-SENSING TECHNOLOGY
REDUCES HYPOGLYCAEMIA IN INDIVIDUALS
WITH TYPE 1 DIABETES USING MULTIPLE DAILY
INJECTIONS (MDI)
J. Kroeger4, R. Weitgasser5
Karolinska Universitetssjukhuset, Department of Medicine,
Stockholm, Sweden
2
Clinica Diabetologica, Department of Medicine, Gijon, Spain
3
Medisch Centrum Haaglanden, Department of Diabetes and
Endocrinology, Den Haag, The Netherlands
4
Zentrum fur Diabetologie Hamburg Bergedorf, Department
of Diabetes, Hamburg, Germany
5
Wehrle-Diakonissen-Krankenhaus and Paracelsus
Medizinische Privatuniversitat, Department of Medicine,
Salzburg, Austria
A-12
Background and Aims: The effectiveness of FreeStyle
LibreTM Flash Glucose Monitoring System in patients with type
1 diabetes (T1DM) using MDI has not been documented. In this
subgroup analysis of MDI users in the IMPACT trial, we as-
sessed its impact on hypoglycaemia compared to conventional
self-monitoring of blood glucose (SMBG).
Methods: 161 patients with well-controlled T1DM, (HbA1c
50.3 6.3 mmol/mol (meanSD) [6.76 0.58%]), age 43 13.1
years and duration of diabetes 21 10 years) using MDI were
randomised to the intervention group (FreeStyle Libre; n = 81) or
to the control group (SMBG; n = 80).
Results: After 6 months, those using FreeStyle Libre signifi-
cantly reduced time in hypoglycaemia (<3.9 mmol/L [70 mg/dL])
by 46.0% vs. control (meanSE: -1.65 0.283 hours per day;
p < 0.0001). Time <2.2 mmol/L (40 mg/dL) was reduced by
65.6%; (p = 0.0012). The proportion of patients who achieved
1 hour per day in hypoglycaemia (<3.9 mmol/L) was signifi-
cantly higher for those using FreeStyle Libre vs. control; 33.3%
vs. 10.0%, p = 0.0005.
Time in range (3.9-10.0 mmol/L [70-180 mg/dL]) signifi-
cantly improved by 0.9 0.37 hours per day (meanSE);
p = 0.0106 vs. control. There was no change in HbA1c.
Using FreeStyle Libre, scanning frequency at 6 months av-
eraged 14.7 per day, whereas SMBG tests dropped from a me-
dian of 5.4 (baseline) to 0.1 per day. In the controls, SMBG tests
were 5.1 per day at 6 months.
Treatment satisfaction (DTSQ/DQoL) and perception of
hypo- and hyperglycaemia (DTSQ) were significantly improved.
Conclusions: Well-controlled T1DM patients using FreeStyle
Libre with MDI significantly reduced time in hypoglycaemia
without deterioration of HbA1c, and reported improvements in
treatment satisfaction.
033
CLINICAL UPDATE WITH A LONG TERM,
UNOBTRUSIVE, FULLY-IMPLANTED CONTINUOUS
GLUCOSE MONITORING SYSTEM
J. Lucisano1, L. Kurbanyan1, S. Martha1, T. Routh1
1
GlySens Incorporated, Technology Development,
San Diego, USA
Background and Aims: Recent investigational human ex-
perience with a second generation long term fully-implanted (no
skin-attached elements) continuous glucose monitoring system
(the GlySens Eclipse ICGM System) includes sensor im-
plantations in five new adult human subjects, as well as same-
pocket re-implantations with new sensors in six adult human
subjects following completion of a 12-month initial implant
period.
Methods: The Eclipse ICGM system is implanted in a
minor outpatient surgical procedure utilizing local anesthesia.
Following sensor implantation, study subjects self-monitor blood
glucose four times per day via finger stick glucose meter and
undergo monthly clinic visits that include meal-based glucose
excursions with YSI plasma glucose comparison measurements.
Some subjects also utilize a Dexcom G4 CGM to provide ad-
ditional paired values. Monthly subject interviews including a
standardized survey questionnaire are conducted to assess tol-
erance of the device.
Results: All implantations were completed successfully and
no significant sensor-adherent capsular tissue was observed
ATTD 2017 ORAL ABSTRACTS
during explantations. Early performance measures indicate
same-pocket re-implantations may be feasible for sensor re-
placement/renewal.
Conclusions: Use of the fully-implanted ICGM Sensor re-
quires an annual user decision (whether to implant/re-implant or
not) and an occasional decision to recalibrate; no body-worn
components or other regular user intervention is required to re-
ceive glucose readings. This combination of features offers
minimal barriers for adherence to treatment modalities requiring
continuous glucose monitoring.
CAUTION - Investigational Device. Limited by United States
law to investigational use. Eclipse is a trademark of GlySens
Incorporated. GlySens and ICGM are trademarks of GlySens
Incorporated registered in the U.S. Patent and Trademark Office.
034
EVIDENCE OF A STRONG ASSOCIATION BETWEEN
FREQUENCY OF FLASH GLUCOSE MONITORING
AND GLUCOSE CONTROL MEASURES DURING
REAL-WORLD USAGE
T. Dunn1, Y. Xu1, G. Hayter2
1
Abbott Diabetes Care, Clinical Affairs, Alameda, USA
2
Abbott Diabetes Care, Research and Development,
Alameda, USA
Background and Aims: The aim was to evaluate association
of the real-world scanning with flash glucose monitoring (Free-
Style Libre) and glucose control measures. FreeStyle Libre is a
sensor-based glucose monitor, and the reader scans the sensor to
collect the current glucose and glucose trend, along with up to
8 hours of glucose readings automatically stored every 15 min-
utes. When connected to the PC-based software with an active
internet connection, the readers 90-day memory is de-identified
and uploaded to a database.
Methods: For analysis, sensors were required to have at least
120 hours of operation, and all sensors were grouped per reader,
resulting in 50,831 readers with 279,446 sensors (86.4 million
monitoring hours by 63.8 million scans). Twenty equally-sized
groups by scan rate were analyzed (n = 2,542 each).
Results: Users performed an average of 16.3 scans per day
(median:14, interquartile range: 10-20). Estimated HbA1c re-
duced (p < 0.001) as scan rate increased, from 8.0% to 6.7% from
the lowest (mean 4.4 scans/day) to highest (mean 48.1 scans/day)
ATTD 2017 ORAL ABSTRACTS
groups, while simultaneously time below 70, 55 and 45 mg/dL
decreased by 15%, 40% and 49%, respectively (all p < 0.001).
Time above 180 mg/dL decreased from 10.4 to 5.7 h/day (44%,
p < 0.001), and time in range 70-180 mg/dL increased from 12.0
to 16.8 h/day (40%, p < 0.001).
Conclusions: In real-world use, higher rates of scanning to self-
monitor glucose were found to strongly associate with improved
glucose measures, including decreased mean glucose and time in
hyper- and hypoglycemia as well as increased time in range.
035
EFFICACY OF CONTINUOUS GLUCOSE
MONITORING IN DIABETIC PREGNANCY:
THE GLUCOMOMS TRIAL
D. Voormolen1
1 significant reduction in mean (SD) HFS-II score from baseline to
UMC Utrecht, obstetrics, Utrecht, The Netherlands
Background and Aims: Hyperglycemia in pregnancy is as-
sociated with poor neonatal outcome. Glycemic control is tra-
ditionally monitored with self-measured glucoseprofiles and
periodical HbA1c measures. We investigated the efficacy of
Continuous Glucose Monitoring (CGM) in diabetic pregnancies.
Methods: In a multicenter open label randomized controlled
trial, pregnant women >18 years with diabetes type 1, type 2 on
insulin therapy (gestational age (GA) <16 weeks) or insulin depen-
dent gestational diabetes (GA <30 weeks) were randomly allocated
to intermittent use of retrospective CGM for 5-7 days every six
weeks Glycemic control was monitored by day-curves and HbA1c
checks. Macrosomia (birthweight >90th percentile), was the primary
outcome. Secondary outcomes were glycemic control, maternal and
neonatal complications. Primary analyses were according to inten-
tion to treat, while a secondary per-protocol analysis was limited to
women using the CGM at least once every trimester.
Results: Between July 2011 and September 2015, we ran-
domized 304 women (109 type 1, 83 type 2, 112 gestational
diabetes), 150 to CGM and 154 to conventional treatment. The
incidence of macrosomia was 29% in both the intervention and
control group (RR .99, 95%CI .76-1.28). No difference was
observed in the per protocol analysis (66% of total population,
RR 1.00, 95%CI .70-1.42). Glycemic control in terms of HbA1c
measures throughout pregnancy are presented in figure 1 and
other outcomes in the table. Preeclampsia was less common in
the CGM group, while otherwise no differences were seen on
maternal and neonatal outcomes.
Conclusions: Intermittent CGM use in diabetic pregnancy
does not reduce the incidence of macrosomia.
036
IMPACT OF REAL-TIME CONTINUOUS GLUCOSE
MONITORING AND INTERMITTENT GLUCOSE DATA
ON HYPOGLYCAEMIA FEAR IN ADULTS WITH
IMPAIRED AWARENESS OF HYPOGLYCAEMIA
AND TYPE 1 DIABETES
N. Jugnee1, M. Reddy1, S. Anantharaja1, N. Oliver1,
E. Spanudakis1
1
Imperial College London, Department of Medicine- Diabetes-
Endocrinology and Metabolism division, LONDON, United
Kingdom
A-13
Background and Aims: We aimed to evaluate the impact of
real-time continuous glucose monitoring (RT-CGM, Dexcom G5)
and intermittent flash glucose monitoring (Abbott Freestyle Libre)
on diabetes-related emotional distress and fear of hypoglycaemia,
using the Problem Area in Diabetes (PAID) and Hypoglycaemia
Fear Survey-II (HFS-II) questionnaires respectively, in adults with
type 1 diabetes (T1D) and impaired awareness of hypoglycaemia
(IAH).
Methods: This is a prospective randomized parallel group
study. Participants were randomized to either Libre or G5 for 8
weeks after two weeks run-in with blinded CGM. They were
asked to complete the PAID (score range 0-100, higher score is
worse) and HFS-II (range 0-132, higher score is worse) at
baseline and endpoint.
Results: 32 adults with T1D on multiple daily injections of
insulin and IAH (Gold score 4) have completed the study (66%
male, mean (SD) age 50 (15) years, diabetes duration 29 (12)
years, Gold score 4.7 (1), HbA1c 58 (11) mmol/mol). There was
endpoint with G5 (52.7(22.5) vs 47.3 (25.3), p = 0.03) compared
to Libre (52.1(24.5) vs 50.8 (28.1), p = 0.7). There was no sig-
nificant change in PAID score from baseline to 8 weeks with
either G5 (27.9 (19) vs 27.1 (16.5), p = 0.7) or Libre (29.9 (20.3)
vs 27.2 (20.2), p = 0.2). The HbA1c improved significantly in
both groups.
Conclusions: Our preliminary data suggest that real-time
CGM has a significantly greater benefit compared to intermittent
flash glucose monitoring in reducing fear of hypoglycaemia in
this high risk T1D population group.
037
HYBRID CLOSED-LOOP (HCL) THERAPY IN
ADOLESCENTS AND YOUNG ADULTS WITH TYPE 1
DIABETES (T1D) INCREASES TIME IN RANGE
L. Messer1, G. Forlenza1, R.P. Wadwa1, E. Westfall1, E. Jost1,
G.T. Alonso1, D. Maahs2, R. Slover1
1
Barbara Davis Center for Childhood Diabetes, University
of Colorado, Denver, USA
2
Stanford University School of Medicine, Department
of Pediatric Endocrinology, Stanford, USA
Background and Aims: Changes in total daily insulin dose
(TDD) and use patterns of the Medtronic HCL system in ado-
lescents and young adults, during a 3-month outpatient trial are
described.
Methods: Twelve subjects with T1D, aged 14-21 years, wore a
Medtronic MiniMed 670G pump and Guardian Sensor 3 for
7 days in open loop mode, and 3 months in auto mode (HCL with
manual meal boluses). Remaining in auto mode required blood
glucose calibrations and avoidance of prolonged hypoglycemia
A-14 ATTD 2017 ORAL ABSTRACTS

and hyperglycemia. Data were analyzed for patterns of use and Results: The proposed methods are able to estimate the PIC
changes in TDD from baseline to trial conclusion. in real time by using only CGM measurements and infused
Results: TDD did not significantly change from baseline to insulin data.
end of trial (p = 0.47), however insulin-to-carbohydrate (I:C) Conclusions: These methods will be beneficial for an AP
ratios were significantly more aggressive after 3 months of auto system in terms of real-time estimation of PIC for preventing
mode. Time in range (70-180 mg/dl) increased during auto excessive insulin infusions if plasma insulin levels indicate
mode (p = 0.01), however not when the system was operating in insulin-on-board.
open loop (p = 0.91). Mean time in auto mode decreased sig-
nificantly from the first two weeks of use (86 11%) to the final
2 weeks of use (72 21%) (p = 0.01), however there were no
differences in number of events triggering the system to exit 039
auto mode (p = 0.96), including hypoglycemia and calibration VARIABILITY OF AUTOMATED NIGHTTIME
alerts. INSULIN DELIVERY AND GLUCOSE LEVELS
Conclusions: Increased time in range was achieved with HCL
compared with open loop without changing TDD in adolescents/ A. Roy1, B. Grosman1, N. Parikh1, D. Wu1, N. Kurtz1, R. Brazg2,
young adults. More aggressive I:C ratios were required during R. Slover3, S. Garg4, J. Ilany5, B. Bode6, B. Buckingham7,
HCL. Decreased time spent in auto mode during the study re- S. Weinzimer8, S. Anderson9, T. Bailey10, R. Bergenstal11,
quires further evaluation to optimize patient outcomes. F. Kaufman12
1
Medtronic Diabetes, R&D, Northridge, USA
2
Rainer Clinical Research Center, Metabolism and
Endocrinology, Renton, USA
038 3
Barbara Davis Center for Childhood Diabetes, Pediatric
REAL-TIME PLASMA INSULIN ESTIMATION Diabetes, Aurora, USA
4
USING CONTINUOUS SUBCUTANEOUS GLUCOSE Barbara Davis Center for Childhood Diabetes, Adult Diabetes,
MEASUREMENTS FOR AN ARTIFICIAL PANCREAS Aurora, USA
5
SYSTEM Institute of Endocrinology- Sheba Medical Center,
Endocrinology, Tel Hashomer, Israel
A. Cinar1, I. Hajizadeh1, K. Turksoy2, S. Samadi1, J. Feng1, 6
Atlanta Diabetes Associates, Endocrinology & Metabolism,
M. Sevil2, N. Frantz2, C. Lazaro Martinez3, Z. Mahoney2, Atlanta, USA
E. Cengiz4 7
Stanford University, Pediatric Endocrinology, Stanford, USA
8
1 Yale University School of Medicine, Pediatric Endocrinology,
Illinois Institute of Technology, Chemical and Biological
New Haven, USA
Engineering, Chicago, USA 9
2 UVA Center for Diabetes Technology, Endocrinology and
Illinois Institute of Technology, Biomedical Engineering,
Metabolism, Charlottesville, USA
Chicago, USA 10
3 AMCR Institute, Advanced Metabolic Care Research,
Illinois Institute of Technology, Electrical and Computer
Escondido, USA
Engineering, Chicago, USA 11
4 Park Nicollet Clinic-International Diabetes Center,
Yale University, Division of Pediatric Endocrinology,
International Diabetes Center, Minneapolis, USA
New Haven, USA 12
Medtronic Diabetes, Global Medical- Clinical & Health
Affairs, Northridge, USA
Background and Aims: Artificial pancreas (AP) systems
use CGM data to calculate the optimum amount of insulin to be
Background and Aims: The MiniMed 670G hybrid closed-
infused with an insulin pump for regulating blood glucose
loop (HCL) system was shown to be safe and effective in a multi-
concentration. Real-time plasma insulin concentration (PIC)
center pivotal trial conducted with 124 type 1 diabetes patients.
estimations would be beneficial for increasing the accuracy of
The algorithm calculates a patient-specific maximum insulin
AP control algorithms to calculate more realistic insulin in-
delivery rate daily.
fusion rates and prevent hypoglycemia caused by overdosing
of insulin. Our objective is to fulfill a real-time PIC estimation
from CGM data using different mathematical models and es-
timation techniques.
Methods: Two different glucose-insulin compartmental mod-
els, Hovorkas model and extended Bergmans minimal model,
which were developed to describe glucose-insulin dynamic in
different parts of the human body, have been incorporated into
different estimation techniques namely, continuous-discrete ex-
tended Kalman filtering, unscented Kalman filtering, and moving
horizon estimation, to provide an estimate of PIC. Furthermore,
because of variability in system dynamics, some uncertain pa-
rameters have been considered as new states in the compartmental
models to be estimated by the estimators. Partial least squares
models are developed for the initial guess of the time-varying un-
known model parameters used in the estimators. Thirteen datasets
from nine different subjects with T1D are used. The study was
conducted in adolescents with T1D who attended the Yale Chil-
drens Diabetes Clinic (New Haven, CT).
ATTD 2017 ORAL ABSTRACTS
Methods: A 2-week run-in phase was followed by a 3-month
at-home study phase of HCL. Sensor glucose (SG) data and the
amount of insulin delivered was analyzed during the overnight
period (10:00pm7:00am).
Results: The top panel of Figure-1. represents overnight
SG tracings from the run-in (gray-patch) and the study phases
(red- patch). The inter-quartile range (IQR) reduced signifi-
cantly comparing the run-in and study phases (71 versus
37mg/dL, at 7:00am). This was mostly achieved by trans-
ferring the variability from glucose levels to the insulin in-
fusion rate (bottom panel of Figure-1). The maximum IQR of
insulin delivered by the algorithm increased by *3 fold
compared to the pre-set basal rates (0.55 versus 1.58 units/hr).
The nightly variation of insulin delivery by the HCL system is
further demonstrated in Figure-2. During the nighttime, the
system suspended insulin a mean of 100 minutes and deliv-
ered insulin at the maximum limit a mean of 175 minutes. For
the remainder of 265 minutes, it delivered insulin between
1 99% of the maximum limit.
Conclusions: The greater variability of automated insulin
delivery, such as that achieved with the HCL algorithm com-
pared to pre-set basal rates, improves glucose control during the
night. The value of the HCL system is its ability to transfer
variability from glucose to insulin.
040
DELTA A1C IN THE PIVOTAL TRIAL
EVALUATING MEDTRONICS HYBRID
CLOSED-LOOP SYSTEM
A. Roy1, B. Grosman1, N. Parikh1, D. Wu1, N. Kurtz1,
R. Slover2, S. Garg2, J. Ilany3, B. Bode4, B. Buckingham5,
S. Weinzimer6, S. Anderson7, T. Bailey8, R. Bergenstal9,
F. Kaufman10
1
Medtronic Diabetes, R&D, Northridge, USA
2
Barbara Davis Center for Childhood Diabetes, Pediatric
Diabetes, Aurora, USA
3
Institute of Endocrinology, Sheba Medical Center,
Endocrinology, Tel Hashomer, Israel
A-15
4
Atlanta Diabetes Associates, Endocrinology & Metabolism,
Atlanta, USA
5
Stanford University, Pediatric Endocrinology, Stanford,
USA
6
Yale University School of Medicine, Pediatric Endocrinology,
New Haven, USA
7
UVA Center for Diabetes Technology, Endocrinology and
Metabolism, Charlottesville, USA
8
AMCR Institute, Advanced Metabolic Care Research,
Escondido, USA
9
Park Nicollet Clinic-International, International Diabetes
Center, Minneapolis, USA
10
Medtronic Diabetes, Clinical Affairs, Northridge, USA
Background and Aims: Medtronics hybrid closed-loop
(HCL) system was evaluated in a 10-center, at-home pivotal trial.
The system was designed to automatically adjust basal insulin
delivery every 5 minutes based on sensor glucose values. The
system included the MiniMed 670G pump, Guardian Sensor
3, and a control algorithm. Patients needed to calibrate the sen-
sor, enter mealtime carbohydrate estimates, and notify the sys-
tem of exercise.
Methods: During the 2-week run-in phase, the system was
used in manual mode (open-loop). During the 3-month at-home
study phase, subjects enabled the auto-mode (closed-loop) fea-
ture. A total of 124 type 1 diabetes patients (age range 14 75yrs)
with A1C <10% were studied.
Results: The HCL system was used for 12,389 patient-days
with no severe hypoglycemia or DKA. Mean glycated hemo-
globin (A1C) was 7.4 0.9% at run-in and 6.9 0.6% at study
end. A linear fit of the delta A1C (end of study A1C minus
baseline A1C), as shown in the figure (red dashed line), indicates
that subjects experienced a drop in A1C levels if the initial A1C
was >6.4%. A Pearsons correlation coefficient also shows a
significant inverse correlation between initial and delta A1Cs
(R = -0.75), demonstrating a larger drop in A1C levels for pa-
tients with higher initial A1C. 88% of subjects with initial A1C
>7.0%, experienced a drop in their A1C levels by the end of the
study.
Conclusions: The HCL system was safe for unsupervised at-
home use by adults and adolescents. The system resulted in a
significant decrease in A1C levels, especially when the initial
A1C was >7.0%.
A-16
041
ONE WEEKEND ON HYBRID-CLOSED-LOOP (HCL):
THE DREAM5-STUDY
T. Biester1, I. Muller2, K. Remus1, S. Blasig1, E. Atlas2,
R. Nimri3, K. Dovc4, N. Bratina4, T. Battelino4, M. Philip3,
O. Kordonouri1, T. Danne1
1 Sheba Medical Center, Institute of Endocrinology, Tel
Kinder- und Jugendkrankenhaus AUF DER BULT, Diabetes
Center for Children and Adolescents, Hannover, Germany
2
DreaMed Diabetes Ltd., DreaMed Diabetes Ltd., Petach
Tikvah, Israel
3
Schneider Childrens Medical Center of Israel, The Jesse Z
and Sara Lea Shafer Institute for Endocrinology and Diabetes,
Petah Tikvah, Israel
4
Ljubljana University Medical Centre, Department of
Endocrinology- Diabetes and Metabolism, Ljubljana, Slovenia
Background and Aims: Previous DREAM studies showed
the safety of the CE-marked closed loop (DreaMed Substance
Administration System) in overnight use (1 night, adolescents)
at a Camp and at home (4 nights, all age groups). The objective of
the present study was to evaluate the system for a 60 hours con-
tinuous use, weekend time at home, without remote monitoring.
Methods: Subjects were randomized to one weekend with
sensor-augmented pump therapy (SAP) or HCL: respectively in a
crossover study. In the intervention arm only the amount of
carbohydrate was entered into the bolus calculator, automated
insulin dosing was guided wirelessly by a tablet computer.
Primary endpoint was the percentage of glucose values be-
tween 70-180 mg/dl.
Results: 5 adults, 5 adolescents, 5 children (10f, 5m) experi-
enced in sensor use were included: (median, [IQR]): age 16.8y
[12.9-18.5], diabetes duration 10.66y [7.1-13.8], pump use 10.7y
[5.3-12.6], HbA1c 7.6% [7.2-8.2].HCL lead to improved mean
glucose: 173 57 mg/dl vs. 150 47 mg/dl, SAP vs. HCL,
p = 0.021 and increased.
percentage of time in 70-180 mg/dl : 50.2% vs. 71.2% SAP vs.
HCL, p = 0.006.
Overall 11 events <60 mg/dl in SAP- and 12 in HCL-use oc-
curred. No events of ketosis or severe hypoglycemia were observed.
Conclusions: The results confirm the security of this HCL in
an around-the-clock setting. The system is safe and efficacious
both in the administration of automated correction doses and in
prevention of hypoglycemia.
The lack of a remote monitoring did not lead to a worsening of
results or emerging dangerous events.
042
DYNAMIC INSULIN DELIVERY RATE AT NIGHTTIME
R. Slover1, R. Brazg2, T. Bailey3, B. Bode4, I. Jacob5,
B. Buckingham6, S. Anderson7, S. Garg8, S. Weinzimer9,
R. Bergenstal10, J. Shin11, S. Huang11, T. Cordero12,
F. Kaufman13
ATTD 2017 ORAL ABSTRACTS
1
University of Colorado Denver, Barbara Davis Center for
Childhood Diabetes, Aurora, USA
2
Rainier Clinical Research Center, Rainier Clinical Research
Center, Renton, USA
3
AMCR Institute, AMCR Institute, Escondido, USA
4
Atlanta Diabetes Associates, Endocrinology & Metabolism,
Atlanta, USA
5
Hashomer, Israel
6
Stanford University, Department of Pediatric Endocrinology,
Stanford, USA
7
UVA Center for Diabetes Technology, UVA Center for
Diabetes Technology, Charlottesville, USA
8
University of Colorado Denver, Barbara Davis Center for
Diabetes, Aurora, USA
9
Yale University School of Medicine, Pediatric Endocrinology,
New Haven, USA
10
International Diabetes Center, Park Nicollet Clinic,
Minneapolis, USA
11
Medtronic Diabetes, Clinical Research, Northridge, USA
12
Medtronic Diabetes, Medical Affairs, Northridge, USA
13
Medtronic Diabetes, Clinical and Medical Affairs,
Northridge, USA
Background and Aims: At-home use of the MiniMed
hybrid closed-loop (HCL) system on A1c levels, glycemia
and glucose variability in adolescent and adult subjects with
type 1 diabetes (T1D) has been previously reported. The effect
of this system on nighttime (10:00pm-7:00pm) insulin delivery
and sensor glucose (SG) time-in-range of 70-180 mg/dL were
evaluated.
Methods: After a 2-week run-in period (HCL not enabled),
30 adolescents (14-21 years) and 94 adults (22-75 years) with
T1D used the system with HCL enabled, for a 3-month at-
home study phase. Relative to the pre-set basal insulin de-
livery rates during run-in, the enabled HCL system allowed a
variable basal insulin delivery rate ranging from 0 units to a
daily individualized insulin limit that could be delivered every
5 minutes.
Results: The table shows the mean nighttime insulin delivered,
two measures of variability of nighttime insulin delivery (stan-
dard deviation (SD) and coefficient of variation (CV)), and SG
percentage of time in-target range (70-180mg/dL) during the run-
in and study phase; for all subjects, adolescents and adults. While
mean nighttime insulin delivered between the run-in and study
phase increased, it was not significant for either group. However,
there was a significant increase in the variability of insulin de-
livery between the run-in and the study phase, in addition to an
increase in the percentage of time in-target range during the study
phase.
Conclusions: The dynamic insulin delivery rate, available
with the MiniMed 670G system, may partly contribute to im-
proved nighttime SG, suggesting that patients with sub-optimally
controlled glycemia should benefit from this hybrid closed-loop
system.
ATTD 2017 ORAL ABSTRACTS
043
ORCHESTRA REGISTRY: A MULTICENTER
OBSERVATIONAL STUDY ON THE USE OF CSII/SAP
THERAPY BEFORE AND DURING PREGNANCY IN
WOMEN WITH TYPE 1 DIABETES MELLITUS IN
POLAND
K. Cyganek1, J. Sieradzki2, K. Cypryk3, E. Wender-O_zegowska4,
B. Telejko5, S. Runzis6, J. Shin7, K. Skoczylas8
1 CHU NANCY, Service de Diabetologie, NANCY, France
The University Hospital in Cracow, Department of Metabolic
Diseases, Cracow, Poland
2
Jagiellonian University of Cracow, Collegium Medicum,
Cracow, Poland
3
Medical University of Lodz, Diabetology and Metabolic
Diseases Department, Medical University of Lodz, Lodz, Poland
4
Poznan University of Medical Sciences-, Department of
Reproduction, Poznan, Poland
5
Medical University of Bialystok, Department of
Endocrinology, Diabetology and Internal Medicine Diseases,
Bialystok, Poland
6
Medtronic, Tolochenaz, Switzerland
7
Medtronic, Clinical Research, Northridge, CA, USA
8
Medtronic, Clinical Department, Warsaw, Poland
Background and Aims: The ORCHESTRA Registry study is
a multi-center, prospective, observational, post-market study
investigating the use of insulin pump therapy (Continuous Sub-
cutaneous Insulin Infusion, CSII) alone or incorporating sensor-
augmented therapy (SAP) before and during the pregnancy in
women with type 1 diabetes mellitus.
Methods: The study is conducted in 24 centers in Poland and
included total of 499 women. The aim is to follow up 100 women
from preconception phase and second group is observing already
pregnant women. Each participant is contributing data for up to 22
months (up to 12 months preconception, throughout pregnancy, and
6 weeks after delivery): pregnant women can be enrolled up to the
16th week of pregnancy, while patient in the planning group have up
to 1 year to conceive. Data are collected during routine follow-up
visits. Maternal outcomes include HbA1c before and during preg-
nancy, serious adverse events and neonatal outcomes will be eval-
uated for both groups. The CSII devices used in the study are the
Medtronic Paradigm REAL-time (722) insulin pump, including
the sensor augmented Paradigm Veo (754) system (insulin
pump plus Enlite sensor plus MiniLink transmitter).
Results: The enrollment started in May 2013 and was com-
pleted in December 2015, and to date 221 and 60 patients de-
livered from pregnancy group and planning group respectively.
Last patient will complete the study in September 2017.
Conclusions: The Orchestra Registry offers the opportunity to
describe pregnancy outcomes according to the use of CSII with
or without CGM either before or during pregnancy.
044
DIABELOOP CLOSED-LOOP DOES BETTER THAN
SENSOR-AUGMENTED-PUMP ON BLOOD GLUCOSE
DURING 3 DAYS WITH INTENSIVE PHYSICAL
EXERCISES: A RANDOMIZED CROSSOVER TRIAL
S. Franc1,2, S. Borot3, P.Y. Benhamou4, M. Doron5, B. Guerci6,
H. Hanaire7, E. Huneker8, N. Jeandidier9, E. Renard10,
Y. Reznik11, I. Xhaard1, A. Penfornis2, G. Charpentier1,2,
P. Schaepelynck12
A-17
1
CERITD, Research, EVRY, France
2
CHSF, Service dendocrinologie, CORBEIL ESSONNES,
France
3
CHU BESANCON, Service dEndocrinologie-Metabolisme
et Diabetologie-Nutrition, BESANCON, France
4
CHU GRENOBLE, Pole DigiDune - Endocrinologie
Diabetologie, GRENOBLE, France
5
CEA_Leti- technology research institute, Micro Technologies
Department for Biology and Health, GRENOBLE, France
6
7
CHU TOULOUSE, Service de Diabetologie- Maladies
metaboliques et Nutrition, TOULOUSE, France
8
DIABELOOP SAS, Industrial development, GRENOBLE,
France
9
CHU STRASBOURG, Service dEndocrinologie- Diabete
et des maladies de la Nutrition, STRASBOURG, France
10
CHU MONTPELLIER, Service des maladies endocriniennes,
MONTPELLIER, France
11
CAEN, Service dEndocrinologie, CAEN, France
12
Hopital de la conception AP-HM, Service de Nutrition-
Endocrinologie-Maladies Metaboliques, MARSEILLE, France
Background and Aims: Controlling BG after intensive
physical exercises (PE) is an issue in type-1-diabetes because
of an increased risk of immediate and delayed nocturnal hy-
poglycemia. Diabeloop is a Closed-loop (CL) system with a
MPC algorithm reinforced by a decisional matrix, uploaded
on an android smartphone linked to Dexcom CGM and a
Cellnovo insulin patch-pump. The primary aim of the study
was to compare BG control following PE with Diabeloop
CL versus sensor-augmented insulin pump (SAP), in well-
educated patients practicing moderate or intensive PE repeat-
edly during 3-days.
Methods: Fourteen T1D patients on insulin pump (48.7
11.8 years old, diabetes duration: 20.9 10.6 years, HbA1c: 8.0
0.5%) participated in a randomized three-center crossover study,
including two 72-hour periods, either with SAP or CL, included
similar standardized meals and exercises. PE were performed on a
cycle ergometer (1st-day: 45mn-intense exercise VO2max = 75%;
2nd-day 30mn moderate exercise VO2max = 50%; 3rd-day: 30mn-
moderate exercise in the morning and 45mn-intense exercise in the
afternoon). Meals and exercises were announced in CL period.
Results: Time in range 80-140mg/dL during the 3-nights, was
significantly higher in CL compared with SAP (66.6[57.8;76.9]
vs. 30.9[17.2;55.3]% P < 0.0076) as was time in range 70-180 mg/dL
during the whole 72hrs (79.8[74.2;85.7] vs. 61.8[52.7;72.5]%
P = 0.0021). Three-day mean BG was significantly lower in CL
than in SAP (138.0[129.4;147.1] vs. 155.8[142.8;170.0]mg/dL,
P = 0.0037). Day and nocturnal times spent in hypoglycemia
were significantly lower in CL.
Conclusions: In case of repeated PE, Diabeloop was able to
double the time spent in the 80-140mg/dL range and to reduce
time in hypoglycemia during the night following PE, compared
to SAP.
045
DIABELOOP CLOSED-LOOP DOES BETTER THAN
SENSOR-AUGMENTED PUMP ON BLOOD GLUCOSE
CONTROL DURING 3 DAYS WITH GASTRONOMIC
DINNERS: A RANDOMIZED CROSSOVER TRIAL IN
PATIENTS WITH T1D
H. Hanaire1, P.Y. Benhamou2, S. Borot3, M. Doron4,
S. Franc5,6, B. Guerci7, E. Huneker8, N. Jeandidier9,
A-18
Y. Reznik10, P. Schaepelynck11, I. Xhaard5, A. Penfornis6,
G. Charpentier5,6, E. Renard12
1
University hospital of Toulouse, Service de Diabetologie-
Maladies metaboliques et Nutrition, TOULOUSE, France
2
University hospital of Grenoble, Pole DigiDune,
Endocrinologie Diabetologie, GRENOBLE, France
3 K. Dovc1, M. Macedoni2, N. Bratina1, D. Lepej3, R. Nimri4,
University hospital of Besancon, Service dEndocrinologie-
Metabolisme et Diabetologie-Nutrition, BESANCON,
France
4 1
CEA_Leti, technology research institute, Micro
Technologies Department for Biology and Health,
GRENOBLE, France
5
CERITD, Research, EVRY, France
6 3
Hospital center of Sud Francilien, Service de diabetologie,
EVRY, France
7 4
University hosiptal of Nancy, Service de Diabetologie,
NANCY, France
8
DIABELOOP SAS, Industrial development, GRENOBLE,
France
9
University hospital of Strasbourg, Service dEndocrinologie-
Diabete et des maladies de la Nutrition, STRASBOURG,
France
10
University hospital of CAEN, Service dEndocrinologie,
CAEN, France
11
University hospital of Marseille, Service de Nutrition-
Endocrinologie-Maladies Metaboliques, Marseille,
France
12
University hospital of Montpellier, Service des maladies
endocriniennes, MONTPELLIER, France
Background and Aims: Blood glucose (BG) control after
gastronomic dinners is an issue in type 1 diabetes (T1D) as
CHO can be very difficult to evaluate and increased amount or
fat or protein can induce delayed long duration hyperglycaemia
during night-time due to transient impaired insulin sensitivity
and/or hyperglucagonemia. Diabeloop is a Closed-loop (CL)
system with a MPC algorithm reinforced by a decisional ma-
trix, uploaded on a dedicated android smartphone linked to
Dexcom CGM and a Cellnovo insulin patch-pump. The pri-
mary aim of the study was to compare BG control with Dia-
beloop CL versus sensor-augmented insulin pump therapy
(SAP), in well-educated patients enjoying gastronomic dinners
during 3 days.
Methods: Ten T1D patients on insulin pump therapy (46.4
16.1 years old, diabetes duration: 23.6 13.1 years, HbA1c:
7.7 0.8%) participated in a randomized three-center crossover
study, including two 72-hour periods, either with SAP or CL.
Each session included three different dinners (1st-day: Japanese
meal, 2nd-day: French gastronomy, 3rd-day: pizza-tiramisu meal)
and three usual breakfasts and cafeteria lunches. Meals were
announced for bolus computing.
Results: Percent time in 80-140mg/dL range during the 3 nights,
was significantly higher in CL compared with SAP (58.4[49.7;68.7]
vs. 14.7[7.6;28.6], P < 0.0001) as was %time in 70-180mg/dL target
range during the whole 72hrs: 80.2[73.9;87.1] vs. 51.7[43.1;62.0],
P < 0.0001. Three-day mean BG(mg/dL) was significantly lower
in CL than in SAP (141.7[131.7;152.4] vs. 169.7[153.7;187.5],
P = 0.0003).
Conclusions: In difficult situations such as repeated heavy
dinners, Diabeloop CL system was able to increase by nearly
four-fold the %time spent in 80-140mg/dL BG range during
the night, and to decrease the average BG level compared to
SAP.
ATTD 2017 ORAL ABSTRACTS
046
GLUCOSE CONTROL WITH MD-LOGIC
CLOSED-LOOP SYSTEM USE IN YOUTH WITH
TYPE 1 DIABETES DURING PHYSICAL ACTIVITY
AND THE NIGHT AFTER
M. Phillip4, E. Atlas5, I. Muller5, T. Danne6, O. Kordonouri6,
T. Biester6, T. Battelino1
University Childrens Hospital, Department of Endocrinology-
Diabetes and Metabolism, Ljubljana, Slovenia
2
Ospedale dei Bambini Vittore Buzzi, Department of Pediatrics-
University of Milano- Milan- Italy, Milano, Italy
University Childrens Hospital, Department of Pulmonology-,
Ljubljana, Slovenia
Schneider Childrens Medical Center of Israel, Jesse Z. and
Sara Lea Shafer Institute for Endocrinology and Diabetes-
National Center for Childhood Diabetes, Petah-Tikva, Israel
5
DreaMed Diabetes Ltd, DreaMed Diabetes Ltd, Petah-Tikva,
Israel
6
Kinder- und Jugendkrankenhaus AUF DER BULT, Diabetes
Centre for Children and Adolescents, Hannover, Germany
Background and Aims: The objective of this clinical study
was to evaluate the safety and the efficacy of closed-loop (CL)
insulin delivery system MD-Logic and the occurrence of hypo-
glycemia during physical activity and the night after in children
and adolescents with type 1 diabetes (T1D).
Methods: In a two-arm, randomized, open-label, in-hospital,
crossover clinical trial 20 children on insulin pump therapy (9
females, mean age 14.24 2.02 years, HbA1c 7.67 0.62%)
performed two exercise protocols: moderate (55% of VO2max)
physical activity (PA) and moderate PA with integrated sprints
(55/80% of VO2max) in 4 visits with CL use and in a control
open-loop (OL) group in random order. Subjects in control group
disconnected the pump during the exercise and reduced the basal
for 20% for 4 hours after exercise.
Results: Closed-loop system use increased the proportion of time
within the target glucose range 70 180 mg/dl (3.9 10 mmol/l) for
the whole study period (84.08 (IQR: 70.03 85.48) % for CL and
68.67 (IQR: 56.00 77.70) % for OL, p = 0.006) This was achieved
with significantly less basal insulin delivered (p = 0.007) in CL. The
proportion of time in hypoglycemia below 60 mg/dl (3.3 mmol/l)
was 0.00% for both groups (IQR: 0.00 0.76% for CL and 0.00
1.06% for OL, p = 0.79).
Conclusions: CL insulin delivery was safe and effective in
maintaining glucose values with significantly more time spend
within target range without increased risk of hypoglycemia in the
in-hospital environment.
047
FEASIBILITY OF OMNIPOD HYBRID CLOSED-LOOP
CONTROL IN ADULTS WITH TYPE 1 DIABETES
USING A PERSONALIZED MODEL PREDICTIVE
CONTROL ALGORITHM
B. Buckingham1, J. Pinsker2, M. Christiansen3, J. Schneider4,
T. Peyser4, E. Dassau5, J. Bok Lee6, J. OConnor6, J. Layne7,
T. Ly7
1
Stanford University, Department of Pediatrics, Stanford, USA
2
William Sansum Diabetes Center, Pediatric Endocrinology,
Santa Barbara, USA
ATTD 2017 ORAL ABSTRACTS
3
Diablo Clinical Research, Endocrinology, Walnut Creek, USA
4
ModeAGC LLC, Research and Development, Palo Alto, USA
5
Harvard University, Harvard John A. Paulson School of
Engineering and Applied Sciences, Cambridge, USA
6
Insulet Corporation, Research and Development, Billerica,
USA
7
Insulet Corporation, Clinical Affairs, Billerica, USA
Background and Aims: To investigate the safety and per-
formance of an automated glucose control algorithm using the
Omnipod Insulin Management System. The system included a
modified version of Omnipod, Dexcom G4 continuous glucose
sensor and a personalized model predictive control algorithm.
Insulin dosing was implemented based upon a 60 minute glucose
prediction horizon.
Methods: The study consisted of a 36-hour inpatient hybrid
closed-loop assessment with announced meals ranging from 30-
90g of carbohydrates and limited physical activity. Subjects aged
18-65 y with type 1 diabetes, A1C between 6.0-10.0% and total
daily dose (TDD) of insulin >0.4 U/kg/day were eligible. End-
points included sensor glucose percentage of time 70-180 mg/dL,
<70 mg/dL, >180 mg/dL and mean blood glucose.
Results: Baseline characteristics for 24 subjects included
(meanSD): age 36.3 15.0 y, diabetes duration 24.9 14.7 y,
A1C 7.6 0.9% and TDD 0.6 0.2U/kg. Glycemic outcomes
are reported in the table. Mean percentage of time in range
70-180 mg/dL was 69.3% overall and 90.0% during the over-
night period. There were 0.3 hypoglycemic events/day, with
meter glucose <70 mg/dL, during 787 hours of system use.
Conclusions: The Omnipod prototype automated glucose
control algorithm performed well and was safe during day and
night use in patients with type 1 diabetes. Additional studies are
underway to further validate the performance in the pediatric
population.
048
SUCCESSFUL ISLET XENOTRANSPLANTATION TO
RESTORE GLYCEMIC CONTROL IN DIABETIC NOD
MICE WITH NOVEL ALGINATE PURIFICATION
TECHNOLOGY
M. Alexander1, A. Flores1, S. Lee1, S. Zhang1, T. Tucker1, S. Li1,
P. de Vos2, J. Lakey1,3
1
University of California Irvine, Surgery, Orange, USA
2
University Medical Center Groningen, Pathology and Medical
Biology, Groningen, The Netherlands
3
University of California Irvine, Biomedical Engineering,
Irvine, USA
Background and Aims: Islet transplantation is an attractive
option for treatment of type 1 diabetes, but are limited by lack of
A-19
cadaveric donor and chronic immunosuppression. Islet encap-
sulation has been potential for decades, but has been limited
especially in its application in autoimmune diabetes. We have
improved on material selection, purification, and capsule design
to produce consistent 400 lm diameter purified islet capsules.
Methods: Rat islets were encapsulated using extra-purified
UPLVM alginate (Gp1) or in unpurified alginate (Gp2). Diabetic
NOD mice (>3 days of non-fasting hyperglycemia >350 mg/dL), 9-
10 weeks old, received encapsulated islet transplant into the peri-
toneal cavity (Gp1 and 2, n = 10 per group), or non-transplanted as
control (Gp3). Blood glucose and body weight was measured, and
glucose tolerance was tested at 1 month post-transplant. Mice were
euthanized after 2 months, and explants were analyzed by histology
for CD68, Masson Trichrome, and insulin.
Results: Using viable and functional encapsulated islet
transplant in Gp1 and Gp2, in Gp1, 8/10 mice returns to eu-
glycemia (bg <200 mg/dL) within 3 days of transplant. Gp2 mice
also reversed hyperglycemia, but within 5 days retuned back to
the diabetic state. Control mice remained hyperglycemic for
>30 days after diabetes induction Glucose tolerance test in Gp1
mice showed equivalent function to non-diabetic mice. Histol-
ogy showed intact islet capsules (Gp1), compared to free and
damaged islets, immune cells, and capsule debris (Gp2).
Conclusions: Our results indicated that improved purification
steps is necessary for a successful encapsulated islet transplant,
and maybe indicative of the problems encountered in other en-
capsulated islet and xenotransplant studies.
049
PATIENT PERSPECTIVES, TECHNOLOGY
ATTITUDES AND GLUCOSE CONTROL: A MIXED-
METHOD STUDY OF AN ARTIFICIAL PANCREAS
TRIAL IN PREGNANCY
C. Farrington1
1
University of Cambridge, Cambridge Centre for Health
Services Research, Cambridge, United Kingdom
Background and Aims: Recent publications (e.g. Stewart
et al., N Engl J Med 2016:375) demonstrate the efficacy, safety
and feasibility of artificial pancreas (AP) systems in pregnancy.
Less is known about users perceptions of AP systems - e.g. their
views about their level of control, or how their wider attitudes to
technology may influence their experiences.
Methods: A mixed-methods study embedded within the trial
reported by Stewart et al. The study incorporated semi-structured
qualitative interviews with 14 women alongside biomedical data
on glucose control response to AP therapy (relative to response to
sensor-augmented pump therapy).
Results: Overall, patients control with AP therapy was
slightly worse than patients believed. However, there was sig-
nificant inter-participant variation, with some patients reporting
markedly better control than they in fact achieved (n = 3) and
others reporting control that was moderately better or worse than
they achieved (n = 5). Six patients reported levels of control that
matched biomedical data. With regard to technology attitudes,
patients ending the study with more positive attitudes towards
technology not only demonstrated better opinions of their control
but also worse control than those with more neutral attitudes
towards technology. Once again, participants differed markedly.
Conclusions: These findings highlight the complexity of the
relationship between patient attitudes and biomedical outcomes.
A-20
It cannot be assumed that AP users have accurate perceptions of the
level of control they achieve; nor can it be assumed that positive
attitudes to technology will align with better control using AP
systems. To allow a range of users to achieve good control, future
interventions should take account of this complexity.
050
DIGITALLY DELIVERED DIABETES SELF-
MANAGEMENT SUPPORT: KEYS TO SUSTAINING
AND SCALING PROGRAMS THAT WORK
N. Kaufman1
1 Methods: 193 insulin-treated diabetic patients (11% T1DM;
Canary Health, Medical, Los Angeles, USA
Background and Aims: Individuals with type 2 diabetes must
manage their everyday lives and their behaviors if they are going
to remain healthy and slow the rate of adding additional condi-
tions or complications. When trying to impact outcomes for a
population of patients, key challenges for success are to (1) en-
gage enough of the population to take positive action, (2) provide
an effective approach to those who engage which can promote
sustainable behavior changes and improved outcomes, (3) pro-
vide the intervention at price and logistical burden that is ac-
ceptable to whomever is paying for the services and supports, and
(4) impact outcomes that matter to those who can scale and
sustain a successful program.
Methods: 1,010 patients with Type 2 diabetes were recruited
from a large US Health Plan and provided a six week intervention
to increase self-efficacy especially related to 3 key issues in self-
management of a chronic disease- role management, chronic
condition management, and emotional management. Individuals
were part of a 20-30 person online group, facilitated by 2 peers.
In addition to specific content, individuals created action plans
and posted concerns and celebration which were commented on
by other participants in the workshops.
Results: N = 1,010 enrolled and demonstrated at 6 month post
the end of the program:
1. HbA1c decreased 0.93% for those >9%
2. Depression improved
3. Frequent hypoglycemic symptoms decreased
4. Medication-taking adherence improved
5. Exercise increased 43 minutes per week
Medication adherence, doctor-patient communication and
self-efficacy also improved.
Conclusions: Digital delivery of a self-management support
intervention proven effective in person can positively impact
outcomes that matter for patients, providers and payers.
051
ONETOUCH VERIO: IMPACT ON DIABETES
SELF-MANAGEMENT AND GLYCEMIC CONTROL
O. Schnell1, G. Klausmann2, B. Gutschek3, R. Garcia-Verdugo4,
M. Hummel5
1
Forschergruppe Diabetes e.V., Diabetology, Munich
Neuherberg, Germany
2
Gemeinschaftspraxis Drs. Klausmann, Studienzentrum
Aschaffenburg, Aschaffenburg, Germany
ATTD 2017 ORAL ABSTRACTS
3
LifeScan- Johnson & Johnson Medical GmbH, Strategic
Affairs, Neuss, Germany
4
Sciarc GmbH, Sciences, Baierbrunn, Germany
5
Diabetologische Schwerpunktpraxis, Institut fur
gesundheitliche Fortbildung, Rosenheim, Germany
Background and Aims: Self-monitoring of blood glucose
(SMBG) is a key component to personal diabetes management.
OneTouch Verio is a blood glucose meter system allowing for
an instant, color-coded display of glucose levels, which helps
identify out of range glucose levels. The objective of the ob-
servational study was to analyze diabetes self-management be-
fore and during system implementation in real-life settings and
demonstrate its effects on glycemic control.
45% female, age 60 14 yr, diabetes duration 14 9 yr, HbA1c
8.7 1.9%) were provided a OneTouch Verio. Both the Diabetes
Self-Management Questionnaire (DSMQ) and glycemic control
were analyzed at baseline, and 3 and 6 months after study initiation.
Results: OneTouch Verio resulted in improved glycemic
control, as shown by decreased mean HbA1c, from 8.7 1.9% at
baseline to 8.1 1.0% after 3 months (p = 0.0009) and to
7.9 1.1% at 6 months (p < 0.0001).
Compared to baseline, patients attitudes with respect to nu-
trition, lifestyle, and adherence showed a significant improve-
ment, as observed from the results from the DMSQ (p < 0.001).
Both patients and diabetes advisor personnel reported similar
advantages of the color-coded indicator of glucose levels pro-
vided by OneTouch Verio and helpfulness in assisting pa-
tients with diabetes management, as drawn from the results of the
self-reported satisfaction questionnaire.
Conclusions: This real-world study demonstrates that SMBG
implemented via OneTouch Verio leads not only to an im-
provement in metabolic control, but is also associated with a
significant improvement in diabetes management.
052
THE HYPO-TRIAD: A NEW COMPOSITE METRIC
FOR THE COMPREHENSIVE ASSESSMENT OF
HYPOGLYCEMIA
R. Vigersky1, A. Thomas2, J. Shin3, B. Jiang4, C. McMahon4,
R. Kolassa5
1
Medtronic Diabetes, Medical Affairs, Northridge, USA
2
Medtronic GmbH, Market Development, Meerbusch, Germany
3
Medtronic Diabetes, Clinical Research, Northridge, USA
4
Medtronic Diabetes, Engineering, Northridge, USA
5
Private Practice, Private Practice, Bergheim/Erft, Germany
Background and Aims: Hypoglycemia is usually expressed
uni-dimensionally (# of daily episodes; area-under-the-curve
(AUC) below a threshold, e.g., 50 or 70 mg/dL). This approach
describes neither the intensity nor overall impact of hypoglyce-
mia on a patient. The Hypo-Triad is a composite metric
combining AUC, time, and frequency of events to more com-
pletely reflect a patients daily exposure to hypoglycemia.
Methods: We first defined a 2-component metric - intensity of
hypoglycemia (IntHypo) - as the combination of AUC and time/
day of sensor glucose less than 50 or 70 mg/dL expressed as the
vector length (Figure). The HypoSpace or Hypo-Triad is a
3-component metric adding frequency/day of hypoglycemia. We
calculated these composite metrics using data from the ASPIRE
ATTD 2017 ORAL ABSTRACTS
In-Home trial which compared low-glucose suspend (LGS)
(N = 121) to sensor-augmented pump (SAP) (N = 126) therapy (1).
(1) Bergenstal RM, et al. N Engl J Med 2013;369:224-232.
Results: LGS reduced IntHypo under 50 mg/dL by 56.1%
(181.6 277.6 to 79.2 85.4; p = 0.001) compared to a 2.2%
increase for SAP (176.4 2173 to 180.4 181.4; p = 0.075)
(p = 0.003 between groups). The HypoSpace under 50 mg/dL
rose 68% in the SAP group (p = 0.001) while the LGS group had a
9.3% decrease (p = 0.352) (p = 0.007 between groups). There was
a similar reduction in the IntHypo under 70/mg/dL by 31.4%
compared to a 14.3% decrease for SAP. The HypoSpace under
70 mg/dL rose in the SAP group (+44.8%; p = 0.03) while there
was no change in the LGS group (+2.2%; p = 0.308).
Conclusions: The Hypo-Triad is a composite metric that
provides a comprehensive and clinically relevant way to assess
hypoglycemia numerically and graphically.
053
ACCURACY EVALUATION OF A NOVEL SYSTEM
FOR SMARTPHONE-COUPLED BLOOD GLUCOSE
MONITORING
N. Jendrike1, A. Baumstark1, S. Pleus1, D. Rittmeyer1,
U. Kamecke1, C. Haug1, G. Freckmann1
1
Institut fur Diabetes-Technolgie Forschungs- und
Entwicklungsgesellschaft mbH, an der Universitat Ulm, Ulm,
Germany
Background and Aims: While conventional blood glucose
monitoring systems consist of meters and corresponding test
strips, the novel PixoTestTM (iXensor Co. Ltd.) does not require a
separate meter but glucose values are measured by a smartphone
camera through color change of test fields inside a small device
integrated with a lancet and attached to the smartphone. In this
study, accuracy of this system was evaluated.
Methods: Capillary blood samples with defined glucose con-
centration distribution from 100 subjects were measured with each
of three different reagent system lots of the system as well as with a
glucose oxidase-based comparison method. The applicable stan-
dard ISO 15197:2013 (EN ISO 15197:2015) specifies that 95% of
measured values have to be within 15 mg/dl of a comparison
method at glucose concentrations <100 mg/dl and within 15% at
higher concentrations. In addition, 99% of the results shall fall in
zones A and B of the consensus error grid. Percentages of the
results within the above-mentioned limits were calculated.
Results: All three lots fulfilled the ISO 15197:2013 (EN ISO
15197:2015) criteria with 99%, 97% and 98.5% of values, re-
spectively, within the accuracy limits and 100% of values within
consensus error grid zone A. The relative bias ranged from
-0.6% to -1.0%.
A-21
Conclusions: The novel smartphone-based blood glucose
monitoring system showed a high level of accuracy fulfilling ISO
15197:2013 (EN ISO 15197:2015) system accuracy criteria. The
possibility to discretely and conveniently measure blood glucose
levels might support regular self-monitoring of blood glucose
which is important for an efficient diabetes therapy.
054
IMPROVEMENT OF GLYCEMIC CONTROL
WITH REMOTE SUPPORT IN CHILDREN
ADOLESCENTS WITH TYPE 1 DIABETES
MELLITUS ON INSULIN-PUMP THERAPY
D.N. Laptev1, A.O. Emelyanov1, S.V. Pereverzeva1,
A.A. Kukushkina1, A.V. Karpushkina1, V.A. Peterkova1,
I.I. Dedov1
1
Endocrinology Research Centre, Department of Pediatric
Endocrinology, Moscow, Russia
Background and Aims: Healthcare access plays a significant
role in the maintaining glycemic control and quality of life for
diabetic patients on continuous subcutaneous insulin infusion
(CSII). The aim of our study was to evaluate the feasibility of
remote support in children and adolescents with type 1 diabetes
mellitus (T1DM) and its effect on glycemic control.
Methods: In 40 children and adolescents (13 2.8 years, 18/
22 m/f) on CSII with inadequately controlled T1DM (HbA1c7.5%)
we evaluated the effectiveness of telemedical support (TS), as
compared with conventional support (CS). Patients and their parents
in TM group twice a month sent their insulin pump data using
CareLink software to diabetes center and diabetologists sent back
their advice via e-mail or Skype. The primary end point was the
change from the baseline HbA1c level.
Results: At 6 month, the baseline mean HbA1c (8.7% in the
two study groups) had decreased to 7.7% in the TS group, as
compared with 8.4% in the CS group (P < 0.05). The proportion of
patients who reached the HbA1c target (<7.5%) was greater in the
TS group (50%) than in the CS group (20%, p < 0.05). The pro-
portion of readings above target (10 mmol/l) was 48.0% in CS
group, as compared with 32.2% in TS group (P < 0.05).The pro-
portion of readings below target (4 mmol/l) was non-significantly
lower in TS group (P > 0.05).
Conclusions: In children with inadequately controlled type 1
diabetes, telemedical support proved to be feasible and resulted
in significant improvement in HbA1c levels, as compared with
conventional support.
055
PROJECTION OF HEALTH-ECONOMIC BENEFITS
OF SENSOR-AUGMENTED PUMP (640G AND PLGM
SYSTEM) VERSUS INSULIN PUMP THERAPY ALONE
(CSII) IN TYPE 1 DIABETES PATIENTS IN SWEDEN
J. Jendle1, A. Delbaere2, S. de Portu2, S. Roze3
1
Orebro University, Faculty of Medical Sciences, Orebro,
Sweden
2
Medtronic International Trading SARL, HEOR, Tolochenaz,
Switzerland
3
HEVA HEOR, HEOR, Lyon, France
Background and Aims: To assess the cost-effectiveness and
to project the clinical benefits of the Sensor-Augmented-Pump
A-22
640G and PLGM system (SAP) versus Continuous Subcutaneous
Insulin Infusion alone (CSII) in type 1 diabetes (T1D) patients in
Sweden.
Methods: The Core Diabetes Model was used to project the
incidence of diabetes-related complications for a T1D population
with uncontrolled HbA1c and for a population with hypo-
unawareness. The Pickup meta-analysis showed, for the uncon-
trolled cohort based on the Swedish National Diabetes Registry
NDR-2014, (mean HbA1c: 63.14 mmol/mol; age 46 years), a
HbA1c reduction of -0.58% versus -0.14% for SAP and CSII
respectively. In the hypo-unaware population (Hba1c 58.5
mmol/mol, age 18.6 years) severe hypoglycemic events were
observed at 2.2 and 0 (based on a randomized trial from Ly et al.)
per 100 patients months for CSII and SAP respectively.
Results: The incremental cost effectiveness ratio (ICER) was
251896 SEK per Quality Adjusted Life Year gained (QALY) for
the uncontrolled T1D-population. In the hypo-unaware popula-
tion the ICER was 139795 SEK/QALY. The improvement in
QALYs were 1.07 and 1.88 years in favor of SAP in the un-
controlled and hypo-unaware population respectively. In the
uncontrolled T1D-population, as compared to CSII, SAP delayed
the onset of complications such as neuropathy (1.04 years), ulcer
(0.92 years) and stroke (0.64 years). Extensive sensitivity anal-
ysis on key drivers confirmed the robustness of results.
Conclusions: These results indicate that the pump 640G with
Predictive Low Glucose Management can be considered good
value for money compared to CSII alone in both uncontrolled
hyperglycemia and hypo-unaware T1D-populations.
056
ENGAGING PEOPLE WITH TYPE 2 DIABETES:
CLINICAL DECISION SUPPORT ANALYZES
STRUCTURED GLUCOSE DATA TO SUPPORT
SELF-MANAGEMENT
D. Greenwood1, T. Forsman2
1
Sutter Health, Research Development and Dissemination,
Granite Bay, USA
2
Lumina Decisions Systems- Inc, Senior Consulting Analyst,
Campbell, USA
ATTD 2017 ORAL ABSTRACTS
Background and Aims: Clinical decision support systems
(CDSS) can be specifically designed to empower people with
type 2 diabetes (T2D), not on insulin, to interpret structured
glucose data and make informed health decisions. Our CDSS
used best-in-class decision theory, control theory, artificial in-
telligence, data mining, data science, and machine learning in a
cloud based environment. Participants conducted paired glucose
tests using in-home glucose monitors with results transmitted,
via remote monitoring platform, to a clinician portal. Feedback
and recommendations were compiled and then delivered to pa-
tients in an intuitive, supportive, and graphical manner with
dashboards for ease of understanding enabling a complete
feedback loop. The core software facilitated customization by
participant using up-to-date real-time processing.
Methods: Data were analyzed using pattern analysis and
summarized by premeal, postmeal, and change values following
ADA guidelines. Individualized feedback was augmented and
personalized using secure messaging via the EHR. Participants
were encouraged to make one or two small changes. The com-
plete feedback loop repeated weekly.
Results: Participants (n = 40) averaged 38/90 (42%) paired
glucose tests over 12 weeks. 32% (n = 193/606) CDSS secure
messages were read by participants, of those 67% (n = 130/193)
responding to the clinician engaging in discussion. 96% of par-
ticipants agreed or strongly agreed they were more involved in their
care and 93% reported their health was better following CDSS.
Conclusions: CDSS designed for T2D, incorporating a com-
plete feedback loop, engages people in self-management increas-
ing the likelihood of improved health outcomes. Opportunities to
simplify participant-clinician communication are required to in-
crease productive interactions.
057
GLUCOMMANDER OUTPATIENT, A CLOUD-BASED
INSULIN MANAGEMENT SOLUTION, TITRATED
PATIENTS TO GOAL IN 12.5 DAYS AND SUSTAINED
A 2.5% DROP IN HBA1C OVER 6 MONTHS
J. Clarke1, B. Bode2
1
Atlanta Diabetes Associates, Education, Atlanta, USA
2
Atlanta Diabetes Associates, Research, Atlanta, USA
Background and Aims: Treatment of diabetes with multiple
daily injections, using a regimen of basal and rapid-acting insulins,
is widely accepted as a standard of care in the treatment of diabetes.
This study evaluated Glucommander Outpatient, a commercially
available, cloud-based software solution that analyzed patient
glucose data and calculated individualized insulin doses.
Methods: The study was comprised of 38 patients who were
previously treated with standard of care methods. The patient
mix included both type 1 and type 2 diabetes. All patients had
HbA1c measurements at start and 6-months; a 3-month HbA1c
was also collected. All insulin dose adjustments were calculated
by Glucommander Outpatient.
Glucose data was collected using the Telcare glucose meter,
which was able to provide near real-time glucose results into the
cloud. Adjusted insulin doses from the software were provided to
a healthcare professional for review then sent to the patient,
either on the display of the meter or via a text message.
Results: During treatment with Glucommander Outpatient,
HbA1c decreased from a baseline average of 10.1% to 7.7% at 3
months and 7.6% at 6 months (P < 0.00001 by paired T-test).
Hypoglycemia was infrequent throughout (see Table). Out of a
ATTD 2017 ORAL ABSTRACTS A-23

self-management and potentially improve post-prandial glucose

control in people with T1D.

059
MULTI-LAYERED DECISION SUPPORT SYSTEM
FOR INSULIN TREATED PATIENTS WITH DIABETES
SHOWS IMPROVEMENT IN SHORT TERM
GLUCOSE CONTROL

total of 17,058 BGs recorded, the average number of BG tests per C. Rogers1, M. Breton2, S. Patek2, P. Keith-Hynes1
day was 2.9 during the first 3 months and 2.0 during the final 1
TypeZero Technologies LLC, CEO, Charlottesville, USA
3 months. The median time for patients to achieve three con- 2
UVA, Center for Diabetes Technology, Charlottesville, USA
secutive days of BGs <10 mmol/l (180 mg/dl) was 12.5 days.
Conclusions: Glucommander Outpatient was found to be easy Background and Aims: Insulin dosing to control glucose
and effective to use by both client and provider. levels in Diabetes is a complex, multi-factorial process where
small errors can lead to significant discomfort and potential harm
via exposure to hypo and hyperglycemia. With the University of
Virginia, TypeZero Technologies has developed unique, user
058 centric, decision support technologies (DSTs) to facilitate a safe
A WEB-BASED CLINICAL PLATFORM FOR and stress free life with Diabetes.
AUTOMATED MEAL BOLUS ADJUSTMENTS Methods: TypeZero DSTs are informed by the concept of
actionable risk; they currently consist of 6 modules im-
P. Pesl1, M. Reddy2, N. Oliver2, D. Johnston2, C. Toumazou1, plemented on mobile devices: (i) a biweekly treatment para-
P. Herrero1, P. Georgiou1 digm review, proposing modifications to the insulin therapy
1
Imperial College London, Institute of Biomedical Engineering, to improve glucose control, (ii) an estimate of glycemic
Centre for Bio-Inspired Technologies, London, United Kingdom control trends (estimated HbA1c), (iii) a CGM based bolus
2
Imperial College London, Division of Diabetes, Endocrinology calculator, accounting for the metabolic state of the user, (iv)
and Metabolic Medicine, London, United Kingdom a CGM-based hypoglycemia alert: predictions up to 3h ahead,
(v) an exercise adviser: optimal insulin/carbohydrate modu-
lation, and (vi) a bedtime adviser: appropriate mitigation for a
Background and Aims: Insulin bolus calculators use pa-
safe night of sleep. DSTs are currently being tested in a ran-
rameters insulin:carbohydrate ratio (ICR) and insulin-sensitivity
domized crossover clinical trial, recruiting 35 subjects with
factor (ISF) to calculate the amount of insulin needed to cover a
type 1 diabetes (NCT02558491), consisting of two 48h ad-
meal. Because of significant variability in insulin require-
missions (usual control vs. adviser), with standardized meals
ments, these parameters often need re-adjustments by a clinical
and exercise.
expert in order to maintain or improve glucose control. How-
Results: 15 subjects have completed the trial, with enrollment
ever, adjustments are often based on retrospective glucose
continuing. Partial results demonstrate a strong trend to better
data and can be challenging if clinical visits are scheduled in-
glucose control: time between 70-180mg/dl rose from 56% to
frequently. Current diabetes management systems are able to
68%, <70mg/dl decreased to 1.8% from 2.9%, and glucose
visualise and summarise glucose related data but do not auto-
variability (ADRR) decreased to 27 from 41.
matically provide insulin therapy adjustments for people with
Conclusions: The TypeZero decision support technologies
type 1 diabetes (T1D).
are currently being validated in clinical trials and show encour-
Methods: We have developed a secure web-based clinical
aging results towards improved and safer glucose control. A
platform with the capability of automated insulin therapy ad-
3-months home study is planned for 2017.
justments, that works in combination with the previously pre-
sented Advanced Bolus Calculator for Diabetes (ABC4D).
ABC4D recommends meal boluses via the users smartphone
and periodically sends glucose related data (e.g. meal and in-
sulin information, exercise, continuous glucose monitoring
data) via WIFI or 3G to the clinical web-platform. The system
automatically analyses the data and optimises parameters ICR
and ISF, which are then synchronised with the ABC4D plat-
form.
Results: A prototype system has been developed and tested
with real-life glucose data obtained from previous clinical trials.
The web-based clinical platform is planned to be included in a
large-scale study evaluating the efficacy of ABC4D.
Conclusions: Automated insulin therapy adjustments, as im-
plemented within the proposed platform, may aid clinical experts
in optimising meal dosing parameters (ICR and ISF), encourage
A-24
060
CLINICAL DECISION SUPPORT FOR THE
MANAGEMENT OF TYPE 2 DIABETES IN HOSPITAL
WARDS - DEVELOPMENT AND EVALUATION OF A
MEDICAL DEVICE SOFTWARE SYSTEM
P. Beck1,2, K.M. Lichtenegger3, J.K. Mader3, K. Donsa2,
B. Holl2, S. Spat2, J. Plank3, T.R. Pieber2,3
1 Methods: The ABC4D system is currently being evaluated in
decide Clinical Software GmbH, SME, Graz, Austria
2
Joanneum Research, HEALTH - Institute for Biomedicine
and Health Sciences, Graz, Austria
3
Medical University of Graz, Department of Internal Medicine,
Graz, Austria
Background and Aims: Despite affecting up to 1/3 of ad-
missions, hospital management of type 2 diabetes is still
challenging. Clinical guidelines recommend basal-bolus in-
sulin therapy to maintain blood glucose levels in range and
avoid further complications. However, the efficacy of this
therapy depends on individualised patient-centric approaches
with constant follow-ups during the day. Thus, this therapy
becomes a complex task, increasing the workload for the al-
ready saturated personnel and enhancing the overall risk of
medical errors.
Methods: In response, we have created a novel software
based decision support system (GlucoTab) conceived as a
medical device. The system provides guidance and support for
nursing staff and physicians involved with insulin therapy of
patients with type 2 diabetes at the hospital ward. It supports
the glycaemic management workflow and automatically sug-
gests the correct insulin dosage. GlucoTab was developed in
an interdisciplinary and research driven approach, early in-
volving end users in the design and utilizing the findings from
clinical trials in a stepwise approach.
Results: A clinical trial performed in four different general
wards showed that standardized glycaemic management could
be implemented efficiently and safely. 73% of all blood glucose
measurements were in the target range 70-180 mg/dl without
causing additional hypoglycemic events. Compared to another
trial performed previously with standardized paper-based dia-
betes management, the computerized system led to a consider-
able reduction of insulin dosing errors which were shown to be
associated with hypoglycaemic events.
Conclusions: GlucoTab improves quality in hospital care by
standardising diabetes management according to current guide-
line recommendations and increases patient safety by reducing
treatment errors.
061
ACCEPTABILITY AND USABILITY OF THE
ADVANCED BOLUS CALCULATOR FOR DIABETES
(ABC4D) AFTER 6 MONTHS OF USE
M. Reddy1, P. Pesl2, N. Jugnee1, C. Toumazou2, D. Johnston1,
P. Georgiou2, P. Herrero2, N. Oliver3
1
Imperial College London, Division of Diabetes- Endocrinology
and Metabolism, London, United Kingdom
2
Imperial College London, Centre for Bio-inspired Technology-
Department of Electrical and Electronic Engineering, London,
United Kingdom
3
Imperial College London, Division of Diabetes- Endocrinology
and Metabolism, London, United Kingdom
ATTD 2017 ORAL ABSTRACTS
Background and Aims: To evaluate the long-term accept-
ability and usability of the Advanced Bolus Calculator for Dia-
betes (ABC4D) system. The ABC4D is an insulin bolus dose
decision support system based on case-based reasoning (CBR)
and works with real-time continuous glucose monitoring (RT-
CGM). The system is implemented in a smartphone application
to provide personalized and adaptive insulin bolus advice for
people with type 1 diabetes(T1D).
a prospective 6-months blinded randomised controlled trial. At
the end of the study participants are asked to complete a ac-
ceptability questionnaire. The ABC4D application looks exactly
the same for the intervention (ABC4D algorithm) and control
(standard bolus calculator) group.
Results: 22 participants with T1D on either pump therapy or
multiple daily injections of insulin have completed the study to
date (59% female, mean (SD) age 39(12) years, diabetes duration
17(9) years and HbA1c 61(10) mmol/mol). 94% agreed that
entering information on the app was straightforward, 67% trusted
the insulin dose recommendation generated, 94% agreed that the
use of RT-CGM was acceptable, 100% considered the ABC4D
app user-friendly and 78% would be happy to continue using the
ABC4D for bolus calculation. 11% were reluctant to use the
ABC4D while at work, 6% while travelling abroad, 6% before/
after exercise, 11% when eating out, 22% when consuming al-
cohol and 17% when feeling unwell.
Conclusions: Our preliminary data suggests that the ABC4D
smartphone application used with RT-CGM is user-friendly and
remains well-accepted after 6 months of continuous use.
062
QUANTIFYING THE EFFECT OF ANTECEDENT
PHYSICAL ACTIVITY ON PRANDIAL GLUCOSE
CONTROL IN TYPE 1 DIABETES: DEFINING
EXERCISE ON BOARD
B. Ozaslan1, S. Patek1, M. Breton2
1
University of Virginia, Center for Diabetes Technology,
Charlottesville, USA
2
UVA, Center for Diabetes Technology, Charlottesville, USA
Background and Aims: Exercise is a major hurdle to insulin
dosing in Type 1 Diabetes (T1D). While physical activity (PA) is
encouraged in patients with T1D, metabolic adjustments to ac-
tivity (e.g. increased insulin sensitivity, increased glucose dis-
posal, and catecholamine secretion) creates a significant
glycemic imbalance with increased risk for hypo/hyperglycemia.
Quantifying the impact of antecedent PA on prandial glucose
(PG) could allow for better mealtime insulin dosing and reduced
glycemic risks.
Methods: 12 subjects with T1D on insulin pump participated
in a clinical trial (NCT02558491), where they continuously wore
a blinded continuous glucose monitor (Dexcom G4/505), a PA
tracker (Fitbit Charge HR), and followed regular pump therapy
(integrated bolus calculator) for a month.
To assess PG, dinner meals were identified from the dataset
and glucose area under the curve (AUC) was computed from 2h
to 6h after dinner. Additionally, we derived a new index from
PA data: exercise on board (EOB): an exponentially weighted
sum of steps over time (1h,3h,6h,12h). We also computed in-
sulin on board relative to total daily insulin (IOB/TDI) and
carbohydrate on board relative to bodyweight (COB/BW) from
the pump records.
ATTD 2017 ORAL ABSTRACTS A-25

app, accessible on their smartphone or online, to implement on

their insulin pump.
Results: Initial trials indicate patients achieve better glucose
EOBs, IOB/TDI and COB/BW were associated with AUC control by implementing the algorithms insulin pump settings
using linear regression. adjustments.
Results: We collected complete datasets from 8 subjects Conclusions: This clinical decision support tool is well-
(13.4 5.1 dinners/subj), with variable conditions before dinner: positioned to revolutionize the way T1D data is used for insulin
BG = 161 63mg/dl, IOB/TDI = 0.14 0.06, COB/BW = 0.59 pump patients by:
0.23.  Offering a safe, effective self-management tool to op-
Linear regression coefficients for EOBs are shown below.
timize insulin pump settings during and between clinic
Conclusions: We have shown that an easily available quan-
tification of PA has a significant impact on glycemic exposure
visits
 Providing insights and recommendations for physicians
after a meal. By relating this effect to the effect of insulin, one
may build an exercise-informed bolus calculator. to individualize and optimize management of patients
on insulin pumps
 Offering a population health management tool that
highlights patients needing insulin pump adjustments to
063 their healthcare providers
DREAMED ADVISOR AUTOMATES INSULIN PUMP
SETTINGS ADJUSTMENTS WITH DATA FROM
GLOOKOS DIABETES MANAGEMENT PLATFORM
M. Phillips1, J. Chang2
1
Institute for Endocrinology and Diabetes, National Center for
Childhood Diabetes, Schneider Childrens Medical Center of
Israel, Israel
2
Glooko, Product, Mountain View, USA

Background and Aims: Adjusting insulin pump settings is

often a tedious and unsuccessful task, due to the complexity of
factors impacting blood glucose trends and the risk for hypo-
glycemia.
DreaMed Advisor features an insulin pump adjustments al-
gorithm, targeting Type 1 patients on insulin pumps, aims to
streamline the adjustment process. Leveraged in Glookos FDA
cleared, HIPAA compliant platform, which seamlessly aggre-
gates data from insulin pumps, continuous glucose monitors,
blood glucose meters, fitness apps and devices, biometric devices
and a built-in food and medication database, the DreaMed al-
gorithm analyzes blood glucose and contextual data to identify
trends and make insulin pump setting adjustment recommenda-
tions.
Methods: Healthcare providers are notified of adjustment
recommendations and review/modify the adjustments. Once
approved, the adjustments are delivered to the patients Glooko
A-26
064
IMPACT OF NON-SEVERE HYPOGLYCEMIC
EPISODES ON QUALITY OF LIFE, SLEEP AND WORK
PRODUCTIVITY IN PATIENTS WITH TYPE 1
DIABETES (T1D) ON CSII AND MDI THERAPY
E. Patrakeeva1, M. Dunicheva1, L. Chernilova1, A. Mosikian1
1 regression analysis (alpha level = 0.05), including factors that
Saint-Petersburg Medical University, Endocrinology, Saint-
Petersburg, Russia
Background and Aims: To evaluate the impact of non-severe
hypoglycemic events on the quality of life (QoL), quality of sleep
and work productivity; to reveal the main reasons for the fear of
hypoglycemia (FoH).
Methods: Anonymous validated questionnaire on minor hy-
poglycemic episodes was given to 1340 individuals registered at
diabetes-related on-line resource. To analyze the results we used
hi-squared test, two-way ANOVA on ranks and linear regression
model.
Results: 93 people (82% women) with T1D (60% on MDI,
40% used CSII) agreed to fill out the questionnaire. The partic-
ipants are (meanSD) 30 9 years old and have (meanSD)
12 8 years diabetes duration. Our analysis revealed a positive
correlation between the hypoglycemia duration and its negative
influence on patients work quality (p = 0.048). The more time is
needed for achieving normal range of blood glucose concentra-
tion, the greater is negative influence on patients daily activity
(p = 0.04) and sleep quality (p = 0.009). The main reasons for the
fear of hypoglycemia are being alone at the moment of hypo-
glycemia (p = 0.008), not being able to recognize the symp-
toms of hypoglycemia (p = 0.001) and causing disturbance to
other people (p = 0.013), especially in women (meanSD
1.8 0.2 and 0.8 0.3 points out of 5, respectively).
Conclusions: Non-severe hypoglycemic events have negative
impact on quality of life and quality of sleep (regardless of pa-
tients gender). Physicians should pay special attention on pa-
tients knowledge of hypoglycemia symptoms. All the revealed
factors for fear of hypoglycemia are modifiable and the decrease
of its impact might improve the QoL.
065
FACTORS AFFECTING THE SUCCESS OF INSULIN
DOSE INTENSIFICATION IN PATIENTS WITH TYPE 2
DIABETES: AN ANALYSIS FROM THE OPT2MISE
RANDOMIZED TRIAL
O. Cohen1, I. Schutz-Fuhrmann2, J. Castaneda3, Y. Reznik4,
R. Aronson5, I. Conget6, S. Liabat7, S. Runzis7, S. de Portu7
1
Sheba Medical Center, Institute of Endocrinology, Ramat Gan,
Israel
2
City Hospital Vienna-Hietzing, Department of Endocrinology,
Vienna, Austria
3
Medtronic, Bakken Research Center, Maastricht, The
Netherlands
4
University of Caen Cote de Nacre Regional Hospital Center,
Department of Endocrinology, Caen, France
5
LMC Diabetes & Endocrinology, LMC Diabetes &
Endocrinology, Toronto, Canada
6
Endocrinology and Nutrition Department, Diabetes Unit-
University Hospital Clinic, Barcelona, Spain
7
Medtronic International Trading Sarl, Medtronic International
Trading Sarl, Tolochenaz, Switzerland
ATTD 2017 ORAL ABSTRACTS
Background and Aims: Identification of factors influenc-
ing the outcome of insulin treatment intensification during the
8-week run-in period of the OpT2mise study could be useful in
informing management decisions.
Methods: In OpT2mise, patients with HbA1c 8% despite
optimized multiple daily dose (MDI) insulin therapy were ran-
domized to continued MDI or pump therapy. Multivariate logistic
were significant (alpha level = 0.20) in univariate analysis, was
performed to assess associations between baseline demographic
or clinical characteristics and the likelihood of randomization.
Sensitivity and specificity were calculated for several values of
initial HbA1c to assess its predictive value in identifying partici-
pants in whom MDI treatment optimization was not beneficial.
Results: 134 of 495 participants were not randomized because
their HbA1c had decreased to <8.0% following insulin dose op-
timization. On multivariate analysis, the only factor associated
with randomization was HbA1c at the beginning of dose opti-
mization. Two HbA1c cut-off values were identified: a baseline
HbA1c of 8.4% was found to give optimal sensitivity (90%) and
specificity (37%) for the prediction of dose optimization success
or failure, while a value >9.0% (sensitivity = 62% and specific-
ity = 76%) was considered on clinical grounds to indicate a low
likelihood of achieving glycaemic goals with MDI alone.
Conclusions: This finding supports the early consideration of
alternative interventions, including insulin pump therapy, in pa-
tients with HbA1c 9% despite optimized MDI therapy. Limita-
tions of this analysis include its post hoc nature and the lack of use
of newer therapies introduced after the trial ended.
066
ROUTINE USE OF BOLUS CALCULATOR IMPROVE
THE METABOLIC CONTROL IN CHILDREN WITH
TYPE 1 DIABETES IN THE FIRST YEAR OF INSULIN
PUMP TREATMENT
B. Obermannova1, L. Petruzelkova1, S. Kolouskova1,
S. Pruhova1, Z. Sumnik1
1
2nd Faculty of Medicine- Charles University in Prague,
Department of Paediatrics, Prague, Czech Republic
Background and Aims: The treatment with CSII using bolus
calculator (BC) may improve metabolic control in type 1 dia-
betes (T1D). The aim of our study was to assess the impact of
routine bolus calculator use in comparison with fixed boluses in
the first year of CSII treatment in children with T1D.
Methods: In this single-centre, retrospective cohort study, 66
children (34 boys, 50%; age 10.0 3.1 years; diabetes duration
3.6 2.1 years; HbA1c 65.3 mmol/mol) in first year of insulin pump
treatment, were observed. We compared children with routine use
of bolus calculator (BC+ group; 31 children, 47%) with children
without using this technology (BC- group; 35 children, 53%) from
CSII start. We have retrospectively assessed the HbA1c, total daily
dose of insulin (TDD), basal/bolus ratio, number of boluses/day and
BMI; all in 0, 3, 6, 9, and 12 months after the CSII initiation. The
differences between groups were analyzed using non-parametric
tests (Kruskal-Wallis, ANOVArepeated measurement).
Results: In both groups the most significant drop in HbA1c
was in first three months of CSII treatment (p < 0.001). In the last
quarter of year the HbA1c shifts differently: in BC- arises
(65.00 / 68.00 mmol/mol), in BC+ declines (62.00 / 61.00
mmol/mol); p = 0.007, see graph. In BC+ group was significantly
ATTD 2017 ORAL ABSTRACTS
higher boluses percentage of TDD (BC +58% vs. BC- 47% of
TDD, p = 0.01). The insulin TDD, number of boluses per day and
BMI did not differ between the groups.
Conclusions: In children with T1D routine use of bolus cal-
culator precise the bolus size which improves the metabolic
control in the first year of CSII treatment.
067
BENEFIT OF AN AMBULATORY INSULIN PUMP (AIP)
IN INSULIN REQUIRING TYPE 2 DIABETIC (T2D)
PATIENTS WITH HIGH INSULIN NEEDS (1.3 U/KG/D)
F. Travert1, D. Huet2, S. Clavel3, O. Dupuy4, E. Ghanassia5,
K. Mohammedi1, J.F. Thuan6, K. Krompa1, J.P. Courreges7
1
CHU Bichat, Diabetology, Paris, France
2
CH Saint Joseph, Diabetology, Paris, France
3
CH Hotel Dieu, Diabetology, Le Creusot, France
4
CH Saint Jospeh, Diabetology, Paris, France
5
Clinique Sainte Therese, Diabetology, Sete, France
6
CH Narbonne, Diabetology, Narbonne, France
7
Hopital General, Service de Medecine interne et Diabetologie,
Narbonne, France
Background and Aims: T2D patients may show very high
insulin needs with failure in glycemic control. How do these
patients evolve with an AIP on a day-to-day basis?
Methods: 110 T2D patients who show insulin optimization
failure (HbA1c8% in spite of 3 injections/d - 0.7 U/kg/d)
benefit from an AIP in an observational, multicentric trial. Among
them, 31 (HD) need 1.3 U/kg/d (21 1.5 U/kg/d) and are com-
pared with 32 patients (C) need 1.1 U/kg/d.
Results:
HbA1c, decreased identically from T0 (identical initial level):
Insulin needs (significantly different at T0 p < 0.0001)
dropped very significantly in the HD Group vs. C Group.
No difference was noticed concerning hypoglycemia between
both groups (0 severe hypoglycemia).
Conclusions: In case of multi-injections failure associated
with high insulin needs, the use of insulin infusion through AIP
leads to a good glycemic control, with a very noticeable decrease
in insulin needs (-30%), better than in patients with moderate
A-27
insulin needs, but with a superior and no significant weight gain,
probably linked to persisting high insulin needs.
068
EFFECT OF INSULIN DELIVERY ON GLYCEMIC
CONTROL IN PEOPLE WITH TYPE 2 DIABETES
D. Kruger1, R. Morlock2, R. Wood3, A. Davis4, C. Kuerschner5,
J. Warner5
1
Henry Ford Health System, Endocrinology, Detroit, USA
2
YourCareChoice, Managing Director, Ann Arbor, MI, USA
3
dQ&A, Research, San Francisco, USA
4
Metabolic Markets, Research, San Clemente, USA
5
CeQur, Clinical Development, Marlborough, USA
Background and Aims: Insulin is critical therapy for people
with T2 diabetes. However, insulin injections interfere with
daily life and can cause embarrassment. Choice of insulin delivery
may impact glycemic control. This study examines HbA1c control
in people withT2 diabetes (T2DM) using pumps, pens, and syringes.
Methods: An online survey for people with diabetes was fielded
1Q2016 using the dQ&A Patient Panel. Type of insulin delivery
device, years using insulin, age at diagnosis, comorbidities, use of
glucose monitoring, self-reported adherence, insurance and patient
sociodemographics were collected. Descriptive statistics were used
to describe patients achieving HbA1c < 7 vs. HbA1c > 9 by insulin
delivery.
Results: Adults with T2DM using an insulin device (n = 1,579)
had mean age of 61.15(9.91) years, 60.27% were female and
mean duration of insulin was 9.24 years. Less than 40% reported
achieving HbA1c<7 and 10% had an elevated HbA1c>9. Dif-
ference in HbA1c by delivery device indicate patients using
syringe+pen were most likely to have HbA1c>9 followed by
patients using syringe alone, pen only and pump (30% vs.
26.5% vs. 20.3% vs. 12.5%; p = 0.03, respectively). Pump us-
ers reported using insulin for longest time and pen only users
for shortest (13.48 vs. 7.52 years; p < 0.001). Pump users were
most likely to be married followed by pen only, syringe+pen,
and syringe only (75.33% vs. 60.40% vs. 59.24% vs. 53.92%;
p < 0.001, respectively).
Conclusions: This study identifies differences in levels of
HbA1c control by insulin delivery. People using more discreet
(pens/pumps), easier to adhere and less inconvenient (pumps)
delivery report greater levels of control.
069
LONG-TERM GLYCAEMIC CONTROL OF CHILDREN
WITH TYPE 1 DIABETES ON INSULIN PUMP
THERAPY IN A POPULATION BASED CASE-
CONTROL STUDY
M.A. Burckhardt1,2, G. Smith3, M.N. Cooper3, T.W. Jones1,2,3,
E.A. Davis1,2,3
1
Department of Endocrinology and Diabetes, Princess
Margaret Hospital for Children, Perth, Australia
2
School of Paediatrics and Child Health, The University of
Western Australia, Perth, Australia
3
Telethon Kids Institute, The University of Western Australia,
Perth, Australia
A-28 ATTD 2017 ORAL ABSTRACTS

Background and Aims: Long-term glycaemic outcomes in

patients with type 1 diabetes (T1D) on insulin pump therapy
(CSII) in real world are still debated. The aim of this study is to
investigate the long-term outcome of CSII compared to injection
therapy in children with T1D in a population-based paediatric
diabetes service in Western Australia.
Methods: Patients using CSII between January 1999 and July
2016 were matched to patients on injection therapy on the basis
of age, date of diagnosis and HbA1c at pump start.
Results: Of 760 eligible patients on CSII, 535 pump-injection
matches were identified. The mean age, duration of diabetes and
HbA1c at pump start was 11.1 years (SD 3.79), 3.3 years (SD
2.74) and 7.8% (SD 1.0). The mean duration of follow-up was
3.9 years (SD 2.5), the maximum length was 9.2 years.
CSII improved HbA1c significantly at all measured time points
except at 1 year compared to injection therapy throughout 6 years
of follow-up. The greatest improvements were observed early at 3 Background and Aims: Predictive low glucose management
months and as late as 6 years (N = 109 matched pairs) with a (PLGM) system suspends insulin infusion when patient glucose
decrease in HbA1c of 0.4% (SEM 0.07,p <0.001) and 0.5% (SEM levels are still in normal range to avoid reaching a pre-set low
0.22,p = 0.04) respectively. While the HbA1c beyond 7-years limit. The aim of this study was to determine the efficacy of this
duration was lower in the CSII group, statistical significance was algorithm in the prevention of exercise-induced hypoglycemia
not reached but the number of matched pairs was much smaller. under free-living conditions.
Conclusions: Patients using CSII had a sustained improve- Methods: This was an observational, controlled study in
ment in their glycaemic control compared to a matched cohort which 34 participants exercised (same amount for 2 consecutive
over nine years. To our knowledge, this is the longest and largest days with various sessions of high to moderate-intensity exercise
population-based cohort study in children and adolescents with during free-living conditions during a camp) using two preset
T1D on CSII. PLGM threshold (90 mg/dL vs 70 mg/dL). The primary outcome
was the requirement for hypoglycemia treatment (symptomatic
hypoglycemia with plasma glucose <70 mg/dL or plasma glu-
070 cose <50 mg/dL) and was compared in both groups.
Results: We analyzed 31/34 patients because of missing sen-
EXERCISE MANAGEMENT IN INSULIN PUMP sor data (mean age 15.0 1.5 years, 58.1% males, diabetes dura-
TREATED ADOLESCENTS WITH TYPE 1 DIABETES: tion 7.0 3.6 years, HbA1c at baseline 7.2 0.7%). No significant
PREDICTIVE LOW GLUCOSE MANAGEMENT IS difference has been observed about hypoglycemic events between
SAFE AND EFFECTIVE IRRESPECTIVE OF groups using threshold 70 or 90, with a mean blood glucose levels
THRESHOLDS USED in hypoglycemia 56.8 17.0 mg/dL vs 63.6 6.5 mg/dL (p = 0.07).
V. Cherubini1, I. Rabbone2, C. Arnaldi3, R. Bonfanti4, Time spent in target was similar in both groups, as well as time
G. dAnnunzio5, A.P. Frongia6, F. Lombardo7, E. Piccinno8, spent in hypo or hyperglycemia (Table), with only 3.1% and 3.2%
R. Schiaffini9, S. Toni10, S. Tumini11, P. Cipriano11, N. Minuto5, time respectively spent <70 mg/dL.
L. Lenzi12, S. Giorda2, L. Ferritto1, C. Ventrici7, F. Ortolani8, Conclusions: PLGM system in adolescents with type 1 dia-
O. Cohen13, A. Scaramuzza14 betes was effective to prevent hypoglycemia during and after
1 exercise, irrespective of the PLGM thresholds used.
Department of Womens and Childrens Health- AOU Salesi
Hospital, Division of Pediatric and Adolescent Diabetes,
Ancona, Italy 071
2
University of Turin, Paediatrics, Torino, Italy
3 CAN SMARTGUARD TECHNOLOGY RELIEVE
ASL Viterbo, Diabetologia Pediatrica, Viterbo, Italy
4 HYPOGLYCEMIA FEAR AND IMPROVE QUALITY
Scientific Institute San Raffaele, Paediatrics, Milano, Italy
5 OF LIFE? A MULTICENTER STUDY
Istituto Giannina Gaslini, Diabetologia Pediatrica, Genova,
Italy W.B. Gawel1, A. Tabor1, O. Goik1, G. Deja1, T. Klupa2,
6
Ospedale Brotzu, Paediatrics, Cagliari, Italy V. Szostek-Gawel3, M. Zalinska4, M. Mysliwiec4, A. Gawrecki5,
7
University of Messina, Paediatrics, Messina, Italy D. Zozulinska-Ziolkiewicz5, P. Jarosz-Chobot1
8
Hospital Giovanni XXIII, Division of Pediatric and Adolescent
1
Endocrinology and Diabetes, Bari, Italy Medical University of Silesia, Upper Silesia Centre for Childs
9
Bambino Gesu Hospital, Pediatric Diabetology, Rome, Italy Health, Paediatric Diabetology, Katowice, Poland
10 2
Anna Meyer Childrens Hospital, Juvenile Diabetes Center, Jagiellonian University Medical College, Metabolic Diseases,
Florence, Italy Krakow, Poland
11
University of Chieti, Center of Pediatric Diabetology, Chieti,
3 _
NZOZ Med-Art, Diabetology, Zory, Poland
4
Italy Medical University of Gdansk, Department of Paediatrics,
12
Anna Meyer Childrens Hospital, Juvenile Diabetes Center, Diabetology and Endocrinology, Gdansk, Poland
5
Florence, Italy Poznan University of Medical Sciences, Internal Medicine and
13
Sheba Medical Center, Institute of Endocrinology, Ramat Diabetology, Poznan, Poland
Gan, Israel
14
ASST Cremona, Ospedale Maggiore, Paediatrics, Cremona, Background and Aims: A multicenter study was performed
Italy to assess the quality of life (QoL) of the patients who suffer from
ATTD 2017 ORAL ABSTRACTS
type 1 diabetes (DM1) after introducing personal insulin pump
(IP) 640G with SmartGuard technology.
Methods: 23 women and 22 men with well-controlled DM1
(mean HbA1C was 7.26%) were examined, mean age 15.7 years.
The mean time from diagnosis was 5.2 years. Patient were previ-
ously treated with IP with or without hypoblocade. 2-11 months
after introducing 640G pump therapy two surveys were conducted:
PedsQLTM 3.0 Diabetes which measured the QoL in diabetic pa-
tients (Survey I) and the authorial questionnaire (Survey II) which
measured satisfaction of 640G therapy (11questions).
Results: The mean scores of QoL in Survey I regarding
communication (76%), concerns (59%), treatment (74%) and
diabetes (68%) which according to our scale ( 0-19% very low
QoL, 20-39% low, 40-59% moderate, 60-79% high, 80-100%
very high) means QoL was intact. The results of Survey II showed
gladness and assurance of the patients with 640G pump therapy.
Over a half of participants (35 people) certified a serious reduction
of both hypo/hyperglycemia episodes. 19 respondents highlighted
a better coherence between blood glucose(BG) measured by sensor
and glucose meter(GM) which enabled them to decrease the fre-
quency of pricking fingers with GM to measure BG and improve
QoL. 27 patients noticed easier management of DM1 and better
cooperation with 640G.
Conclusions: Patients with DM 1 using 640G pump are sat-
isfied with the effects of the therapy, feel safer and their QoL
measured by PedsQL is relatively high.
072
CGM-PROVED HYPOGLYCEMIA IN SGLT2-I
TREATED TYPE 2 DIABETES PATIENTS: A LINK TO
KETOACIDOSIS?
S. Levit1, J. Wainstein3, I. Abadi-Korek4, R. Barnea4
1 reactive protein (hs-CRP), lipid profile, metalloproteinase-2 (MMP-
Assuta Medical Center, Institute of Endocrinology,
Diabetology and Metabolism, Tel Aviv, Israel
2 (sICAM-1, sVCAM-1), sE-selectin, adiponectin (ADN).
Hebrew University Medical School, Jerusalem, Diabetes Unit-
Department of Internal Medicine, Hadassah Hebrew University
Hospital, Jerusalem, Israel
3 metformin + pioglitazone + sitagliptin. There was an improvement
Institute of Diabetes, Edith Wolfson Medical Center, Sackler
School of Medicine Tel-Aviv University, Israel, Holon, Israel
4 recorded a decrease of Hs-CRP, sICAM-1, sVCAM-1, and an in-
Assuta Medical Center, Tel-Aviv, Israel, Department of
Academy and Research, Tel Aviv, Israel
Background and Aims: SGLT2- Inhibitors (SGLT2-i) are a
relatively novel class of anti-diabetic medications. Latest studies
have shown their ability to reduce body weight, cardiovascular
morbidity and mortality. Real-life data however is contradictory and
points out some serious side effects: renal impairment, ketoacidosis
(KA), elevated fracture risk, urinary tract infections and even toe
amputations. It was suggested that SGLT2-i per se do not cause
hypoglycemia, until combined with some well-known hypoglycemic
agents like Insulin, Sulfonylurea or Glinides. The combination of
SGLT2-i with anti-hyperglycemic agents (GLP-1 analogues, Met-
formin, DPP4 inhibitors) was proposed as hypoglycemia-safe.
Methods: We report the results of a two-year retrospective
analysis of 136 Type 2 Diabetes (T2DM) patients treated with a
combination of SGLT2-i with Incretin-Based therapy (Mt-IBT). In
52 patients, professional CGM recordings were performed. In nine
patients, CGM-proved hypoglycemic episodes were discovered.
Results: SGM data analysis showed significantly lower av-
erage Sensor Glucose (129.0 22.5 vs. 148.4 30.7 mg%,
p = 0.04) and estimated HBA1C (6.1 0.7 vs. 6.8 1.1, p = 0.02)
A-29
in hypoglycemia group. We also report three cases of KA, proved
by elevated capillary b-hydroxybutyrate concentrations. Patho-
physiological link between frequent hypoglycemia rate (17.3%)
and KA development (2.2%) was suggested.
Conclusions: To our knowledge, this is the first study inves-
tigating the real-life rates of hypoglycemia and KA in SGLT2-i
treated persons with the help of such precise tools as CGM and
capillary blood b-hydroxybutyrate measurement. Rates of hy-
poglycemia and KA were discovered to be more frequent than
previously reported. Pathophysiological link between two con-
ditions is assumed.
073
EFFECTS ON GLYCEMIC VARIABILITY AND GLYCO-
METABOLIC CONTROL OF METFORMIN,
PIOGLITAZONE AND SITAGLIPTIN IN TYPE 2
DIABETIC PATIENTS
G. Derosa1, D. Romano1, A. DAngelo1, P. Maffioli1
1
University of Pavia, Internal Medicine and Therapeutics,
Pavia, Italy
Background and Aims: The aim of the study was to evaluate
the effects of a triple therapy with metformin, pioglitazone and
sitagliptin on glycemic control and glycemic variability com-
pared to metformin monotherapy, and compared to a combina-
tion of metformin and pioglitazone.
Methods: We enrolled 66 not well controlled, type 2 diabetic
patients. Patients were instructed to take metformin 500 mg three
times a day for three months, then pioglitazone 15 mg twice a day
was added for further three months, and finally sitagliptin 100 mg
once a day was added for the latest three months. At the baseline,
and every three months, a continuous glucose monitoring system
was performed. We assessed: glycemic control, high sensitivity C-
2), metalloproteinase-9 (MMP-9), soluble adhesion molecules
Results: We recorded a significant decrease of glycated hemo-
globin with metformin + pioglitazone, and a further decrease with
of lipid profile with metformin + pioglitazone + sitagliptin. We
crease of ADN with metformin + pioglitazone, and with metformin
+ pioglitazone + sitagliptin. A decrease of sE-selectin was recorded
only with metformin + pioglitazone + sitagliptin. No variations of
MMP-2, and 9 were recorded. Regarding glycemic variability, there
was a reduction of AUC>180 and of mean amplitude of glycemic
excursion with metformin + pioglitazone + sitagliptin.
Conclusions: Combination of metformin + pioglitazone +
sitagliptin proved to be effective in improving glycemic control,
and in decreasing glycemic variability.
074
IMPROVED GLYCAEMIC CONTROL AND SUPERIOR
REDUCTION OF PPG INCREMENTS WITH DOUBLE-
BLIND MEALTIME FASTER-ACTING INSULIN
ASPART VS CONVENTIONAL INSULIN ASPART IN
T1D: THE ONSET 1 TRIAL
D. Russell-Jones1, B.W. Bode2, C. De Block3, E. Franek4,
S. Heller5, C. Mathieu6, A. Philis-Tsimikas7, L. Rose8, V. Woo9,
A.B. sterskov10, T. Graungaard10, R. Bergenstal11
A-30
1
Diabetes and Endocrinology, Royal Surrey County Hospital,
Guildford, United Kingdom
2
Department of Clinical Research, Atlanta Diabetes Associates,
Atlanta, USA
3
Department of Endocrinology- Diabetology, and Metabolism,
Antwerp University Hospital, Antwerp, Belgium
4
Department of Human Epigenetics, Mossakowski Clinical
Research Center- Polish Academy of Sciences, Warsaw, Poland
5
Department of Oncology and Metabolism, University of
Sheffield, Sheffield, United Kingdom
6
Laboratory and Clinic of Experimental Medicine and
Endocrinology, University Hospital Leuven, Catholic
University of Leuven, Leuven, Belgium
7
Scripps Whittier Diabetes Institute, Scripps Health, San Diego,
USA
8
Department of Internal Medicine, Institute of Diabetes
Research, Munster, Germany
9
Section of Endocrinology and Metabolism, University of
Manitoba, Winnipeg, Canada
10
Novo Nordisk A/S, Sborg, Denmark
11
International Diabetes Center, Park Nicollet, Minneapolis, USA
Background and Aims: Limiting excursions of postprandial
glucose (PPG) is desirable in people with diabetes. This multi-
centre, treat-to-target, phase 3 trial evaluated the efficacy of
faster-acting insulin aspart (faster aspart) in adults with type 1
diabetes (T1D). The primary endpoint was change from baseline
in HbA1c after 26 weeks treatment.
Methods: Post 8-week run-in, subjects were randomised to
double-blind mealtime (administered 0-2 min before meal) faster
aspart (n = 381), or conventional insulin aspart (IAsp; n = 380), or
open-label postmeal (administered 20 min after the start of meal)
faster aspart (n = 382); each with basal insulin detemir.
Results: After 26 weeks of treatment, HbA1c was reduced for
faster aspart and IAsp (Figure), confirming non-inferiority to IAsp
for both mealtime and postmeal dosing (estimated treatment dif-
ference [ETD], % [95% confidence interval]: mealtime, 0.15
[0.23; 0.07]; postmeal, 0.04 [0.04; 0.12]; P < 0.0001 for non-
inferiority); the reduction in HbA1c was statistically significantly
greater for mealtime faster aspart vs IAsp (P = 0.0003). Superiority
to IAsp for the 2-h PPG increment during a standardised meal test
was confirmed for mealtime faster aspart (ETD: 0.67 [1.29;
0.04] mmol/L; 12.01 [23.33; 0.70] mg/dL; P = 0.0375). The 1-h [95% confidence interval]) was 0.02% [0.15; 0.10]. Both
PPG increment was also statistically significantly reduced (ETD:
1.18 [1.65; 0.71] mmol/L; 21.21 [29.65; 12.77] mg/dL; (PPG) control. The 1-hour PPG increment (meal test) was
P < 0.0001). There were no statistically significant differences in
the overall rate of severe or blood glucose (BG)-confirmed (BG
<3.1 mmol/L [56 mg/dL]) hypoglycaemic episodes.
Conclusions: In summary, faster aspart effectively improved
glycaemic control with superior PPG control for mealtime faster
aspart vs IAsp, representing a clinical advance in treating T1D.
ATTD 2017 ORAL ABSTRACTS
075
FASTER-ACTING INSULIN ASPART VS INSULIN
ASPART AS PART OF BASAL-BOLUS THERAPY
IMPROVES POSTPRANDIAL GLYCAEMIC CONTROL
IN UNCONTROLLED TYPE 2 DIABETES: THE ONSET
2 TRIAL
K. Bowering1, C. Case2, J. Harvey3, M. Reeves4, M. Sampson5,
R. Strzinek6, D.M. Bretler7, R.B. Bang7, B.W. Bode8
1
Division of Endocrinology and Metabolism, University of
Alberta, Edmonton, Canada
2
Medical Building, Jefferson City Medical Group, Jefferson
City, USA
3
Wrexham Academic Unit, Bangor University, Bangor, United
Kingdom
4
Department of Endocrinology, Diabetes Clinical Trials,
Chattanooga, USA
5
Department of Diabetes, Endocrinology and General
Medicine, Norfolk and Norwich University Hospitals NHS
Foundation Trust, Norwich, United Kingdom
6
CEO & Principal Investigator, Protenium Clinical Research,
Hurst, USA
7
Novo Nordisk A/S, Sborg, Denmark
8
Department of Clinical Research, Atlanta Diabetes Associates,
Atlanta, USA
Background and Aims: This multicentre, double-blind, treat-
to-target trial evaluated the efficacy of faster-acting insulin aspart
(faster aspart) vs conventional insulin aspart (IAsp) in adults with
inadequately controlled type 2 diabetes (T2D) on basal insulin
and oral antidiabetic drugs.
Methods: Following optimisation of basal insulin glargine
U100 during an 8-week run-in (mean HbA1c 7.9%), subjects
were randomised 1:1 to mealtime faster aspart (n = 345) or IAsp
(n = 344), each with insulin glargine U100 and metformin, using
a simple daily patient-driven titration algorithm.
Results: The primary endpoint, mean HbA1c change from
baseline to Week 26, was 1.38% and 1.36% for faster aspart
and IAsp, respectively; mean HbA1c was reduced to 6.6% for
both arms. Faster aspart demonstrated non-inferiority vs IAsp
in reducing HbA1c; the estimated treatment difference (ETD;
basalbolus regimens improved postprandial plasma glucose
statistically significant in favour of faster aspart (P = 0.0198;
ATTD 2017 ORAL ABSTRACTS
Figure). Rates of overall severe or blood glucose (BG) con-
firmed hypoglycaemia (BG <3.1 mmol/L [56 mg/dL]) were
comparable. In T2D, mealtime faster aspart and IAsp in a
basalbolus regimen achieved glycaemic control and reduced
HbA1c from baseline to 6.6%, confirming non-inferiority of
faster aspart to IAsp, using a simple daily patient-driven ti-
tration algorithm.
Conclusions: Faster aspart effectively improved 1-hour PPG
control vs IAsp without increasing overall hypoglycaemia.
076
INSULIN GLARGINE 300 U/ML (GLA-300) PROVIDES
MORE STABLE AND MORE EVENLY DISTRIBUTED
STEADY-STATE PHARMACODYNAMIC/
PHARMACOKINETIC PROFILES COMPARED WITH
INSULIN DEGLUDEC IN TYPE 1 DIABETES (T1DM)
1 2 3 4 2 hydrates (CHO) is essential for computing meal insulin doses and
T. Bailey , R. Dahmen , J. Pettus , R. Roussel , K. Bergmann ,
M. Maroccia5, N. Nassr2, O. Klein6, G. Bolli7, T. Heise6
1
AMCR Institute, Escondido, CA, USA
2 food intakes and needed insulin dose according to patients
Sanofi-Aventis Deutschland GmbH, Diabetes Division,
Frankfurt am Main, Germany
3 life on post-meal glucose control in a randomised control study.
University of California, San Diego, CA, USA
4 Methods: Thirty adult T1D patients, under basal-bolus insulin
Assistance Publique Hopitaux de Paris, Bichat Hospital, Paris,
France
5 GLUCAL or patient (CONTROL) estimations of meal CHO
Umanis, Levallois-Perret, Paris, France
6 were used for computing meal insulin doses during two 1-month
Profil, Institut fur Stoffwechselforschung GmbH, Neuss,
Germany
7 sulin doses and 2-hour post-prandial blood glucose (PPG) levels
University of Perugia, School of Medicine, Perugia, Italy
Background and Aims: To compare steady-state pharma-
codynamic (PD) and pharmacokinetic (PK) profiles of insulin
glargine 300 U/mL (Gla-300) with insulin degludec 100 U/mL
(IDeg1) in two parallel cohorts with fixed once-daily dose regi-
mens in T1DM, in a multiple-dosing, crossover, euglycemic
glucose clamp study.
Methods: For both insulins participants received 0.4 U/kg/day
(Cohort 1; n = 24) or 0.6 U/kg/day (Cohort 2; n = 24), before
breakfast, for 8 days. Metabolic activity was measured by glu-
cose infusion rate (GIR) over 30 hours. Main endpoint: within-
day variability (fluctuation) of smoothed GIR over the dosing
interval (GIR-smFL024; treatment ratios were obtained using a
linear mixed-effects model). Insulin concentrations were mea-
sured using validated radioimmunoassays.
Results: GIR-smFL024 was significantly lower with Gla-300
than IDeg1 at 0.4 U/kg/day (p = 0.047; treatment ratio 0.7978
[90% CI: 0.6637 to 0.9591]) (LOESS smoothing 0.15), but was
comparable for Gla-300 and IDeg1 at 0.6 U/kg/day. Both doses
of Gla-300 provided plateau-like insulin exposure from 2 to
16 hours post-injection, with a slight decline afterwards, whereas
IDeg1 concentrations (total insulin) after both doses increased
from *1 hour to a Tmax at *10 hours after dosing, followed by a
steady decline with no plateauing. Both insulins provided ex-
posure and activity until 30 hours and were generally well tol-
erated.
Conclusions: This PK/PD analysis supports a superior glu-
codynamic profile of Gla-300 versus IDeg1 at a dose clinically
relevant for T1DM (0.4 U/kg/day), in terms of within-day vari-
ability. An overall more stable and more evenly distributed in-
sulin exposure over the dosing interval was observed at both dose
levels under Gla-300.
Study supported by Sanofi.
A-31
077
USE OF THE GLUCAL APPLICATION FOR
CARBOHYDRATE COUNTING RESULTS IN
IMPROVED POST-MEAL GLUCOSE CONTROL
IN PATIENTS WITH TYPE 1 DIABETES IN A
RANDOMISED CONTROL STUDY
O. Diouri1, M. Traverso2, J. Place1, V. Georgescu3,
M.C. Picot3, A. Farret1,2, E. Renard1,2
1
Institute of Functional Genomics, CNRS UMR 5203- INSERM
U1191- University of Montpellier, Montpellier, France
2
Montpellier University Hospital, Department of
Endocrinology, Diabetes, Nutrition, Montpellier, France
3
Montpellier University Hospital, Department of Medical
Information, Unit of Clinical and Epidemiological Research,
Montpellier, France
Background and Aims: The accurate estimation of carbo-
achieving targeted post-meal glucose level in patients with type 1
diabetes (T1D). We developed the Android application GLU-
CAL that automatically computes CHO content of declared
CHO/insulin ratio. We assessed the outcomes of its use in free-
regimen, were randomised in a two-month cross-over study.
periods in random order. Computed CHO amounts, injected in-
were recorded for each meal.
Results: Twenty-for patients (age 43 15, HbA1c 7.5 0.6%)
completed the study. Number of GLUCAL vs. CONTROL study
days and meals were respectively 30.6 2.6 vs. 31.3 4.3 and
80.8 17.4 vs. 86.8 19.8. Percentage of PPG values in 80-180mg/
dl range (primary study endpoint) was higher with GLUCAL:
53.8 13.1 vs. 48.1 12.5 (p = 0.0002), thanks to reduced %PPG
>180mg/dl: 32.3 11.6 vs. 38.3 11.3 (p = 0.0010), while %PPG
<80mg/dl were similar: 13.9 6.9 vs. 13.6 5.7 (p = 0.7875). Mean
of PPG was also reduced significantly with GLUCAL: 158 23 vs.
167 25 (p = 0.0094) while SD of PPG increased slightly: 72 19
vs. 65 20 (p = 0.0156).
Conclusions: Our data supports the benefits of using GLU-
CAL to improve post-meal glucose control in T1D patients
through better adjusted insulin doses which reduce PPG values
>180mg/dl without increasing hypoglycaemia. Longer term
studies are expected to confirm sustainability with time.
078
ACHIEVING NEAR EUGLYCAEMIA USING LONG-
TERM INSULIN PUMP THERAPY DIFFERENTIALLY
IMPROVES C-PEPTIDE LEVEL OR DISPOSITION
INDEX IN TYPE 2 DIABETES
S. Choi1, Y. Noh2
1
School of Medicine- Konkuk University, Internal Medicine,
Seoul, Republic of Korea
2
School of Medicine- Konkuk University, Biochemistry, Seoul,
Republic of Korea
Background and Aims: Through insulin pump (CSII) ther-
apy, hyperglycemia can be controlled to near normal level in
A-32
patients with type 2 diabetes (T2D). We wanted to find out
whether the changes in beta cell function, insulin sensitivity, and
disposition function would be observed in T2D patients during
long-term CSII therapy.
Methods: We applied CSII therapy to T2D patients (number,
163 with 56.4% of male; age, 59.7 9.7 years; duration,
11.1 6.9 years; HbA1c 8.9 1.9%; BMI 24.4 3.1 kg/m2).
Blood samplings were performed yearly for 4 years at overnight
fasting and 120 minutes after ingestion of a standard mixed meal
(500 kcal). Serum C-peptide, glucose, and HbA1c were mea-
sured and C-peptidogenic Index (CI), Matsuda Index (MI), and
disposition Index (DI) were calculated. Patients were grouped
into high MI [insulin sensitive (IS) group; age 58.0 10.2 years]
and low MI [insulin resistant (IR) group; age 61.1 9.1 years] by
the mean value of baseline MIs.
Results: HbA1c decreased significantly from 8.9% to 6.6% in
both groups. In IS group, serum C-peptide increased significantly
but DI did not change. Whereas, in IR group, serum C-peptide
did not increase but the DI increased significantly. Glycemic
control to near normal level was associated with increase in C-
peptide level only in IS group but not in IR group, while it was
associated with increased DI level in IR group but not in IS
group.
Conclusions: Achieving near euglycaemia using long-term
insulin pump therapy seems to restore the original defect in each
diabetic group.
079
USING CONTINUOUS GLUCOSE MONITORING
(CGM) TO EVALUATE THE SENSITIVITY OF
HYPOGLYCEMIA DETECTION IN DIABETES ALERT
DOGS (DADS)
L. Gonder-Frederick1, J. Grabman1, J. Poler, Jr.1, J. Shepard1
1 widely discussed. Liver biopsy as diagnostics is invasive and
University of Virginia, Psychiatry & NB Sciences,
Charlottesville, USA
Background and Aims: Despite more patients with type 1
diabetes (T1DM) using DADs to assist in their diabetes man-
agement, few studies have systematically investigated DAD
accuracy. This study compared CGM data to participant reported
DAD alerts to test real-world DAD sensitivity to hypoglycemia.
Methods: All participants had DADs placed in their homes
for 5 months by the same training organization. Eight adults (22
43 yrs) and eight youth (8 17 yrs) with T1DM wore a Dexcom
G4 Platinum for 13 50 days (Median = 29). Participants used
ATTD 2017 ORAL ABSTRACTS
the CGM event recorder to report DAD alerts, and completed
paper diaries detailing further information (e.g., alerts not re-
corded electronically). CGM readings 3.9 mmol/L for 15 con-
secutive minutes were considered hypoglycemic events. To
account for anecdotal reports that DAD alerts may precede hy-
poglycemia, alerts 30 minutes before to 30 minutes after the
onset of an event were categorized as hits, with failures to alert
in this time frame categorized as misses. Data was included
only if participants were awake and with their DADs.
Results: Table 1 displays an overview of each participants
results. DAD sensitivity varied substantially between partici-
pants, ranging from 0.0 100.0% (42.1% across all participants).
Five DADs demonstrated >50.0% sensitivity, or alerted to more
than half of hypoglycemic episodes. Eleven DADs alerted to
fewer than half of events.
Conclusions: Sensitivity to hypoglycemia appears to be
highly variable across DADs. More research is needed to assess
DAD accuracy and factors that contribute to DAD variability.
080
CORRELATION OF TRANSIENT ELASTOGRAPHY
WITH OTHER NON-INVASIVE METHODS
OF NON-ALCOHOLIC LIVER FIBROSIS
ASSESSMENT IN DIABETIC PATIENTS
J. Jirkovska1, L. Vedralova1, M. Koula1, P. Hribek1,
P. Urbanek1, S. Solar1, M. Zavoral1
1
Medical Department of the First Faculty of Medicine and
Military University Hospital Charles University, Internal
Medicine Dpt, Prague, Czech Republic
Background and Aims: Influence of non-alcoholic fatty liver
disease (NAFLD) and steatohepatitis (NASH) on diabetes is
expensive. Therefore, non-invasive methods are recommended.
Aim was to compare grade of fibrosis assessed by transient
elastography (Fibroscan) with NAFLD Fibrosis Score (NAFLD
Score) and FIB-4 Score.
Methods: Study included 21 diabetics with NAFLD
(62% men, mean BMI 29.1). Liver stiffness examined with
transient elastography was assessed as a median of at least 10
valuable measurements (E_med) in kiloPascales (kPa). Corre-
lation analysis was applied to compare E_med with NAFLD
Score and FIB-4 Score. F0-F4 grade od fibrosis was assessed for
each method.
Results: Mean E_med was 8.17 2.81kPa, mean NAFLD
Score -0.73 1.15, mean FIB-4 Score 1.45 0.64. F0-1 (absence
of significant fibrosis) was assessed in 47% of patients with Fi-
broscan, in 44% with NAFLD Score and in 62% with FIB-4
Score, respectively. F2 (grey zone) was assessed in 29% of
subjects with Fibroscan, in 39% with NAFLD Score and in 38%
with FIB-4 Score. F3-4 (significant fibrosis) was assessed in 24%
of patients with Fibroscan, in 17% with NAFLD Score and
in nobody with FIB-4 Score. Significant correlation was found
in comparison of Fibroscan with NAFLD score (r = 0.481,
p < 0.05), whereas correlation with FIB-4 Score was not signifi-
cant (r = 0.155 NS).
Conclusions: Significant correlation was found between
grade of liver fibrosis assessed by Fibroscan and NAFLD Score.
Combination of these methods in detection of liver fibrosis is
helpful. Physicians are then better able to select patients in higher
risk of NASH where biopsy should be considered.
ATTD 2017 ORAL ABSTRACTS
081
IN VITRO PRODUCTION OF INSULIN FROM
MONOCYTES WITH AND WITHOUT THE USE
OF LIRAGLUTIDE AND GROWTH FACTORS
A. Kyventidis1, T. Didangelos1, G. Tzimagiorgis2,
A. Hatzitolios1
1 Results: 10598 admissions with data identified. A U-shaped
AHEPA University Hospital, 1st Propeudetic Department
of Internal Medicine, Thessaloniki, Greece
2
Aristotle University of Thessaloniki, Department of Biological
Chemistry, Thessaloniki, Greece
Background and Aims: To investigate the abilities of
monocytes to differentiate into insulin-producing cells in cell
cultures in vitro using growth factors and liraglutide.
Methods: Monocytes have been cultured in vitro for 7 and
14 days with and without growth factors and liraglutide in three
experiments. We used the following 4 growth factors: M-CSF
Interleukin-3, EGF, and HGF. Afterwards, they were tested for in-
sulin production at 100 and at 250 mg/dl glucose concentrations.
Results: In two experiments, monocytes that have been cul-
tured for 7 days (1st) and 14 days (2nd) with growth factors and
liraglutide produced 10.32 6.78 lU/ml insulin (n = 10) and
17.03 12.76 lU/ml insulin (n = 18), respectively. In the third
experiment, monocytes that have been cultured for 14 days
without growth factors and liraglutide produced 15.05 6.20 lU/
ml insulin (n = 10). After the rise of glucose concentration from
100 to 250 mg/dl for one hour, they increased significantly the
amount of insulin to 22.81 6.02 lU/ml (p = 0.001). The differ-
ence in the amount of insulin between the monocytes cultivated
with and those cultivated without growth factors for 14 days was
not significant (p = 0.811).
Conclusions: Monocytes can produce sufficient amounts of
insulin after 7 and 14 days of culture. Growth factors and liraglutide
are not necessary to achieve efficient insulin production, but when
added there was an increase in insulin production. In addition, cells
grown without growth factors were able to increase insulin pro-
duction according to the glucose increase of the supernatant.
082
ADMISSION GLUCOSE NUMBER (AGN): A NOVEL
POINT-OF-ADMISSION SCORE ASSOCIATED WITH
PROLONGED ADMISSION DURATION AND WITH
GLYCAEMIC CHARACTERISTICS IN PATIENTS
WITH TYPE 1 DIABETES
R. Maitland1, R. Srivastava2, S. Cunningham3, G. Jones1,
C. Sainsbury1
1
Gartnavel General Hospital, Diabetes, Glasgow, United
Kingdom
2
Queen Elizabeth University Hospital, Clinical Biochemistry,
Glasgow, United Kingdom
3
Ninewells Hospital, Clinical Technology Centre, Dundee,
United Kingdom
Background and Aims: To assess associations between ad-
mission glucose number (AGN) and admission outcomes for
inpatients with T1D.
Methods: Inpatient capillary blood glucose (CBG) data for
patients with T1D in our health board were identified for 6-year
period and associated with most recent pre-admission HbA1c.
AGN was calculated as first CBG measured during admission
(mmol/L), subtracted from most recent pre-admission HbA1c
A-33
(converted to estimated median glucose mmol/L) within 15-
months pre-admission. The association between AGN and CBG
variability (interquartile range), length of stay (LOS), and number
of hypoglycaemic (<4mmol/L) episodes/day were investigated.
Hypoglycaemic episodes defined as sequences of contiguous
CBG measures below 4mmol/L where the time interval between
each measure was <60 minutes.
association between AGN and CBG variability was seen with
lowest variability at AGN of 0-2 (IQR 3.7mmol/L), with peak
variability AGN of negative 16-18 (6.9mmol/L) and 12-14
(5.9mmol/L). Median LOS was negatively associated with AGN
from AGN negative 18-20 (6.1 days) to AGN 8-10 (1.9 days), with
AGN >10 associated with an increase to AGN 16-18 (2.9 days). A
U-shaped association between AGN and hypoglycaemic episodes/
day was seen with minimum 0.13 episodes/day at AGN (-2-0) and
peak frequency at AGN negative 14-12 (0.34 episodes/day) and
AGN 8-10 (0.51 episodes/day) (p < 0.05 for all values compared
with minimum).
Conclusions: AGN is a simple metric which combines 2 mea-
sures readily available very early during admission. AGN may be a
useful tool to stratify patients for risk of glycaemic variability, hy-
poglycaemia and prolonged hospital stay at the point of admission.
083
IMPAIRED AWARENESS OF HYPOGLYCAEMIA
IS ASSOCIATED WITH BLUNTED THALAMIC,
BUT INCREASED FRONTAL ACTIVATION
IN RESPONSE TO HYPOGLYCAEMIA
M. Nwokolo1, S. Amiel1, F. Zelaya2, M. Byrne1, B. Wilson1,
L. Green1, A. Pernet1, P. Choudhary1
1
Kings College Hospital, London, UK, Division of Diabetes
and Nutritional Sciences, Faculty of Life Sciences and
Medicine, London, United Kingdom
2
Kings College London, London, UK, Department of
Neuroimaging, Institute of Psychiatry, Psychology and
Neuroscience, London, United Kingdom
Background and Aims: To investigate the impact of type 1
diabetes and impaired awareness of hypoglycaemia (IAH) on the
brains response to hypoglycaemia, using arterial spin labelling
functional MRI (ASL-fMRI).
Methods: 15 hypoglycaemia-aware (HA) type 1 subjects (age
39 13.5years, diabetes duration 24 12.8years, Gold score 1.5
0.5, 6 male) and 15 matched subjects with IAH ( age 38 10.6years,
diabetes duration 22 7.8years, Gold score 5.7 1.4, 7 male) un-
derwent ASL-fMRI scans at 5mmol/L and 2.6mmol/L. Symptoms
were scored using a visual analogue scale. Global and regional ce-
rebral blood flow (rCBF) were analysed.
Results: Total symptom score increased significantly in HA,
euglycaemia vs hypoglycaemia; 18.9 6.9 vs 37.4 10.8,
p < 0.0001, but not in IAH, 17.8 5.4 vs 18.7 5.7, p = 0.4).
Global CBF increased significantly in both HA and IAH (HA
6.3%, p = 0.01; IAH 8.0%, p = 0.03). A within group, paired t-test
(euglycaemia vs hypoglycaemia) in HA showed an increase in
rCBF in the thalamus and a decrease in the hippocampus and
temporal lobes in response to hypoglycaemia. The same analysis
in IAH showed no changes in the thalamus, but significant in-
creases in the dorsolateral prefrontal cortex and orbitofrontal
cortex, areas involved in executive function. A significant de-
crease in rCBF was noted in the temporal cortex, involved in
memory and processing of sensory input.
A-34
Conclusions: IAH is associated with loss of the thalamic re-
sponse to hypoglycaemia, a region involved in the modulation of
stress pathways. Differences in frontal responses between HA and
IAH may be maladaptive, explaining dissimilarities in behavioural
responses to hypoglycaemia between IAH and HA.
084
NON-CONTACT, IMAGE ANALYSIS OF THE
PUPILLARY PROCESS AS A MEANS OF DETERMINING
AND MONITORING HYPER/HYPOGLYCEMIA
K. Steinberg1
1
GlucoSight, Engineering, Nashua, USA
Background and Aims: To develop a completely non-
invasive, no-contact method of determining blood glucose level.
The intent is to allow a person with diabetes to measure his or her
glucose level and only employ traditional blood-based analysis
when out-of-range indication is provided.
Methods: The controlled stimulation of the pupillary process
is correlated with the blood sugar level of a person with diabetes.
Infrared video is recorded while the patients eye is placed in a
high-isolation environment and stimulated with a brief flash of
white light. The pupil diameter is analyzed over the duration of
the stimulation (8 seconds), and correlated against previously
derived, patient specific, baselines.
Results: Various data points along the pupillary reaction
curve have shown to be indicators of the patients blood sugar
level, allowing the method to provide feedback as to whether the
patients glucose is normal, hyper- or hypoglycemic.
Conclusions: The method will allow persons with diabetes to
check their glucose range without the need for blood-based anal-
ysis. This will increase the frequency with which a person will and
can check their glucose, increasing their ability to control their
glucose level, decreasing the pain associated with glucose moni-
ATTD 2017 ORAL ABSTRACTS
toring, reducing possible complications of subcutaneous sensors/
lancing, cutting healthcare costs, and increasing better long-term
outcomes due to more frequent monitoring.
085
SHORT-TERM EFFECTS OF LOW CARBOHYDRATE
DIET ON GLYCAEMIC CONTROL AND METABOLIC
RISK MARKERS IN PATIENTS WITH TYPE 1
DIABETES A RANDOMISED OPEN-LABEL
CROSS-OVER STUDY
A. Ranjan1, S. Schmidt1, C. Damm-Frydenberg1, I. Steineck1,
J.J. Holst2, S. Madsbad1, K. Nrgaard1
1
Copenhagen University Hospital Hvidovre, Department
of Endocrinology, Research Unit, Hvidovre, Denmark
2
University of Copenhagen, Department of Biomedical
Sciences, Faculty of Health and Medical Sciences,
Copenhagen, Denmark
Background and Aims: To compare effects of high versus
low carbohydrate diet on glycaemic control and on metabolic
risk markers in patients with type 1 diabetes.
Methods: A randomised cross-over study was performed on ten
patients with insulin pump-treated type 1 diabetes (4 females, me-
dianSD age 48 10 years, diabetes duration 23 7 years, HbA1c
53 6 mmol/mol (7.0 0.6%)). Patients followed one week of high
carbohydrate diet (HCD >250 g daily) and one week of isocaloric
low carbohydrate diet (LCD <50 g daily) in random order. At the
end of each week, we downloaded data from sensor-augmented
insulin pumps and collected fasting blood and urine samples.
Results: Diet compliance was high (meanSD 225 30
vs 47 10 g carbohydrates, p < 0.0001) and change in body weight
did not differ between diets (-0.8 1.5 vs -1.6 1.5, p = 0.50).
Mean sensor glucose values did not differ between diets (7.3 1.1
vs 7.4 0.6 mmol/l, p < 0.05). However compared with HCD,
patients on LCD had lower glucose variability (SD 2.6 0.4 vs
1.9 0.4 mmol/l, p = 0.009) and lower total daily insulin dose
(38.8 8.1 vs 21.6 3.5 U/day, p < 0.0001). LCD further increased
fasting levels of glucagon (5.0 2.6 vs 6.9 4.1 pmol/l, p = 0.02),
ketones (214.9 100.3 vs 944.6 387.7 lmol/l, p < 0.001) and free
fatty acids (0.6 0.3 vs 0.9 0.4 mmol/l, p < 0.001). Other lipid
and renal biomarkers were unaffected by the diets.
Conclusions: One week of LCD reduced glycaemic vari-
ability and daily insulin dose without altering mean glucose
levels but elevated concentration of ketones, free fatty acids and
glucagon. Long-term studies are needed to determine whether
these study effects are persistent.
ClinicalTrials.gov: NCT02578498
086
CONTINUOUS GLUCOSE MONITORING IN VERY
PRETERM INFANTS: A RANDOMIZED
CONTROLLED TRIAL
A. Galderisi1, A. Facchinetti2, G. Steil3, P. Ortiz-Rubio3,
F. Cavallin4, E. Baraldi5, D. Trevisanuto5, C. Cobelli2
1
Yale University, Pediatric Endocrinology, New Haven, USA
2
University of Padova, Department of Information Engineering,
Padova, Italy
3
Harvard University, Boston Childrens Hospital, Boston, USA
4
Independent Statistician, Padova, Padova, Italy
5
University of Padova, Department of Womans and Childs
Health, Padova, Italy
ATTD 2017 ORAL ABSTRACTS A-35

Background and Aims: Impaired glucose control in very

preterm infants is associated with increased morbidity, mortality
and poor neurological outcome. Strategies based on insulin ti-
tration have been unsuccessful in achieving euglycemia in the
absence of severe complications. We assessed whether use of an
algorithm based on continuous glucose monitoring(CGM) data
for adjustment of glucose infusion is more effective than stan-
dard care in maintaining very preterm infants in euglycemia
during the first week of life.
Methods: We conducted a randomized controlled trial at the
Neonatal Intensive Care Unit of University of Padova (Italy).
Fifty newborns, born 32 weeks gestational and/or with birth-
weight 1500 g, were randomized (1:1) to two groups within
48 hrs of life: unblinded-CGM (UB-CGM), with glucose infu-
sion adjusted according to an algorithm driven by CGM (Dex-
comG4Platinum) continuously and hypoglycemic alarms active;
blinded-CGM (B-CGM), with display darkened and no alarms.
The primary outcome was defined as time spent in euglycemic
range (4-8mmol/L). Secondary outcomes were time spent in mild
(<4mmol/L) and severe (<2.6mmol/L) hypoglycemia; mild
(>8mmol/L) and severe (>10mmol/L) hyperglycemia; and glu-
cose variability. Clinicaltrials.govNCT02583776.
Results: UB-CGM group showed an increase of time spent
in euglycemic range vs. B-CGM (median, 84% vs. 68%, p <0.001),
with decreased time spent in severe hypoglycemia (1.5% vs. 0.2%,
p = 0.007), mild hypoglycemia (16.9% vs. 12.1%, p = 0.04) and
severe hypoglycemia (0.3% vs. 0.0%, p = 0.04), respectively. UB-
CGM showed decreased glycemic variability vs. B-CGM (glucose
SD 1.1 0.3mmol/L vs. 1.5 0.4mmol/L, p = 0.0106; coefficient of
variation 22.8 4.2% vs. 27.9 5.0%; p < 0.001). cemia and minimizes glycemic variability in preterm infants in
Conclusions: CGM coupled with a glucose infusion algorithm neonatal intensive care unit, during the first week of life.
increases the time spent in euglycemic range, reduces hypogly-

087
EFFECTS OF HAWTHORN ON HBA1C
AND LIPIDS LEVELS IN JORDANIAN
DIABETES PATIENTS (TYPE2)
A. Aljamal1
1
Al al-Bayt University, Biological Sciences, Mafraq, Jordan

Background and Aims: The present study was designed to

investigate the effects of supplementation of Hawthorn on
HbA1C and lipids levels among type2 diabetes patients.
Methods: The samples consisted of 55 subjects with type2
diabetes and the doses of Hawthorn were equally administered
orally in the form of capsules each capsules contain (500 mg),
with breakfast, lunch and dinner. The doses were given for 12
weeks. Blood samples were taken on the starting day of the
experiment and at the end of 12 weeks.
Results: The fasting blood glucose, HbA1C and lipid levels of
type2 patients were determined. The results at starting day were
found to be 223.6 mg/dl, the mean value of HbA1C was 8.5%, and
lipid levels were: triglycerides (235.5 mg/dl), total cholesterol
(310 mg/dl), low-density lipoprotein (LDL) (155.2 mg/dl), and
high density lipoprotein (HDL) (52.4 mg/dl). When the diabetic
individuals used the doses of Hawthorn for 12 weeks, their mean
fasting blood glucose level dropped to 186.34 mg/dl, HbA1C 7.2,
triglycerides (160 mg/dl), total cholesterol (187.6 mg/dl), LDL
(115.5 mg/dl), and HDL increased (69.2. mg/dl).
Conclusions: The administration of Hawthorn caused re-
duction in the blood glucose; HbA1C and lipid levels were sig-
nificant at P < 0.05, P < 0.001 respectively.
ATTD 2017 E-Poster Discussion Abstracts
088
IS CANCER SCREENING IN DIABETES JUSTIFIED?
INSIGHTS FROM ELECTRONIC MEDICAL RECORDS
1 1 1 1
J. Kesavadev , A. Shankar , L. Ramachandran , G. Krishnan ,
S. Jothydev1
1 3
Jothydevs Diabetes Research Centre, Diabetes,
Thiruvanathapuram, India
Background and Aims: Evidences are on the rise which in-
dicates a strong and consistently increased risk of incident cancer
associated with diabetes. Biomarkers constitute major tests for
the early detection of cancer. To explore this association, we
performed a retrospective analysis of our Electronic Medical
Records to assess the utility of certain cancer markers and early
detection of malignancy in asymptomatic subjects with diabetes.
Methods: EMR of diabetes patients enrolled at our centre
(n = 1300) from January 2014 to 2016, who were diagnosed of
cancer were de-identified.
Results: 1324 patients were screened. 2.95% (n = 39) were
diagnosed of cancer after the onset of diabetes. Of these, 17 cases
were screened and diagnosed during routine visits. Mean age
63.77 9.77 yrs; males (64.10%). Type of cancers detected were-
21.51% breast; 12.82% pancreas; 10.26% each of liver and
prostrate; 7.69% each of multiple myeloma, CA colon/intestine,
stomach; and 2.56% each of gall bladder, lung, oral, kidney,
bladder, uterus, endometrium and non-Hodgkins lymphoma.
CA of prostrate, liver and pancreas (16.00% each) were equally
predominant among males whereas CA breast (42.86%) was
predominant among females.
Conclusions: Cancer markers such as CA 125, CA 19.9, AFP,
PSA etc. are non-specific but sensitive. Higher levels may not
always be significant. But early detection at a curable stage of
malignancy makes it an economically viable step. Our study
highlight the significance of cancer screening in diabetes due to a
higher likelihood of incident cancers among this population. De-
spite the expensive nature of cancer diagnostic tests, incorporating
them into routine diabetes treatment protocol may be justifiable.
089
2016 RESULTS OF THE MULTI-CENTRIC STUDY
RENACED DIABETES TIPO 1
R.N. Faradji1, M. Valenzuela-Lara2,
J.F. Bustamante-Martinez3, N.E. De La Garza-Hernandez4,
A.P. Diaz-Barriga-Menchaca5, A. Escobedo-Ortiz6,
A. Flores-Camargo5, L. Islas-Ortega7, C. Lopez-Miramontes8,
A. Martinez-Ramos-Mendez9, S. Miracle-Lopez10,
L.A. Ramirez-Toscano8, E. Rodriguez-Sanchez11,
M. Tavera-Hernandez12, J.C. Valenzuela-Montoya13,
A-36
M. Vidrio-Velazquez8, R.S. Nino-Vargas14,
E. Sainz-De La Maza-Viadero15, C. Magis-Rodriguez2
1
Instituto Tecnologico de Monterrey / Centro Medico ABC,
Endocrinologia, Mexico, Mexico
2
Centro Nacional para la Prevencion y el Control del VIH y el
Sida- Secretaria de Salud, Epidemiologia, Mexico City, Mexico
Hospital General de Tepic, Departamento de Medicina
Interna, Tepic, Mexico
4
CEMEDIN, Endocrinologia, Monterrey, Mexico
5
Instituto Tecnologico de Monterrey, Ciencias Basicas y
Clinicas, Mexico City, Mexico
6
Hospital General Dr. Miguel Silva, Secretaria de Salud,
Endocrinologia, Morelia, Mexico
7
Hospital DIF de la Ninez Hidalguense, Endocrinologia
Pediatrica, Pachuca, Mexico
8
HGR 110 IMSS Guadalajara, Jal, Endocrinologia,
Guadalajara, Mexico
9
Hospital Espanol, Endocrinologia Pediatrica, Mexico City,
Mexico
10
Hospital Angeles Lomas, Endocrinologia, Mexico City,
Mexico
11
Hospital Rovirosa, Secretaria de Salud, Diabetes,
Villahermosa, Mexico
12
Centro Medico ABC Santa Fe / Hospital Angeles Lomas,
Endocrinologia Pediatrica, Mexico City, Mexico
13
Hospital De Gineco, Pediatra No. 31 IMSS, Endocrinologia
Pediatrica, Mexicali, Mexico
14
Centro para la Prevencion y Atencion Integral del VIH/SIDA
del Distrito Federal, Secretaria de Salud, Jefatura de Sistemas
de Informacion, Mexico City, Mexico
15
UNIVERSIDAD IBEROAMERICANA, EDUCACION, Mexico
City, Mexico
Background and Aims: The information regarding treatment
practices and follow-up of type 1 diabetes (T1D) patients in
Mexico is limited. An online system, RENACED Diabetes Tipo
1 (DT1) was created to have a longitudinal T1D registry with
real-life data in Mexico.
Methods: Descriptive analysis of 474 T1D patients registered
on RENACED DT1 in 10 Mexican States (12 different medical
units), until 10/5/2016.
Results: Forty-one percent of patients were men, mean age 25
years. Fifteen percent have family history of T1D and 58% of
T2D. Thirty-three percent performs SMBG (self monitor of
blood glucose) 4 times/day, 32% uses an insulin-pump and 67%
are on basal-bolus regimen. Patients that perform SMBG 4
times/day, had lower HbA1c levels (8.04; CI95% 7.78.4) than
those that monitor less (8.6; CI 95% 8.48.9) (p < 0.05). A lower
HbA1c level (<0.05) was observed in patients that use a con-
tinuous glucose monitor (CGM) (7.8; CI 95% 7.48.1) than in
those who do not (8.7; CI 95% 8.59.0). A total of 19% and 32%
of patients had HbA1c level <7% and <7.5%, respectively. The
ATTD 2017 E-POSTER DISCUSSION ABSTRACTS
presence of mild/moderate hypoglycemia is high (68.8%), as
well as that of severe hypoglycemia (18%), the presence of
chronic complications was low (6.5%).
Conclusions: According to the literature, the percentage of
patients with HbA1c at goal is lower than desired, even though they
are on state-of-the-art treatment. Performing SMBG 4 times/day
and CGM use are associated with better glycemic control. This is
the first online system for T1D registry in Mexico. A larger number
of cases will lead to better national representation.
090
EVALUATION OF A HOME OGTT TEST KIT: A
CONVENIENT, SENSITIVE AND SPECIFIC TEST
FOR GLUCOSE INTOLERANCE AND DIABETES
J. Jackson1, S. Luzio2, A. Allinson3, C. Peters4
1
SmartSensor telemed Ltd, Executive Office, Didcot, United
Kingdom
2 1
Swansea University Medical School, Institute of Life Sciences,
Swansea, United Kingdom
3
Ramsey Group Practice, GP Surgeries, Ramsey, Isle of Man
4
Great Ormond St Hospital, Department of Endocrinology
and Diabetes, London, United Kingdom
Background and Aims: There is considerable controversy
over the performance of HbA1c for screening and diagnosis, with
many studies showing poor sensitivity and specificity. OGTT
offers greater sensitivity and specificity, but is inconvenient for
patients to access and for health care professionals to provide.
Additionally, there are several circumstances where OGTT is the
most or the only recommended test, such as detecting gestational
diabetes. A new test kit aims to provide the performance of
OGTT with the convenience of a home test; Home OGTT.
Aims: To establish usability and acceptability of a recently
optimised version of Home OGTT and to determine its perfor-
mance for detecting dysglycaemia.
Methods: Home OGTT (SmartSensor telemed Ltd, Didcot,
UK) uses a novel disposable device to perform an OGTT pro-
cedure and record the test data for analysis by a healthcare pro-
fessional. The latest version allows the patient to scan the test
data using a smartphone, with results immediately available in an
electronic record.
A-37
Results: Usability by patients was evaluated at Oxford Uni-
versity (2011, published elsewhere), Great Ormond St Hospital
and Ramsey Group Practice (2015/6). Universal ease of use was
observed, with high patient acceptance.
At Swansea University (2015) Home OGTT demonstrated
good correlation to laboratory glucose (R2 * 0.96). SmartSensor
telemed has reprocessed (2015) Home OGTT data collected in an
earlier comparative OGTT study; sensitivity and specificity are
above 97%.
Conclusions: Home OGTT is easy to use, acceptable to pa-
tients, and easy to administer in the clinic. With considerable
improvements in performance over alternatives, Home OGTT
could transform detection of glucose intolerance and diabetes.
091
INPATIENT AND INSULIN COSTS AMONG TYPE 1
DIABETES PATIENTS TREATED WITH SENSOR-
AUGMENTED INJECTION VERSUS SENSOR-
AUGMENTED PUMP THERAPIES
C. Zhu1, M. Bansal1, M. Gill1
Medtronic plc, Health Economics and Reimbursement,
Northridge, USA
Background and Aims: Continuous glucose monitoring
(CGM) has been proven to enhance the clinical outcomes of type
1 diabetes (T1D) patients. Sensor-augmented injection (SAI) and
sensor-augmented pump (SAP) therapies use CGM with multiple
daily injections and insulin pumps, respectively.
Methods: Assessment of inpatient and insulin costs from a pri-
vate payers perspective among patients treated with SAI and SAP
was performed. Data were extracted from Truven MarketScan
database (2010-2014) for patients with a minimum 1 year follow-up
time since study index date. Specific algorithms were applied to
define T1D patients on treatment regimens (SAI vs. SAP). The an-
alyses were restricted to patients aged 18-64 years with continuous
enrollment in the same health plan with pharmacy benefits and
continuously receiving therapy from the analysis index date.
Results: Two cohorts (N = 644 for both) were matched based on
patient characteristics: age, gender, Charlson Comorbidity Index
(CCI), and macrovascular and microvascular complications. Mat-
ched annual costs, adjusted to 2015 dollars, showed that SAP patients
had approximately 32% lower inpatient cost and 30% lower insulin
cost. SAI therapy was associated with an increased readmission rate
and average length of stay in hospitals compared to SAP usage.
A-38
Conclusions: According to this matched cohort analysis, payer
costs were higher for inpatient admissions and insulin among
T1D patients using CGM technology with injections versus pump
therapy. SAP therapy should be considered as a means to reduce
healthcare expenditures and improve resource utilization.
092
FROM HUMAN MESENCHYMAL STEM CELL
TO INSULIN-PRODUCING CELLS
A. Refaie1, M. Gabr2, M. Zakaria2, S. Khater3, S. Ashamallah3,
A. Moustafa4, M. Ghoneim5
1 studies so far focused specifically on well controlled type 1 di-
Urology & Nephrology Center, Mansoura University,
Nephrology, Mansoura, Egypt
2
Urology & Nephrology Center, Mansoura University,
Biotechnology, Mansoura, Egypt
3
Urology & Nephrology Center, Mansoura University,
Pathology, Mansoura, Egypt
4
Urology & Nephrology Center, Mansoura University,
Immunology, Mansoura, Egypt
5
Urology & Nephrology Center, Mansoura University,
Urology, Mansoura, Egypt
Background and Aims: We could produce insulin-producing
cells (IPCs) from human mesenchymal stem cells (MSCs) by di-
rected differentiation. Although the yield of the formed IPCs was
modest, yet transplantation of these cells in diabetic mice resulted in
their cure. We have tried to provide an explanation for this obser-
vation. Differentiated MSCs, were transplanted under the renal
capsule of diabetic mice. The kidneys were harvested after 1, 2, 4
and 12 weeks. IPCs were counted at each period. The proportion of
IPCs increased to reach a maximum of *20% at 4 weeks.
Aim: To study the efficiency of these cells in treatment of
larger animals and identify their functional longevity.
Methods: we have induced diabetes in 6 dogs (15 20 Kg) by
a mixture of alloxan and streptozotocin. Differentiated human
cells (5 million/kg) were encapsulated and transplanted beneath
the rectus sheath.
Results: Six dogs are currently under follow up. Three had
completed a 6 months follow up. Two became euglycemic with
normal glucose tolerance curve. The third is on the hypergly-
cemic side although the profile of its glucose tolerance resembles
a normal one. A harvested capsule after 6 months form trans-
plantation was examined. By immunoflourescence, IPCs were
seen and co-expression with c-peptide was confirmed. The pro-
portion of IPCs was again in the range of *20%.
Conclusions: In conclusion, IPCs can be formed by directed
differentiation from of MSCs. These cells undergo further differ-
entiation in vivo. Evidence was provided that these cells can cure
chemically induced diabetes in small as well as large animals.
093
CLOSED-LOOP INSULIN DELIVERY IN WELL-
CONTROLLED ADULTS WITH TYPE 1 DIABETES:
A FREE-LIVING DAY-AND-NIGHT RANDOMISED
CROSS-OVER TRIAL
L. Bally1,2,3, H. Thabit1,3, S. Hartnell3, M. Tauschmann1,4,
J.K. Mader5, H. Kojzar5, M.E. Wilinska1,4, T.R. Pieber5,
M.L. Evans1,3, R. Hovorka1,4
ATTD 2017 E-POSTER DISCUSSION ABSTRACTS
1
University of Cambridge, Wellcome Trust-MRC Institute
of Metabolic Science, Cambridge, United Kingdom
2
Inselspital- Bern University Hospital, University of Bern,
Department of Diabetes, Endocrinology, Clinical Nutrition
& Metabolism, Bern, Switzerland
3
Cambridge University Hospitals NHS Foundation Trust,
Department of Diabetes & Endocrinology, Cambridge,
United Kingdom
4
University of Cambridge, Department of Paediatrics,
Cambridge, United Kingdom
5
Medical University of Graz, Department of Internal Medicine-
Division of Endocrinology & Diabetology, Graz, Austria
Background and Aims: None of the home closed-loop
abetes. In this population, we aimed to establish if the risk of
hypoglycaemia could be alleviated and glucose control improved
by the application of closed-loop insulin delivery.
Methods: In an open-label randomised crossover study design,
seventeen type 1 diabetes adults with HbA1c<7.5% on insulin
pump therapy (7 male, age 45 9 years, HbA1c 6.9 0.4%, diabetes
duration 29.7 12.0 years) underwent a period of day-and-night
closed-loop insulin delivery, and a period of usual pump therapy, the
latter reflecting current clinical practice. Each period lasted four
weeks. The study was carried out during free-living without su-
pervision. During closed-loop, model predictive control algorithm
directed insulin delivery; prandial insulin delivery was applied using
standard bolus wizard. Analyses were by intention to treat.
Results: Time when glucose was in target range 3.9 to 10mmol/l,
primary outcome, was significantly increased during closed-loop
compared to usual therapy (p < 0.001; Table). Mean glucose, time
spent above and below target range were significantly lower during
closed-loop compared to control (p < 0.001 to p = 0.007). Hypogly-
caemia burden measured by AUC <3.5mmol/l was reduced during
closed-loop (p = 0.001). Glycaemic variability as measured by
standard deviation of glucose was also reduced (p = 0.002). Total
daily insulin was comparable (p = 0.29). No serious adverse events
occurred.
Conclusions: Four-week home use of unsupervised day-and-
night hybrid closed-loop under free-living in well-controlled
adults with type 1 diabetes is safe, improves glucose control and
reduces hypoglycaemia burden. Larger and longer studies are
warranted.
ATTD 2017 E-POSTER DISCUSSION ABSTRACTS
094
ACCURACY OF CONTINUOUS GLUCOSE
MONITORING DURING POSTPRANDIAL PERIOD
AND ITS INFLUENCE ON CLOSED-LOOP
PERFORMANCE
L. Biagi1,2, A. Hirata Bertachi1,2, I. Conget3, C. Quiros3,
M. Gimenez3, F.J. Ampudia-Blasco4, P. Rossetti5, J. Bondia6,
J. Veh 1
1
Universitat de Girona, Institut dInformatica i Aplicacions,
Girona, Spain
2
Federal University of Technology, Parana, COMIN,
Guarapuava, Brazil
3
Hospital Clnic i Universitari, Endocrinology Dpt, Barcelona,
Spain
4
Hospital Clnico Universitario de Valencia, Endocrinology
and Nutrition Dpt, Valencia, Spain
5
Hospital Francesc de Borja, Endocrinology Dpt, Gandia,
Spain
6
Universitat Politecnica de Valencia, Instituto Universitario
de Automatica e Informatica Industrial, Valencia, Spain
Background and Aims: Postprandial period (PP) represents a
challenge for closed-loop (CL) systems. The development of more
accurate sensors will contribute to increase the performance of CL
control. In this study we analyzed the accuracy of the Medtronic
Paradigm VeoTM EnliteTM continuous glucose monitoring sys-
tem used in a CL study aimed to PP glucose control and the impact
of sensors accuracy in the CL performance.
Methods: Twenty subjects underwent a standardized mixed
meal test on 4 occasions wearing two glucose sensors in parallel
(randomised, prospective, crossover). On 2 occasions glycemic
control was made by CL and in another two, usual pump therapy
was used. During 8 hours plasma glucose (PG) was measured
every 15 min. Sensor accuracy was assessed through the mean
absolute relative difference (MARD) in different glucose ranges.
Times in each glycaemic range were compared between the trials
with the 10 sensors with best and worst MARD.
Results: Overall, MARD was 12.0 7.5%; 18.9 11.9% and
10.3 + 8.7% in <70 mg/dl and >180 mg/dl glucose ranges, re-
spectively. In CL studies, the 10 best sensors displayed a MARD
of 4.5 0.9% in comparison to 19.8 7.5% in trials with the
10 worst sensors. Studies performed with the 10 best sensors
showed less time in hypoglycaemia (PG <70mg/dl) (2 7 vs.
32 38 min; p = 0.03) and needed less rescues using carbohy-
drates, (1 vs 11).
Conclusions: Under postprandial circumstances, Medtronic
Paradigm VeoTM EnliteTM system showed a numerical accu-
racy in different glucose ranges close to previously reported. The
performance of closed-loop algorithm to control postprandial
period was related to sensor accuracy.
095
ACCURACY AND STABILITY OF A NOVEL
SUBCUTANEOUS GLUCOSE SENSOR
J. Leach1, J. Welsh2, D. Le3, J. Hughes1
1 9
Dexcom Inc., Research & Development, San Diego, USA
2
Dexcom Inc., Clinical Affairs, San Diego, USA
3
Dexcom Inc., Biometrics, San Diego, USA
Background and Aims: Users of continuous glucose moni-
toring (CGM) systems are concerned with the frequency of
A-39
inserting and calibrating new sensors and with sensor accuracy
and reliability throughout its functional life. We developed a new
sensor for our next-generation system and tested its accuracy
versus reference venous (YSI) values collected during clinic
visits throughout 10 days of wear.
Methods: Fifty subjects (49 with type 1 diabetes, 1 with type 2
diabetes, 20 male, mean SD age 32.5 18.7 years) enrolled and
1 subject withdrew early. Subjects wore 1 sensor each, and used
SMBG values (CONTOURNEXT meter) for once-daily cali-
brations. Clinic visits were conducted on days 1, 2, 4, 7, and 10 of
sensor wear; sensor readings were compared to venous YSI
values for up to 8 hours (ages 6-17) or 12 hours (adults). A total
of 994 paired CGM-YSI values were analyzed for mean absolute
relative difference (MARD) and within-15% and within-20%
agreement rates (matched pairs within 15 or 20 mg/dL for ref-
erence values 100 mg/dL or within 15 or 20% for reference
values >100 mg/dL).
Results: The overall MARD was 8.1% (95% confidence in-
terval, 7.6 to 8.5%). The Table shows accuracy metrics overall
and for each in-clinic day. Thirty-nine (79.6%) of the 49 de-
ployed sensors were functional at the end of Day 10; adhesive
failure accounted for most of the early attrition.
Conclusions: This new CGM systems accuracy throughout
its 10-day functional life, together with the convenience associ-
ated with once-daily calibrations, supports its nonadjunctive use
in diabetes management and closed-loop insulin delivery systems.
096
PRECISE II PIVOTAL TRIAL OF A LONG TERM
IMPLANTABLE CGM SYSTEM: 90 DAYS
OF SUSTAINED ACCURACY AND STRONG SAFETY
PROFILE
M. Christiansen1, L. Klaff2, R. Brazg2, A. Chang3, C. Levy4,
D. Lam4, D. Denham5, G. Atiee6, B. Bode7, S. Walters8,
T. Bailey9
1
Diablo Clinical Research, Clinical, Walnut Creek, USA
2
Rainier Clinical Research Center, Clinical, Renton, USA
3
John Muir Physician Network Clinical Research Center,
Endocrinology and Metabolism, Concord, USA
4
Mount Sinai Diabetes Center, Endocrinology- Diabetes and
Metabolism, New York, USA
5
Clinical Trials of Texas, Clinical, San Antonio, USA
6
Worldwide Clinical Trials, Clinical, San Antonio, USA
7
Atlanta Diabetes Associates, Clinical, Atlanta, USA
8
Senseonics, Clinical, Germantown, USA
AMCR Institute, Clinical, Escondido, USA
Background and Aims: A pivotal trial studying the efficacy
and safety of an implantable continuous glucose monitoring
(CGM) system (Eversense) was investigated throughout a 90-
day period.
A-40
Methods: Blinded, single-arm, 90-day prospective multi-center
study assessing safety and accuracy of a long-term CGM sensor.
Enrollment included 82 subjects in the Primary Effectiveness Anal-
ysis Population for accuracy assessment by comparing matched
CGM glucose values to YSI measured venous glucose values and
an additional 8 site training subjects. The primary safety objective
was the incidence of device-related or sensor insertion/removal
procedure-related adverse events. All sensors were inserted in the
upper arm and 15 subjects were inserted with 2 sensors, bilaterally.
Results: The accuracy assessment found an MARD (40-
400 mg/dL) for the Primary Effectiveness Population of 8.8%
(n = 16,653, SD 8.6%, 95% CI 8.6%8.9%). A Kaplan-Meier
survival analysis found 91% of the sensors functioning through
90 days. Fourteen (14) device or procedure related adverse
events occurred in 7 subjects over the 9,773 sensor in vivo days.
The most common adverse events were mild bruising or ery-
thema. There was one SAE where a second procedure was
needed for a sensor removal due to issues of locating the sensor.
There were no incisional infections either at insertion or removal.
Unlike other CGM systems, there were no complaints of skin
irritation or reaction to the adhesive patch.
Conclusions: The Eversense CGM demonstrates both an ex-
cellent safety profile and sub 9.0% MARD accuracy during
continuous use for up to 90 days.
097
ACCURACY ASSESSMENT FOR A LONG TERM
IMPLANTABLE CGM SYSTEM WITH ONE PER DAY
CALIBRATION IN THE PRECISE II STUDY
M. Christiansen1, L. Klaff2, R. Brazg2, A. Chang3, C. Levy4,
D. Lam4, D. Denham5, G. Atiee6, B. Bode7, X. Chen8, T. Bailey9
1
Diablo Clinical Research, Clinical, Walnut Creek, USA
2
Rainier Clinical Research Center, Clinical, Renton, USA
3
John Muir Physician Network Clinical, Endocrinology
and Metabolism, Concord, USA
4
Mount Sinai Diabetes Center, Endocrinology, Diabetes
and Metabolism, New York, USA
5
Clinical Trials of Texas, Clinical, San Antonio, USA
6
Worldwide Clinical Trials, Clinical, San Antonio, USA
7
Atlanta Diabetes Associates, Clinical, Atlanta, USA
8
Senseonics, Engineering, Germantown, USA
9
AMCR Institute, Clinical, Escondido, USA
Background and Aims: The PRECISE II pivotal trial was a
blinded, single-arm, 90 day prospective multi-center study of the
fully implantable sensor based Eversense CGM System. Parti-
cipants used the system per the manufacturers instruction by
performing two per day calibration. The impact of one per day
calibration on sensor accuracy was evaluated with the 82 subjects
in the Primary Effectiveness Analysis Population.
Methods: For the analysis of one per day calibration, only one
of the two calibrations was used to assess the calibration stability
throughout 24 hrs. When possible, the SMBG measurement
taken the night before a next day 12 hour in-clinic visit was used
to enable accuracy assessment.
Results: The overall 90 Day accuracy measured by >16,000 YSI
glucose values found an MARD (40-400 mg/dL) of 9.5% (SD 9.3%,
95% CI 9.3% 9.6%) for one per day calibration compared to 8.8%
(SD 8.6%, 95% CI 8.6% 8.9%) for two per day calibration. Similar
stability in performance was maintained with 90.5% and 93.3% of
matched CGM glucose within 20/20% of YSI glucose for the one per
day calibration and two per day calibration, respectively.
ATTD 2017 E-POSTER DISCUSSION ABSTRACTS
Conclusions: One per day calibration maintained system
accuracy throughout the 90-day period for the Eversense CGM
system, which is equal to or better than the current two per day
calibration CGM systems. The Eversense CGM system pro-
vides the benefit of a long term implantable that is accurate
while having the potential to lessen the burden of daily diabetes
management.
098
THE EFFECT OF THE MOBILE APPLICATION
EUGLYCA ON GLYCEMIC CONTROL
OF CHILDREN AND ADOLESCENTS WITH DIABETES
MELLITUS TYPE 1
C. Chatzakis1, D. Floros2, K. Tsiroukidou1, A. Vamvakis1,
K. Kosta1, I. Tsanakas1, M. Papagianni1
1
Hippokrateion General Hospital of Thessaloniki- Aristotle
University of Thessaloniki, Pediatric Endocrinology
Unit, Third Department of Pediatrics, Thessaloniki, Greece
2
Aristotle University of Thessaloniki, Electrical Engineering,
Thessaloniki, Greece
Background and Aims: Euglyca is a mobile application that
we developed for patients with diabetes. It calculates the amount
of carbohydrates and lipids that a patient consumes during a meal
and by taking into consideration eight more parameters (pre-
meal blood glucose, targeted blood glucose, insulin/carbs and
insulin/lipids ratio, insulin sensitivity, active insulin, physical
activity and illness) calculates the required bolus dose of insulin.
Aim of this study is to evaluate the efficacy of this application on
patients glycemic control.
Methods: 36 children and adolescents with T1DM were in-
cluded in the study. 18 of them were appointed to use the appli-
cation for three months and the other 18 were matched controls.
At the baseline and three months later, we calculated the amount
of hypoglycemias, hyperglycemias and normoglycemias for each
patient and their HbA1c as well, in order to proceed with the
appropriate comparisons.
Results: In our target group we found an increase in the
number of normoglycemias by 18% while in our control group
there was a decline by 5% (P < 0.001). Furthermore, we found
6.7% and 12% decline in the number of hypoglycemias and
hyperglycemias respectively while in our control group they
were elevated by 0.2% and 5.5%. In addition, in the target group
it was revealed a reduction in HbA1c by 1% while in the control
group there was a 0.25% increase (P < 0.001).
Conclusions: Mobile application Euglyca improved the
glycemic control of children and adolescents with T1DM, how-
ever further research is needed.
099
PERFORMANCE AND ACCURACY CAPABILITY
OF A NEW, WIRELESS-ENABLED BLOOD GLUCOSE
MONITORING SYSTEM THAT LINKS TO A SMART
MOBILE DEVICE: LABORATORY AND CLINICAL
SAMPLE REAPPLICATION STUDIES
B. Harrison1, D. Brown1, M. Takeshima2
1
Ascensia Diabetes Care, Parsippany NJ, USA
2
Panasonic Healthcare Co. Ltd., Toon City Ehime, Japan
Background and Aims: To evaluate performance and accu-
racy of the ContourNext ONE blood glucose monitoring system
ATTD 2017 E-POSTER DISCUSSION ABSTRACTS
(BGMS) during Second-Chance sampling. The BGMS features
an easy-to-use, wireless-enabled BG meter that links to a smart
mobile device via Bluetooth technology and syncs with the
Contour Diabetes app.
Methods: In the laboratory study, samples were tested at 3
temperatures (16C, 22C, 34C) with blood adjusted to 3 BG
levels (70, 300, 500 mg/dL) at 3 hematocrit levels (20%, 42%,
55%). Two sample reapplication methods were used (initial
volume, 0.28 and 0.46 lL); each sample was tested with 3 delay
times between initial and second inoculation (5, 30, 55 sec-
onds). For each sample and condition, 10 replicate BGMS
readings were obtained with each of 3 test strip lots. In the
clinical study, 52 subjects with diabetes performed self-tests
with an intentionally insufficient initial blood application to
produce a number of Second-Chance sampling opportunities.
Results were compared with YSI reference results and assessed
per the following acceptance criterion: 95% of results within
15 mg/dL (BG <100 mg/dL) or 15% (BG 100 mg/dL) of
reference result.
Results: In the laboratory study, results met protocol-
specified acceptance criteria. In the clinical study (BG range,
65-347 mg/dL; hematocrit range, 35%-55%), 100% (85/85) of
subject fingertip self-test results were within 15 mg/dL or
15% of YSI reference result. Moreover, 92.9% (79/85) of
self-test results were within 10 mg/dL or 10% of YSI ref-
erence result.
Conclusions: In the laboratory and in a clinical setting used by
subjects with diabetes, BGMS sample reapplication results met
acceptance criteria.
100
EFFECT OF VILDAGLIPTIN ON ARTERIAL
STIFFNESS IN DRUG NAIVE PATIENTS
WITH TYPE 2 DIABETES MELLITUS
I. Zografou1, P. Doukelis1, T. Griva1, E. Spentzou1,
P. Anyfanti1, D. Papadopoulou1, C. Sampanis1
1
Hippokration General Hospital, Diabetes Center,
Thessaloniki, Greece
Background and Aims: Arterial Stiffness (AS) is a predictor
of cardiovascular (CV) events and mortality in patients with
diabetes mellitus. We assessed the effect of a DPP-4 inhibitor
vildagliptin (V) on AS in drug nave patients with type 2 diabetes
mellitus (T2DM).
Methods: Sixty-four drug nave subjects with T2DM and
inadequate glycemic control participated in this randomized,
open-label study. Half of the patients received metformin ( M)
1700 mg/d ( M group) and the other half M 1700 mg/d plus
vildagliptin 100 mg/d (V group) for 6 months. AS (carotid
femoral pulse wave velocity, cfPWV), body weight (BW),
body mass index (BMI), systolic blood pressure (SBP), dia-
stolic blood pressure (DBP), glycosylated hemoglobin
(HbA1c), Albumin/Creatinine ratio (A/C ratio), C-peptide,
HOMA-IR and HOMA-b were assessed at baseline and after
6 months.
Results: cfPWV, BW, BMI, SBP, DBP remained unchanged
after 6 months in both groups (p = NS). V decreased HbA1c
more effectively than M alone (V group: D (HbA1c) =
-1.7 + 0.7%, M group: D (HbA1c) = -1.2 + 1.2%, p < 0.05).
Moreover C-peptide and HOMA-b raised significantly in V
A-41
group (V group D (C-peptide) = 1.3 + 3.6 ng/ml, M group D (C-
peptide) = -0.3 + 1.5 ng/ml, p < 0.05, V group D (HOMA-
b) = 22.0 + 33.8%, M group D (HOMA-b) = 8.1 + 55.8%,
p < 0.05).
Conclusions: The addition of V to M for a period of six
months had no effect on AS in drug nave T2DM patients but V
treatment improved glycemic control (HbA1c) and b-cell func-
tion (C-peptide, HOMA-b).
101
PHARMACOKINETICS, PHARMACODYNAMICS,
AND SAFETY FOLLOWING SINGLE OR REPEATED
3 MG NASAL GLUCAGON DOSES IN ADULTS
WITH TYPE 1 OR TYPE 2 DIABETES (T1D OR T2D)
H. Dulude1, E. Sicard2, M. Rufiange3, C. Piche1, C.B. Guzman4,
S. Zhang5, T. Shen6, J.G. Jacobson7, X.M. Zhang8
1
Locemia Solutions, Clinical Development, Montreal,
Canada
2
Altasciences/Algorithme Pharma, Principal Investigator,
Montreal, Canada
3
Altasciences/Algorithme Pharma, Scientific and Regulatory
Affairs, Montreal, Canada
4
Eli Lilly and Company, Diabetes Business Unit. Development,
Indianapolis, USA
5
Eli Lilly and Company, Statistics, Indianapolis, USA
6
Eli Lilly and Company, PK/PD and Pharmacometrics,
Indianapolis, USA
7
Eli Lilly and Company, Diabetes, Indianapolis, USA
8
Eli Lilly and Company, Diabetes Business Unit, Development,
Toronto, Canada
Background and Aims: Examine the pharmacokinetics (PK),
pharmacodynamics (PD), and safety of single or repeated 3-mg
nasal glucagon (NG) doses given in randomized sequence in a
4-period, cross-over study.
Methods: Subjects (insulin-using adults with T1D or T2D,
BMI 18.5-35.0 kg/m2) received 4 NG treatments (Trts) 1 wk
apart. Trts were given 4 hrs after a low-carbohydrate breakfast.
Trts were: 1) Single 3-mg NG; 2) 3-mg NG plus another 3-mg
NG 15 minutes later (same nostril); 3) 3-mg NG plus another
A-42
3-mg NG 15 minutes later (opposite nostril); 4) 2 concurrent 3-
mg NG doses (both nostrils).
Results: 32 subjects were enrolled (T1D: 23, T2D: 9).
Number of subjects who received Trts 1, 2, 3, 4 were 27, 28, 25
and 29, respectively. Baseline (BL) blood glucose was 40-
181 mg/dL. For Trts 1-4, PK parameters of change from BL for
glucagon were mean area under the curve 0-3 hrs: 2471, 4097,
4639, and 3611 hr  pg/mL, median Tmax: 0.17, 0.33, 0.50, and
0.33 hrs; PD parameters of change from BL for glucose were
mean area under the effect concentration 0-3 hrs: 157, 168, 190,
and 194 hr  mg/dL, median Tmax: 0.75, 1.00, 1.00, and 1.00 hrs.
Repeated NG doses resulted in higher glucagon concentrations,
but gave glucose responses comparable to single dose (Figure).
The only serious adverse event (AE; cellulitis) was not drug-
related. Most drug-related AEs were transient and resolved
within 2 hours.
Conclusions: Although repeat dosing resulted in greater
systemic glucagon exposure, it did not result in a meaningful
increase in observed glucose response. All NG treatments were
well-tolerated.
102
DIFFERENTIATING PRESENTATION OF PATIENT-
GATHERED DATA BETWEEN TYPE 1 AND 2
DIABETES DURING CONSULTATIONS
M. Bradway1, A. Holubova2, R. Joakimsen3, E. Arsand1
1
University Hospital of North Norway, Norwegian Centre
for E-Health Research, Troms, Norway
2
Czech Technical University in Prague, Faculty of Biomedical
Engineering, Prague, Czech Republic
3
University Hospital of North Norway, Institute of Clinical
Medicine, Troms, Norway
Background and Aims: The integration of mobile health
(mHealth) technology within medical practice is a discussion
riddled with debate and unresolved questions. In addition to
privacy and security is the question of how to present patients
mHealth self-gathered data during consultations. For chronic and
resource-heavy illnesses, such as diabetes, it is necessary to
consider adaptive formatting for the presentation of patients
sensor/app data to medical personnel, with the aim to determine
sound strategies and formats for presentation during consulta-
tions.
Methods: Both an anonymous online patient survey as well
as three workshops involving clinicians involved in diabetes
treatment, EHR-vendors, patients and researchers were con-
ducted. Diabetes patients in Norway answered questions re-
lated to experienced challenges and desired consultation
ATTD 2017 E-POSTER DISCUSSION ABSTRACTS
discussion topics, given more time for discussing self-
gathered data.
Results: Individuals with Type 1 (n = 15) and Type 2 (n = 9)
completed the survey (Figure 1). While motivation was a
common challenge, stress management (Type 1), BG variability,
exercise and mood (Type 2) were the most wanted consultation
topics. The workshops revealed large differences in preferred
ways of data presentation, e.g. GPs preferred quick ways of re-
viewing data during consultation, while specialist preferred to
receive and review more detailed data before consultations
(Table 1).
Conclusions: Due to numerous factors associated with dia-
betes, it is necessary to not only consider a patients diabetes type
and clinicians specialties but also patients personal challenges,
resources, and capacity when preparing patient-gathered data for
consultations. The Full Flow project (2016-19) will study use of
dynamic data-formats for presenting patient-gathered data dur-
ing consultations.
103
THE IMPLEMENTATION OF MYSTAR CONNECT
CLINICAL INFORMATION SYSTEM IMPROVES
INTERMEDIATE OUTCOMES IN 42498 PEOPLE
WITH DIABETES
V. Provenzano1, D. Brancato1, G. Picone1, A. Scorsone1,
M. Fleres1, G. Saura1, V. Aiello1, F. Provenzano1, A. Di Noto1,
L. Spano1
1
Hospital of Partinico, Regional Reference Center
for Diabetology and Insulin Pumps, Palermo, Italy
Background and Aims: The Diabetes Network of Palermo
District links all the public healthcare diabetes resources
of Palermo District. Since 2012, DNPD implemented a Chronic
Care Model (CCM) mainly based on the full sharing of
clinical data between primary care resources and special-
ized diabetes centers, through a single clinical information
system ( MyStar Connect). Aim of the present study is to
assess if the implementation of MyStar Connect was fol-
lowed by an improvement of the management of people with
diabetes.
Methods: Assessment of the trend of the proportion
of people with diabetes who yearly (from 2012 until to
2015) achieved some target values of intermediate (primary)
outcomes: HbA1C <7.0%; LDL <100 mmHg; systolic blood
ATTD 2017 E-POSTER DISCUSSION ABSTRACTS
pressure (SBP) <140 mmHg; a triple target including all the
previous outcomes. Secondary outcomes were defined by dif-
ferent target values of the primary outcomes. A sub-analysis for
diabetes type was also performed.
Results: MyStar Connect implementation from 2012 until
to 2015 was followed by a significant increase, on 42,498 people
with diabetes, of those who achieved HbA1c <7.0% (from 39.8
to 45.9%; p < 0.001), LDL <100 mmHg (from 51.8 to 57.4%;
p < 0.001), SBP <140 mmHg (from 53.0 to 57.5%; p < 0.001).
Triple target was achieved by an increasing rate of 4,254 people
with diabetes (from 37.2 to 51.6%; p < 0.001).
Conclusions: Though we are not able to exclude the influence
of other factors, such as the introduction of new drugs and of
other tools of the CCM, MyStar Connect implementation was
followed by a significant improvement of the health of people
with diabetes.
104
THE UNIVERSITY OF VIRGINIA/PADOVA TYPE 1
DIABETES SIMULATOR GOES SINGLE DAY
R. Visentin1, E. Campos Nanez2, M. Schiavon1, D. Lv2,
M. Breton2, A. Facchinetti1, C. Dalla Man1, B. Kovatchev2,
C. Cobelli1
1
University of Padova, Department of Information Engineering,
Padova, Italy
2
University of Virginia, Center for Diabetes Technology,
Charlottesville, USA
Background and Aims: A new version of the UVA/Padova
Type 1 Diabetes (T1D) Simulator has been recently developed in
order to provide more realistic testing scenarios. Here we present
these upgrades to the previous simulator, which was accepted by
the Food and Drug Administration in 2013.
Methods: Intra-day variability of insulin sensitivity (SI)
has been modeled, based on clinical experiments in T1D
(Hinshaw et al., Diabetes2013), accounting for intra-subject
variability of daily SI and high inter-subject variability. As
a result, time-varying distributions of both subjects basal in-
sulin infusion and insulin-to-carbohydrate ratio were calculated
and included. A model of dawn phenomenon has been in-
cluded, based on clinical findings in T1D subjects (Mallad
et al., DTT2015). Moreover, using a rich clinical T1D dataset
(Schiavon et al., ATTD2013 and ATTD2016), the model of
subcutaneous insulin delivery has been updated with com-
mercially available fast-acting insulin analogs. Finally, a model
of intra-dermal insulin delivery (Lv et al., JDST2015) and a
new CGM error model (Facchinetti et al., MBEC2015) have
been added.
Results: One hundred in silico adults, adolescent, and
children have been generated accounting for the above de-
scribed modifications. The new simulator captures the intra-
day glucose variability observed in real experiments, also well
reproducing the nocturnal glucose increases, and the simu-
lated insulin profiles reflect the kinetics observed in clinical
data.
Conclusions: The new modifications introduced in the T1D
simulator allow to extend its domain of validity from single-
meal to single-day scenarios, thus enabling a more realistic
framework for in silico testing of continuous glucose monitors,
closed-loop algorithms, and new insulin formulations.
A-43
105
A RANDOMIZED TRIAL COMPARING CONTINUOUS
SUBCUTAENOUS INSULIN INFUSION VERSUS
CONTINUING MULTIPLE DAILY INSULIN
INJECTIONS IN PATIENTS WITH TYPE 1 DIABETES
USING CONTINUOUS GLUCOSE MONITORING
E. Toschi1, T. Riddlesworth2, K. Ruedy2, C. Kollman2,
D. Price3, R. Beck2
1
Joslin Diabetes Center, n/a, Boston, USA
2
Jaeb Center for Health Research, n/a, Tampa, USA
3
Dexcom Inc., n/a, San Diego, USA
Background and Aims: To assess the incremental benefits of
changing the insulin delivery method from multiple daily injec-
tion (MDI) to continuous subcutaneous insulin infusion (CSII)
in patients with type 1 diabetes (T1D) already using continuous
glucose monitoring (CGM).
Methods: A randomized trial was conducted at 21 endocri-
nology practices in the US. Subjects were in the CGM Group in a
preceding 24-week randomized trial comparing CGM versus
usual care in adults >25 years old with T1D using MDI. In ad-
dition, it was necessary for eligibility for this trial that the subject
used CGM at least 75% of the time in the last month of the
preceding trial and had a total daily insulin dose <100 units of
insulin/day. Eligible subjects were randomly assigned to con-
tinue MDI or start CSII (OmniPod) plus continuing CGM
(Dexcom G4 Platinum CGM System with software 505).
The primary outcome was CGM-measured time in range 70 to
180 mg/dL over 24 weeks.
Results: Mean age of the 75 subjects was 46 + 14 years (range
26 to 72 years), 47% were female, and 88% nonHispanic white.
Mean T1D duration was 21 + 14 years and total daily insulin dose
was 59 + 21 units/day. Baseline mean HbA1c was 7.6 + 0.8%
with 20% <7.0%, 23% 7.0-7.4%, and 57%> 7.5%. Mean time 70
to 180 mg/dL was 12.2 hours/day with median time >180 mg/dL
10.6 hours/day and time <60 mg/dL 15.1 minutes/day.
Conclusions: The final 24-week outcome visit will be com-
pleted in November 2016. Outcome results will be presented.
106
BUDGET IMPACT OF CONTINUOUS SUBCUTANEOUS
INSULIN INFUSION COMPARED WITH MULTIPLE
DAILY INSULIN INJECTIONS FOR THE TREATMENT
OF TYPE 1 DIABETES IN SPAIN
M. Gimenez1, I. Elas2, M. Alvarez2, C. Quiros1, I. Conget1
1
Hospital Clnic i Universitari de Barcelona, Diabetes Unit.
Endocrinology Department. IDIBAPS, Barcelona, Spain
2
Medtronic Iberica, Health Economics & Outcomes Research,
Madrid, Spain
Background and Aims: Objective: To estimate the budget
impact (BI) of continuous subcutaneous insulin infusion (CSII)
compared with multiple daily insulin injections (MDI) for the
treatment of patients with type 1 diabetes (T1D) presenting re-
current severe hypoglycaemic events in Spain.
Methods: A BI model was developed to estimate direct
healthcare for T1D patients over a four-year period from the Spanish
healthcare system perspective. Target population was defined based
A-44
on a retrospective observational study evaluating the efficacy of
CSII at Hospital Clnic i Universitari de Barcelona (20032008),
where one of the main indications for switching to CSII was
recurrent severe hypoglycaemia episodes; in this study, the mean
number of episodes per year in the last 2 years before starting CSII
was 1.33, being 0.08 in the last 2 years of follow up (p = 0.003).
Total cost included therapy costs (insulin and CSII) and major
hypoglycaemic events costs. Unitary costs (e,2016) were ob-
tained from national databases.
Results: The average total cost of treating a patient with T1D
presenting recurrent severe hypoglycaemic episodes over a four-
year period was 13,274e and 23,094e with CSII and MDI, re-
spectively. During this time horizon, therapy costs per patient were
higher with CSII (11,902e vs 2,393e) while major hypoglycaemic
events costs were less with CSII compared with MDI (e1,371
versus e20,701). The total BI was e9,821 ( e2,455 per patient
per year).
Conclusions: The higher therapy costs associated with CSII
compared with MDI were totally offset by the reduction of severe
hypoglycaemic events and result in cost savings.
107
INFLUENCE OF PSYCHOSOCIAL FACTORS
ON INTEREST IN AND USE OF AUTOMATED INSULIN
DELIVERY SYSTEMS: PERSPECTIVES OF YOUTH
WITH TYPE 1 DIABETES (T1D) AND THEIR PARENTS
K. Barnard1, D. Naranjo2, S. Suttiratana2, L. Laffel3,
J. Weissberg-Benchell4, K. Hood5
1
BHR Limited, Research Management, Nr Portsmouth,
United Kingdom
2
Stanford University, Psychology, San Francisco, USA
3
Harvard University, Joslin Diabetes Center, Boston, USA
4
Ann and Robert H. Lurie Childrens Hospital of Chicago,
Northwestern Universitys Feinberg School of Medicine,
Chicago, USA
5
Stanford University, Psychology & Behavioural Science,
San Francisco, USA
Background and Aims: Aim: To explore the influence of
psychosocial factors on interest in and uptake of automated in-
sulin delivery systems among children/adolescents with T1D and
their parents.
Methods: A qualitative study consisting of focus groups and
semi-structured interviews held across four sites in the United
States and United Kingdom with children/adolescents with T1D
and their parents. Data were transcribed verbatim and analyzed
with content and thematic analyses methodology.
Results: Participants were 16 children (mean age 10.3 yrs,
range 9-11; mean A1c 6.4%, range 6.4-13.0%), 35 adolescents
(mean age 15.1, range 12-20.8; mean A1c 8.7%, range 8.0%-
13.0%), and 65 parents (mean youth age = 12.8; mean A1c of
youth = 8.1%, range 6.4%-13%). We conducted 23 focus groups
[n = 8 children; n = 3 adolescent; n = 12 parent] and 41 individual
interviews [n = 7 children; n = 16 adolescent; n = 18 parent]. Key
themes were burden and benefits of the systems, impact on
quality of life and relationships, and how much the system
controlled diabetes versus the youth. Children were most con-
ATTD 2017 E-POSTER DISCUSSION ABSTRACTS
cerned with systems affecting specific social situations such as
school and friendships; adolescents were most interested in the
physical features of the system, wearability, and time-savings;
whereas parents were most concerned about device safety, trade-
offs, and the bumpy process of developing trust in a system.
Conclusions: Incorporating stakeholder perspectives on use
of automated insulin delivery may improve adoption and health
and quality of life indicators among users. Efforts are needed to
build trust in systems, optimize device interactions, and provide
clear guidance on use in order to optimize update and sustained
device use.
108
THE INFLUENCE OF PSYCHOSOCIAL FACTORS
ON INTEREST IN AND USE OF AUTOMATED INSULIN
DELIVERY SYSTEMS: PERSPECTIVES OF ADULTS
WITH TYPE 1 DIABETES (T1D) AND PARTNERS
K. Barnard1, S. Suttiratana2, D. Naranjo2, K. Hood2, L. Laffel3,
J. Weissberg-Benchell4
1
BHR Limited, Research Management, Nr Portsmouth,
United Kingdom
2
Stanford University Medical School, Psychology
& Behavioural Science, San Francisco, USA
3
Harvard University, Joslin Diabetes Center, Boston, USA
4
Ann and Robert H. Lurie Childrens Hospital of Chicago,
Northwestern Universitys Feinberg School of Medicine,
Chicago, USA
Background and Aims: To explore the influence of psy-
chosocial factors on interest in and uptake of automated insulin
delivery among adults with T1D and partners.
Methods: A qualitative study consisting of focus groups and
semi-structured interviews held across four sites in the United
States and United Kingdom with adults with T1D and partners.
All data were transcribed verbatim and analyzed with content
and thematic analyses methodology.
Results: 113 adults (mean age 39.5yrs, range 18-77; mean
A1c 7.5%, range 5.0-11.8%) and 55 partners participated. We
conducted 23 focus groups [n = 16 adult; n = 7 partner] and 48
individual interviews [n = 38 adult; n = 10 partner]. Adults and
partners were most concerned about the accuracy, adaptability,
features and algorithm quality of these systems alongside ex-
pectations that systems would stabilize blood glucose levels and
reduce long-term complications. Concerns included device
safety and trust and control for adults while partners were rela-
tively more concerned about the potential disappointment asso-
ciated with devices given past device experiences. Invasiveness
in life generally and specifically in social situations were raised
by both groups.
Conclusions: Incorporating stakeholder perspectives on use
of automated insulin delivery may improve adoption of devices
and health and quality of life indicators among persons with di-
abetes. Efforts are needed to set realistic expectations and provide
education on device safety and component features. Continued
attention should be paid to psychosocial factors of system use and
people affected beyond those diagnosed with T1D along with
family members.
ATTD 2017 E-Poster Viewing Abstracts
109
CSII AND CGM IN REAL CLINIC PRACTICE
IN MOSCOW REGION
I. Barsukov1, A. Dreval1, T. Shestakova1, M. Taisumova1,
O. Medvedev2, M. Panteleev2, A. Sveshnikova2
1 consultation of specialists to identify complications of diabetes.
Moscow Regional Research and Clinical Institute named after
M.F. Vladimirsky, Endocrinology, Moscow, Russia
2
Moscow State University, Department of Basic Medicine,
Moscow, Russia
Background and Aims: CSII and CGM are generally used
in Moscow Region but advantages of these methods are not
obvious yet.
Aim: To estimate effectiveness of CSII in patient with dia-
betes mellitus and compare different basal regimes
Methods: 187 patients with diabetes mellitus: 175 (93.6%)-
type 1, 12 (6.4%) - type 2. All used CSII (Accu-check Spirit
Combo, Rosh) and SGM was performed in the first week after
the pump therapy was introduced (iPro2, Medtronic). We
compared two basal regimes: Renners scale with different
basal rate during the day (n = 82) and constant basal rate
(n = 105).
Results: Change from MII to CSII lead to the reduce in daily
insulin dose by 30.8% and cut down HbA1c by 1.2% in three
months. Number of hypoglycemia decreased from 2.0 0.8 per
day to 0.8 0.5 per day.
Patients with different basal rate had more hypoglycemia
comparing with constant basal rate: AUC less goal was consid-
erably bigger in the group of patients with different basal rate
(0.17 0.27 and 0.07 0.16, p = 0.016).
Conclusions: Change from MII to CSII lead to the decrease in
HbA1c; constant basal rate of insulin is safer because it induces
less hypoglycemia.
110
LIPID PEROXIDATION SYSTEM IN MEN WITH
DIABETES MELLITUS TYPE 1
L.I. Kolesnikova1, L.V. Belenkaya1, L.F. Sholokhov1,
M.A. Darenskaya1, I.M. Mikhalevich1
1
Scientific Centre for Family Health and Human Reproduction
Problems, Department of Pathophysiology, Irkutsk, Russia
Background and Aims: Oxidative stress induced by hyper-
glycemia and subsequent cellular damage is thought to be one of
the major pathophysiological factors causing complications in
diabetes. The objective of this study was to identify features of
the lipid peroxidation-antioxidant defense system in men of re-
productive age with diabetes mellitus type 1.
A-45
Methods: 22 men with diabetes mellitus type 1 (the average
age of 27.1 7.38 years) and 30 healthy men of the same age
(control group) (the average age of 28.0 4.3 years) were in-
volved in the study. The main and control groups were formed on
the principle of copy pair. Standard clinical examination
methods were used: history taking, physical examination and
Spectrophotometric and fluorometric methods were used.
Results: In men with diabetes mellitus type 1, there is increase
in the level of active products reacting with thiobarbituric acid
compared to the same indicator in the control group. The level of
antioxidant defense in men with diabetes mellitus type 1 unlike
the control was characterized by decrease in total antioxidant
activity. However, stability of processes of superoxide dismutase
activity and the glutathione system in comparison with control is
observed against the backdrop of intensity increase of oxidative
processes.
Conclusions: Activation of lipid peroxidation is observed in
men with diabetes mellitus type 1.
111
LOW POWER LASER ACCELETRATES WOUND
HEALING IN DIABETIC RATS
M. Shabani1, M. Aminforghani1, M. Babaei1, S. Haghayegh1
1
Iran University of Medical Sciences, Biochemistry, Tehran,
Iran
Background and Aims: Introduction: Diabetic wounds
have been the area of challenge since many years with different
approaches to improve the problem. Nitric Oxide (NO) has been
shown to play a crucial role in wound healing. In addition, ap-
plication of laser on wound healing has already been examined.
Thus, this study was designed to investigate the efficacy of low
power laser irradiation for dermal wound healing of diabetic rats.
Materials and Methods: 36 male SD rats were used in this
study. Diabetes was induced by IP injection of streptozotocin. A
full-thickness circular wound was made on the back of all rats.
Rats were selected to be irradiated directly upon their wound
with a combination of 670 nm (100 mw, 2J/cm2) and 810 nm (50
mw, 1 J/cm2) every other day. Wound imaging was performed on
days 0, 7, 12, 16, 20 and 22. The wounds margin and context
were scored pathologically. NO was measured by NO analyzer.
Results: Percent open wound area (POWA) was significantly
lower in the Diabetic Laser group in comparison to the Diabetic
Non-Laser group in all measurement days. Also the POWA de-
crease in DML group was quicker than DMNL group (P = 0.021;
mean difference = 19.7%). and P = 0.013, respectively). NO
production was increased in DML group as compared to DMNL
group.
A-46
Conclusions: Our study showed that the irradiation of diabetic
wounds with a combination of low dose 670 nm and 810 nm
lasers accelerates wound healing process possibly by stimulation
of macrophage-derived NO.
112
CORRELATIONS OF PLASMINOGEN ACTIVATOR
INHIBITOR-1 IN CHILDHOOD OBESITY
B. Virgolici1, O. Timnea2, H. Virgolici3, L. Popescu4
1
Carol Davila University of Medicine and Pharmacy,
Biochemistry, Bucharest, Romania
2
Ecologic University, Physiology, Bucharest, Romania
3
Carol Davila Univ of Medicine and Pharmacy, Marketing,
Bucharest, Romania
4
Carol Davila Univ of Medicine and Pharmacy, Physiology,
Bucharest, Romania
Background and Aims: Plasminogen activator inhibitor-1
increases the risk of atherothrombosis and promotes fibrosis and
has high levels in obesity. Obese children have high risk for
cardiovascular diseases in early childhood.
The aim of this study was to calculate the correlations of PAI-
1 in childhood obesity and to observe the metabolic differences
between obese children with normal or high PAI-1 levels.
Methods: Sixty obese children (10-16 years) and thirty lean
children were enrolled. The obese children were divided in two
groups according to the cutoff value of 43 ng/mL for PAI-1. The
group with high values (n = 43) had the PAI-1average 73.7 ng/mL
and the second obese group (n = 17) had PAI-1average 30.3 ng/mL.
Spectrophotometric and immunoenzymatic methods were used.
Results: The obese children had higher PAI-1 level than the
lean children ( p < 0.001). The obese group with high PAI-1 level
versus the obese group with normal PAI-1 level had lower HDL-
c (p < 0.03), plasma magnesium (p < 0.01), plasma A immuno-
globulins (p < 0.02), TSH (p < 0.05) and higher levels for white
blood cells and lymphocytes (p < 0.01) and higher activity for
ALT and AST (p < 0.01). In obese children PAI-1 was negatively
correlated (p < 0.05) with magnesium (r = -0.31), with TSH (r =
-0.33) and positively correlated with lymphocytes (r = 0.40) and
AST (r = 0.27).
Conclusions: In conclusion, in childhood obesity, high PAI-1
acts in cluster with low magnesium, with dyslipidemia, with
inflammation and hepatic cytolysis increasing the risk for hepatic
fibrosis and atherosclerosis.
113
ABNORMAL GLUCOSE TOLERANCE AFTER
GESTATIONAL DIABETES MELLITUS
IN JAPANESE WOMEN
H. Watanabe1, S. Nomachi2, Y. Honda3, S. Fukuda3, Y. Sato3
1
Osaka University Graduate School of Medicine, Children
and Womens Health, Suita, Japan
2
University of Hyogo, Nursing Art & Science, Akashi, Japan
3
Sato Hospital, Department of Obstetrics and Gynecology,
Takasaki, Japan
Background and Aims: Various maternal and pregnancy
characteristics among women with gestational diabetes mellitus
ATTD 2017 E-POSTER VIEWING ABSTRACTS
(GDM) is are considered to be risk factors for the onset of dia-
betes in later life. The purpose of this study was to identify the
risk factors associated with abnormal glucose tolerance on the
first postpartum 75-g oral glucose tolerance test (OGTT) among
Japanese women with GDM.
Methods: Forty-four women completed a 75-g OGTT at 12
weeks postpartum to diagnose abnormal glucose tolerance, in-
cluding impaired glucose tolerance and type 2 diabetes (T2DM)
in women with GDM. Dietary habits by a self-administered di-
etary history questionnaire were examined at 28 gestational
weeks and 12 weeks postpartum. All the women diagnosed with
GDM received nutrition counseling and routine antenatal care.
Results: None of the participants had insulin treatment during
pregnancy. Of 44 women with GDM, 35 (79.5%) had normal
glucose tolerance, 7 (15.9%) had impaired glucose tolerance, and
2 (4.5%) had overt T2DM. No significant difference was found
between the criteria of GDM at diagnosis and the abnormal
glucose tolerance at the postpartum. The significant risk factor
associated with postpartum AGT was pre-pregnancy BMI over
25 kg/m2 (P < 0.05). Total weight gain, age, parity, and nutri-
tional status were not associated with postpartum AGT.
Conclusions: Identification of antepartum risk factors in ad-
vance is crucial for preventing impaired glucose tolerance and
the onset of T2DM. Maintaining an appropriate BMI before
pregnancy may reduce the risk of future T2DM in reproductive-
aged women.
114
DOES THE ARTIFICIAL PANCREAS REDUCE
DIABETES DISTRESS AND HYPOGLYCEMIA
WORRY IN INDIVIDUALS WITH TYPE 1 DIABETES?
C. Berget1, K.A. Driscoll1, S. Hanes2, T. Marcal3, L.S. Towers1,
D.M. Maahs3, D.P. Howsman4, S. Deshpande5,
R. Gondhalekar5, G. Forlenza1, B.W. Bequette4, F. Cameron4,
E. Dassau6, S.D. Patek7, T. Ly2, F.J. Doyle III5,
B. Buckingham2, K.K. Hood2
1
University of Colorado Denver, Barbara Davis Center,
Aurora, CO, USA
2
Stanford University, Pediatric Endocrinology, Palo Alto, CA,
USA
3
Stanford University, Pediatric Endocrinology, Palo Alto, CA,
USA
4
Rensselaer Polytechnic Institute, Chemical and Biological
Engineering, Troy, NY, USA
5
Harvard, John A. Paulson School of Engineering and Applied
Sciences, Cambridge, MA, USA
6
Harvard, John A. Paulson School of Engineering and Applied
Sciences, Cambridge, MA, USA
7
University of Virginia, Center for Diabetes Technology,
Charlottesville, VA, USA
Background and Aims: The purpose of this study was to
examine the impact of artificial pancreas (AP) use on diabetes
distress and worry about hypoglycemia in adolescents and adults
with type 1 diabetes (T1D).
Methods: Twenty-five adolescents and adults (mean age =
25.9 10.5 years; 52% male) with T1D (mean duration = 14.5 8.0
yrs) used the Diabetes Assistant (DiAs) AP system with the Zone
Model Predictive Control (Zone-MPC) algorithm for 1-2 weeks
(adolescents 1 week, adults 2 weeks). The Diabetes Distress Scale
and Worry scale of the Hypoglycemia Fear Survey were completed
ATTD 2017 E-POSTER VIEWING ABSTRACTS
at baseline and immediately following study completion with higher
scores indicating greater distress and worry. Focus groups were
conducted at study completion to assess human factors.
Results: At study entry, scores on both diabetes distress
(mean = 46.1 19; range = 28-102) and hypoglycemia worry
(mean = 8.0 7.6; range = 0-24) were low. Repeated measures
ANOVA revealed no change in distress (mean = 46.3 21.2;
F = 0.31, p > 0.58) or worry (mean = 9.9 8.8; F = 1.1, p > 0.30) at
study completion. Focus group responses revealed variability in
experience with the system. Participants experienced less worry
about nocturnal hypoglycemia and lows in general and flexibility
when eating. Connectivity issues and charging batteries daily
were considered burdensome.
Conclusions: Using the DiAs AP system with Zone-MPC
algorithm did not add distress and hypoglycemia worries for
study participants. Future research is needed to better understand
both the overall psychosocial impact of AP use as well as the
specific impact for highly distressed and worried individuals
with T1D.
115
MONITORING AND SUPERVISION OF ARTIFICIAL
PANCREAS OPERATION WITH MULTIVARIABLE
STATISTICAL ALGORITHMS
A. Cinar1, K. Turksoy2, I. Hajizadeh1
1
Illinois Institute of Technology, Chemical and Biological
Engineering, Chicago, USA
2
Illinois Institute of Technology, Biomedical Engineering,
Chicago, USA
Background and Aims: Detection and mitigation of the ef-
fects of faults in an artificial pancreas (AP) is critical for its safe
operation. Faults in glucose sensors, insulin pump and control
system can yield insulin infusion rates that can cause hypogly-
cemia or hyperglycemia. The multivariable AP system devel-
oped at IIT enables the use of additional variables in monitoring
the AP operation, detection abnormalities in its operation, and
diagnosis of faults. The algorithms developed focus on real-time
detection of unexpected changes in signals that may be caused by
faults or disturbances.
Methods: This novel system monitoring approach uses dy-
namic time warping for synchronization of several signal tra-
jectories, Savitzky-Golay filter and multiway principal component
analysis.
Results: Data from 14 subjects that participated in 60-hour
closed-loop AP experiments with variations in meal amounts
and physical activity levels and times are used. Glucose mea-
surements from a CGM sensor and biometric variables such as
heat flux, skin temperature, galvanic skin response, energy
expenditure and acceleration from a physical activity armband
are monitored for fault detection. The unexpected changes in
signals are detected successfully. The results illustrate that the
proposed method is able to detect various types of faults with
high accuracy. No faults were missed in the fault scenarios
tested.
Conclusions: The algorithm detects faults or unexpected
dynamic changes and labels them according to predefined rules,
and it can be used to warn about sensor and AP faults. This will
be a new module in our multivariable AP that can be integrated
with our controller performance assessment and data recon-
ciliation modules.
A-47
116
AN UNANNOUNCED MEAL DETECTION MODULE
FOR ARTIFICIAL PANCREAS CONTROL SYSTEMS
A. El Fathi1, S. Mohamed Raef2, A. Haidar3
1
McGill University, Department of Electrical and Computer
Engineering, Montreal, Canada
2
McGill University, Department of Biomedical Engineering,
Montreal, Canada
3
McGill University, Department of Biomedical Engineering,
Montreal, Canada
Background and Aims: Most artificial pancreas systems rely
on patient announcement of upcoming meals and deliver accom-
panying insulin boluses in order to achieve better postprandial
glucose levels. However, the omission of prandial insulin boluses
is common in patients with type 1 diabetes, especially adolescents.
We developed a novel module for detection of unannounced meals
during the operation of our artificial pancreas.
Methods: From real-time glucose measurements and a meal
digestion model, the novel module constructs, i) a probability
density function characterizing the amount of carbohydrate
content of a hypothetical missed meal and ii) the time of the
hypothetical missed meal. The module will flag a meal if the
variance of the density function is smaller than a threshold.
Results: The detection module is evaluated in a four-week
virtual experiment using our metabolic simulator that runs our
artificial pancreas control algorithm. We tested the module on 12
virtual type 1 diabetes patients who fail to announce the meal
to the artificial pancreas three times per week. Out of the 144
non-announced meals, 138 meals are detected (Sensitivity of
95.83%). The detection time is 40 (30-50) min, and the precision
of the estimated mealtime is 10 (0-20) min. Our algorithm reports
a false positive detection once every 56 days. These findings
were also confirmed by running our module on clinical data of a
72-hour artificial pancreas outpatient study.
Conclusions: Our meal detection algorithm performed well
on simulation data, and validated with clinical data. Control
actions based on this meal detection module has to be developed.
117
THE ARTIFICIAL PANCREAS (AP) IMPROVES
GLYCEMIC CONTROL DURING EXTENDED
EXERCISE AT SKI CAMP IN ADOLESCENTS
WITH TYPE 1 DIABETES (T1D)
G. Forlenza1, D. Chernavvsky2, M. DeBoer2, J. Robic2,
B. Kovatchev2, R.P. Wadwa1, L. Messer1, D. Maahs1,
M. Breton2
1
University of Colorado Denver, Barbara Davis Center,
Aurora, USA
2
University of Virginia, Center for Diabetes Technology,
Charlottesville, USA
Background and Aims: Intense exercise often leads to ab-
normal glucose control in patients with T1D. Adjusting man-
agement for exercise remains one of the major burdens of T1D
therapy. AP systems can improve glycemic control during and
after exercise, but exercise studies have been limited. Skiing
camps present a unique mix of prolonged physical activities of
varied intensities, with metabolic effects compounded by cold,
altitude, and stress/fear/excitement.
A-48
Methods: In a randomized controlled clinical trial, 32 ado-
lescents with T1D (ages 10-16; 17 males) participated in a 5-day
ski camp (*5h skiing/day), with N = 16 fitted with the UVA AP
system (vs. sensor augmented pump), at two sites: Wintergreen
VA and Breckenridge CO. Control and treatment groups were
matched by age and HbA1c; ski/snowboard proficiency was
balanced overall but with a strong site effect. All subjects were
physician monitored 24h/day using the UVA Diabetes Web
Monitoring (DWM) system, allowing for strict enforcement of
safety protocols on and off the slopes.
Results: Percent time between 70-180mg/dL was signifi-
cantly better in the AP group (67% vs 73%; p = 0.03) overall
with maximum effect in the second half of the night. Daytime
% <70 mg/dL was also significantly decreased (3.5% vs. 1.8%;
p = 0.006). Effects were site dependent with VA showing re-
duced hypoglycemia and similar percent in range and CO
showing improved time in range without hypoglycemia reduc-
tion (Figure 1). Post-study qualitative feedback was highly
positive regarding the AP system and study experience.
Conclusions: During the first winter-sport AP camp, we re-
port significantly improved glycemic control without any device-
related adverse events and with overwhelmingly positive patient
feedback.
118
APPLICATION OF ZONE MODEL PREDICTIVE
CONTROL (ZONE-MPC) ARTIFICIAL PANCREAS (AP)
DURING EXTREME FAULT DETECTION TESTING
CONDITIONS: A RANDOMIZED CROSSOVER-
CONTROLLED HOME-USE TRIAL
G. Forlenza1, S. Deshpande2, T. Ly3, D. Howsmon4,
F. Cameron4, N. Baysal4, L. Schulhof-Towers1, T. Marcal3,
B.W. Bequette4, R. Gondhalekar2, F.J. Doyle III2, D. Maahs1,
B. Buckingham3, E. Dassau2
1 1
University of Colorado Denver, Barbara Davis Center,
Aurora, USA
2 2
Harvard University, John A. Paulson School of Engineering
and Applied Sciences, Cambridge, USA
3 3
Stanford University, Pediatric Endocrinology, Palo Alto, USA
4 4
Rensselaer Polytechnic Institute, Chemical and Biological
Engineering, Troy, USA
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Background and Aims: Zone-MPC permits patients to remain
fully in closed-loop for prolonged, multi-month, periods of time.
As long-term, fully autonomous, sparsely supervised AP operation
becomes routine, consideration of automatic fault detection and
mitigation becomes vital. We conducted a randomized-crossover
study of home use of the Zone-MPC system versus sensor aug-
mented pump (SAP) in which insulin infusion set (IIS) and con-
tinuous glucose monitor (CGM) sensor failures were provoked via
prolonged wear.
Methods: Monitored home use of an Android phone-based
AP system was conducted in 19 adults (58% female, median 23
years-old, 11 years of type 1 diabetes, 8% A1c) in a randomized
crossover study. Participants wore their IIS for up to 7 days and
their CGM for up to 14 days to increase the probability of sensor
and infusion set failures.
Results: Use of the Zone-MPC system (SAP vs closed loop)
improved percent time 70-140 mg/dL (41 vs 48%; p = 0.02), time
70-180 mg/dL (66 vs 73%; p = 0.004), and decreased median
CGM glucose (150 vs 141 mg/dL; p = 0.02) and glycemic vari-
ability (SD 56 vs 51 mg/dL; p = 0.03) while decreasing percent
time <70 mg/dL (3.1 vs 1.7%; p = <0.001) and time <50 mg/dL
(0.3 vs 0.1%; p = 0.01) [Table 1]. CL also greatly improved
overnight control as measured by mean CGM glucose MN-6AM
(158 vs 141 mg/dL; p = 0.01).
Conclusions: Zone-MPC significantly improved glycemic
control in a home-use environment despite prolonged CGM and
IIS wear. This project represents the first home use AP study
attempting to provoke and detect component failure while suc-
cessfully maintaining safety and glucose control.
119
FULLY CLOSED LOOP MULTIPLE MODEL
PROBABILISTIC PREDICTIVE CONTROLLER
(MMPPC) ARTIFICIAL PANCREAS (AP)
PERFORMANCE IN ADOLESCENTS AND ADULTS
IN A SUPERVISED HOTEL SETTING
G. Forlenza1, F. Cameron2, T. Ly3, D. Lam4, D. Howsmon2,
N. Baysal2, L. Messer1, P. Clinton3, C. Levister4, S. Patek5,
C. Levy4, R.P. Wadwa1, D. Maahs1, B.W. Bequette2,
B. Buckingham3
University of Colorado Denver, Barbara Davis Center,
Aurora, USA
Rensselaer Polytechnic Institute, Chemical and Biological
Engineering, Troy, USA
Stanford University, Pediatric Endocrinology, Palo Alto, USA
Mount Sinai Ichan School of Medicine, Department of
Endocrinology- Diabetes and Metabolism, New York, USA
ATTD 2017 E-POSTER VIEWING ABSTRACTS
5
University of Virginia, Center for Diabetes Technology,
Charlottesville, USA
Background and Aims: The goal of AP systems is to reduce
complications and burdens of T1D. Early systems will be hybrid
closed-loop, requiring prandial meal announcements. Such sys-
tems do not eliminate the burden of pre-meal insulin dosing and
will provide suboptimal benefits if patients forget to bolus.
MMPPC is a fully closed-loop system which uses probabilistic
estimation of meals to allow for automated meal detection. Here
we describe the performance of the MMPPC system with adap-
tive hypoglycemia minimization in a supervised hotel setting.
Methods: The Android phone-based AP system with remote
monitoring was tested for 72 hours in 6 adults and 4 adolescents
(30% female, 23 years-old, 10.6 years of T1D, 8.1% enrollment
A1c) across 3 clinical sites with daily exercise and meal chal-
lenges involving both announced and unannounced meals.
Controller aggressiveness was adapted daily based on prior hy-
poglycemic events.
Results: Mean 24-hour CGM glucose was 157 mg/dL, with
63.3% of readings between 70-180 mg/dL, 2.9% of readings
<70 mg/dL, and 9.0%> 250 mg/dL [Table 1]. Moderate hyper-
glycemia was relatively common with 24.5% of readings be-
tween 180-250 mg/dL, primarily within 3 hours of a meal.
Overnight mean CGM glucose was 140 mg/dL, with 75.0% be-
tween 70-180 mg/dL, 4.0% <70 mg/dL, 16.8% between 180-
250 mg/dL, and 3.9%> 250 mg/dL. Breakfast glycemic peak was
higher for unannounced meals with values normalizing by 2-
3 hours post-meal [Figure 1].
Conclusions: Adaptive MMPPC was effective in a supervised
setting despite meal and exercise challenges. Further studies are
needed in a less supervised environment with additional miti-
gations to prevent exercise induced hypoglycemia.
A-49
120
DIABELOOP CLOSED-LOOP DOES BETTER THAN
SENSOR-AUGMENTED PUMP ON BLOOD GLUCOSE
CONTROL DURING 3 DAYS WITH EITHER
INTENSIVE PHYSICAL EXERCISES, GASTRONOMIC
DINNERS OR REST IN T1D
Y. Reznik1, N. Jeandidier2, P.Y. Benhamou3, S. Borot4,
M. Doron5, S. Franc6,7, H. Hanaire8, E. Huneker9,
E. Renard10, P. Scaepelynck11, I. Xhaard7, A. Penfornis6,
G. Charpentier6,7, B. Guerci12
1
CHU de CAEN, Endocrinologie, Diabetologie, CAEN,
France
2
CHU STRASBOURG, Endocrinologie, Diabete et des maladies
de la Nutrition, STRASBOURG, France
3
CHU GRENOBLE, Endocrinologie, GRENOBLE, France
4
CHRU BESANCON, Service dEndocrinologie, Metabolisme
et Diabetologie, Nutrition, BESANCON, France
5
CEA_Leti, Technology Research Institute, Micro Technologies
Department for Biology and Health, GRENOBLE, France
6
CHSF, Service Diabetologie, CORBEIL ESSONNES, France
7
CERITD, Research, EVRY, France
8
CHU TOULOUSE, Service de Diabetologie, Maladies
metaboliques et Nutrition, TOULOUSE, France
9
DIABELOOP SAS, Industrial Development, GRENOBLE,
France
10
CHU MONTPELLIER, Service des maladies endocriniennes,
MONTPELLIER, France
11
HOPITAL DE LA CONCEPTION, Service de Nutrition,
Endocrinologie, Maladies Metaboliques, MARSEILLE, France
12
CHU NANCY, Service de Diabetologie, NANCY, France
Background and Aims: Variability of way of life, is an issue
for good BG control in type 1 diabetes.(T1D) Diabeloop is a
Closed-loop (CL) system with a MPC algorithm reinforced by
a decisional matrix, uploaded on an android smartphone linked
to Dexcom CGM and a Cellnovo insulin patch-pump. The
primary aim of the study was to compare BG control with
Diabeloop CL versus sensor-augmented insulin pump therapy
(SAP), in well-educated patients practicing intensive physical
exercises repeatedly, or gastronomic dinners or rest, during
3 days.
Methods: Thirty-eight T1D patients on insulin pump ther-
apy (49.9 14.5 years old, diabetes duration:25.1 13.6
years, HbA1c:7.8 0.7%) participated in randomized nine-
center crossover study, including two 72-hour periods under
conditions of various exercises for the 1st group, gastronomic
dinners for the 2nd group, and rest for the 3rd one, either with SAP
or CL. Meals and exercises were announced in CL period.
Results: Percent time in 80-140mg/dL range during the
3 nights, was significantly higher in CL compared with
SAP (61.1[56.1;66.7] vs. 27.4 [19.2;39.0], P < 0.0001) as was
%time in 70-180mg/dL target range during the whole 72hrs:
79.0[75.6;82.5] vs. 60.8[55.2;67.0] P < 0.0001). Three-day
mean BG(mg/dL) was significantly lower in CL than in SAP
(138.7[133.5;144.2] vs. 156.5[148.5;165.0], P<0.0001), as was
the %time spent in hypoglycemia. Satisfaction of treatment
(DTSQ) was higher with CL (31.0 5.5) compared to SAP
(26.0 5.5), P = 0.0003.
Conclusions: In various situations such as intensive exercises,
gastronomic dinners or rest, Diabeloop was able to double the
%time spent in 80-140mg/dl BG range during the night, to re-
duce the time in hypoglycemia and to decrease average BG level,
compared to SAP.
A-50
121
HYSTERESIS-LIKE CURVE OF THE GLUCOSE/
PROTEIN BINDING AND DISSOCIATION: WHY VERY
STRICT BS CONTROL FAILS TO REDUCE LONG-
TERM SIDE EFFECTS OF DIABETES
K. Khodabakhshi Pirkalani1, Z. Talaeerad1
1 and 30%, the calcBolus %error ranges were [-17%,20%] (SD
Mehr Medical Group, Internal Medicine/Gynecology,
Tehran, Iran
Background and Aims: Mathematical modelling explaining
why very strict BS control cannot reduce long-term side effects
in large cohort studies.
Methods: Normal range of blood glucose has traditionally
been chosen arbitrarily or at most statistically. Both patients and
physicians are happy if FBS is under 90-110 and PP BS under
180. But if we regard 70 as a the healthy BS value based on
childhood samples, possible BS of the prehistoric mankind and
related animals with a different meal composition140mg/dl will
face us with twice as fast reversible glycosylation and 100%
more irreversible glycosylation. In this way the patient must cope
with three problems:
1. Degrade the surplus malfunctioning protein
2. Replace it with functioning proteins
3. Renew the regular cooperation of different proteins in a
pathway that are basically glycosylated by their structure
and not function. As in a factory aberrant function of a
worker affects the whole pathway.
Results: Based on complex mathematical calculations, a very
strict blood glucose control with conventional treatments or even
by closed loop systems must target a fasting BS at any time
around 70 and an HbA1C lower than 4.5-5. Though this cannot
be tolerated early in the treatment, strategy techniques are sug-
gested on how to achieve this goal in middle to long term.
Control in the range of 5.5-7 is not much different from higher
ranges in regard to long term side effects.
Conclusions: New definition of BS target can solve the recent
controversies. Novel methods to increase compliance for lower
BS values are presented.
122
UNCERTAINTY ANALYSIS OF INSULIN DOSES
FROM BOLUS CALCULATORS
R. Kircher1, R. Mauseth2, D. Matheson3
1
Engineering & Regulatory Affairs, Seattle, USA
2
Seattle Childrens Hospital, Seattle, USA
3
Dose Safety, Inc., Seattle, USA
Background and Aims: Accurate calculation of insulin bo-
luses is a challenge for people with diabetes (PWD), even with a
hybrid closed loop artificial pancreas pump. The objective is to
quantify errors of insulin bolus calculators as a function of pa-
tient uncertainties in their insulin to carb ratio (ICR), correction
factor (CF) and estimating carbs (CHO). The formula is: calc-
Bolus = CHO/ICR + (BGcurrent - BGtarget)/CF where ICR,
CHO and CF are patient specified inputs.
Methods: An uncertainty analysis was performed on the
calculator bolus, given selected % uncertainties of input pa-
rameters CHO, ICR and CF. Doses were characterized as +/-
ATTD 2017 E-POSTER VIEWING ABSTRACTS
%error = (calcBolus - idealBolus)*100/idealBolus, where calc-
Bolus is from the calculator and idealBolus is the dose assuming
perfect ICR, CHO and CF. The ICR and CF inputs were set at
12g/U and 50mg/dL/U respectively. Meal size estimates (CHO)
ranged from 10 to 100g, and (BGcurrent - BGtarget) ranged
from 50 to 300mg/dL.
Results: With inputs ICR, CHO and CF set at +/-10%, 20%,
0.17), [-32%,47%] (SD 0.13), and [-44%,80%] (SD 0.19) re-
spectively. Maximum %errors occurred when CHO was the
maximum (100g) and BGcurrent - BGtarget was the smallest
(50mg/dL).
A sensitivity analysis showed that for the 20% uncer-
tainty case, when CHO, ICR and CF were individually set to zero
the calcBolus %error went down to [-20%,20%](SD 0.10),
[-20%,24%](SD 0.10) and [-29%,44%](SD 0.11) respectively;
making calcBolus more sensitive to CHO and ICR.
Conclusions: More research is needed to help PWD make
better estimates of CHO, ICR and CF.
123
ON THE SENSITIVITY OF CONTINUOUS GLUCOSE
MONITORING TO INSULIN INFUSION FAULTS
K. Kolle1,2,3, A.L. Fougner1,2,3, . Stavdahl1,3
1
Norwegian University of Science and Technology NTNU,
Department of Engineering Cybernetics, Trondheim, Norway
2
Central Norway Regional Health Authority, RHA, Trondheim,
Norway
3
Norwegian University of Science and Technology NTNU,
Artificial Pancreas Trondheim APT, Trondheim, Norway
Background and Aims: The artificial pancreas is subject to
faults that the automated system must deal with while keeping
the user safe. Fault detection is important in order to distinguish
between disturbances, physiological variations and component
faults. Whereas the first two are handled by the nominal con-
troller, the latter requires dedicated fault mitigating actions,
possibly even a system shut-down. Current body-worn systems
provide continuous glucose monitoring (CGM) data from the
subcutaneous tissue as the only standard measurement. Any
change of blood glucose concentration appears delayed in these
sensor readings.
Methods: The dynamic model by Dalla Man et al. (2007)
(DOI:10.1177/193229680700100303) is the basis for a for-
ward sensitivity analysis using the Sundials CVODES package
in MATLAB. An insulin infusion fault, a meal and decreased
insulin sensitivity are simulated. All of these changes eventu-
ally lead to increased blood glucose concentrations. The sen-
sitivity of CGM to these glucose changes is investigated for
different sensing dynamics, using the intravascular glucose
concentration as reference.
Results: The sensitivity of glucose measurements to insu-
lin infusion faults is low, and notably lower than the sensi-
tivity to normal variations of insulin sensitivity. A meal has
the strongest impact and possibly even masks the onset of
glucose excursions caused by infusion faults before they be-
come apparent.
Conclusions: An early distinction between physiologi-
cal variations and an insulin infusion fault is hardly possi-
ble based exclusively on deviations in glucose concentration
without more advanced pattern recognition that reveals subtle
ATTD 2017 E-POSTER VIEWING ABSTRACTS
differences. Slow glucose dynamics from plasma to the
sensing site potentially obscures fault detection and diagnosis
based only on CGM.
124
OVERNIGHT GLUCOSE CONTROL WITH DUAL- AND
SINGLE-HORMONE ARTIFICIAL PANCREAS IN TYPE
1 DIABETES WITH HYPOGLYCEMIA UNAWARENESS
VERSUS HYPOGLYCEMIA AWARENESS:
RANDOMIZED CONTROLLED TRIAL
R. Rabasa-Lhoret1, A. Abitbol2, V. Messier1, L. Legault3,
M. Smaoui4, M. Ladouceur5, A. Haidar4
1
Institut de recherches cliniques de Montreal, Metabolic
diseases, Montreal, Canada
2
LMC Diabetes & Endocrinology, Diabetes, Toronto, Canada
3
Montreal Childrens Hospital, Endocrinology, Montreal,
Canada
4
McGill University, Biomedical engineering, Montreal, Canada
5
Centre de recherche du Centre Hospitalier de lUniversite de
Montreal, Biostatistics, Montreal, Canada
Background and Aims: The dual-hormone (insulin and
glucagon) artificial pancreas may be justifiable in some but not
all patients, among them are hypoglycemia unaware patients. We
conducted a randomized crossover trial comparing dual- and
single-hormone artificial pancreas over one night in 18 adult
patients with hypoglycemia unawareness and 17 patients with
hypoglycemia awareness.
Methods: All patients had documented nocturnal hypogly-
cemia during two weeks of screening. Analysis was performed
using plasma glucose.
Results: In patients with hypoglycemia unawareness, the
time spent below 4 mmol/L was 0% [010] on single-hormone
nights and 0% [00] on dual-hormone nights (P = 0.28). In
patients with hypoglycemia awareness, the time spent below
4 mmol/L was 0% [00] on single-hormone nights and 0% [0
0] on dual-hormone nights (P = 0.79). In hypoglycemia un-
aware patients, there were 3 hypoglycemic events (< 3.3 mmol/
L with symptoms of hypoglycemia or <3.0 mmol/L without
symptoms of hypoglycemia) on single-hormone nights and 2
events on dual-hormone nights. In hypoglycemia aware pa-
tients, there was 1 event on single-hormone nights and none on
dual-hormone nights.
Conclusions: We conclude that the single-hormone artificial
pancreas might be sufficient for hypoglycemia-free overnight
control in patients with hypoglycemia unawareness. Day and
night studies in this population are needed.
125
STOCHASTIC SEASONAL MODELS FOR GLUCOSE
PREDICTION IN TYPE 1 DIABETES
E. Montaser1, J. Luis Diez1, J. Bondia1
1
Universitat Politecnica de Valencia, Systems Engineering and
Automation, Valencia, Spain
Background and Aims: An important feature of any arti-
ficial pancreas (AP) is its ability to predict glucose along a
given prediction horizon (PH), either as part of the control
algorithm or the patient supervision subsystem. However,
A-51
current models accuracy seldom allow to predict beyond 60
minutes. Increasing PH values may play a significant role to
improve AP performance. The extension of the concept of
seasonality in time-series models for glucose prediction is
evaluated here in a proof-of-concept study to improve pre-
diction accuracy.
Methods: The main idea is that seasonality may emerge
after the pre-processing of CGM data collecting periods with
similar glycemic patterns (e.g. post-prandial periods for
similar meals). Then a familiy of seasonal stochastic models
can be built. Data covering 7 post-prandial periods for a same
60g CHO meal was used, both in open-loop (OL) and closed-
loop (CL) scenarios. SARIMA and SARIMAX models were
identified and evaluated following a one-leave-out procedure.
To evaluate goodness-of-fit, residual analysis, Akaike infor-
mation criterion (AIC) and mean squared error ( MSE) were
compared. Forecast accuracy was evaluated via root mean
squared error (RMSE) and mean absolute percentage error
(MAPE).
Results: RMSE in OL study was larger than in CL study due
to the larger fluctuations in OL when SARIMA models were used
(35.04 vs. 25.47). SARIMAX model further improved perfor-
mance in CL, by using insulin infusion and amount of meals as
exogenous variables. In this case, PH could be extended to up to
180 min for a MAPE below 10%.
Conclusions: Seasonality improved model accuracy allowing
the extension of the PH.
126
MID-TERM BLOOD GLUCOSE PREDICTION:
A HYBRID APPROACH USING GRAMMATICAL
EVOLUTION AND PHYSIOLOGICAL MODELS
S. Oviedo1, J. Veh1, I. Contreras1, R. Visentin2, M. Vettoretti2
1
Universitat De Girona, Institute of Informatics and
Applications, Girona, Spain
2
Padova University, Department of Information Engineering,
Padova, Italy
Background and Aims: In this work a proposal of a hybrid
model using Grammatical Evolution (GE) and physiological
model for personalized mid-term (120 minutes) blood glucose
predictions is introduced. The inclusion of physiological models
in the overall GE model is to our knowledge, the first approach of
this kind.
Methods: Insulin-on-Board and Glucose Rate of Appearance
models were included into a hybrid predictive model that uses
symbolic regression through Grammatical Evolution (GE). Four
personalized models per patient were developed, corresponding
to 6-hour periods.
The personalized models were evolved for 10 days of con-
tinuous data generated from 100 in-silico patients simulated
A-52 ATTD 2017 E-POSTER VIEWING ABSTRACTS

AS (GT3X+, ActiGraph) were acquired, while the subjects per-

formed a set of 24 5-min activities of various intensity (rest to
using the UVA-Padova simulator to predict BG 120 minutes
vigorous) under lab-conditions. The proposed model is compared
ahead. A glucose-specific fitness function (gRMSE) that penal-
with 1 linear model trained on the same data and 1 classical linear
izes the deviations according to their clinical harmfulness was
model for converting AS (counts per minutes from Actilife) into
used. Four additional days were used for validation.
EE. A leave-one-subject-out approach and the classical perfor-
Results: For the validation days, gRMSE and RMSE were
mance indicators were chosen for comparison purposes.
10.89 mg/dL and 11.8 mg/dL respectively during the nocturnal
Results: Table 1 shows performance obtained by each model.
period while average gRMSE and RMSE during the day were
Conclusions: Results displayed in Table 1 demonstrate that
26.93 mg/dL and 24 mg/dL respectively. The percentage in Clarkes
the proposed model yields better performances than the two
zones A and B was 99.37% at night and 97.95% during the day.
linear models. This model allowed EE computation for activities
Tables 1 and 2 show detailed results for the 4 time periods.
where linear models failed (cycling activity). Performance of the
Conclusions: Grammatical Evolution enhanced with physi-
AP developed by our research group may be further improved by
ological models is a feasible strategy for mid-term Blood Glu-
including other non-linear structural equations to obtain more
cose prediction.
accurate EE estimations.

127
A NONLINEAR MODEL FOR CONVERTING 128
ACCELEROMETERS SIGNALS INTO ENERGY
EXPENDITURE: TOWARDS THE ARTIFICIAL FACTORS THAT INFLUENCE THE PERFORMANCE
PANCREAS WHICH WILL CONSIDER PHYSICAL OF A HYBRID CLOSED-LOOP SYSTEM
ACTIVITY
A. Roy1, B. Grosman1, N. Parikh1, D. Wu1, N. Kurtz1,
1 2
H.M. Romero Ugalde , M. Garnotel , I. Xhaard , 3
R. Slover2, S. Garg3, T. Bailey4, R. Bergenstal5, B. Bode6,
G. Charpentier4, S. Franc4, E. Huneker5, C. Simon2, S. Bonnet1, R. Brazg7, J. Ilany8, B. Buckingham9, S. Anderson10,
on behalf of the Diabeloop consortium S. Weinzimer11, F. Kaufman12
1 1
Univ. Grenoble Alpes- F-38000 Grenoble- France. CEA LETI Medtronic Diabetes, R&D, Northridge, USA
2
MINATEC Campus- F-38054 Grenoble, France Barbara Davis Center for Childhood Diabetes, Pediatric
2
CARMEN INSERM U1060/Universite de Lyon 1/INRA U1235 Diabetes, Aurora, USA
3
Lyon- France. CRNH-Rhone-Alpes- Lyon, France Barbara Davis Center for Childhood Diabetes, Adult Diabetes,
3
CERITD - BIOPARC GENOPOLE Campus 3 batiment 5 - F- Aurora, USA
4
91058 Evry, France AMCR Institute, Advanced Metabolic Care Research,
4
CERITD - BIOPARC GENOPOLE Campus 3 batiment 5 - F- Escondido, USA
5
91058 Evry, France; and Centre Hospitalier Sud-Francilien Park Nicollet Clinic, International Diabetes Center,
CHSF-116- Bd Jean Jaures - 91106 Corbeil-Essonnes Cedex, Minneapolis, USA
6
France Atlanta Diabetes Associates, Endocrinology & Metabolism,
5
DIABELOOP SAS F-38000 Grenoble, France Atlanta, USA
7
Rainier Clinical Research Center, Metabolism and
Background and Aims: Physical activity (PA) has strong Endocrinology, Renton, USA
8
effects on glucose dynamics. Therefore, current research is Institute of Endocrinology, Sheba Medical Center,
conducted for including PA information on artificial pancreas Endocrinology, Tel Hashomer, USA
9
(AP) to improve glucose regulation performance. Among a va- Stanford University, Pediatric Endocrinology,
riety of PA indicators, energy expenditure (EE), computed from Stanford, USA
10
accelerometer signals (AS), is the preferred physiological vari- UVA Center for Diabetes Technology, Endocrinology and
able in AP applications. The most popular models for converting Metabolism, Charlottesville, USA
11
AS into EE are linear models. The aim of this work is to dem- Yale University School of Medicine, Pediatric Endocrinology,
onstrate that a nonlinear model improves EE estimation and may New Haven, USA
12
thus improve AP performance. Medtronic Diabetes, Clinical Affairs, Northridge, USA
Methods: A nonlinear model (sigmoid neural network) is
proposed for converting AS into EE. This model is obtained from Background and Aims: A multi-center pivotal trial of the
a database composed of 53 1955-year-old subjects in which MiniMed 670G hybrid closed-loop (HCL) system revealed a
indirect calorimetry (SERVOPRO 4100, Servomex, UK) and strong correlation between initial A1C and A1C delta, with a larger
ATTD 2017 E-POSTER VIEWING ABSTRACTS
drop for higher initial A1C levels. Pivotal trial data was analyzed to
investigate several potential factors on the outcome of the trial.
Methods: A total of 51 subjects (of 124 subjects in the
trial) had initial A1C between 6.57.5% and were divided into 3
groups: those who didnt experience any change (No-change),
those who had a rise (Rise), and those who had a drop (Drop) in
A1C levels. The reason to select such a tight A1C-range was to
minimize the influence of initial-A1C on the analysis.
Results: The table lists data from the three groups. There were
no significant differences between the Rise and Drop groups
for the initial A1C, average total daily dose of insulin, and av-
erage daily carbohydrate input. However, study phase data
showed the percentage of daily insulin from meal-bolus was
significantly higher for the Drop group (p = 0.0082), with a
lower carb-insulin ratio (p = 0.08). Furthermore, the daytime
mean sensor glucose values for the Drop group were signifi-
cantly lower than those of the Rise group, likely due to more
appropriate mealtime boluses. There was no difference in the
overnight mean glucose levels, indicating equivalent effective-
ness of the system in the absence of meal disturbances.
Conclusions: The results of the HCL pivotal trial demonstrate
the positive effect of automating insulin delivery, particularly at
night, and the need to continue to effectively manage postpran-
dial glucose levels.
129
MODEL-BASED IN-SILICO VERIFICATION
OF ARTIFICIAL PANCREAS CONTROL
ALGORITHMS
S. Sankaranarayanan1, F. Cameron2, B.W. Bequette2,
D. Maahs3
1
University of Colorado- Boulder, Computer Science, Boulder,
USA
2
Rensselaer Polytechnic Institute, Chemical and Biological
Engineering, Troy, USA
3
Stanford University, Pediatric Endocrinology, Stanford, USA
A-53
Background and Aims: We apply formal specification and
verification techniques for checking correctness properties of
artificial pancreas control algorithms. Formal specification and
verification techniques systematically and exhaustively explore
the behaviors of closed loop in silico models to discover the
worst case effects of disturbances such as meals, external bo-
luses, sensor noise and set failures on the predicted blood glucose
levels of a virtual patient.
Methods: Our study examines two artificial pancreas con-
trollers: (a) PID-based hybrid closed loop controller (Steil et al.,
2011) and (b) Kalman filter-based predictive pump shutoff sys-
tem (Cameron et al.2012) using the Dalla-Man model for the
virtual patient (Dalla-Man et al., 2008).
We formulate 10 different properties for the closed loop sys-
tems. Examples include (a) Are insulin infusions at/above the
basal rates possible when the patient is under hypoglycemia? (b)
Is the pump ever shut down, when the patient is under hyper-
glycemia?
The tool S-Taliro (Fainekos et al., 2011) is used to systemat-
ically search over a large range of disturbance inputs to discover
potential violations. The figure below shows a situation where
the Kalman-filter based system (Cameron et al., 2012) allows
insulin delivery to resume while the virtual patient is still under
hypoglycemia.
Results: Our analysis discovered potential issues and miti-
gations for each algorithm: specifically, we analyze the sensi-
tivity of the PID controller to choices of the gain parameters, and
the sensitivity of the Kalman filter algorithm to sensor noise.
Conclusions: In conclusion, we demonstrate how formal veri-
fication techniques can be useful in identifying possible defects and
their mitigations for artificial pancreas control algorithms.
130
GLYCAEMIC MANAGEMENT IN PATIENTS WITH
TYPE 2 DIABETES IN GERIATRIC CARE FACILITIES
A. Libiseller1, K.M. Lichtenegger1, A. de Campo2,
T. Wiesinger2, N. Stolletz2, G. Cuder1, B. Holl3,
P. Beck3, T.R. Pieber1
1
Medical University of Graz, Endocrinology and Diabetology,
Graz, Austria
2
Geriatric Health Centers of the city of Graz, Acute Geriatric
Department, Graz, Austria
3
Joanneum Research Forschungsgesellschaft mbH, HEALTH
Institute for Biomedicine and Health Sciences, Graz, Austria
Background and Aims: Diabetes guidelines recommend in-
dividualized treatment strategies in older patients with diabetes
with the main focus on avoiding hypoglycaemia. The aim of this
A-54 ATTD 2017 E-POSTER VIEWING ABSTRACTS

study was to assess glycaemic management in patients with type 2 132

diabetes with and without insulin therapy in geriatric care facilities.
Methods: 170 medical records of geriatric patients with type 2
diabetes were analysed retrospectively. Based on main diabetes
therapy 46 patients were allocated to the insulin group (52.2%
female, 78 8 years, HbA1c 60 22 mmol/mol, BMI 28.2 5.4 kg/
m2) and 124 patients to the no-insulin group (69.4% female, 80 9
years, HbA1c 48 12 mmol/mol, BMI 27.8 6 kg/m2).
Results: The overall blood glucose (BG) was 201 47 mg/dl
(insulin) compared to 160 38 mg/dl (no-insulin). 39.8% versus
59.3% of BGs were between 100-180 mg/dl, 3.9% versus 4.6%
below 100 mg/dl, and 0.2% versus 0.2% below 60 mg/dl, re-
spectively. In the insulin group 76% received premixed, 22%
basal, and 2% bolus insulin as main diabetes therapy. In the no-
insulin group 42% received no diabetes medication, 33% bi-
guanids, 17% sulfonylureas, 6% DPP4-inhibitors, 1% glinides,
and 1% biguanids combined with sulfonylureas.
Conclusions: Despite complex insulin therapies, overall BG in
the insulin group was higher than in the no-insulin group. Basal
insulin with its low hypoglycaemic risk is underutilized although
recommended by guidelines, whereas biguanids/sulfonylureas
are commonly used although they should be used with caution in
older patients with diabetes. Therefore the individualization of
diabetes therapy is an issue, which could be solved in part by
implementing electronical decision support systems considering
geriatric needs.
131
ACCURACY AND USABILITY EVALUATION
OF COMMERCIALLY AVAILABLE BLOOD
GLUCOSE MONITORING SYSTEMS
IN A UNIVERSITY HOSPITAL IN GREECE
A. Tentolouris1, I. Eleftheriadou1, P. Grigoropoulou1,
T. Nikolaos1
1
Medical School- National and Kapodistrian University of
Athens, First Department of Propadeutic and Internal
Medicine, Athens, Greece
SEVERE CRITICAL-ILLNESS INSULIN RESISTANCE
TREATED WITH U-500 INSULIN INFUSION:
A CASE SERIES
L. Igneri1, A. Schorr
1
St. Mary Medical Center, Pharmacy, Langhorne, USA
2
St. Mary Medical Center, Endocrinology, Langhorne, USA
Background and Aims: Insulin resistance is a marker of
disease severity in critically-ill patients and is associated with
increased morbidity and mortality.
Methods: We report two cases of severe insulin resistance
treated with regular insulin (U-500) infusion.
Results: Case 1: 66-year-old male with DM 2, CAD, and atrial
fibrillation was diagnosed with acute pancreatitis. On day 3, he
was intubated for acute respiratory distress syndrome. Insulin
aspart (U-100) intravenous infusion protocol was initiated on day
4 in response to BG levels above 200 mg/dL. On days 6-8, the
patient developed acute kidney injury and BG ranged 280-
389 mg/dL despite maximum insulin infusion at 40 units/hr. He
was transitioned to U-500 infusion at 43 units/hr with titration
per physician order. BG trended from 389 to 120 mg/dL on day 9.
U-500 was discontinued and the patient was transitioned back to
insulin aspart infusion. The patient expired from PEA cardiac
arrest on day 10. Case 2: 51-year-old male with DM 2 and hy-
pertension presented with ST-elevation myocardial infarction.

Background and Aims: Self-monitoring of blood glucose

(BG) is essential for achieving glycaemic control in individuals
with diabetes mellitus. The aim of our study was to evaluate the
accuracy according to the ISO15197:2013 requirements (95% of
the BG results within 15mg/dl or 15% of the reference method
at BG concentrations <100mg/dl and at BG concentration
100mg/dl, respectively) as well as the usability of 6 different
commercially available self-monitoring blood glucose monitor-
ing systems (SMBG).
Methods: A total of 120 adult individuals with both types of
diabetes mellitus, were recruited. Capillary BG was measured on
6 SMBG, while the YSI 2300 STAT PLUS was used as a ref-
erence instrument. Usability testing of the SMBG was performed
by Likert Scale Questionnaire.
Results: Four out of 6 SMBG fulfilled the minimum accept-
able performance according to the ISO15197:2013 requirements
in BG values <100mg/dl (n = 40), while 5 out of 6 in BG values
100mg/dl (n = 80) (Table 1). Among the 3 SMBG with the
highest performance (>99%) in the overall BG range (29-475mg/
dl), the one with an innovative strip insertion technique was less
favored by the participants.
Conclusions: Across the overall BG range tested, the majority
of SMBG satisfied the ISO requirements. A user-centered design
could enhance usability of the SMBG devices.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Insulin aspart (U-100) infusion protocol was initiated on day 1
for BG above 500 mg/dL. Despite insulin aspart 40 units/hr, BG
trended only from 504 to 387 mg/dL. On day 2, he was transi-
tioned to U-500 infusion at 40 units/hr with titration per physi-
cian order, and after 14 hours BG reduced to 144 mg/dL. The
patient remained on U-500 infusion until care was withdrawn on
day 5.
Conclusions: Differences in metabolism of concentrated in-
sulin may account for the attainment of glycemic control and
may be considered for refractory insulin resistance.
133
EFFECT OF CHROMIUM SUPPLEMENTATION ON
CHROMIUM STATUS AND BLOOD SUGAR AMONG
TYPE 2 DIABETES PATIENTS ATTENDING THIKA
HOSPITAL, KENYA: A RANDOMIZED PLACEBO
CONTROLLED STUDY
M. Judith1
1 Ramadan. Ramadan fasting induced a non-significant decrease in
Kenyatta University, Food- Nutrition and Dietetics, Nairobi,
Kenya
Background and Aims: Type 2 diabetes is characterized by
insulin resistance and relative insulin deficiency. Studies show
contradictory findings on beneficial effects of chromium sup-
plementation on blood sugar (FBS and HbAlc) that warrant ad-
ditional similar studies for conclusive evidence. Studies in Kenya
report a challenge with management of tight blood sugars re-
sulting to amputation of lower limbs among other complications
while chromium supplementation is not a component of man-
agement of blood sugar.
Methods: This was a double blind randomized placebo con-
trolled trial with 180 participants on hypoglycemic drugs, ran-
domized into two study groups at a ratio of 1:1. Participants in the
intervention group received chromium picolinate (500mcg/day)
and control group received placebo for a period of 4 months.
Data was collected at baseline and end of month 4. Blood sam-
ples were analyzed for chromium levels, fasting blood sugar and
HbAlc. T-test, Chi-square and Wilcoxon tests were used to
compare data between the study groups. Multiple regressions
were used to determine predictors of elevated HbAlc at p 0.05.
Results: At baseline, elevated fasting blood sugar with low
serum chromium levels were observed in both study groups.
Chromium supplementation significantly reduced HbAlc (DID:
intervention 1.44% versus control -0.79%; p = 0.001). No sig-
nificant difference in chromium status and fasting blood sugar
between the study groups. The predictors for elevated HbAlc
were age and fasting blood sugar.
Conclusions: Chromium supplementation should be a com-
ponent of treatment and management of blood sugar among type
2 diabetes patients.
134
DYSLIPIDEMIA AND GLUCOSE MONITORING
AMONG TYPE 2 DIABETES PATIENTS DURING
RAMADAN: A PROSPECTIVE STUDY
M.B. Khaled1, G. Tiboura2
1
university, Sidi Bel Abbes, Algeria
2
Djillali Liabes University, Biology, Sidi Bel Abbes, Algeria
A-55
Background and Aims: The purpose of this thesis was to
assess the impact of Ramadan fasting on lipid profile and gly-
cemic monitoring among a group of patients with type 2 diabetes
before and during the holy month of Ramadan.
Methods: The survey included 80 patients with T2D. The
average age was 56 8 years. The body weight, height, waist
circumference, BMI were measured. Total cholesterol, HDL
cholesterol, LDL cholesterol, triglycerides, apolipoprotein A1,
apolipoprotein B and fasting serum glucose were assessed.
Results: No significant change was noticed for body weight,
waist circumference and BMI during Ramadan. A significant
decrease in HDL-c levels during T2 (0.35 0.08 g/L) compared
to T1 (0.38 0.11 g/L) was found. No significant change in TC,
LDL-c and TGs was observed during the two periods. However,
Apo A-1 showed a significant decrease, while Apo B was sig-
nificantly higher during Ramadan. The calculation of lipid
fractions ratio showed a significant difference between T1 and
T2 on TG/HDL-c unlike the other ratios (CT/HDLc, LDLc/
HDLc, apoB/apoA1). The daily energy intake between the two
periods decreased not significantly during Ramadan. The Iftar
meal provided the largest part of the daily energy intake during
carbohydrate amounts, fats and proteins. However, the decrease
in caloric intake was associated with an increase of saturated
fatty acids intake during Ramadan.
Conclusions: This study suggests that fasting during Rama-
dan could be beneficial for some patients with T2D who are well
controlled and balanced.
135
CHARACTERIZATION OF GASTROINTESTINAL
MOTILITY IN EXPERIMENTAL MODELS
OF HYPERGLYCEMIA
J.F. Matos1, M. Americo2, Y. Sinzato3, D. Damasceno3,
J.R. Miranda1
1
Institute of Biosciences of Botucatu, Physics and Biophysics,
Botucatu, Brazil
2
Institute of Biological Sciences and Health Barra do Garcas-
MT, Parasitology, Barra do Garcas, MT, Brazil
3
Botucatu Medical School-SP-UNESP, Gynecology, Botucatu,
Brazil
Background and Aims: Acute changes in glucose concen-
tration in the blood have important effects on motor and sensory
function of the upper gastrointestinal tract (TGI), and at the same
time, the TGI plays an important role in the regulation of post-
prandial blood. The aim is to characterize the profile of gastric
motility in rats with severe diabetes model and evaluate the in-
fluence of glycemic variations in TGI.
Methods: Biosusceptometry of Alternating Current (BAC) is
a fairly simple technique, low cost and versatile in research re-
lated to the human TGI. BAC is composed of magnetic sensors
based in inductions coil. An electrode was inserted for mea-
surement of electromyography (EMG), and a ferrite bead to
measure the BAC in the rats. Severe diabetes was induced by a
beta-cytotoxic agent (streptozotocin 40 mg/kg, ip) at adult rats.
They were evaluated contractility and gastric emptying of seri-
ous diabetic and control animals. Concomitant to this experiment
was also performed the hyperglycemic clamp in non-diabetic
animals to evaluate the hyperglycemic condition. P < 0.05 as
statistical significance limit.
A-56
Results: There was a significant decrease in contraction fre-
quency and increase in gastric emptying time of the diabetic animals
compared with control. As for the hyperglycemic clamp experiment
no significant differences were gastric contraction rate during hy-
perglycemic period. However, morphologically there was a sign of
irregularity obtained gastric motility during hyperglycemic time.
Conclusions: There is an influence of glycemic status on the
GI tract and may have alterations of frequency and gastric
emptying.
Acknowledgment: FAPESP 2015/05045-8.
136
RELATIONSHIP BETWEEN THE DEGREE
OF IMPROVEMENT IN GLUCOSE METABOLISM
AND OXIDATIVE STRESS IN TYPE 2 DIABETES
PATIENTS
M. Ohara1, H. Nagaike1, N. Maeki1, S. Yamamoto1,
H. Kushima1, M. Hiromura1, T. Yamamoto1, T. Hayashi1,
T. Fukui1, T. Hirano1
1 mic ranges (Rodbard, 2009).
Showa University, Diabetes Metabolism & Endocrinology,
Shinagawa-ku, Japan
Background and Aims: To evaluate whether glucose vari-
ability and markers of diabetic control improve oxidative stress
in type 2 diabetes (T2DM).
Methods: The study subjects were thirty-six T2DM outpatients
(mean age, 61.6 11.9 years; HbA1c level, 8.4 1.6%). The pa-
tients underwent 72 hours of continuous glucose monitoring
(CGM) and the diacron-reactive oxygen metabolites (d-ROMs) test
before and after a 6-month intervention (target: HbA1c<7%). The
following variables were calculated from the CGM data: fasting
plasma glucose (FPG), mean glucose level (MGL), mean ampli-
tude of glycemic excursions (MAGE), mean of daily differ-
ences (MODD), and area under the postprandial plasma glucose
curve (AUCPP). The relationship between glucose metabolism
improvement and oxidative stress improvement was evaluated.
Results: MGL, FPG, HbA1c, MAGE, AUCPP, and d-ROMs
were significantly improved in the second determination com-
pared to the first, but no significant difference was observed in
MODD. The changes in FPG (r = 0.574), MGL (r = 0.439), and
HbA1c (r = 0.403) were significantly correlated with the change
in d-ROMs but not the changes in MAGE, MODD, or AUCPP.
The changes in d-ROMs and FPG were still significantly related
after adjustment for the other markers of diabetic control in
multiple linear regression analysis (multiple R2 = 0.309).
Conclusions: Improved glucose metabolism reduces oxida-
tive stress in T2DM. In contrast to earlier cross-sectional findings
showing a strong correlation between oxidative stress and gly-
cemic variability in T2DM, reduced oxidative stress in T2DM
was strongly associated not with improved glucose variability or
postprandial glucose, but with improved FPG.
137
NEW ENHANCEMENTS TO THE AMBULATORY
GLUCOSE PROFILE (AGP)
D. Rodbard1
1
Biomedical Informatics Consultants, Clinical Research
and Biostatistics, Potomac MD, USA
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Background and Aims: The Ambulatory Glucose Profile
(AGP) was introduced to reveal underlying patterns in glucose
by time of day ( Mazze et al., 1987). Key features included
display of the median (50th percentile), 25th and 75th percen-
tiles, with smoothing to minimize influence of random fluctu-
ations. We propose several ways to improve the clinical utility
of the AGP.
Methods: I proposed the use of 25th, 50th and 75th percentiles
and a complete Box plot for 8 point glucose profiles (1986).
This evolved into the original AGP (Mazze et al., 1987) allowing
one to examine the scattergram, the percentiles or both, super-
imposed by time of day. The method was adapted to display
CGM data with addition of 10th and 90th percentiles (Mazze
et al., 2008, 2009). The AGP can be augmented by simultaneous
display of IQR (75th 25th percentiles) or SD, and of estimated
insulin pharmacodynamic activity profiles by time of day. One
can display results for two days to facilitate evaluation of the
overnight period. One can synchronize and normalize data at
the onset of meals, bedtime and awakening, to focus on patterns
during these time segments (Rodbard, 2013). Logarithmic
transformation provides better symmetry of the glucose distri-
bution and improved balance of hyper-, target-, and hypoglyce-
Results: Several new modifications of the AGP will be dis-
played to illustrate their utility and advantages.
Conclusions: The AGP is useful, well accepted, easy to learn
and use both by patients and physicians. These several new
modifications are expected to further enhance the effectiveness
of the AGP.
138
DATA DRIVEN BLOOD GLUCOSE PREDICTION:
INTERVAL VS. POINT BLOOD GLUCOSE
PREDICTION?
A.Z. Woldaregay1, E. Arsand2,3, G. Hartvigsen1,3
1
UiT The Arctic University of Norway, Computer Science,
Troms, Norway
2
UiT The Arctic University of Norway, Clinical Medicine,
Troms, Norway
3
Norwegian Centre for E-health Research, University Hospital
of North Norway, Troms, Norway
Background and Aims: Since diabetes patients are chal-
lenged to maintain their blood glucose (BG) levels as close as
possible to the normal range, BG prediction has a great potential
in improving decision support tools. Recently, due to more
widespread use of glucose sensors and patient-gathered data in
general, research on data driven BG prediction are now more
relevant than ever. We present an overview of the current prac-
tices and address the knowledge gap within these practices.
Methods: We searched various electronic databases, see
Figure 1. The search targeted peer reviewed journal articles and
conference proceedings.
Results: 31 articles were critically analyzed, see Figure 1.
Predicting an interval or a point is dependent upon the choice
whether to include possible realization of uncertainties or not.
Interestingly, our review identified inclination towards ma-
chine learning approaches. BG, insulin and diet are the most
used input parameters, see Figure 2. Most of the studies have
used significant number of participants. Furthermore, the re-
view found that point BG prediction is the most used form
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Figure 1: Flow diagram of reviewed literature.
compared to interval. Despite its ability of capturing un-
certainties, interval prediction has got little attention.
Conclusions: Recently, data driven models have seen success
in terms of simplicity and accuracy. However, the accuracy de-
grades after certain prediction horizon possibly due to stochastic
phenomena involved in BG dynamics. In this regard, the current
research efforts lack use of interval prediction mechanisms with
all its flavors in coping uncertainties.
Figure 2: Types of algorithm and input parameters used
by the identified prediction models
A-57
139
A PHYSIOLOGICAL MODEL OF TYPE 2 DIABETES
FOR SIMULATING GLYCAEMIC VARIANCE AND
EFFECT OF INSULIN DOSE ADJUSTMENTS
T.B. Aradottir1,2, B. Van Orden3, D. Boiroux1, J.B. Jrgensen1,
H. Bengtsson2
1
Technical University of Denmark, Department of Applied
Mathematics and Computer Science, Kongens Lyngby,
Denmark
2
Novo Nordisk A/S, Technology Explorations, Hillerd,
Denmark
3
Novo Nordisk A/S, Digital Health, Seattle, USA
Background and Aims: More than 60% of type 2 diabetes
(T2D) patients on insulin treatment in USA do not reach re-
commended goals. The reasons reported include lack of em-
powerment, sub-optimal dosage, fear of hypoglycaemia and
complexity. Automatic dose adjustment algorithms use self-
monitored blood glucose (SMBG) measurements. SMBG is
prone to high variance due to intra-individual physiological
fluctuations and when done incorrectly. However, pharmacoki-
netic variance decreases with new ultra-long acting insulins.
With continuous glucose monitoring (CGM) becoming cheaper,
more accurate, and convenient in the near future, we see op-
portunities in using CGM data to address the barriers to reaching
treatment goals.
Methods: We present an adjusted model of the insulin-
glucose dynamics in type 1 diabetes (T1D) that also describes
endogenous insulin production in T2D. We adjust insulin sen-
sitivity, body weight and distribution volume of the T1D model
to represent a cohort similar to a clinical trial in T2D.
Results: We use the model to simulate CGM data in T2D
basal insulin treatment and compare the results with clinical
trial results. We investigate sources of variance and through
simulations we evaluate the contribution of adherence, erroneous
measurements and ultra-long acing insulins. The results suggest
that the simulation model is sufficient for testing dose adjustment
algorithms.
Conclusions: We find that dose adjustment algorithms
should compensate for adherence levels and high variance
for safety through methods including adherence detec-
tion and support, and implicit elements in dose adjustment
calculations.
140
A MINIMAL MATHEMATICAL MODEL
FOR INTERPRETATION OF DATA FROM
CONTINUOUS GLUCOSE MONITORING
I. Barsukov1, A. Dreval1, T. Shestakova1, O. Medvedev2,
M. Panteleev2, A. Sveshnikova2
1
Moscow Regional Research and Clinical Institute named after
M.F. Vladimirsky, Endocrinology, Moscow, Russia
2
Moscow State University, Department of Basic Medicine,
Moscow, Russia
Background and Aims: Aim. Development of a minimal
mathematical model of the interstitial glucose dynamics
suitable for interpretation of data from continuous glucose
monitoring.
A-58 ATTD 2017 E-POSTER VIEWING ABSTRACTS

Methods: The data of CGM of 6 pregnant women with dia- 142

betes mellitus type 1, age 27.2 3.,4 years, 15.3 2.7 weeks of
pregnancy. The data of two patents with diabetes mellitus (one
with MII and one with CSII) with detailed diary. In diary dose
insulin, amount of carbohydrates, physical activity was checked
in. The mathematical model consists of six ordinary differential
equations, describing dynamics of blood and interstitial glucose
level and the hormones and drugs concentration in blood. The
model integration and parameter estimation were performed in
COPASI software (http://www.copasi.org/).
Results: The developed model described experimental data
well. For patients with type 1 diabetes mellitus generally insulin
production was zero and parameters of insulin elimination higher
than those for healthy donors. Patient-specific parameters in-
cluded glucose uptake efficiency and rate of blood-interstitial
glucose interconversion.
Relative objective value is 3% for the patients with accurate
data and 1% for the patients without exactly data.
Conclusions: The constructed mathematical model could be
utilized for assessment of patient-specific parameters from con-
tinuous glucose monitoring data.
141
SIMULATION FRAMEWORK TO TEST ALGORITHMS
FOR THE OPTIMISATION OF INSULIN BOLUS
PARAMETERS IN TYPE 1 DIABETES THERAPY
G. Cappon1, M. Vettoretti1, A. Facchinetti1, G. Sparacino1,
C. Cobelli1
1
University of Padova, Department of Information Engineering,
Padova, Italy
GLYCEMIC VARIABILITY ASSESSED BY
TEMPORALLY-ADJUSTED, REGULARIZED
GLYCEMIC EXCURSION TARGETS (TARGET):
THINKING OUTSIDE THE BOX
R. Carter1, R. Basu2, A. Basu2, Y. Kudva2
1
Mayo Clinic, Health Sciences Research, Rochester, MN, USA
2
Mayo Clinic, Endocrinology, Rochester, MN, USA
Background and Aims: Widespread use of continuous glucose
monitors (CGMs) has enabled insight into glycemic variation.
Numerous summary measures exist to reduce a CGM profile into a
single, clinically-meaningful patient-centered summary; however,
the commonly used summary measures do not account for expected
variation during the day (Fig 1A) and provide little information
about specific patient-centered interactions that may be considered
to improve glucose control. We propose a novel glycemic variation
measure entitled Temporally-Adjusted, Regularized Glycemic
Excursion Targets (TARGET) that accounts for expected variation.
Methods: Each 24-hour period is divided into seven mutually
exclusive and exhaustive bins (Fig 1B). These bins represent periods
where one would expect relative homogeneity of glucose values
within the bin and heterogeneity between bins. As conceptualized,
the binning follows a daily routine consisting of three meals per
day at regular times and sleep overnight; however, the method is
flexible in that it can be adjusted to fit individual daily habits.
TARGET is structured on a 0-100 point scale, with higher scores
indicating a greater alignment of the observed CGM data stream
with the values determined to represent expected glycemic variation.
Results: TARGET removes the single box that is formed
by standard in range calculations (e.g., 70 140 mg/dl for the

Background and Aims: Type 1 diabetes (T1D) therapy is

based on basal+bolus insulin administrations. The key parameter
for calculating meal boluses is the carbohydrate-to-insulin ratio
(CR), which is normally tuned by trial-and-error procedures and,
as such, suboptimal. The aim is to create a realistic simulation
framework to test algorithms for CR optimization from CGM
data.
Methods: The simulation framework is composed by the T1D
patient decision-making model of (Vettoretti et al., Proc. IEEE
EMBS, 2015), where we integrate the UVA/Padova T1D simu-
lator (2013 release) with insulin sensitivity variability (Visentin
et al., IEEE TBME 2015) and models of CGM error (Facchinetti
et al., MBEC 2015), and patients behaviour, thus allowing to
generate reliable multiple-day scenarios. This framework is used
to assess two CR optimization algorithms: the run-to-run (R2R)
approach described in (Herrero et al., CMPB, 2015) and a new
method (R2R+CBR), where the R2R is integrated with case-
based reasoning (CBR (Herrero et al., IEEE J-BHI, 2014), with
the main difference of employing as case parameters the carbo-
hydrate load and pre-meal glycemic level, in addition to meals
time, instead of exercise intensity.
Results: We simulated four 30-day sessions on 100 virtual
patients with R2R, R2R+CBR and no optimization. On av-
erage, in the fourth session, time spent in euglycemia and
risk index result, respectively, 82.68% and 3.84 with R2R,
75.87% and 4.90 with R2R+CBR, 67.37% and 7.02 with no
optimization.
Conclusions: We developed a simulation framework that al-
lows generating realistic scenarios to test existing and develop
new algorithms for CR optimization.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
entire day). CGM data (Fig 1C-D) can be used to summarize
TARGET values to represent overall glucose control as well as
control within particular epochs during the day.
Conclusions: Trends and profiles informed through TARGET
will serve as a means to describe personalized management
strategies to improve glycemic variation.
143
NOVEL MEDTRONIC TURNING POINT PROGRAM
IMPROVES COMPLIANCE AND HBA1C IN AT-RISK
PATIENTS WITH TYPE 1 OR TYPE 2 DIABETES
D.S. Schwartz1, D.E. Dick2, C. McMahon3, D.O. Cohen3,
J. Knoulton4, S. Arunachalam3
1
DGD Clinic, Chief Clinical Consultant, San Antonio, USA
2
Methodist Healthcare Ministries, Medical Director,
San Antonio, USA
3
Medtronic Diabetes, Diabetes Service & Solutions,
Northridge, USA
4
Methodist Healthcare Ministries, Director of Nursing, San
Antonio, USA
Background and Aims: The Medtronic Turning Point Pro-
gram was introduced at the Methodist Healthcare Ministries of
South Texas, Inc. (San Antonio, Texas) to demonstrate the fea-
sibility of a novel service to enhance compliance and improve
outcomes in high-risk patients with diabetes.
Methods: From January-August 2016, 50 patients ages 50 11
(Mean SD) years with uncontrolled type 1 or type 2 diabetes
(A1C = 10.3 1.2%) were enrolled in the program. All patients
were instructed to measure blood glucose (SMBG) 3-4/day.
Follow-up A1Cs were done in 28 subjects who used a smartphone
mobile application that captured physical activity and nutrition
information; provided patient self-management education, med-
ication reminders and observation-driven feedback from a health
coach (HC) to a Nurse or a primary care physician (PCP) or an
endocrinologist. Forty six percent (13/28) transiently wore a
continuous glucose monitoring (CGM) system (iPro 2, Med-
tronic, Northridge, CA). Data and mobile application informa-
tion, in addition to standard of care algorithms were analyzed by
the health care team approximately every 2-4 weeks.
Results: At a mean of 94 42 [IQR = 63-122] days, the program
had a retention rate of 74%, and demonstrated a mean change of
-2.8 1.5% in A1C (paired t-test, p < 0.001). Mean compliance with
SMBG measures (2.0 0.9/day) was observed at a rate of 71 25%.
Conclusions: The Program showed a significant reduction in
A1C, at 3-6 months. Extending PCP access through weekly patient-
HC interactions; and ongoing mobile or remote data monitoring,
HC-PCP coordination and endocrinologist-PCP engagement help
to provide high-risk patients an effective and feasible solution to
achieve health goals.
144
CONSUMER CHOICE THEORY AND HEALTH
TECHNOLOGY ASSESSMENTS IN AUSTRALIA -
A DISCRETE CHOICE EXPERIMENT TO ELICIT
PREFERENCES AMONG ADOLESCENT PATIENTS
WITH TYPE 1 DIABETES
N. Barnett1, E. Davis2, T. Jones2, E. Geelhoed1, M. De Bock2,
R. Norman3, G. Smith4
A-59
1
University of Western Australia, School of Population Heath,
Perth, Australia
2
Princess Margaret Hospital for Children, Diabetes and
Endocrinology, Perth, Australia
3
Curtin University, School of Public Health, Perth, Australia
4
Telethon Kids Institute, Centre for Research Excellence in
Type 1 Diabetes, Perth, Australia
Background and Aims: To apply consumer choice theory to
quantify lifestyle benefits of insulin therapies to adolescent pa-
tients with type 1 diabetes and their parents in Western Australia,
generating additional quality-of-life measures to complement
standard measures used by policymakers in subsidisation deci-
sions. A Discrete Choice Experiment survey will be developed to
determine what factors influence treatment preferences and
how important they are in patient decision-making to evaluate
whether improved access to the costly gold-standard treatment
(continuous glucose monitoring) will result in cost-savings for
the Australian Government.
Methods: Focus groups were held with patients and parents to
identify appropriate treatment attributes for inclusion in the
survey. Comprehension of the survey was tested during clinic
appointments. A sample of 200 adolescent patients (and parents)
with type 1 diabetes in Western Australia will be recruited to
complete the survey. A multinomial logit analysis will determine
the relative importance of each treatment attribute for male and
female adolescent patients and a willingness-to-pay analysis will
be conducted with data from the parent survey to determine how
financial burden influences final treatment decisions.
Results: Focus groups were held with male (n = 2) and female
(n = 6) adolescent patients and parents. Final results from the
Discrete Choice Experiment are expected by November 2016.
Conclusions: This project will generate new health economic
data to improve understanding of patient preferences for insulin
therapies and providing quantified lifestyle benefits to policy-
makers in addition to quality-adjusted life-year measures.
145
SMART INSULIN DOSING FROM THE REAL-TIME
ASSESSMENT OF INSULIN EFFECTIVENESS
IN TYPE I DIABETES
C. Fabris1, M. Breton1
1
University of Virginia, Center for Diabetes Technology,
Charlottesville, USA
Background and Aims: Imperfect insulin replacement is a
cause of hypo/hyperglycemia and increased glucose variability
in T1D. Insulin sensitivity (SI) is a primary factor mediating BG
responses to administered insulin. We propose a novel method
for optimal insulin dosing in T1D leveraging the real-time esti-
mation of Insulin Effectiveness (IE), an index related to SI, from
CGM and insulin pump data.
Methods: We propose to modulate insulin boluses using real-
time estimates of IE compared to the patients usual IE at the
same time of day, while systematic circadian fluctuations are
managed by retrospective tuning of the insulin therapy parame-
ters (e.g., insulin-to-carbohydrate ratio and insulin-sensitivity
factor profiles). At the time of a meal, IE is estimated from
CGM and pump data using a 3-states Kalman filter which de-
scribes glucose-insulin dynamics in a logarithmic risk-space; the
patients usual IE is estimated from a month of historical data.
A-60
The smart bolus then consists in a standard bolus modulated by
the ratio of usual and real-time IEs. The algorithm was tested in
the UVa/Padova T1D Simulator (1-meal scenario with varying
SI) and a clinical trial (NCT02558491).
Results: In simulation, the IE-informed bolus calculator al-
lowed to reduce hyperglycemic (hypoglycemic) risk in case of
decreased (increased) IE, limiting the impact of SI fluctuations,
compared to standard therapy (see Figure). In-vivo, preliminary
results (N = 5) show decreased postprandial time-below-70mg/dl
(14.1% to 1.9%) and time-above-250mg/dl (2.1% to 1.7%).
Conclusions: We propose a new, data-oriented, paradigm for
insulin dosing in T1D, based on the real-time assessment of the
patients insulin need from sensor and pump data.
146
THE CREATION OF A NATIONAL TYPE 1
DIABETES REGISTRY IN MEXICO: RENACED
DIABETES TIPO 1
R.N. Faradji1, M. Valenzuela-Lara2, J.F. Bustamante-Martinez3,
N.E. De La Garza-Hernandez4, A.P. Diaz-Barriga-Menchaca5,
A. Escobedo-Ortiz6, A. Flores-Camargo5, L. Islas-Ortega7,
C. Lopez-Miramontes8, A. Martinez-Ramos9, S. Miracle-
Lopez10, L.A. Ramirez-Toscano8, E. Rodriguez-Sanchez11,
M. Tavera-Hernandez12, J.C. Valenzuela-Montoya13,
M. Vidrio-Velazquez8, R. Nino Vargas14,
E. Sainz-De La Maza-Viadero15, C. Magis-Rodriguez2
1 AND IMPAIRMENT OF MICROCIRCULATION
Instituto Tecnologico de Monterrey / Centro Medico ABC,
Endocrinologia, Mexico, Mexico
2
Centro Nacional para la Prevencion y el Control del VIH y el
Sida-Secretaria de Salud, Epidemiologia, Mexico City, Mexico
3
Hospital General de Tepic, Departamento de Medicina
Interna, Tepic, Mexico
4 1
CEMEDIN, Endocrinologia, Monterrey, Mexico
5
Instituto Tecnologico de Monterrey, Ciencias Medicas Basicas
y Clnicas, Mexico, Mexico
6
Hospital General Dr. Miguel Silva- Secretaria de Salud,
Endocrinologia, Morelia, Mexico
7
Hospital DIF de la Ninez Hidalguense, Endocrinologia
Pediatrica, Pachuca, Mexico
ATTD 2017 E-POSTER VIEWING ABSTRACTS
8
HGR 110 IMSS Guadalajara-Jal, Endocrinologia,
Guadalajara, Mexico
9
Hospital Espanol, Endocrinologia Pediatrica, Mexico City,
Mexico
10
Hospital Angeles Lomas, Endocrinologia, Mexico City,
Mexico
11
Hospital Rovirosa-Secretaria de Salud, Diabetes,
Villahermosa, Mexico
12
Hospital Angeles Lomas / Centro Medico ABC Santa Fe,
Endocrinologia Pediatrica, Mexico City, Mexico
13
Hospital De Gineco-Pediatra No. 31 IMSS, Endocrinologia
Pediatrica, Mexicali, Mexico
14
Centro para la Prevencion y Atencion Integral del VIH/SIDA
del Distrito Federal- Secretaria de Salud, Jefatura de Sistemas
de Informacion, Mexico City, Mexico
15
UNIVERSIDAD IBEROAMERICANA, EDUCACION,
Mexico City, Mexico
Background and Aims: Worldwide there has been an in-
crease in type 1 diabetes (T1D) incidence and prevalence,
leading to the creation of T1D registries. In Mexico, there is a
knowledge gap regarding these variables, treatment practices and
degree of diabetes control in patients with T1D. Our aim is to
describe the creation of a national T1D registry in Mexico:
RENACED Diabetes Tipo 1.
Methods: We developed an online system for longitudinal
data capture based on LAMP (Linux, Apache, MySQL, PHP)
technology, on a secure website, following the national laws of
privacy and confidentiality (informed consent and notice of
privacy). The system allows for data capture relevant to T1D,
based on St. Vincent Declaration. The data capture is performed
by registered attending physicians with online access. The in-
formation can be analyzed at clinic, state or national level.
Results: The online system development version 1.0 was
finished in June 2014. 9% of patients were captured in 2014, 22%
in 2015 by one medical unit. Multiple improvements were done
on the database for ease of capture, addition of graphics and
reports. In 2016 69% of patients were captured in 12 medical
units in 10 different states. As of October 5th, 2016 a total of 494
patients have been captured, 474 with T1D, that live in 18 dif-
ferent states of the Republic.
Conclusions: This is the first online T1D national registry in
Mexico. More support and diffusion will lead to more physicians
registering their patients, and will provide more knowledge of the
T1D reality in Mexico.
147
SCREENING OF OBSTRUCTIVE SLEEP APNEA
SYNDROME WITH RESPECT TO THE INCIDENCE
OF MACROVASCULAR COMPLICATIONS
IN PATIENTS WITH THE DIABETIC FOOT
V. Fejfarova1, M. Klementova1, J. Polak2, A. Jirkovska1,
R. Bem1, M. Dubsky1, V. Woskova1, A. Nemcova1,
M. Krzova1, J. Skibova1
Institute for Clinical and Experimental Medicine, Diabetes
Center, Prague, Czech Republic
2
II. Internal department, FNKV, 3.LFUK, Prague,
Czech Republic
Background and Aims: The aims of our study were to assess
subjectively described sleep disorders, the possible occurrence of
ATTD 2017 E-POSTER VIEWING ABSTRACTS
OSAS in patients with diabetic foot (DF) and its possible asso-
ciation with macrovascular complications and the impairment of
microcirculation.
Methods: We included into our study 105 patients with the
DF completing screening questionnaires (Berlin, STOP-Bang
questionnaires, ESS), questionnaires evaluating the quality of
sleep, and performing anthropometric examinations.The pres-
ence of cardiovascular heart disease (CHD) was present in 28.2%
of all patients with the DF, strokes (9.7%), peripheral arterial
disease (PAD in 58.3%), and the values of transcutaneous oxy-
gen pressure (TcPO2) determining the microcirculation were
examined in all study patients. Patients were divided into 3
groups (category 1- positive both screening questionnaires, high
risk of OSAS, category 2- positive one questionnaire, category 3-
both questionnaires negative).
Results: 29.8% of patients with DF (31/105) belonged to cate-
gory 1, 63.5% (67/105) to category 2 and 6.7% to category 3 (7/
105). Only category 1 correlated significantly with awakening
(p = 0.03), poor quality of sleep (p = 0.0064), lack of sleep
(p = 0.001), tired feeling (p = 0.0001) and with higher excessive
daytime sleepiness (ESS; p = 0.0039). Selected anthropomet-
ric measurements positively correlated with category 1- BMI
(p = 0.0012), neck (p = 0.001), waist (p = 0.0004) and hip circum-
ferences (p = 0.0099). Category 1 correlated significantly only with
the presence of PAD (p = 0.023) but not with CHD and strokes.
Compared to category 3 (0% of patients), significantly more patients
with DF had TcPO2 below 40mmHg in category 1 (62.5%;
p = 0.017), marginally significantly in category 2 (45.6%; p = 0.068).
Conclusions: The incidence of OSAS is probably higher in
risk group of patients with DF. Screening OSAtests correlated
significantly in patients with DF with subjectively described
sleep disorders, selected anthropometric parameters, PAD
and with the impairment of microcirculation. Supported by
00023001.
148
GENERAL PRACTICE OPTIMISING STRUCTURED
MONITORING TO IMPROVE CLINICAL OUTCOMES
IN TYPE 2 DIABETES: THE GP-OSMOTIC STUDY
PROTOCOL
J. Furler1
1
University of Melbourne, General Practice, Parkville,
Australia
Background and Aim: Our aim is to trial the (cost) effec-
tiveness of retrospective continuous glucose monitoring (r-
CGM), in an inclusive population of people with type 2 diabetes
managed in primary care. We will also gather robust hypogly-
caemia prevalence data in this population.
Methods: OSMOTIC is an individually randomised con-
trolled trial set in General Practices in Victoria testing the effect
of r-CGM (applied 14 days, 4 occasions per year), compared with
usual care. A collaborative educational consultation with a
Credentialed Diabetes EducatorRegistered Nurse (CDE-RN)
will be provided to all patients.
Patients with T2D (>12 months), aged 18-80 years, diabetes
duration >1 - <20 years and most recent HbA1c (in the previous 6
months) >7mmol/mol (0.5%) above their individualised target
on maximum oral therapy and/or injectable therapy (insulin and
GLP1 agonists).
Results: Evaluation at baseline and 12 month will include
HbA1c (primary), time in target, and diabetes distress. We
A-61
will also measure hypoglycaemia, glycaemic variability,
patient-reported outcomes, acceptability to health profes-
sionals and patients, and cost-effectiveness. Baseline and 12
month r-CGM trace will be undertaken for all patients (blind
to control group).
Sample size: 50 clinics with 6 participants per clinic (150 in
each arm), will allow 10% clinic attrition and 20% patient at-
trition and give 80% power to detect a difference in mean
HbA1c of 0.5% with a standard deviation of 1.3 and an alpha
of 0.05.
Conclusion: Our trial will generate cost effectiveness evi-
dence about the potential of this technology to drive personalised
treatment intensification to achieve glycaemic targets.
149
VIRTUAL PATIENTS DERIVED
FROM THE CARELINK DATABASE
B. Grosman1, A. Roy1, D. Wu1, N. Parikh1, S. John2, S. Lee3,
K. Francine4
1
Medtronic Diabetes, Closed Loop, Northridge, USA
2
Medtronic Diabetes, Clinical Research Data, Northridge, USA
3
Medtronic Diabetes, Clinical Research Administration,
Northridge, USA
4
Medtronic Diabetes, Medical Affairs, Northridge, USA
Background and Aims: The CareLink database has been
used to generate a large number of virtual patients to be used for
in silico testing.
Methods: A mathematical model was developed with a tai-
lored parametric optimization method. Each virtual subject was
trained from 20 days of CareLink data. Using data from the
ASPIRE Clinical Trial and from a hybrid closed-loop feasibility
study, the virtual patients were validated. Insulin action speed
and the meal absorption rates used in the mathematical model
were validated with published literature.
Results: Six-hundred sixty-three virtual patients were gener-
ated. Circadian rhythm in daily insulin sensitivity was identified
in 590 virtual patients. In addition, each virtual patient was as-
sociated with specific meal absorption rates, an age group, and a
total daily dosage of insulin. The Table shows the overall con-
cordance between the glucose levels of the virtual and the
CareLink patients.
Table. Glucose Levels for CareLink and Virtual Patients
Mean Glucose
glucose 70-180 Glucose
mg/dL mg/dL <70mg/dL
CareLink Patients 154 69 1.2
Virtual Patients 157 72 2.9
Conclusions: The Medtronic CareLink database was dem-
onstrated to be a rich database for producing a large number of
virtual patients with a variety of time dependent insulin sensi-
tivities, variable pharmacokinetics, and meal absorption rates.
These virtual patients can be used to advance further refinements
in the development of artificial pancreas algorithms and auto-
mated insulin delivery systems.
A-62
150
SAFETY LAYER FOR AN INSULIN DELIVERY
SYSTEM
P. Herrero1, P. Peter1, R. Monika2, E.S. Mohamed1,
T. Christofer1, O. Nick2, G. Pantelis1
1
Imperial College London, Electrical and Electronic
Engineering, London, United Kingdom
2
Imperial College London, Medicine, London, United Kingdom
Background and Aims: Safety is paramount in (semi-)
automatic insulin delivery systems such as a closed-loop, or a de-
cision support, system for insulin dosing. Therefore, a safety layer is
desired in order to minimise any risk of adverse events (i.e. hypo-
and hyperglycaemia) due to any malfunctioning of the system (e.g.
dosing algorithm miscalculation or sensor/pump failure).
Methods: This work presents a novel safety layer for an in-
sulin delivery system which includes: a robust dynamic insulin
constraint using an interval-based bolus calculator; a predictive
low-glucose insulin suspension system embedding an innovative
glucose forecasting algorithm using a physiological model of
glucose dynamics; an adaptive carbohydrate recommender; a
model-based fault detection algorithm; and an alarm manager for
patients and carers. The system has been designed to be im-
plemented on a mobile platform (e.g. insulin pump handset or
smartphone) and is planned to be clinically tested, together with
an intelligent insulin recommender, within the framework of the
EU-funded PEPPER project.
Results: In silico results with the UVa-Padova simulator on
an adult population (n = 10) using a bolus calculator showed
that the dynamic insulin constraint is able to eliminate severe
hypoglycaemia (<50mg/dL), while the predictive low-glucose
suspend completely eliminates hypoglycaemia (<70mg/dL)
without increasing hyperglycaemia. Using retrospective clini-
cal data, the implemented glucose forecasting algorithm out-
performs a state-of-the-art forecasting algorithm - i.e.
autoregressive model (order 3) with recursive identification of
the coefficients- (rRMSE: 32.6% vs 24.2% - prediction horizon:
90min).
Conclusions: A novel dynamic insulin constraint and a pre-
dictive low-glucose suspension algorithm have the potential to
minimise hypoglycaemia in an adult type 1 population.
151
COMPARISON OF STATISTICAL DISTRIBUTIONS
TO ESTIMATE HYPOGLYCEMIA AND
HYPERGLYCEMIA METRICS
S. Jangam1, T. Dunn1, G. Hayter1
1
Abbott Diabetes Care, Research and Development,
Alameda, USA
Background and Aims: With the availability of continuous
glucose (CGM) data, statistical distributions have been used to
estimate hypoglycemia and hyperglycemia metrics when data is
sparse and to reduce the effect of outliers. Two distributions have
been used: the lognormal distribution and the gamma distribu-
tion. The latter is used in the FreeStyle Libre Glucose Pattern
Insights Report for determination of zones of low, moderate and
high hypoglycemia.
Methods: Here, CGM data from the baseline period of a study
(n = 87, T1DM = 42, T2DM = 45) has been fitted to both distribu-
ATTD 2017 E-POSTER VIEWING ABSTRACTS
tions and metrics for hypoglycemia and hyperglycemia estimated.
The metrics used are Minutes below 70 mg/dL (MB70) and Minutes
above 240 mg/dL (MA240). Agreement of metrics (mean = 11.53
+/- 2.12 days per subject of sensor glucose) was analyzed by linear
regression and Bland-Altman analyses. It was observed that esti-
mates showed strong correlation with the measured MB70 (Gamma:
R-square = 0.95, slope = 0.80, intercept = 2.96; Lognormal: R-
square = 0.96; slope = 0.82; intercept = -4.71) and MA240 (Gamma:
R-square = 0.99; slope = 0.96; intercept = 3.12; Lognormal: R-
square = 0.98; slope = 0.90; intercept = 20.72) values. The bias
against measured values was analyzed using a Bland-Altman plot
(Figure 1).
Results: The lognormal distribution slightly underestimated
MB70 and slightly overestimated MA240 compared to the
gamma. Though both show large bias at high MB70 values
(>150 min/day), the distributions are generally used for estima-
tion at MB70 levels less than 120 min/day to detect transitions
from low to high hypoglycemia.
Conclusions: Both distributions are a reasonable choice for
estimating degrees of hypoglycemia risk; however, the gamma
distribution is preferred since it has less estimate bias.
152
HOW MUCH DO THE RELATIVES OF DIABETES
PATIENTS KNOW ABOUT DIABETES?
P. Karakaya1
1
Bakirkoy Dr Sadi Konuk Training and Research Hospital,
Department of Endocrinology, ISTANBUL, Turkey
Background and Aims: The relatives of diabetic patients have
an important role in the care, follow-up, treatment, and glycemia
control of the patients. The aim of this study was to investigate the
knowledge and experience of relatives of diabetic patients re-
garding diabetes mellitus (DM), its treatment and follow-up.
Methods: A survey was filled out in face-to-face meetings with
relatives of 550 diabetic patients visited the internal medicine clinic
of our hospital, majority of whom were elderly. Socio-demographic
characteristics, knowledge about DM, patient treatment and follow-
up of the participants were questioned.
Results: A total of 550 patient relatives, 64.5% of which were
female, were included in the study.
Results of a rough comparison based on the level of education
showed that while 50.8% of those holding a university degree were
trained and knowledgeable about DM, only 14% knew the name
and the dosage of the medications. Among those with an elemen-
tary school degree, while only 24.6% had received training on DM,
44.9% knew the names and the dosage of the medications.
Conclusions: The patient relatives have roles just as sig-
nificant as physicians in follow-up and treatment of patients,
their medications, diet, and exercise compliance, an accurate
glycemia control; and follow-up and prevention of acute and
chronic complications. Therefore, it is important to train the
ATTD 2017 E-POSTER VIEWING ABSTRACTS A-63

patient relatives as it is important to train the patients them-
selves to ensure control DM and to prevent complications. This
study demonstrates that the patient relatives are still not suf-
ficiently trained on this matter.
153
COMPARISON OF HOMA-IR AND ANP VALUES
IN CONTROLLED AND UNCONTROLLED
DIABETES PATIENTS
P. Karakaya1, M. Mert1
1
Bakirkoy Dr Sadi Konuk Training and Research Hospital,
Department of Endocrinology, Istanbul, Turkey
Background and Aims: Increase of plasma Atrial Na-
triuretic Peptide (ANP) level is very important in the response
to hyperglycemia in diabetic patients due to the insulins so-
dium sparing effect that is known as a chronic stimulator of
ANP. We aimed to compare fasting and postprandial HOMA-
IR and ANP levels in patients with regulated and unregulated
diabetes
Methods: Sixty obese or non-obese patients with type 2 dia-
betes aged 30-70 years were included in the study. Systemic
chronic diseases like functional thyroid disorder, liver failure,
kidney failure., insulin use, as well as pregnancy were the
exclusion criteria. Blood samples were drawn from all patients
for the routine biochemical tests, lipid profile, fasting and post-
prandial glucose and insulin levels and high sensitive CRP (hs-
CRP) and ANP.
Results: Demographic and laboratory data of all type 2 diabetes
patients with regulated (HbA1c<7) and unregulated (HbA1c> = 7)
blood glucose levels are presented in Table 1. Blood glucose,
fasting and postprandial HOMA and K levels were significantly
higher in patients with unregulated diabetes. ANP and hs-CRP
levels were similar in both groups. Laboratory and demographic
data of patients with fasting and postprandial HOMA levels >2.7
and < = 2.7 were statistically similar.
Conclusions: ANP levels are expected to be increased in
unregulated diabetes but our results did not support this. This
result may be due to the number of patients included in the
study.
acuity, polypharmacy, peripheral neuropathies and insulin ther-
apy in elderly with DM.
The aim of this study was the investigation the effects of fear
of falling on time-distance parameters of gait in elderly with
type-2 diabetes mellitus.
Methods: The study included 31 Type-2 DM patients who
were diagnosed by a specialist doctor and 29 healthy control
group over aged of 55 years. Fear of falling was assessed by
International Fall Efficacy Scale. Time-distance parameters of
gait were measured with Zebris FDM-2.
Results: In diabetics, as the fear of falling increased, the
length of step (r: -.660, p < 0.01) and cadance (r: -.401, p < 0.01)
decreased and duration of the step (r: .390, p < 0.05) increased.
There was no statistically significant relationship between the
fear of falling and the time-distance parameters of gait in the
control group (p > 0.05).
Conclusions: Fear of falling affected time-distance pa-
rameters of gait negatively. In the management of Type-2
DM patients, health professionals provide individualized
gait training.
155
TARGET POPULATION FOR INNOVATIVE
TECHNOLOGY ON DIABETES IN BRAZIL:
EVERYBODY NEEDS TO KNOW ABOUT
PREVALENCE
F. Laranjeira1, G. Brito1, G. Tannus1, M. Fonseca1
1
AXIA.BIO Life Science Consulting Group, Research,
Sao Paulo, Brazil
Background and Aims: Worldwide diabetes (DM) prevalence
is around 9%, affecting approximately 415 million people. In
Brazil, although there are several epidemiological studies on this
subject, there are still uncertainties about how many people have
diabetes.
Methods: We performed a systematic review on the prevalence
of diabetes in Brazil. Potentially relevant studies were identified
through an exhaustive search in MEDLINE, SciELO, LILACS,
Ministry of Health and hand-search. Eligibility criteria were cross-

154
INVESTIGATION ON THE EFFECTS OF FEAR
OF FALLING ON TIME-DISTANCE PARAMETERS
OF GAIT IN ELDERLY WITH TYPE 2 DIABETES
MELLITUS
_xntasx ark1, K. Onbasx2, H. Akkan1
H. Kiloatar1, M. Is
1
Dumlupinar University, physical therapy and rehabilitation,
Kutahya, Turkey
2
Dumlupinar University, Internal Diseases, Kutahya, Turkey

Background and Aims: Diabetes mellitus (DM) is a chronic

metabolic disease which is deterioration of carbohydrate, fat and
protein metabolisms due to lack of insulin secretion or decreased
insulin sensitivity of tissues and requires continuous medical
care. Patients with DM fall more than their peers. The factors that
increase the risk of falls are previous falling tale, decreased lower
extremity function, impaired balance, presence of coronary ar-
tery disease, musculoskeletal pain, depression, decreased visual
A-64
sectional population-based studies, censuses, surveys or cohorts
which reported the prevalence of diabetes, regardless if type 1 or
type 2, in the Brazilian population. We used meta-analysis methods
to achieve a more precise estimate of the prevalence proportions.
Descriptive analysis of studies was performed.
Results: Between 968 located references, we included 28
studies, reporting DM prevalence. Among them, thirteen are
population-based studies with national representation and 15
are studies with local/regional representation. In addition, 15
studies were self-reported and 13 relied on blood glucose tests
(BGT) to confirm diagnosis. On self-reported studies, the mean
prevalence was 6.25% (95% CI 5.75% - 6.74%; I2 50%) and on
studies confirmed by BG, the mean prevalence was 10.05%
(95% CI 6.41% - 13.68%; I2 64%) (Table 1). People (24.0% to
50.4%) were unaware of their diabetes status.
Conclusions: There is difference between the prevalence
stated by self-reported studies and studies confirmed by BGT
tests. Increase the awareness about DM is a critical need.
156
INTERCURRENT AUTOIMMUNE DISEASES
AS FACTOR CONTRIBUTING TO DIABETIC
RETINOPATHY PROGRESS IN PATIENTS
WITH TYPE 1 DIABETES MELLITUS: 20-YEAR
FOLLOW-UP STUDY
L. Bolotskaya1, T. Niconova1, V. Lavrenova2, E. Bessmertnaya1,
A. Ilin1, A. Zolotychin1
1
FGBY, Moscow, Russia
2 Background and Aims: PEPPER (Patient Empowerment
Lomonosov Moscow State University, Biochemistry
Department, Moscow, Russia
Background and Aims: Polyautoimmunity can be an essen-
tial factor contributing to the progress of type 1 diabetes mellitus
(T1DM) and its complications which significance has been un-
derestimated. According to this fact we decided to monitor
DHbA1c values within two cohorts of T1DM patients with and
without intercurrent autoimmune diseases (IAD). We also
compared the frequency and severity of diabetic retinopathy
within two groups.
Methods: The investigated group included 155 patients with
T1DM onset occurred in 1994. HbA1c values in every patient were
measured once in 3 months for 22 years (1994-2016). DHbA1c
values were estimated using the relative frequency method with
significance level a 0.05. Examination of eye-ground was per-
formed twice a year.
Results: 25 from 155 monitored patients received a diagno-
sis of IAD. From 25 patients with IAD 15 (60%) had non-
proliferative DR, 8 (32%) had proliferative DR, and 2 patients
(8%) suffered from unilateral blindness. From 130 patients
without IAD 60 (46%) had nonproliferative DR and 70 had not
any symptoms of DR.
Average annual oscillations of HbA1c value (DHbA1c, %) in
patients with IAD were (data is presented as min-max scatter):
18.3-26.7 in patients with nonproliferative DR, 24.3-30.3 in
patients with proliferative DR, 50.4-56.3 in patients with blind-
ness. DHbA1c values, %, in patients without IAD had not sig-
nificant differences and were 7.3-11.4 in patients with
nonproliferative DR, 7.2-11.1 in patients without complications.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Conclusions: The presence of IAD in patients with T1DM
leads to higher variability of HbA1c values and greater proba-
bility of DR development and progress.
157
PERSONALISED CLINICAL DECISION SUPPORT
FOR DIABETES MANAGEMENT USING
REAL-TIME DATA
C. Martin1, A. Aldea1, D. Brown1, D. Duce1,
J.M. Fernandez-Real2, P. Gay3, P. Georgiou4, R. Harrison1,
P. Herrero4, B. Lopez3, Y. Leal2, L. Nita5, P. Pesl4,
R. Petite3, M. Reddy6, J. Shapley7, F. Torrent-Fontbona3,
M. Waite8, M. Wos2, N. Oliver6
1
Oxford Brookes University, Computing and Communication
Technologies, Oxford, United Kingdom
2
Institut dInvestigacio Biomedica de Girona Dr. Josep Trueta,
Girona, Spain
3
University of Girona, Electrical Engineering, Electronics and
Automation, Girona, Spain
4
Imperial College London Institute of Biomedical
Engineering, Dept. of Electrical and Electronic Engineering,
London, United Kingdom
5
Romsoft SRL, Iasi, Romania
6
Imperial College London, Division of diabetes-endocrinology
and metabolism, London, United Kingdom
7
Cellnovo Ltd, Bridgend, United Kingdom
8
Oxford Brookes University, Faculty of Health and Life
Sciences, Oxford, United Kingdom
through Predictive PERsonalised decision support) is an EU-
funded research project to develop a personalised clinical deci-
sion support system for Type 1 diabetes self-management. The
tool provides insulin bolus dose advice and carbohydrate rec-
ommendations, tailored to the needs of individuals. The former is
determined by Case-Based Reasoning, an artificial intelligence
technique that adapts to new situations according to past expe-
rience. The latter uses a predictive computer model that also
promotes safety by providing glucose alarms, low-glucose in-
sulin suspension and fault detection.
Methods: The user-centered design methodology aims to
ensure that the tool meets patient needs and improves clinical
outcomes. A dual architecture accommodates insulin dosing
either by insulin pen or via the Cellnovo patch-pump. Data are
gathered wirelessly in real-time from multiple sources includ-
ing a continuous glucose monitor, capillary glucose monitor
and physical activity monitor. The design ethos is to offer
maximum benefit for minimum effort, so additional manual
data entry is strictly limited.
Results: The first prototype system has been designed, using
feedback from patients and clinicians, and tested using the UVA/
Padova Type 1 diabetes simulator. Three subsequent phases of
clinical tests are planned. The first two will study safety, feasibility
and usability in situ; the last is a randomised control trial, in 2018.
Conclusions: The first milestones have been reached towards
the integration of multiple types of real-time data into a mobile
decision support system that uses artificial intelligence and pre-
dictive modelling to adapt its advice according to the needs of the
individual.
ATTD 2017 E-POSTER VIEWING ABSTRACTS A-65

158
DIABETIC FOOT 3D ANGIOGRAPHY SETS MAJOR
AMPUTATION RISK IN HEEL WOUND
F. Mercier1,2, B. Herve1, I. Jungfer1, L. Potier3,
M. Kamel3, M.P. Lacomme2, G. Trouillet2, D. Nuytens4,
V. Labbe Gentils5
1
Clinique Internationale Parc Monceau, 75, PARIS, France
2
Hopital Europeen de Paris, Hopital Europeen de Paris,
Aubervilliers, France
3
Hopital Bichat, 75, Paris, France
4
Institut National Podologie, 75, Paris, France
5
Hopital Jean Verdier, 93, Bondy, France

Background and Aims: Heel diabetic foot lesion (H.D.F.L.)

leads to major amputation if the external plantar arch artery
(E.P.A.A.) is missing. Collaterals dont supply this small ter-
minal artery. Revascularisation technics are hopeless.
Osteo-myelitis progress as antibiotics cannot reach the heel,
calcaneum fracture eventually occurs.
3D angiography is a new foot imaging technic.
Methods: Diabetic patients (n = 132) were evaluated for feet
wound during 24 months period, starting September 2014.
In 23 heel wound missing the E.P.A.A. arch artery was sus-
pected.
Mean age 67 (41 89) yld, sex ratio 81 men / 51 women,
diabetes type 2 (n = 99), type 1 (n = 33).
Chronic wound evolution was at least 6 weeks. 159
Wound excision, off loading, adjusted antibiotics, revascular-
isation if possible (not for E.P.A.A.), alginate dry dressing were EFFECT OF BODY MASS INDEX ON DIFFERENT
systematically proposed. GLYCEMIC RESPONSES TO PSYCHOLOGICAL
3D Angiography was performed in Inova GE hybrid cathlab STRESS IN PATIENTS WITH TYPE 1 DIABETES
suite, with 4F introductor, 4F straight catheter, 30 cc of non ionic
B. Ozaslan1, S.D. Patek1, J.H. Grabman2, J.A. Shepard2,
iodine.
E. Dassau3, M. Breton4, Y.C. Kudva5, S.A. Brown4,
Results: 23 patients had heel lesions, for which 18 patients
A. Basu5, J.E. Pinsker6, B.P. Kovatchev4,
had E.P.A.A. but 5 patients missed E.P.A.A.
F.J. Doyle III3, L. Gonder-Frederick7
None patient had bilateral missing E.P.A.A.
1
Conclusions: 3 D angiography is a key evaluation for heel University of Virginia, Systems and Information Engineering,
wound. Center for Diabetes Technology, Charlottesville, USA
2
E.P.A.A. missing leads to amputation in our experience. University of Virginia, Behavioral Medicine Center,
Charlottesville, USA
3
Harvard University, John A. Paulson School of Engineering
and Applied Science, Cambridge, USA
4
University of Virginia, Center for Diabetes Technology,
Past medical
history Charlottesville, USA
wound of bilateral 5
Mayo Clinic, Endocrine Research Unit, Rochester, USA
>6 Calcaneum Calcaneum wound le- 6
age sexe dialysis weeks osteomyelitis fracture sion DECEDED William Sansum Diabetes Center, Pediatric Diabetes Clinical
Service, Santa Barbara, USA
56 f no yes yes yes no no 7
62 h yes yes yes no yes yes University of Virginia, Center for Diabetes Technology,
62 f no yes yes yes yes no Behavioral Medicine Center, Charlottesville, USA
76 h yes yes yes yes yes yes
69 f no yes yes yes no no
Background and Aims: Psychological stress is understood to
be an important consideration in the management of type 1 di-
abetes (T1D), though the factors that contribute to variation in
glycemic responses under stress are largely unknown. This study
investigated the role of body mass index (BMI) on glycemic
control under stress.
Methods: Continuous glucose monitoring (CGM) and insulin
pump (continuous subcutaneous insulin infusion (CSII)) data
were collected from 37 patients with T1D over a one-week pe-
riod, along with meal records and daily self-assessment of psy-
chological stress levels (0 [none] - 4 [extreme]). Daily reported
carbohydrates (CHO), total insulin bolus amounts, and average
blood glucose (BG) from CGM were compared among patients
A-66 ATTD 2017 E-POSTER VIEWING ABSTRACTS

based on (i) BMI and (ii) the presence of stress. In addition, daily
averages of a model-based effectiveness index (quantifying
the combined impact of insulin and carbohydrates on glucose
levels) were compared in these groups.
Results: Figure 1 presents daily carbohydrate intake, insulin
bolus, average blood glucose, and average effectiveness index
for BMI in different ranges (above and below 26), with and
without stress. We observed a trend of reduced average BG in
higher BMI individuals under stress despite trends of increased
carbohydrate intake and reduced insulin dosing. Linear mixed
effects analysis of the effectiveness index demonstrated a sig-
nificant interaction between BMI and stress (p < 0.01), with both
treated as continuous variables.
Conclusions: Preliminary results suggest that the glycemic
effect of daily stress in T1D can be influenced by BMI, specifi-
cally with a possible increase in effectiveness index under stress
with increasing BMI.

160
AWARENESS OF TYPE 2 DIABETES THERAPY GOALS
collected at baseline using the SF-12 (GP n = 188, DSP n = 223) and
AND PERCEPTION OF PATIENTS HEALTH STATUS:
PAID (GP n = 184, DSP n = 220) questionnaires were analyzed.
PRELIMINARY BASELINE RESULTS
Results: Patients enrolled (n = 969) were by majority >55 years
OF THE PDM-PROVALUE STUDIES
of age (GP 82.0%, DSP 77.7%) with >10 years diabetes duration
K. Kulzer1, W. Daenschel2, I. Daenschel3, C. Parkin4, (63.5%, 62.5%). Baseline HbA1c levels, initial insulin therapy and
I. Vesper5, D. Messinger6, J. Weissmann5, L. Heinemann7 presence of comorbidities were similar in both studies. The ma-
1 jority of patients rated their general health status as good to
Forschungsinstitut Diabetes Akademie Bad Mergentheim, excellent (Figure 1A), whereas, about 2/3 (GP 69.0% and DSP
Clinic, Bad Mergentheim, Germany 63.6%) stated they had no or a minor problem regarding the clarity
2
Arztlicher Leiter Medizinisches Versorgungszentrums and concreteness of their diabetes therapy goals (Figure 1B).
am Kuchwald GmbH, Research, Chemnitz, Germany Conclusions: No notable differences were found in health
3
Hausarztpraxis, Clinic, Lunzenau, Germany status of the PDM-ProValue populations at baseline. The results
4
CGParkin Communications - Inc., Boulder City, USA reported as to patients problems regarding awareness of therapy
5
Roche Diabetes Care GmbH, Roche Diabetes Care GmbH, goals emphasize the importance of appropriate agreements be-
Mannheim, Germany tween patients and their physicians. Final results of the PDM-
6
IST GmbH, Biometrics, Mannheim, Germany ProValue studies will be reported in late 2017.
7
Profil Institute for Metabolic Research- Ltd, Research,
Dusseldorf, Germany

Background and Aims: Patients awareness of their diabetes 161

therapy goals is not only an important pre-condition but also an
indicator of quality of medical care. We explored awareness of
therapy goals and perception of health status among insulin-treated
type 2 diabetes (T2D) patients at 53 general medical practices (GP)
and 47 diabetes-specialized practices (DSP) in Germany.
Methods: Two 12-month, prospective, cluster-randomized
studies (PDM-ProValue-GP, PDM-ProValue-DSP) are underway to
determine if use of a 6-step approach to personalized diabetes
management (PDM) improves glycemic control and other clinical
and psychosocial measures. Preliminary self-reported data from
>400 insulin-treated T2D adults with an enrollment HbA1c 7.5%
QUALITY OF OUTPATIENT CARE OF PATIENTS
WITH TYPE 2 DIABETES: PRELIMINARY BASELINE
RESULTS OF THE PDM-PROVALUE STUDIES
L. Heinemann1, W. Daenschel2, C. Parkin3, I. Daenschel4,
I. Vesper5, D. Messinger6, J. Weissmann5, B. Kulzer7
1
Profil Institute for Metabolic Research, Research, Dusseldorf,
Germany
2
Arztlicher Leiter Medizinisches Versorgungszentrums
am Kuchwald GmbH, Research, Chemnitz, Germany
ATTD 2017 E-POSTER VIEWING ABSTRACTS
3
CGParkin Communications, Inc., Boulder City, USA
4
Hausarztpraxis, Clinic, Lunzenau, Germany
5
Roche Diabetes Care GmbH, Medical Affairs, Mannheim,
Germany
6
IST GmbH, Biometrics, Mannheim, Germany
7
Forschungsinstitut Diabetes Akademie Bad Mergentheim,
Bad Mergentheim, Bad Mergentheim, Germany
Background and Aims: One pivotal clinical goal of an ef-
fective therapy of type 2 diabetes (T2D) is to optimize patients
glycemic control. We explored the long-term blood glucose level
(HbA1c), the 12-month target HbA1c and other diabetes treat-
ment measures among insulin-treated T2D patients at 53 general
medical practices (GP) and 47 diabetes-specialized practices
(DSP) in Germany.
Methods: Two 12-month, prospective, cluster-randomized
studies (PDM-ProValue-GP, PDM-ProValue-DSP) are under-
way to determine if use of a 6-step approach to personalized
diabetes management (PDM) improves quality of outpatient di-
abetes care. Preliminary baseline data of 969 enrolled adults with
an enrollment HbA1c 7.5% were analyzed to describe the initial
study situation as to HbA1c levels, agreement of 12-month HbA1c
target goals and utilization of insulin regimens.
Results: Most patients were >55 years of age (GP 82.0% and
DSP 77.7%) with relatively high percentage of patients age >75
years (GP 21.8%, DSP 13.0%). No notable between-group dif-
ferences were seen in initial HbA1c levels (Mean: GP 8.50% and
DSP 8.34%) or insulin therapy, however, the distribution of
BOT/CT vs. ICT differs (Figure 1A). As to the 12-month HbA1c
target goal, the diabetes specialists tend toward more rigorous
glycemic control compared to GPs (Figure 1B).
A-67
Conclusions: Whereas, no notable difference was found in
HbA1c status of the PDM-ProValue populations at baseline, the
HbA1c target goal in the DSP study is more ambitious, which is
likely due to patients initial age, HbA1c and insulin therapy
patterns. Final results of the PDM-ProValue studies will be re-
ported in late 2017.
162
BETTER LIFESTYLE TOOLS FOR BETTER HEALTH
N. Patel1, S. Steed2, S. Manson-Smith3
1
Guys and St. Thomas NHS Foundation Trust & Kings
College London, Diabetes, LONDON, United Kingdom
2
Mumoactive, Chief Information Officer, London, United
Kingdom
3
Mumoactive, Mumoactive, London, United Kingdom
Background and Aims: To develop an app that enables an
individual to track their diabetes and to use it as a 2 way com-
munication portal with their health care professional.
Methods: Qualitative research to understand the current need
for a digital app to support an individual with diabetes and to
then take this information to develop a user friendly app to that
enables individuals with diabetes to track their diabetes and to
enable them to use the same app as a 2 way communication
portal.
Results: The Needs Identified by both healthcare profes-
sionals and individuals with diabetes
- Easy and direct access to patient data
- Direct communication AS NECESSARY between health-
care professional and individual with diabetes to support
self-management
- development of a tool that enables empowerment, inde-
pendence and self-management
- a simple tool for entering values
- being able to write notes
Patients responses to the app
So this is truly a life saver! Thank you, thank you! This
app deserves awards!
Fast easy and convenient
Why hasnt anyone done this before?
Conclusions: Mumoactive is an app that has been designed
based on the needs of both the healthcare professionals who work
within in the NHS and individuals with Diabetes. It enables the
individual to track their values, add notes and messages, syncs
across devices, is fast secure and simple. This tool has the ability
to support self management and enables health care teams to
promote, encourage and support self management.
163
EVALUATION OF AN AUTOMATED WEB-BASED
GLYCAEMIC PATTERN DETECTION TOOL
M.J. Comellas1, J. Weissmann2, N. Casamira1, E. Albinana3,
R. Corcoy4, D. Fernandez-Garca5, J. Garca-Aleman5,
B. Garcia Cuartero6, C. Gonzalez Blanco4, M.T. Rivero7
1
Roche Diabetes Care Spain, Medical Affairs, Sant Cugat del
Valles, Spain
A-68 ATTD 2017 E-POSTER VIEWING ABSTRACTS

2
Roche Diabetes Care Deutschland GmbH, Medical Affairs,
Mannheim, Germany
3
Vithas Hospital Internacional Medimar, Pediatrics, Alicante,
Spain
4
Hospital de la Santa Creu i Sant Pau, Endocrinology,
Barcelona, Spain
5
Hospital Universitario Virgen de la Victoria, Endocrinology,
Malaga, Spain
6
Hospital Universitario Ramon y Cajal, Pediatrics, Madrid,
Spain
7
Complejo Hospitalario de Orense, Endocrinology, Orense,
Spain

Background and Aims: Emminens eConecta is a web-

based platform which includes an automated pattern detection
tool: eDetecta. It uses algorithms and alerts that can be easily
customized by health care professionals (HCP) for the person-
alized management of diabetes mellitus (DM).
The aim of this evaluation was to assess eDetecta performance
in data analysis measured as 1) pattern detection, concordance
with HCP and required time and 2) HCP satisfaction.
Methods: International multicentre web-based evaluation in
which endocrinologists were asked to analyse 4 anonymised re-
ports of real-life data downloads (2CSII and 2MDI) and indicate
the presence/absence of up to 19 previously defined glycaemic
patterns. Responses and required time were recorded and compared
with automated analysis by eDetecta. Questionnaires focused on
data analysis and on eDetecta satisfaction were answered.
Results: 37 HCP were enrolled and 145 pattern evalua-
tions were recorded (71CSII; 74MDI). Mean time needed by
HCP per report was 15.1 minutes (12.3-17.8 minutes) vs less than
1 minute by eDetecta. Concordance between patterns detected by
HCPs and eDetecta was >65% in 16 patterns. One of the highest
concordances was observed on Hyperglycaemia in Time Block
in case ISCI-1 (97.1%). 94.6% of participants considered that
eDetecta was a reliable or very reliable tool, and 78.3% agreed or
highly agreed it allowed them to make faster decisions.
Conclusions: In the evaluation, eDetecta automated analysis
was performed in less than 1 minute. Concordance between HCP
and eDetecta was good, non-concordant cases requiring further
analysis. HCP indicated it may be helpful in making clinical
decisions, allowing them to dedicate more time to the patient.
Methods: Values from Dexcom G4 PLATINUM sensors with
Software 505 were compared to temporally-matched reference
venous (YSI) values collected during clinic visits on days 1, 4,
and 7 of sensor wear. Data from previous studies of 79 children
and adolescents (2262 paired points) and 90 adults (2263 paired
points) were used. Matched pairs were mapped to the SEG.
Results: The Figure shows good agreement between CGM and
YSI values for adult and pediatric cohorts on each of the 3 in-
clinic days. In the pediatric and adult studies, 1990 (88.0%) and
2056 (90.9%) of the paired points were in the no risk zone,
respectively. Performance was best on Day 4, when 92.7% and
93.3% of points from the pediatric and adult studies, respectively,
were in the no risk zone. Fewer than 0.5% of the points were in
zones corresponding to moderate or more severe risk levels.
Conclusions: SEG analysis suggests that using CGM data
to guide diabetes management decisions poses minimal clinical
risk. Additional CGM-derived information such as trends and
threshold crossings may further mitigate risks of nonadjunctive
use.
165

164 TESTING HEMOGLOBIN A1C IN A PEDIATRIC

RETROSPECTIVE ANALYSIS OF CONTINUOUS
GLUCOSE MONITORING DATA WITH THE
SURVEILLANCE ERROR GRID SUPPORTS
NONADJUNCTIVE DIABETES MANAGEMENT
DECISIONS
T. Walker1, J. Welsh1, D. Le2, D. Price1
1
Dexcom Inc., Clinical Affairs, San Diego, USA
2
Dexcom Inc., Biometrics, San Diego, USA
Background and Aims: Performance characteristics of
current-generation continuous glucose monitoring (CGM) sys-
tems may be sufficient for use in diabetes management decisions
without requiring confirmatory self-monitored blood glucose
(SMBG) values. The surveillance error grid (SEG) assigns a
numerical value and a corresponding risk category to each pair
of CGM/reference glucose values. To assess the risks resulting
from inaccurate CGM values prompting erroneous diabetes
management decisions, SEG analysis was performed.
OUTPATIENT CLINIC: A FINANCIAL ANALYSIS
M. Yafi1, B. Cross2, R. Yetman2
1
University of Texas at Houston Health Science Center,
Pediatric endocrinology, Houston, USA
2
University of Texas at Houston Health Science Center,
Pediatrics, Houston, USA
Background and Aims: Hemoglobin A1c (HbA1c) is one of
the most common measurements used in the assessment of gly-
cemic control and is thought to reflect the average glycemic
control over past 3 months and predict the occurrence of diabetes
related complications. Testing HbA1c can be used to screen for
diabetes as well in population at risk.
Methods: A cost analysis was performed to compare the price
of HbA1c kits purchased in our pediatric endocrinology clinic
over a period of 2 years and compared to the total collections
from payers within the same time. HbA1c testing was performed
on existing patients with diabetes as well as patients at risk
(obesity, existing symptoms).
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Results: The total cost of HbA1c kits in 2 fiscal years was
$14,485.86. The total collections from testing HbA1c in the same
period was $28595. This shows a positive balance of $14,109.14
(Average of $7,000 per year). When adjusted for personnels time
of handling the kits, preparing the machine daily, testing patients
and reporting results (20% of total time multiplied by total salary
of $29,000), the profit is estimated to be around $ 1,200 per year.
Conclusions: Testing HbA1c in the clinic setting offers im-
mediate feedback to both the clinician and patients about dia-
betes control. It can also be a parameter to provide an instant
diagnosis for diabetes when combined with analysis of clinical
symptoms and other laboratory tests.
Testing HbA1c during the clinic visit seems to be profitable
even after adjusting for personnels expenses.
166
ESTIMATION OF OXYGEN CONSUMPTION BASED
ON EXERCISE PATTERNS FOR PEOPLE WITH TYPE 1
DIABETES
A. Cinar1, S. Samadi1, N. Frantz2, M. Park3, K. Turksoy2,
M. Sevil2, I. Hajizadeh1, J. Feng1, C. Lazaro Martinez4,
L. Quinn3
1
Illinois Institute of Technology, Chemical and Biological
Engineering, Chicago, USA
2
Illinois Institute of Technology, Biomedical Engineering,
Chicago, USA
3
University of Illinois at Chicago, Biobehavioral Health
Science- College of Nursing, Chicago, USA
4
Illinois Institute of Technology, Electrical and Computer
Engineering, Chicago, USA
Background and Aims: A new model with two submodels is
proposed for estimation of oxygen consumption in aerobic
treadmill and stationary bike exercises, with various patterns of
exercise intensities.
Methods: The first submodel uses the speed an d inclination
of the treadmill or the speed and resistance of the bike as the
inputs to estimate heart rate during the exercise and recovery
time. It is an extension of a nonlinear model [1] with the speed of
treadmill as its only input. However, changes in grade (inclina-
tion) of treadmill affects the heart rate remarkably. The second
submodel predicts oxygen consumption based on the heart rate
estimated by the first submodel.
Data to build and evaluate the submodels are obtained from
exercise studies conducted for young adults with T1D. Subjects
wore Zephyr BioHarness and performed two episodes of 30-
minute training with treadmill and bike at different intensities.
Oxygen consumption and heart rate are measured during car-
diopulmonary treadmill stress test. The data set of eleven sub-
jects are used.
[1] TM Cheng, AV Savkin, BG Celler, SW Su, L Wang.
Nonlinear modeling and control of human heart rate response
during exercise with various work load intensities, IEEE Trans.
Biomed. Eng., 55: 24992508, 2008.
Results: Mean average error of estimated oxygen consump-
tion for speed, inclination or resistance as model inputs is 0.32 L/
min for training and 0.51 L/min for testing data. Aerobic energy
expenditure is linearly proportional with oxygen consumption.
Conclusions: The model gives good estimates of energy ex-
penditure based on time and intensity of aerobic exercise for
people with T1D.
A-69
167
ONLINE-TUNED MODEL BASED COMPOUND
CONTROLLER FOR BLOOD GLUCOSE REGULATION
IN TYPE 1 DIABETES PATIENTS
A. Bhattacharjee1, A. Easwaran1, M.K.S. Leow2, N. Cho3
1
Nanyang Technological University, School of Computer
Science and Engineering, Singapore, Singapore
2
Tan Tock Seng Hospital, Department of Endocrinology,
Singapore, Singapore
3
Nanyang Technological University, School of Materials
Science & Engineering, Singapore, Singapore
Background and Aims: A major concern of fully-automated
artificial pancreas system is the prediction of optimal insulin dose
without patients intervention for blood glucose regulation in type 1
diabetics. This paper deals with the design of a fully-automated
compound controller based on online-tuned internal model control
(IMC) and enhanced IMC (eIMC) along with meal detection
module.
Methods: Both IMC and eIMC are developed using Volterra
model without any prior knowledge of patient parameter. Volterra
model estimates patient states online in the presence of unan-
nounced meal disturbances and parameter variations. The time-
domain Volterra kernels computed online using recursive least
squares algorithm are converted into frequency-domain to obtain
Volterra transfer function (VTF). Both IMC and eIMC are devel-
oped using VTF. The compound model based controller is de-
signed in such a way that eIMC will operate only when the glucose
rate increase detector (GRID) of meal detection module is positive,
otherwise conventional IMC will take the necessary control action.
Results: The compound controller is evaluated in the UVA/
Padova metabolic simulator for 10 adult subjects and compared
with IMC using scenarios that are used for validation and ro-
bustness analysis. Patients experience hypoglycemia only aver-
age of 1.81% and hyperglycemia 16.76% of the time using
compound controller, when the insulin sensitivity is increased by
+20% and -20% respectively, whereas these values obtained
using IMC are 4.2% and 39% respectively.
Conclusions: The combination of compound control strategy
and meal detection module is able to compensate the short-
comings of slow subcutaneous insulin action and delayed peak of
action that causes both hyper- and hypoglycaemia.
168
REAL-TIME DETECTION OF LOSSES IN INFUSION
SET ACTUATION (LISAS) IN A CLOSED-LOOP
ARTIFICIAL PANCREAS
D.P. Howsmon1, N. Baysal1, B.A. Buckingham2,
G.P. Forlenza3, T.T. Ly2, D.M. Maahs2, T. Marcal2, L. Towers3,
S. Deshpande4, R. Gondhalekar4, F.J. Doyle III4, E. Dassau4,
J. Hahn1,5, B.W. Bequette1
1
Rensselaer Polytechnic Institute, Department of Chemical
& Biological Engineering, Troy, NY, USA
2
Stanford University, Lucile Salter Packard Childrens
Hospital, Palo Alto, CA, USA
3
University of Colorado Denver, Barbara Davis Center,
Aurora, CO, USA
4
Harvard University, John A. Paulson School of Engineering
and Applied Sciences, Cambridge, MA, USA
5
Rensselaer Polytechnic Institute, Department of Biomedical
Engineering, Troy, NY, USA
A-70 ATTD 2017 E-POSTER VIEWING ABSTRACTS

Background and Aims: As evidence emerges that artificial

pancreas systems may improve clinical outcomes for patients
with type 1 diabetes, the burden of this disease will hopefully
begin to be alleviated for many patients and caregivers. However,
a decrease in burden potentially means patients will be slower to
act when devices stop functioning appropriately. One particular
device failure involves a loss in infusion set actuation (LISA),
where the apparent injected insulin fails to affect the patients
glucose as expected. Alerting patients to these events in real-time
has the potential to reduce hyperglycemia following a LISA.
Methods: A LISA detection algorithm was implemented in a
randomized cross-over study with closed-loop and sensor-
augmented-pump arms on 19 subjects. Each arm lasted two
weeks. Participants wore infusion sets for up to 7 days to provoke
failures. A clinician contacted patients to confirm and repair
LISAs detected by the algorithm. LISAs were determined by (i)
failed correction doses, (ii) ketones >0.6, (iii) insulin leaking at 170
insertion sites, and (iv) pump-occlusion alarms.
CORRELATING THE ESTIMATED INSULIN ACTION
Results: The LISA detection algorithm achieved a sensitivity
PEAK EFFECT WITH PATIENT CHARACTERISTICS
of 85% (n = 27) while issuing only 0.22 false positives per day.
IN THE 670G PIVOTAL TRIAL
Furthermore, the artificial pancreas using zone model predictive
control with LISA detection limited the mean hyperglycemia B. Grosman1, A. Roy1, D. Wu1, N. Parikh1, J. Shin2, S. Lee3,
exposure (> 250 mg/dL) in the four hours preceding a LISA to F. Kaufman4
46.4 minutes, compared to 103.0 minutes during sensor- 1
augmented-pump therapy (p-value 0.01). Medtronic Diabetes, Closed Loop, Northridge, USA
2
Conclusions: As patient burden is reduced by each generation Medtronic Diabetes, Clinical Res Data, Northridge, USA
3
of advanced diabetes technology, fault detection algorithms will Medtronic Diabetes, Clinical Research, Northridge, USA
4
help ensure that patients are alerted when they need to manually Medtronic Diabetes, Medical Affairs, Northridge, USA
intervene.
Background and Aims: The data set from the pivotal trial
for the Medtronic MiniMed 670G hybrid closed loop system
was used to estimate the insulin action peak effect (Teff) for
169 individual subjects using a mathematical model. Teff was then
OPEN TO CLOSED-LOOP TRANSITION SCHEMES correlated with a variety of patient variables and measures of
FOR IN VIVO GLUCOSE CONTROL glycemia.
Methods: Teff was determined in 61 subjects (out of the 124
F. Garelli1, N. Rosales1, E. Fushimi1, H. De Battista1 pivotal trial participants) to be 211 30 minutes (median STD).
1
LEICI, EE-UNLP, La Plata, Argentina In the Table, the Pearsons correlation-coefficient (R) between
Teff and the subjects characteristics is given.
Background and Aims: Continuous Subcutaneous Insulin In- Results: The results show a strong positive correlation be-
fusion (CSII) treatments for people with type 1 diabetes can combine tween Teff and A1C after 3 months of the use of the 670G hybrid
the use of a smart insulin pump with a Continuous Glucose Monitor closed loop system. There was essentially no correlation between
(CGM) and a control algorithm to improve the regulation of the Teff and age, duration of diabetes, or total daily dose of (TDD)
insulin delivery. New control algorithms need to be tested in clinical after 3 months of 670G use.
trials under strictly safety conditions for the patients.
Methods: In this work, a safety layer called the SAFE loop Table. Correlation coefficient (R) between Teff
(Revert et al., IEEE-TBME 2013) is reformulated to be em- and A1C, Diabetes Duration, Total Daily
ployed during clinical trials in two different ways: the Time Dose of Insulin and Age
Enable mode, which gives a criterion for the transition between Measurement R
open and closed-loop therapy in hybrid configurations, and the
Amplitude Enable mode, which diminishes the risk of an hypo- A1C measurement after 3 months 0.40
glycemic event when testing fully closed-loop algorithms by of using the 670G
delimiting the Insulin-On-Board (IOB) profile of the new control
algorithm with the IOB profile corresponding to the usual open- Duration of diabetes -0.17
loop therapy of the patient (or a factor of it). TDD after 3 months of 670G use -0.10
Results: In-silico trials show how using the Time Enable Age 0.07
method the transition from open (bolus) to closed-loop is made
automatically and gradually, resulting in a bumpless mechanism
which improves the controller response. In the case of the Am-
plitude Enable mode, the results show how the patient is protected Conclusions: These data suggest that the speed of insulin
from hypoglycemia even when controller gain is disproportionally action is an indicator of the effectiveness of intensive insulin
large, as shown in the figure below. therapy. Since the direction of the relationship is not known, it is
Conclusions: Two IOB constraint profiles are proposed for its also possible that glucose toxicity can increase Teff. However,
use in clinical trials, giving rise to a safe mechanism for in vivo Teff is likely one of many factors that accounts for insulin
testing both hybrid and fully closed-loop controllers. therapy effectiveness.
ATTD 2017 E-POSTER VIEWING ABSTRACTS A-71

171
PERSONALIZED INSULIN LIMITS - MEDTRONIC
HYBRID CLOSED-LOOP SAFEGUARD DURING
AUTOMATED INSULIN DELIVERY
B. Grosman1, D. Wu1, A. Roy1, N. Parikh1, J. Shin2, S. Lee3,
F. Kaufman4
1
Medtronic Diabetes, Closed Loop, Northridge, USA
2
Medtronic Diabetes, Clinical Res Data, Northridge, USA
3
Medtronic Diabetes, Clinical Research Administration,
Northridge, USA
4
Medtronic Diabetes, Medical Affairs, Northridge, USA

Background and Aims: The algorithm used in the Medtronic

hybrid closed-loop system requires patients to administer insulin
for meals, while the system delivers insulin automatically every
5-minutes. The maximal amount of insulin given automatically
is determined by the algorithm, which adapts every 24 hours. In
early feasibility trials that were conducted to assess the safety of
insulin limits, 8 patients set their pumps to their personalized
insulin limits and glycemia was evaluated at 4 hours at which
point there was no hypoglycemia. During the pivotal trial of the
Medtronic hybrid closed-loop system, there was a significant
decrease in the mean sensor glucose values <50 mg/dL and
<70 mg/dL during closed-loop compared to open loop, again
suggesting that the insulin limits provided a safe constraint on
automated insulin delivery. The pivotal data suggested that in-
sulin limits could be extended beyond 4 hours.
Methods: Extension of the 4 hour insulin limit time-out occurs
when the patient measures a blood glucose value. The appearance
of hypoglycemia after resetting insulin limits was evaluated.
Results: During the trial, there were 628 cases where the in-
sulin limit time-out was reset; 74% of the cases were automati-
cally resolved in <60 minutes (total time delivering at insulin
limit between 4-5 hours) and 12% continued on insulin limits for
a total time of 6 to 8 hours. There was not a single case of
hypoglycemia after the extension of insulin limits.
Conclusions: This analysis suggests that insulin limit
time-out can likely be extended without increasing the risk of
hypoglycemia.
172
RELATIONSHIP BETWEEN GLUCOSE VARIABILITY
AND GLYCAEMIC CONTROL DURING SENSOR
AUGMENTED PUMP THERAPY (SAP) AND CLOSED-
LOOP (CL) INSULIN DELIVERY IN ADULTS
WITH TYPE 1 DIABETES (T1D)
L. Leelarathna1, H. Thabit2, S. Hartnell3, M. Willinska2,
S. Dellweg4, C. Benesch4, J. Mader5, M. Holzer5, M. Evans2,
S. Arnolds4, T. Pieber5, R. Hovorka2
1 173
Central Manchester University Hospital NHS Foundation
Trust, Manchester Diabetes Centre, Manchester,
United Kingdom
2
University of Cambridge, Wellcome Trust-MRC Institute
of Metabolic Science, Cambridge, United Kingdom
3 1
Cambridge University Hospitals NHS Foundation Trust,
Department of Diabetes & Endocrinology, Cambridge,
United Kingdom
4
Profil, Profil, Neuss, Germany
5 3
Medical University of Graz, Department of Internal Medicine,
Graz, Austria
Background and Aims: Higher glycaemic variability (GV) is
associated with severe hypoglycaemia and may contribute to
development of diabetes complications independent of HbA1c.
Objectives of the current study was to explore the relationship of
GV with hypo and hyperglycaemia outcomes during SAP and CL
insulin delivery.
Methods: Post-hoc, exploratory analysis of published, day
and night hybrid CL study. During an open-label, three-centre,
multi-national randomised two-period crossover study, 33 adults
with T1D (age 40 9years, duration of diabetes 20 9years, and
duration of pump therapy 7.8 5.9years) treated with continuous
subcutaneous insulin infusion with HbA1c between 7.5% and
10% underwent automated CL and SAP for 12 weeks. GV was
assessed using coefficient of variation (CV) of glucose over the
entire three-month period.
Results: During SAP, GV was positively associated with time
spent in hypoglycaemia (below 3.9mM: r = 0.6, p < 0.001; below
3.5mM: r = 0.6, p < 0.001; below 2.8mM: r = 0.6, p < 0.001). In
contrast, there was no relationship between GV and any level of
hypoglycaemia during CL insulin delivery (figure). Higher GV
during SAP was associated with larger reduction in hypogly-
caemia <3.9mM (r = 0.4, p = 0.013), as well as smaller reduction
of hyperglycaemia >10mM during CL (r = 0.6, P = 0.001). There
was no difference in GV between SAP and CL (39 4% vs.
39 4%, p = 0.5).
Conclusions: Higher glycaemic variability during SAP is
strongly associated with more time spent in hypoglycaemia
and larger reduction in time spent in hypoglycaemia during
CL. The association of GV to time spent in hypoglycaemia was
not observed during CL. Further work is required to understand
the clinical relevance of these observations.
A NOVEL MEAL DETECTION ALGORITHM
FOR AN ARTIFICIAL PANCREAS
C. Ramkissoon1, P. Herrero2, J. Bondia3, J. Vehi1
Informatica i Aplicacions, Enginyeria Electrica Electronica i
Automatica, Girona, Spain
2
Centre for Bio-Inspired Technology, Biomedical Engineering,
London, United Kingdom
Automatica e Informatica Industrial, Ingeniera de Sistemas y
Automatica, Valencia, Spain
A-72
Background and Aims: Many studies have reported that a
high number of missed meal boluses occur, especially in adoles-
cents during insulin pump therapy. It is predicted, that this behavior
will carry over to artificial pancreas therapy and therefore, a means
to reduce poor outcomes due to announced meals must be im-
plemented. The aim is to implement an algorithm to detect meals
using data from a continuous glucose monitor (CGM) and the
insulin delivered to the subject.
Methods: An Unscented Kalman Filter is employed to predict
the states of a composite Bergman-Hovorka model altered to
include an auxiliary disturbance parameter. Then, an algorithm
checks the cross-correlation between the disturbance parameter
and continuous glucose monitor levels and employs a threshold to
detect an abnormal event. At this time point, a positive distur-
bance parameter value indicates a rise in glucose due to a meal.
This methodology was tested using meals simulated in silico with
10 adult patients over a period of ten days (30 meals per subject).
Results: Carbohydrate amounts tested were 85 17 g. The true
positive rate (sensitivity) and false positive rate were 90 12.7%
and 5 1.8%, respectively. The accuracy and specificity were
94 1.5%, and 95 1.8%, respectively. The change in glucose
experienced at detection was 4 14 mg/dl and the detection time
was 28 3 min.
Conclusions: This algorithm provides meal detection with
minimal change in blood glucose levels. When used in con-
junction with a postprandial control strategy, it may improve
postprandial outcomes.
174
VALIDATION OF A SIMULATION MODEL
DESCRIBING THE GLUCOSE-INSULIN-GLUCAGON
PHARMACODYNAMICS IN PATIENTS WITH TYPE 1
DIABETES
S.L. Wendt1, A. Ranjan2, J.K. Mller3, S. Schmidt2,
C.B. Knudsen1, J.J. Holst4, S. Madsbad2, H. Madsen3,
K. Nrgaard2, J.B. Jrgensen3
1
Zealand Pharma A/S, Bioanalysis and Pharmacokinetics,
Glostrup, Denmark
2
Copenhagen University Hospital Hvidovre, Endocrinology,
Hvidovre, Denmark
3
Technical University of Denmark, Applied Mathematics and
Computer Science, DTU Compute, Kongens Lyngby, Denmark
4
University of Copenhagen, Faculty of Health and Medical
Sciences, Copenhagen, Denmark
Background and Aims: Currently, no consensus exists on a
model describing endogenous glucose production (EGP) as a
function of glucagon concentrations. Reliable simulations to de-
termine the glucagon dose preventing or treating hypoglycemia or
to tune a dual-hormone artificial pancreas control algorithm need a
validated glucoregulatory model including the effect of glucagon.
Methods: Eight type 1 diabetes patients each received a
subcutaneous (SC) bolus of insulin on four consecutive days to
induce mild hypoglycemia followed by a SC bolus of saline or
100, 200 or 300 lg of glucagon. Blood samples were analyzed
for concentrations of glucagon, insulin and glucose. We fitted
pharmacokinetic (PK) models to insulin and glucagon data using
maximum likelihood and maximum a posteriori estimation
methods. Similarly, we fitted a pharmacodynamic (PD) model to
glucose data. The PD model included multiplicative effects of
insulin and glucagon on EGP. Bias and precision of PD model
test-fits were assessed by mean predictive error (MPE) and mean
absolute predictive error (MAPE).
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Results: Assuming constant variables in a subject across the
four visits and using thresholds of 15% MPE and 20% MAPE,
we accepted at least one and at most four PD model test-fits per
subject. Thus, we successfully validated the PD model by 4-fold
leave-one-out cross-validation.
Conclusions: The PD model accurately simulates glucose
excursions based on plasma insulin and glucagon concentrations.
The reported PK/PD model including equations and fitted pa-
rameters allows for in silico experiments and were used for in-
vestigations of future study design. Simulation studies may help
improve diabetes treatment involving glucagon for prevention of
hypoglycemia.
175
INTEGRATION OF SCREENING, MONITORING
AND FOLLOW UP TOOLS FOR EFFECTIVE FOOT
CARE: EXPERIENCE FROM A DIABETES CARE
CENTRE
D. A. Padhye1
1
Conquer Diabetes, Foot, Mumbai, India
Background and Aims: The diabetic patients in India are
routinely screened for target end organ damage which includes
retinopathy, cardiomyopathy, and nephropathy. Currently the
practice does not involve routine check for early diabetic neu-
ropathy and vasculopathy. The prevalence of diabetic neuropa-
thy is low in Indian population; we believe this could be because
of lack of active early screening of asymptomatic patients.
Methods: Our retrospective study of 1500 patients over a
period of 10 months looked for diabetic foot related complica-
tions. This was done by using Biothesiometer to assess vibration
perception for neuropathy, Doppler to measure ankle brachial
index (ABI) for vasculopathy and Podiascan for abnormal planter
pressure points. The patients were educated about foot care and
appropriate treatment was initiated
Results: An abnormal vibration perception was present in
46.5% (n = 698/1500) of study population, with 25.9% of patients
had severe impairment of vibration sense. The Ankle Brachial
Index (ABI) of >1.3 in right leg, left leg and bilaterally was re-
corded in 70, 42 and 40 patients respectively. Twenty seven pa-
tients recorded midfoot collapse and 338 patients had 1stmetatarsal
high pressure points. The follow up was maintained to look for
development of complication
Conclusions: The study demonstrates the substantial burden
of neuropathy and vasculopathy. An integrated approach that
includes neuropathic and vascular screening along with other
routine screenings will help achieve an objective of detecting
early diabetes related complications. The early intervention,
education, treatment and follow up tools are important for an
effective preventive management.
176
SELECTED FACTORS ASSOCIATED WITH THE
SENSE OF RESPONSIBILITY FOR THE HEALTH
IN PATIENTS WITH TYPE 2 DIABETES
M. Jaworski1, M. Adamus1
1
Medical University of Warsaw, Department of Medical
Psychology, Warsaw, Poland
ATTD 2017 E-POSTER VIEWING ABSTRACTS A-73

Background and Aims: Preliminary studies have shown a

significant role sense of responsibility for the health in patients
with diabetes in term of health-related behaviour. Responsibility
for health construct is defined as self-perceptions relating to
motivation and use of various behavioral strategies to keep good
health. Two aspects characterize this variable: active involve-
ment and adequate behavior. Aim of this study was analyze se-
lected factors which could influence on the level of sense of
with T1D wore an investigational device and continuous glucose
responsibility for health in patients with diabetes.
monitoring (CGM; Dexcom G4) concurrently (both masked) at
Methods: The study was conducted among patients with
home for 14 nights. A data subset was used to train the ANN; the
diabetes aged between 18 and to 71. Three research tools were
remaining data were then used to assess the efficacy of the device
used in the study: Health Suggestibility Scale (HSS), Health
to detect NH (<4.0 mmol/L).
Sense of Responsibility Scale (HSRS), Life Orientation Test
Results: Fifty adults (24 women; 12/50 Gold score 5;
(LOT-R). The number used drugs, the current age, body weight
mean SD age 46 14.8 years; BMI 27.8 5.5 kg/m2; T1D du-
and growth were analyzed too. The method of structural
ration 24.0 11.2 years; HbA1c 7.8 1.0%) participated. Of 714
equation modeling (SEM) was using to develop models ana-
study nights, n = 187 did not meet pre-specified quality criteria
lyzed the relationship between psychological characteristics
and were excluded, n = 401 were used to train the ANN algo-
(suggestibility and optimism) and sense of responsibility for
rithm, and n = 126 were used to assess efficacy. Analysis during
health in diabetic patients with complications and accompa-
the training phase indicated that micro-tremor at 19Hz and 5Hz
nying diseases.
had greatest sensitivity for NH detection. Other frequency ranges
Results: The SEM analysis showed that there are four main
modulated this relationship. There was negligible association
factors which influence on the formation of sense of responsi-
between skin temperature and NH. During 31/126 (24.6%) as-
bility for the health in diabetic patients with complications and/or
sessment nights, CGM glucose reached <4.0 mmol/L; see Table
accompanying diseases. There are: health suggestibility, dispo-
for device alerts by glucose nadir. No alerts occurred on 77/95
sitional optimism, duration of therapy and number of used drugs.
(81.1%) nights when CGM remained >4.0 mmol/L.
Conclusions: The sense of responsibility for the health is a
Conclusions: Increasing sensitivity for NH detection paral-
very important factor in work with patients with diabetes. These
leled the glucose nadir, supporting a physiological basis for the
results could have a clinical implications. It could be used to
association with micro-tremor. This non-invasive prototype de-
create a new therapys form in context of the biopsychosocial
vice shows initial promise for diabetes management, though
model.
further refinement is required.

177 178
THE FEASIBILITY AND EFFICACY OF EMPLOYING AN EARLY INFECTIOUS DISEASE OUTBREAK
MICRO-TREMOR AND SKIN TEMPERATURE DETECTION SYSTEM BASED ON SELF-RECORDED
TO ALERT FOR NOCTURNAL HYPOGLYCAEMIA DATA FROM PEOPLE WITH DIABETES
IN ADULTS WITH TYPE 1 DIABETES
A.Z. Woldaregay1, T. Chomutare2, D. Albers3, L. Mamykina3,
1 2 3 3 3
S.A. McAuley , N. Cohen , W. Fifield , A. Ratcliff , M. Smith , O. Hejlesen4, C. Lovis5, G. Demiris6, P.J. Toussaint7,
B. Robinson4,5, A.J. Jenkins1,6,7, D.N. ONeal1,7 C.F. Basse8, A. Horsch1,9, F. Godtliebsen2, T. Botsis1,
1 E. Arsand2,10, G. Hartvigsen1,2
St Vincents Hospital Melbourne, Department
1
of Endocrinology and Diabetes, Melbourne, Australia UiT The arctic University of Norway, Computer Science,
2
Baker-International Diabetes Institute, Diabetes, Melbourne, Troms, Norway
2
Australia Norwegian Centre for E-health Research, University Hospital
3
Grey Innovation, Research and Development, Melbourne, of North Norway, Troms, Norway
3
Australia Columbia University, Biomedical Informatics, New York, USA
4 4
Royal North Shore Hospital, Department of Endocrinology, Aalborg University, Department of Health Science
Sydney, Australia and Technology, Aalborg, Denmark
5 5
Royal North Shore Hospital, Kolling Institute of Medical University of Geneva & Geneva University Hospitals, Medical
Research, Sydney, Australia Informatics, Geneva, Switzerland
6 6
University of Sydney, NHMRC Clinical Trials Centre, Sydney, University of Washington, Biomedical Informatics
Australia and Medical Education, Seattle, USA
7 7
St Vincents Hospital Melbourne, University of Melbourne NTNU, Department of Computer and Information Science,
Department of Medicine, Melbourne, Australia Trondheim, Norway
8
University of Bergen, Philosophy, Bergen, Norway
9
Background and Aims: To determine if nocturnal hypogly- TU Munchen, Medical Statistics and Epidemiology,
caemia (NH) can be detected in type 1 diabetes (T1D) using Munchen, Germany
10
changes in micro-tremor and skin temperature as inputs into a UiT The arctic University of Norway, Clinical Medicine,
prototype device. Troms, Norway
Methods: The investigational wrist- and finger-worn device
(Firefly Health, Australia) combines accelerometers, gyroscopes, Background and Aims: During infections, many people with
and skin and environmental temperature sensors. Data were diabetes experiences high blood glucose (BG) levels. We pro-
processed by an artificial neural network (ANN). Participants pose to utilize patient-gathered information and develop an
A-74
Electronic Disease Surveillance Monitoring Network, which can
possibly detect infectious disease outbreaks during incubation
period. The system incorporates data gathered from diabetes
diaries, CGM devices, and other appropriate physiological in-
dicators from people with type 1 diabetes. The system will detect
a cluster of people with elevated BG levels on a spatio-temporal
basis. In this regard, we aim to develop mathematical models on
individual level that can track and detect any unreasonable BG
deviations.
Methods: The models combine a novel approach for BG
tracking and outlier detection, which is based on set of auto-
regressive models and predicts the expected BG intervals for an
individual. The actual BG value is compared against the predicted
intervals, which is generated using auto-regressive and Auto-
regressive moving average methods. The models were developed
using one-month BG data, sampled using Dexcom CGM devices,
based on two type 1 diabetes patients.
Results: The models were capable of accurately monitoring
individuals normal BG fluctuations and detecting statistically
significant BG deviation. However, these models were found to
be affected by the variability of the individuals BG evolution,
quality of diabetes self-management behavior, which needs to be
taken into account in the next phase of the study.
Conclusions: We demonstrated a novel model for using BG
levels as source of information for a disease surveillance purpose.
Further analysis and results will be presented at ATTD 2017 re-
garding the developed models, next steps, and challenges.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
179
CGM-BASED GLYCEMIC VARIABILITY INDICES
ALLOW ACCURATE CLASSIFICATION OF IGT
AND T2D SUBJECTS
E. Longato1, G. Acciaroli1, A. Facchinetti1, A. Maran2,
G. Sparacino1, L. Hakaste3, T. Tuomi3, C. Cobelli1
1
University of Padova, Information Engineering, Padova, Italy
2
University of Padova, Department of Medicine, Padova, Italy
3
University of Helsinki, Diabetes and Obesity Research
Program, Helsinki, Finland
Background and Aims: Tens of Glycemic Variability (GV)
indices are available in the literature to characterize the dynamic
properties of glucose concentration profiles measured by CGM
sensors, in both healthy and disease states. Whether GV indices
are usable for classifying patients is, however, still controversial.
Recently (Acciaroli et al., Diab Tech Meeting, 2016), we dem-
onstrated that for the quite simple task of distinguishing healthy
from and IGT/T2D subjects, a pool of 25 CGM-based GV indices
can be successfully used. Here, we move a step forward by as-
sessing if a GV indices-based classifier can further distinguish
IGT from T2D subjects.
Methods: The dataset consists of 62 subjects classified by the
OGTT test, 36 IGT and 26 T2D subjects. Each subject was mon-
itored by either the Guardian Real Time or the iPro CGM systems
(Medtronic MiniMed, Inc., Northridge, CA), from which 37 GV
indices were extracted. In addition to GV, age, sex, BMI and waist
circumference were also used. To classify each patient a Support
Vector Machine classifier with polynomial kernel was developed.
Results: IGT subjects were distinguished from T2D subjects
with 87.1% accuracy. The addition of some basic clinical pa-
rameters to GV indices improved performance by 12.9%.
Conclusions: GV indices, combined with basic clinical pa-
rameters, can be used to accurately distinguish IGT from T2D
patients. Further work will concern the extension of the database
and the identification of the minimal set of GV indices needed for
classification purposes.
180
CHOLINE DEPRIVATION MODIFIES CRUCIAL
HEPATIC MARKERS OF THE INSULIN SIGNALING
PATHWAY IN STREPTOZOTOCIN-INDUCED
DIABETIC RATS
H. Al-Humadi1
1
Babylon University/Pharmacy College, Pharmacology
and Toxicology, Hilla, Iraq
Background and Aims: The evaluation of induction of
choline-deprivation CD in rats model with or without diabetes
DM depending on the changes of hepatic enzymes & insulin
signaling pathway.
Methods: A 30-day dietary CD with or without DM induced
by intraperitoneal streptozotocin administrated on adult male
rats; the assessment of changes in insulin level IN, blood sugar
BS and gene expression GEX of some hepatic insulin signalling
pathway (IR, IRS-1, Glut-2 except Glut-4) in addition to the
liver histopathological HST sections, enzymes (ALT, AST, ALP,
c-GT) and lipid profile (TC,TG, HDL, LDL).
Results: In combination group, there was a significant in-
crease in BS with a significant decrease in IN; serum liver
ATTD 2017 E-POSTER VIEWING ABSTRACTS
enzymes were demonstrated a significant increase except in ALT.
Non-HDL lipid profile assay revealed also a significant increase
while HDL revealed no significant changes in comparison with
control. HST examination of liver sections revealed micro- and
macrovesicular steatosis with mild degenerative changes. The
mRNA GEX of IR level in rat hepatic tissue was significantly
increased. On the other hand, IRS-1 mRNA GEX level was im-
paired as well as in DM group. For glucose transporters, GLUT 2
mRNA GEX level revealed a significant increasing but GLUT 4
mRNA GEX was reacted positively and significantly more earlier.
Conclusions: Our new design of combined CD with DM
explore that CD increase the sensitization of the hepatic IN
signaling pathways by minimizing the hyperglycemic HYG re-
sponse with an additional anti-diabetic effect as augmenting the
inhibitory action of HYG on GLUT-2 but with hepatotoxic effect
and progressive dyslipidemia.
181
INTRAPERITONEAL GLUCOSE MEASUREMENTS
USING AMPEROMETRIC GLUCOSE SENSORS
AND INTRAPERITONEAL FLUID SAMPLES
IN AN ANIMAL MODEL
M.K. Am1,2,3, A.L. Fougner2,3,4, I. Dirnena-Fusini1,2,
P.C. Bosch2,4, K. Kolle2,3,4, D.R. Hjelme2,5, R. Ellingsen2,5,
. Stavdahl2,4, S.M. Carlsen1,2,6, S.C. Christiansen1,2,6
1
Norwegian University of Science and Technology NTNU,
Department of Cancer Research and Molecular Medicine,
Trondheim, Norway
2
Norwegian University of Science and Technology NTNU,
Artificial Pancreas Trondheim APT, Trondheim, Norway
3
Central Norway Regional Health Authority, RHA, Stjrdal,
Norway
4
Norwegian University of Science and Technology NTNU,
Department of Engineering Cybernetics, Trondheim, Norway
5
Norwegian University of Science and Technology NTNU,
Department of Electronics and Telecommunication, Trondheim,
Norway
6
St. Olavs University Hospital, Department of Endocrinology,
Trondheim, Norway
Background and Aims: Fast, accurate and reliable glucose
sensing is crucial for a well-functioning artificial pancreas (AP).
The glucose dynamics in the peritoneal space are faster than in the
subcutaneous tissue, making it a preferable sensing site for an AP.
The peritoneal space also offers advantages by being less
influenced by temperature variations and mechanical forces re-
ducing vascular perfusion, thus potentially providing a more
stable environment for glucose sensing.
Methods: Two anaesthetised, non-diabetic pigs (27.0 and
31.4 kg) were implanted with four glucose sensors (Abbott
Freestyle Libre Flash), one in each quadrant of the peritoneal
space, and two sensors of the same type placed subcutaneously
on the abdominal wall. Meal glucose excursions were simulated
by intravenous glucose infusions. Frequent blood and intraperi-
toneal (IP) fluid samples were drawn and analysed in a blood gas
analyser (BGA) (Radiometer ABL 725) for comparison.
Results: Intravenous glucose challenges gave a rise in IP glu-
cose levels, measured with both amperometric sensors and BGA.
A potential difference in glucose dynamics was observed
between IP fluid samples from the upper (cranial) part compared
to the lower (caudal) part of the peritoneal space, but this was not
apparent in the corresponding amperometric sensor signals.
A-75
Conclusions: The sensors possibly measure the flux of glu-
cose more closely to the peritoneal membrane and thereby correlate
better to the blood glucose excursions than glucose measured in
samples of peritoneal fluid.
Whether measurements of glucose in the upper abdomen
correlate better to blood glucose fluctuations than measurements
in the lower abdomen, will be one of the questions investigated in
future experiments.
182
LABORATORY AND CLINICAL SAMPLE
REAPPLICATION STUDIES: PERFORMANCE
AND ACCURACY CAPABILITY OF A NEW,
WIRELESS-ENABLED BLOOD GLUCOSE
MONITORING SYSTEM THAT LINKS
TO A SMART MOBILE DEVICE
B. Harrison1, D. Brown1, M. Takeshima2
1
Ascensia Diabetes Care, Parsippany NJ, USA
2
Panasonic Healthcare Co. Ltd., Toon City Ehime, Japan
Background and Aims: To validate ContourPlus ONE
blood glucose monitoring system (BGMS) performance and
accuracy capability during Second-Chance sampling. This new
BGMS features an easy-to-use, wireless-enabled BG meter that
links to a smart mobile device via Bluetooth technology and
syncs with the Contour Diabetes app.
Methods: In the laboratory study, testing was conducted at 3
temperatures (16C, 22C, 34C) with blood adjusted to 3 BG
levels (70, 300, 500 mg/dL) at 3 hematocrit levels (20%, 42%,
55%). Two sample reapplication methods were used (initial
volume, 0.28 and 0.46 lL); each sample was tested with 3 delay
times between initial and second inoculation (5, 30, 55 seconds).
For each sample and condition, 10 replicate BGMS readings
were obtained with each of 3 test strip lots. In the clinical study,
52 subjects with diabetes performed self-tests with an inten-
tionally insufficient initial blood application to produce a number
of Second-Chance sampling opportunities. Results were com-
pared with YSI reference results and assessed per the follow-
ing acceptance criterion: 95% of results within 15 mg/dL (BG
<100 mg/dL) or 15% (BG 100 mg/dL) of reference result.
Results: In the laboratory study, results met protocol-specified
acceptance criteria. In the clinical study (BG range, 65-347 mg/
dL; hematocrit range, 35%-55%), 97.7% (84/86) of subject fin-
gertip self-test results were within 15 mg/dL or 15% of YSI
reference result. Moreover, 90.7% (78/86) of self-test results were
within 10 mg/dL or 10% of YSI reference result.
Conclusions: The BGMS sample reapplication results met
acceptance criteria in the laboratory and in a clinical setting used
by subjects with diabetes.
183
IMPACT OF SENSOR-AUGMENTED INSULIN PUMP
THERAPY ON GLYCAEMIC CONTROL IN CHILDREN
AND ADULTS WITH TYPE 1 DIABETES: A CLINICAL
PRACTICE EXPERIENCE IN SPAIN
P.I. Beato-Vibora1, E. Gil-Poch2, L. Galan-Bueno2,
F. Morales-Perez1, F.J. Arroyo-Dez2
1
Badajoz University Hospital, Department of Endocrinology,
Badajoz, Spain
2
Badajoz University Hospital, Department of Paediatrics,
Badajoz, Spain
A-76
Background and Aims: To evaluate the effect of sensor-
augmented pump therapy (SAP) on HbA1c in routine clinical
practice in adult and paediatric patients with type 1 diabetes
(T1DM).
Methods: We performed a retrospective evaluation of the
effect of SAP on glycaemic control in all T1DM patients treated
in the adult and paediatric Diabetes Departments at a referral
hospital in Badajoz (southwestern Spain).
Results: 85 T1DM patients (14 patients 18 years-old), age
35 14 (2-61), 62% female, diabetes duration 21 12 years,
were on SAP (53 Medtronic-MiniMed-640G with predic-
tive low-glucose suspend feature, 29 Medtronic-MiniMed-
Paradimg-VEOTM with low-glucose suspend feature, 3
Animas vibe+DexcomG4). Median time on SAP was 16
months (range 1-153). 35 patients were using pumps and self-
monitoring of blood glucose (SMBG) before starting SAP, 8
were on multiple daily insulin ( MDI) injections and sensors,
39 were on MDI and SMBG and 3 children had started SAP at
diabetes onset (< 20 months-old). Percentage of patients with
HbA1c 7% increased from 35% to 54% at the end of follow-
up (p = 0.001). HbA1c at end of follow-up was significantly
lower than HbA1c before the start of SAP in the whole group
(7.5 0.9% vs 7.0 0.7%, p = 0.001) and in the group with
baseline HbA1c >%7 (8.0 0.1% vs 7.3 0.1%, n = 52,
p = 0.001). In this group, 81% of the patients improved their
HbA1c and end-of-follow-up Hba1c was significantly lower
when different groups of age; time on SAP and previous and
current treatments were analysed (Table 1).
Conclusions: Sensor-augmented pump therapy provides a
sustained improvement in glycaemic control in real-life clinical
practice in children and adults with T1DM.
184
PATIENTS EDUCATION FOR USING RT-CGM DATA
IN SAP THERAPY MANAGMENT
A. Girelli1, S. Bonfadini1, E. Zarra1, U. Valentini1
1
UO Diabetologia, ASST Spedali Civili, Brescia, Italy
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Background and Aims: SAPs outcome depends on patients
being educated in using RT-CGM data. We analysed the effect
on glycaemic variability of a specific training path.
Methods: 21T1DM patients (16M/21F, age 42.2 1.3 years;
disease duration 19.0 9.4years, starting 640G therapy by 5.8
4.3months) attended a structured SAP education (individual and
collective) focused on the correct use and interpretation of CGM
data and therapy adjustment. We analysed HbA1c and CGM data
considering the date of the course as Day 0, the whole follow up
(from Day60 to Day120) and subintervals (Day30 Day 0),
(Day0 Day30), (Day30 Day60) and (Day60 Day90). We
evaluated: Mean of Sensor Glucose (SG); Coefficient of Varia-
tion (CV); Conga-1; Conga-2; Conga-4; J-index; M-value and
Lability Index.
Results: In the whole follow up (-60 - 120) the time effect
has a significant descending trend for the following variables:
SGM; Conga-4M; J-IndexM and M-valueM and for SGM;
CVM; Conga-1M and LIM in the interval (60 90). The
comparison of the median values of indexes calculated for each
patient in the interval (from -30 to 0) vs all subsequent, were
not statistically significant. The Means Number of Suspen-
sions, in the whole follow up has a significant increasing. The
median values of HbA1c, before, 1 month and 3 months after
the course showed a trend improvement that was not statisti-
cally significant.
Conclusions: These results suggest how a structured educa-
tional intervention is important to acquire competences. The
significant lack for subintervals suggests this process is slow and
continuous and it depends on the basic preparation of patients.
185
SET-UP AND PROCEDURE FOR INTRAPERITONEAL
GLUCOSE MONITORING IN ANAESTHETISED
ANIMALS
P.C. Bosch1,2, M.K. Am2,3,4, . Stavdahl1,2, R. Ellingsen2,5,
A.L. Fougner1,2,4, S.M. Carlsen2,3,6, D.R. Hjelme2,5
1
Norwegian University of Science and Technology NTNU,
Department of Engineering Cybernetics, Trondheim, Norway
2
Norwegian University of Science and Technology NTNU,
Artificial Pancreas Trondheim, www.apt-norway.com,
Trondheim, Norway
3
Norwegian University of Science and Technology NTNU,
Department of Cancer Research and Molecular Medicine,
Trondheim, Norway
4
Helse Midt-Norge, Central Norway Regional Health Authority,
Stjrdal, Norway
5
Norwegian University of Science and Technology NTNU,
Department of Electronics and Telecommunication, Trondheim,
Norway
6
St. Olavs Hospital, Unit for applied clinical research,
Trondheim, Norway
Background and Aims: The peritoneum is a promising lo-
cation for an artificial pancreas (AP). To develop an intraperi-
toneal (IP) AP, it is crucial to understand the dynamics and
distribution of IP glucose. To verify the performance of proto-
types and map IP glucose dynamics two ways of measuring IP
glucose were developed.
Methods: Two proposed ways of obtaining IP glucose data
have been developed and tested on two male pigs (27.0 &
ATTD 2017 E-POSTER VIEWING ABSTRACTS
31.4kg). One procedure is continuous and uses a commercially
available, wireless, amperometric glucose sensor (Abbott Free-
style Libre Flash (FLF)) in combination with an open source
readout unit (LimiTTer by JoernL @ GitHub), which reads
and transmits the sensor data to an Android app (xDrip by
stephenblackwasalreadytaken @ GitHub), from where it was
downloaded for further processing. The other is a manual, dis-
crete sampling, where IP-fluid samples are taken with a spe-
cially designed device that allows sampling from the location of
the FLF. These samples are then analysed with a blood gas
analyser (Radiometer ABL 725).
Results: Both sampling procedures worked reliably al-
lowing a new and unique glucose value to be acquired every
minute.
Conclusions: The quality of the preliminary data obtained
seems good; however, further analysis is needed to confirm
this. These novel ways of monitoring IP glucose allow com-
parison of a continuous measurement device to a gold standard.
Once the reliability of the IP FLF is verified, FLFs may be
utilised for future trials. This might provide a relatively inex-
pensive way for medium- or long-term continuous IP glucose
monitoring in animals.
186
CONTINUOUS GLUCOSE MONITOR SENSOR
SURVIVAL AND ACCURACY OVER 21 CONSECUTIVE
DAYS OF WEAR
D. Tinti1, T. Marcal2, L. Towers3, J. Doiev2, T. Ly1, L. Messer3,
G. Forlenza3, D. Maahs3, B. Buckingham1
1
Stanford University, Pediatric Endocrinology, Palo Alto, USA
2 Background and Aims: To evaluate accuracy of the new
Stanford, Pediatric Endocrinology, Palo Alto, USA
3 ContourNext ONE blood glucose monitoring system (BGMS)
University of Colorado Denver, Pediatric Endocrinology,
Aurora, USA
Background and Aims: As part of a study to develop algo-
rithms to detect sensor failure while in closed-loop we asked
subjects to wear a sensor for 3 weeks. This abstract describes the
causes of sensor failure and sensor accuracy during this 21 day
study.
Methods: A total of 20 subjects (mean age = 28 years) wore
Dexcom G4 sensors for 3 weeks in an outpatient setting on 40
occasions. Meter blood glucose (MBG) measurements were
performed at least four times per day on Accu-Check Aviva
A-77
meters. Sensor performance was assessed by the daily median
absolute relative difference (ARD). Sensor failures were defined
as primary sensor failure (??? for more than two hours or per-
sistent 20% difference between MBG and SG) or failure of the
sensor adhesive.
Results: Sensors were worn for a median (IQ range) of
14.8 days (12.0-19.6). 90% were functioning at end of week 1,
45% at end of week 2, and 20% at the end of week 3. The Median
ARD for week 1 was 10%, for week 2 was 11%, and for week 3
was 13%. The figure provides the overall sensor survival curve,
with curves for sensor failure due to adhesive failures and sensor
failures. All but one sensor failure was due to ??? message on
the sensor for more than 2 hours.
Conclusions: This study showed a significant decrease in
sensors surviving into the third week of wear. Most failures were
due to two hours of ???. Sensor accuracy was slightly de-
creased in the third week.
187
USER PERFORMANCE EVALUATION OF A NEW
WIRELESS-ENABLED BLOOD GLUCOSE
MONITORING SYSTEM THAT LINKS TO A SMART
MOBILE DEVICE IN SUBJECTS WITH AND WITHOUT
DIABETES
M. Christiansen1, C. Greene2, S. Pardo2, R. Morin2, T. Bailey3
1
Diablo Clinical Research, Walnut Creek CA, USA
2
Ascensia Diabetes Care, Parsippany NJ, USA
3
AMCR Institute Inc., Escondido CA, USA
in clinical settings used by subjects with and without diabetes.
The BGMS features an easy-to-use, wireless-enabled blood
glucose meter that links to a smart mobile device via Blue-
tooth technology and can sync with the Contour Diabetes
app.
Methods: This 2-center clinical study enrolled 375 subjects
with (n = 332) or without (n = 43) diabetes, who had never
used this BGMS. Secondary objectives included accuracy per
FDA Draft SMBG Guidance 2014 Section C for all subjects
with or without diabetes (ie, 95% of results within 15% and
99% within 20% of laboratory method across entire tested
range).
Results: Considering both subjects with and without diabe-
tes, 99.5% (370/372) of subject fingertip self-test results were
within 15% and 99.7% (371/372) were within 20% of YSI
reference results. For study staff tests of subject fingertip blood,
99.7% (374/375) of results were within 15% and 100% (375/
375) were within 20% of YSI reference results. At least 95%
of BGMS results for all subjects were within 9.5% and 8.9% of
YSI reference result for subject and study staff-obtained fin-
gertip tests, respectively. Regression analysis of results for
all subjects demonstrated a strong correlation between BGMS
and YSI reference results (adjusted R2 > 0.98 for subject and
study staff-obtained fingertip results). By Parkes-Consensus
Error Grid analysis, 100% (372/372) of all subject-obtained and
100% (375/375) of study staff-obtained fingertip results were
within Zone A.
Conclusions: The BGMS exceeded FDA Draft 2014 cri-
teria in a clinical setting used by subjects with and without
diabetes.
A-78
188
GLYCEMIC VARIABILITY IS ASSOCIATED
WITH ORTHOSTATIC HYPOTENSION IN PATIENTS
WITH TYPE 2 DIABETES MELLITUS
I. Eleftheriadou1, K. Makrilakis1, S. Kalopita1, C. Stathi1,
C. Kapelios1, P. Thomakos1, S. Liatis1
1 on their arm, although it was assessed and approved only to be
Medical School- National and Kapodistrian University
of Athens, First Department of Propadeutic and Internal
Medicine, Athens, Greece
Background and Aims: Orthostatic hypotension is a com-
mon manifestation of cardiac autonomic neuropathy (CAN) in
patients with type 2 diabetes (T2D). Recent studies have re-
ported an association between CAN and glycemic variability
assessed by continuous interstitial tissue glucose monitoring
(CGM). The aim of our study was to investigate the association
between orthostatic hypotension (decrease in systolic blood
pressure >20mmHg or in diastolic blood pressure >10 mmHg
within 3 min of standing) and indices of glycemic variability in a
cohort of patients with T2D.
Methods: A total of 90 participants were examined (age
62.8 9.9 years, diabetes duration 9.0, 4.0-15.0 years). Diagnosis
of CAN was based on the 4 standard cardiovascular tests pro-
posed by Ewing. A commercially available device was used for
the 24-h CGM. Mean interstitial glucose, standard deviation of
the mean glucose (SDMG), M-value and mean amplitude of
glycemic excursions (MAGE) were calculated.
Results: Twenty two participants (24.4%) had CAN, while
45 patients (50%) had orthostatic hypotension. Patients with
orthostatic hypotension had higher mean interstitial glucose val-
ues (152.2 33.0 vs. 136.9 26.0 mg/dl, p = 0.021) and higher
MAGE (118.0, 85.9-159.8 vs. 92.1, 74.6-112.5, p = 0.026) than
patients without orthostatic hypotension. No significant differ-
ences were observed in SDMG and M-value. Multivariate logistic
regression analysis, after controlling for age, diabetes duration,
HbA1c and mean interstitial glucose values, demonstrated that
the odds of orthostatic hypotension increased significantly with
higher MAGE (OR: 1.012, 95%CI: 1.001-1.023, p = 0.037).
Conclusions: Blood glucose fluctuations as assessed by
MAGE are associated with orthostatic hypotension, irrespec-
tive of mean interstitial glucose values and long term glycemic
control in patients with T2D.
189
ACCURACY OF DEXCOM G4 ON PEDIATRIC
PATIENTS IN THREE INSERTION SITES:
ARM, ABDOMEN AND GLUTEUS
S. Faccioli1, S. Del Favero1, R. Bonfanti2, D. Iafusco3,
I. Rabbone4, A. Sabbion5, R. Schiaffini6, D. Bruttomesso7,
C. Cobelli1, on behalf of PedArPan study group1
1
University of Padua, Department of Information Engineering,
Padua, Italy
2
Scientific Institute, Hospital San Raffaele, Pediatric
Department and Diabetes Research Institute-, Milan, Italy
3
Second University of Naples, Department of Pediatrics,
Naples, Italy
4 1
University of Turin, Department of Pediatrics, Turin, Italy
5
Azienda Ospedaliera Universitaria Integrata of Verona,
Regional Center for Pediatric Diabetes- Pediatric Diabetes
and Metabolic Disorders Unit, Verona, Italy
ATTD 2017 E-POSTER VIEWING ABSTRACTS
6
Bambino Gesu- Childrens Hospital, Unit of Endocrinology
and Diabetes, Rome, Italy
7
University of Padua, Unit of Metabolic Diseases- Department
of Internal Medicine-DIMED, Padua, Italy
Background and Aims: Pediatric patients often use Dexcom
G4AP (i.e. G4 Platinum Share with software 505) CGM sensor
inserted on the abdomen or gluteus area.
Here we compare the accuracy of this sensor in these three
sites: abdomen, gluteus and arm.
Methods: A total of 30 T1D children, 5-9 years old, wore the
Dexcom G4AP sensor for 2 sessions of 4 days each, during a
closed-loop study (Del Favero et al., Diabetes Care 2016). Fre-
quent fingerstick blood glucose measurements (SMBG) were
obtained. Sensor was inserted in different sites according to the
patient habit.
We compared absolute deviation (AD) and absolute relative
deviation (ARD) of CGM with respect to SMBG in the three sites
with ANOVA. If the test detected a difference between the sites,
a further pair-wise comparison was performed.
Results: Results are reported in Tab 1. Overall, no accuracy
difference was detected neither in ARD (p = 0.491) nor in AD
(p = 0.315) among the three sites. Similarly, no difference
was detected in the hypo- and eu-glycemic regions. In hyper-
glycemia a significant difference was detected between the two
approved sites, i.e. abdomen and gluteus (DARD = -2.38%
[CI:-4.55%;-0.22%], p = 0.035), whereas the comparisons arm-
abdomen and arm-gluteus were not conclusive.
Conclusions: These results suggest that the accuracy of the
Dexcom G4AP sensor placed on the arm is comparable with
the accuracy in the other approved insertion sites (abdomen and
gluteus). Larger randomized trials are needed to draw final
conclusions.
190
ASSOCIATION OF HYPOGLYCEMIA AND GLUCOSE
VARIABILITY MEASURED BY DIFFERENT INDICES
IN PATIENTS WITH TYPE 2 DIABETES
A.M. Gomez1, O.M. Munoz Velandia2, A. Marn Sanchez1,
M.C. Fonseca Galvis1, M. Rondon2, M.A. Garca Jaramillo3,
F.M. Leon Vargas4
Hospital Universitario San Ignacio, Endocrinology,
Bogota D.C, Colombia
2
Hospital Universitario San Ignacio, Epidemiology
and Biostatistics, Bogota D.C, Colombia
ATTD 2017 E-POSTER VIEWING ABSTRACTS
3
Universidad Antonio Narino, Applied Sciences, Bogota,
Colombia
4
Universidad Manuela Beltran, Applied Sciences, Bogota D.C,
Colombia
Background and Aims: In the last decade multiple studies
have shown the association between glucose variability (GV)
and hypoglycemia. Recent publications constantly introduce
new GV indices, however there is still a lack of evidence
supporting the use of one GV parameter in particular, specially
in clinical practice.
Methods: In this study, Continuous Glucose Monitoring
(CGM) data for 657 days from 140 type 2 diabetes patients (4,69
average days per patient) were analyzed. Mean glucose (MG),
standard deviation (SD), 1, 2 and 4 hour Continuous Overlapping
Net Glycemic Action (CONGA 1, 2 and 4), Mean Amplitude of
Glucose Excursions (MAGE), M Value, J Index, Interquartile
Range (IQR) and both High and Low Blood Glucose Index
(HBGI, LBGI) were estimated.
Results: Hypoglycemia was present in 103 patients, 433
events in 259 days of recording (0.66 events per patient/day). In
the multivariate analysis both SD and MG proved a statisti-
cally significant association with hypoglycemia, OR for
MG 0.87 (CI 0.83-0.92 p = 0.000) and OR for SD 1.22 (CI 1.12-
1.33 p = 0.000), these results remained consistent for intersti-
tial glucose values below 60 and 50mg/dL. A strong correlation
was found between SD and other GV parameters including
CONGA 1,2 and 4 (r = 0.84), (r = 0.89), (r = 0.95) respectively,
M Value (r = 0.77), J Index (r = 0.82), IQR (r = 0.95) and MAGE
(r = 0.95).
Conclusions: This analysis concludes that given the strong
correlation of SD with other GV parameters, the significant as-
sociation with hypoglycemia and considering the ease of their
calculation, MG and SD could be recommended as the preferred
parameter of GV for use in clinical practice.
191
MEASUREMENT ACCURACY OF FOUR BLOOD
GLUCOSE MONITORING SYSTEMS WITH INSULIN
DOSE ADVISORS FOLLOWING ISO 15197:2013
T. Leucht1, N. Jendrike1, A. Baumstark1, S. Pleus1, C. Haug1,
A. Beer2, F. Flacke2, G. Freckmann1
1
Institut fur Diabetes-Technologie Forschungs, und
Entwicklungsgesellschaft mbH an der Universitat Ulm, Institut
fur Diabetes-Technologie Forschungs, und
Entwicklungsgesellschaft mbH an der Universitat Ulm, Ulm,
Germany
2
Sanofi, Global Diabetes Division, Frankfurt, Germany
Background and Aims: Self-monitoring of blood glucose is
a key element in the therapy of people with diabetes treated
with insulin. Some blood glucose monitoring systems (BGMS)
have built-in insulin dose advisors that provide recommenda-
tions for the next insulin dose. Adequacy of the suggested dose
depends strongly on the measurement quality of the BGMS.
Accuracy of four such BGMS was evaluated following ISO
15197:2013 where 95% of blood glucose results measured
with the BGMS have to be within 15 mg/dl from compari-
son method results at glucose concentrations <100 mg/dl and
within 15% at concentrations 100 mg/dl. Furthermore, 99%
of the results have to be within Consensus Error Grid zones
A and B.
A-79
Methods: Accu-Chek Aviva Expert [1], FreeStyle InsuLinx
[2], FreeStyle Precision Neo [3] and MyStar DoseCoach [4] were
evaluated. Blood glucose levels in capillary blood samples from
100 subjects were determined with three lots of each BGMS and
two different comparison methods (hexokinase [HK]- and glu-
cose oxidase [GOD]-based laboratory methods) and deviations
between the results were calculated.
Results: When evaluated against the comparison method in-
dicated by the respective manufacturer, BGMS 1 had 92%99.5%
of the individual lots within the allowed limits, BGMS 2, 97%
99.5%; BGMS 3, 86%96% and BGMS 4, 98%99%. All BGMS
had 100% of the results within Consensus Error Grid zones A
and B.
Conclusions: In this study, only two of the four tested BGMS
(BGMS 2 and 4) with built-in insulin dose advisors fulfilled
the accuracy requirements of ISO 15197:2013 when compared
against the manufacturers comparison method.
192
DIFFERENCE BETWEEN SCANNED DATA
AND CONTINUOUS DATA OF THE FREESTYLE
LIBRE SYSTEM
S. Pleus1, U. Kamecke1, M. Link1, C. Haug1, G. Freckmann1
1
r Diabetes-Technolgie Forschungs, und
Institut fu
Entwicklungsgesellschaft mbH, an der Universitat Ulm, Ulm,
Germany
Background and Aims: The FreeStyle Libre (FSL, Abbott
Diabetes Care Inc.) system is labeled to replace blood glucose
measurements in many situations. Upon scanning the FSL sensor
unit with the FSL reader, it shows current glucose readings
(scanned data) and a graph displaying glucose history of the
last 8 hours. Additionally, all sensor data are stored in the reader.
This analysis aimed at investigating whether FSL scanned data
differs from continuous data.
Methods: Each of 20 participants wore two FSL systems,
one on each upper arm. Each system continuously measured
tissue glucose for up to 14 days and stored 1 value every 15
minutes. To obtain current glucose readings and to store con-
tinuous data on the reader, the FSL sensor unit was scanned
with the FSL reader approximately 16 times daily. Individual
relative differences (RDs) between scanned data points and
individual continuous data points having identical timestamps
A-80
(n = 525) were calculated. Additionally, RDs between scanned
data points and corresponding data points linearly interpolated
from continuous sensor data (n = 8824) were calculated.
Results: The distribution of individual relative differences is
shown in the figure. The middle 95% (interquantile range 2.5th to
97.5th quantile) of values were within -9.9% and +10.2% for
non-interpolated data and within -10.6% and +13.6% for inter-
polated data.
Conclusions: Scanned data are readily available; however, in
this evaluation differences between scanned data and corre-
sponding continuous glucose data were observed. More detailed
information would be helpful to understand the background and
possible impact on therapeutic decisions.
193
FREEDOM FROM ACETAMINOPHEN
INTERFERENCE WITH A LONG TERM
IMPLANTABLE CGM SYSTEM
C. Lorenz1, W. Sandoval1, M. Mortellaro1, L. Kelley2
1
Senseonics, Chemistry, Germantown, USA
2
Senseonics, Clinical, Germantown, USA
Background and Aims: Interference with acetaminophen
(paracetamol), one of the most commonly used over the counter
medications, has been shown to falsely elevate glucose read-
ings in electrochemical CGM sensors. Acetaminophen is oxi-
dized by the CGM applied electrode potential thereby creating
a biased sensor reading. The new fluorescence-based Eversense
CGM System was subjected to standard test methods to de-
termine the effect on performance in the presence of acet-
aminophen.
Methods: A paired-difference test adapted from ISO
15197:2013 was used to screen for interfering effects. Potential
interferents were tested in simulated interstitial fluid media at
concentrations in excess of physiological or therapeutic con-
centrations to simulate worst case concentrations. Each sub-
stance was tested at two glucose concentrations within the ranges
specified by ISO15197: 2013; one low concentration of ap- pay threshold per Quality-Adjusted Life Year (QALY). Results
proximately 4 mmol/L and one high concentration of ap- demonstrate the direct and substantial effect of hypoglycaemia
proximately 18 mmol/L.
Results: The effect of acetaminophen on Eversense sensors
exposed to high (far above therapeutic) dose of acetaminophen
are tabulated below.
Conclusions: Eversense sensor glucose measurements in
media containing a toxic concentration of acetaminophen met
ISO 15197:2013 specified acceptance values of measurement
bias <0.55 mmol/L and <10%. Unlike short duration transcuta-
neous CGM systems, the Eversense sensor does not use elec-
trochemical reactions to measure glucose and thus is not affected
by compounds such as acetaminophen that may be oxidized by
a sensing electrode. The Eversense CGM sensor retained the
ability to accurately sense glucose concentrations in the pres-
ence of acetaminophen providing a potential safety advantage
to patients.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
194
COST-EFFECTIVENESS OF REAL-TIME
CONTINUOUS GLUCOSE MONITORING (CGM)
WITH SELF MONITORING OF BLOOD GLUCOSE
(SMBG) COMPARED TO SMBG ALONE FOR TYPE 1
DIABETES (T1DM) IN FRANCE
B. Klinkenbijl1, S. Tunis2, C. Graham3, S. Chaugule3
1
Dexcom, International Access, Essertines sur Rolle,
Switzerland
2
Consultancy, Pharmacoeconomics and Outcomes Research,
Indianapolis, IN, USA
3
Dexcom, Global Access, San Diego, CA, USA
Background and Aims: To explore the cost-effectiveness of
real-time CGM in France, in T1DM using Multiple Daily In-
jections (MDI), compared to current SMBG standard practice.
Methods: The IMS CORE Diabetes Model (CDM) (v. 9.0)
was used to assess the lifetime (50 year) cost-effectiveness of
CGM (G4Platinum) plus SMBG, compared to SMBG alone for
a T1DM cohort. All model assumptions were based on published
research. Base case (BC) assumptions included a) starting
HbA1c 7.6%; b) change in HbA1c -0.50% for CGM+SMBG,
0.02% for SMBG alone; c) 50% reduction in severe hypogly-
caemic events (SHEs) and non-severe hypoglycaemic events
(NSHEs) when using CGM; d) dis-utilities of -0.0142 for
NSHEs and SHEs not requiring medical intervention, and -0.047
for SHEs requiring medical resources. Assumed direct costs for
these events were e0, e216.27, and e4156.33 respectively.
Results: The BC incremental cost-effectiveness ratio (ICER)
was e11460. Sensitivity analyses (SAs) showed that results were
minimally impacted by changes in baseline HbA1c, direct costs
assumed for SHEs, and shorter time horizons. SAs assuming
25% reduction in hypoglycaemic events for CGM+SMBG, or
50% reduction in dis-utilities resulted in ICERS of e27682 and
e22606. Parallel results were found when direct costs for CGM,
SMBG, complications, and hypoglycaemic events were based on
recent data for Germany, Netherlands and the UK.
Conclusions: Use of CGM is cost effective within the popu-
lation of MDI-using T1DM, assuming a e30,000 willingness-to-
clinical and quality-of-life assumptions for simulations that in-
clude diabetes cohorts at high risk for hypoglycaemia.
195
INCORPORATION OF MODELS OF CGM SENSOR
ERROR AND FAULTS AFFECTING CGM SENSORS
IN THE UVA/PADOVA TYPE-1 DIABETIC
SIMULATOR: ASSESSMENT ON CLINICAL DATA
Y. Leal1, S. Del Favero2, M. Vettoretti2, R. Visentin2,
A. Facchinetti2, C. Cobelli2
1
Institut dInvestigacio Biomedica de Girona, Service
of Diabetes- Endocrinology and Nutrition UDEN Josep Trueta
Hospital, Girona, Spain
2
University of Padova, Department of Information Engineering,
Padova, Italy
Background and Aims: Recently, a new model of the mea-
surement errors in continuous glucose monitoring (CGM) sensor
ATTD 2017 E-POSTER VIEWING ABSTRACTS
was identified for Dexcom G4TM Platinum [Facchinetti et al.
MBEC 2014]. Furthermore, a model for the faults affecting CGM
sensors (e.g. disconnections and compression artifacts) was
proposed [Facchinetti et al. DTT 2016]. The inclusion of these
two components in the UVA/Padova Type-1 diabetic simulator is
critical for accurate in silico testing of CGM-based applications
like the artificial pancreas. In this work, both models are incor-
porated into the most recent version of the simulator and simu-
lated data are compared against clinical data.
Methods: 108 traces of subjects wearing the Dexcom G4TM
Platinum (DG4P) and undergoing an 1 day hospital admission
are available. Blood glucose samples were collected every
15 + 5 min using YSI. The accuracy of these CGM measure-
ments was compared with the accuracy of the simulated CGM in
108 traces obtained replicating the clinical protocol. MARD,
MAD and CEG-Zone-A were used for assessment. Frequency
and duration of real and simulated disconnections were com-
pared. Finally, frequency, duration and amplitude of real and
simulated compression artifacts were compared.
Results: Overall median (IQR) MARD was 12.5(6.9)% for
real data vs 12.7(6.4)% for simulated data ( p = 0.63). Similarly
MAD was 19.8(10.2)% vs 19.0(9.5)% ( p = 0.94), and CEG-
Zone-A was 81.2(22.2)% vs 80.0(20.4)% ( p = 0.12). 997 dis-
connections occurred on real data vs. 1056 on simulated ones.
90.0% vs 89.1% of them lasted <20 min.
Conclusions: Results suggest that the UVA/PADOVA sim-
ulator equipped with the two models are able to reproduce the
clinical trial observations.
196
A FIRST CLINICAL VERIFICATION OF A RADIO
FREQUENCY-BASED SPECTROSCOPY SENSOR
INTENDED FOR GLUCOSE DETECTION
IN INTERSTITIAL FLUID
V. Gonzalez1, M. Lindblad1, M. Renlund2, P. Rangsten2,
F. Huss1
1
Uppsala University Hospital, Burn Center- Dept. of Plastci
and Maxillofacial Surgery, Uppsala, Sweden
2
Ascilion AB, R&D, Kista, Sweden
Background and Aims: A novel, minimal invasive, chipset
that combines extraction of interstitial fluid (ISF) and glucose
sensing is under development. The chipset combines several hun-
dred hollow micro needles, and a radio frequency spectroscopy
sensor element. This abstract presents the first clinical verification
of the sensor using fluid from burn blisters as substitute for ISF.
Methods: Blister fluid was collected from acute burn patients.
Each sample was divided into two parts. One portion was mea-
sured using the radio frequency spectroscopy sensor. The second
portion of blister fluid was used as reference and analyzed with
respect to glucose content using a clinical chemistry ana-
lyzer (Abbott Diagnostics Architect Plus C16000). Two different
teams conducted the measurements separately. The measure-
ments were subsequently organized in pairs and compared using
an accuracy plot.
Results: The spectroscopy sensor showed adequate accuracy
with 92% of the measurements being within accepted range
when compared to the clinical chemistry analyzer half way
through the study. Acceptance criteria from the ISO15197-2013
standard was used. The spectroscopy sensor showed a linear
correlation to glucose concentrations within the range with pre-
A-81
dictable calibration and correlation factors for glucose concen-
tration using standardized units.
Conclusions: Data shows good correlation between mea-
surements obtained using the spectroscopy sensor and the ref-
erence analyzer as shown in the data gathered from extracted
burn blister fluid. The study demonstrates that a minimal invasive
spectroscopy-based glucose sensor system could be a reliable,
pain-free, method for glucose measurements. Clinically, this
system may serve to improve patient compliance with regard to
self-monitoring and thus improved glucose control.
197
EFFECT OF FLASH GLUCOSE MONITORING
ON METABOLIC CONTROL AND SELF ESTEEMED
TREATMENT SATISFACTION IN PEOPLE
WITH TYPE 1 DIABETES
M. Londahl1, K. Filipsson1, E. Lindholm2, P. Katzman1
1
Skane University Hospital, Endocrinology, Lund, Sweden
2
Skane University Hospital, Endocrinology, Malmo, Sweden
Background and Aims: The use of CGM is limited by high
costs and in some cases disadvantages of continuous presentation
of blood glucose levels. Flash glucose monitoring (FGM) re-
quires an active initiative from the patient to present the present
glucose level and the glucose trend. The aim of this study was to
evaluate the effects on HbA1c and diabetes treatment satisfaction
after introduction of FGM in people with type 1 diabetes.
Methods: Patients with type 1 diabetes received FGM if their
individual metabolic goal was not met or if they had problems
with blood glucose fluctuations or repeated hypoglycaemic
events. Their HbA1c was measured before initiating of FGM
and every third month thereafter. A DTSQs questionnaire was
completed before FGM initiation and a DTSQs follow-up
questionnaire three months later.
Results: 803 patients with a follow-up time between 3 and 21
months and a baseline HbA1c level of 66.5 14.5 mmol/mol were
included. HbA1c has decreased to 59.0 11.2 mmol/mol after
3 months. The improvement sustained over time (58.2 10.9
mmol/mol). The mean decrease in HbA1c was 7.3 9.2 mmol/
mol. In those with HbA1c>70 mmol/mol the change was -12.8
10.4 (min:max -62:+10) mmol/mol. Their self-estimated treat-
ment satisfaction was 2.5 (+3 to -3) and rating for continued
FGM use was 2.7. Unacceptable high blood glucose was less
often present (-0.2) as were unacceptable low blood glucose
levels (-0.4). Self-estimated treatment satisfaction scores were
similar over the whole HbA1c range.
Conclusions: Use of FGM adds clinical significant advantage
to individuals with 1 diabetes in terms of HbA1c reduction and
improved self-estimated treatment satisfaction.
198
REALIZATION OF BGM WITHIN 10% ACCURACY
BASED ON INNOVATIVE OPTICAL TRANSMISSION
ABSORBANCE SYSTEM
T. Moriuchi1, H. Satou1, Y. Komata2, R. Aikawa3, K. Sode4
1
Terumo Corporation, DM and Consumer Healthcare Division-
General Hospital Business Group, Nakakoma-gun, Japan
A-82
2
Terumo Corporation, DM and Consumer Healthcare Division-
General Hospital Business Group, Tokyo, Japan
3
Terumo Corporation, DM and Consumer Healthcare Division-
General Hospital Business Group, Ashigarakami-gun, Japan
4
Tokyo University of Agriculture & Technology, Department
of Biotechnology & Life Science, The Graduate School
of Engineering, Tokyo, Japan
Background and Aims: Since the blood glucose monitor-
ing (BGM) is essential in diabetes care and management, fur-
ther improvement of the accuracy of BGM is mandatory to
achieve the better glycemic control of diabetics. In this paper
we report our current results of our new BGM using an inno-
vative single optical transmission absorbance system, to mea-
sure glucose level and hematocrit simultaneously. In addition, a
simple and inexpensive test strip was developed, in order to
measure the blood glucose level of the whole blood accurately
and rapidly.
Methods: To realize the high-accuracy measurement of the
blood glucose level, we have developed highly sensitive re-
agent, with brand new enzyme and original absorption dye, and
accurate hematocrit detection technology. We employed a new
generation GDH(FAD) enzyme, which shows high catalytic
efficiency with low Km value, to measure the reaction end
points. Together with the original high absorption dye, the optical
transmission absorbance principle achieved the increase in the
resolution at a low glucose level. Additionally, high-accuracy
hematocrit compensation was achieved using multi wave-
lengths detection.
Results: Accuracy of our new BGM was evaluated with in-
house blood samples, adjusted to three blood glucose lev-
els (0mg/dL, 100mg/dL, 400mg/dL) with various hematocrit
(Hct20%, Hct40%, Hct60%). From the measurement results of
N = 270, 93.7%(253/270) of results were within 5% (5mg at
0mg/dL) accuracy and 100% (270/270) of results were within
10%(10mg at 0mg/dL) accuracy.
Conclusions: We have developed a novel BGM based on an
innovative optical transmission absorbance system, and achieved
accuracy within 10%.
199
EVALUATION AND UTILITY OF A NOVEL
GLUCOSE MONITORING SYSTEM IN INDIAN
ADULTS WITH DIABETES
Y. Munjal1, G. Pangtey2, J. Chowdhary3, N. Wadhwa4,
N. Kashyap5
1
Banarsidas Chandiwala Institute of Medical Sciences,
Chief Consultant and Director, Delhi, India
2
Lady Hardinge Medical College, Medicine, Delhi, India
3
Banarsidas Chandiwala Institute of Medical Sciences,
Junior Consultant, Delhi, India
4
AUW Global, Medical Sciences, Delhi, India
5
Banarsidas Chandiwala Institute of Medical Sciences,
Dietician, Delhi, India
Background and Aims: Flash glucose monitoring is a
novel glucose sensing technique that estimates interstitial glu-
cose levels for up to 14 days and does not require any calibration.
Methods: The FreeStyle Libre Pro(TM) sensor was utilised
in 112 patients for 14 days. We did a real world evaluation
ATTD 2017 E-POSTER VIEWING ABSTRACTS
from the registry database from July 2015 till Oct 2016. Sta-
tistical analysis was done using Wilcoxon signed rank test and
Mann-Whitney test through the GraphPad Prism 7. 26 non
evaluatable data sets and patients were excluded from the
analysis.
Results: The glycemic variability data was evaluated in 86
patients. Mean duration of diabetes was 13.66 years (SD 9.26
1.12, min 0, max 50 yrs; 95% CI 11.41-15.9, p < 0.0001). Mean
age was 57.61 years (SD 10.97 1.3, Min 31, Max 81 yrs; 95%
CI 54.95-60.27, p < 0.0001). The HbA1c reductions before
(mean 8.5 2.2, Min 5.1, max 15 yrs; 95% CI 7.96-9.07) and
after 3 months (mean 7.8 1.7, min 5, max 16; 95% CI 7.41-
8.25) were numerically important (-0.68), but did not achieve
statistical significance (p = 0.1365, NS). The comparative re-
ductions in HbA1c in patient group <60 & >60 yrs did not
achieve statistical significance (p = 0.7898, NS). 16 patients had
all four drug time changes, drug choice changes, dose changes,
diet modification
Conclusions: The utility of the novel FreeStyle Libre Pro(TM)
translates into a physician led and patient enabled empowerment
tool which helps physicians customise the therapy and empowers
patients through the visual snapshots to sensitively adapt to the
prescribed regimen.
200
DETERMINATION OF THE OPTIMAL TIMING
FOR POSTPRANDIAL GLUCOSE MEASUREMENT
IN PREGNANT WOMEN WITH GESTATIONAL
DIABETES EVALUATED BY THE CONTINUOUS
GLUCOSE MONITORING SYSTEM IPRO
R. Radermecker1, J.C. Philips1, M. Franck1
1
University of Liege, Diabetes, Nutrition and Metabolic
disorders, Liege, Belgium
Background and Aims: Using the Continuous Glucose
Monitoring System (IPro; Medtronic Minimed) for a group
of pregnant women with gestational diabetes (GD) based on
IADSPG criteria (fasting, 5.0 mmol/L; 1-h, 10.0 mmol/L; 2-h,
8.6 mmol/L).We attempted to answer the following question:
when does the physiological peak of postprandial glucose
occur in real life for the 3 meals and after a standardized
breakfast.
Methods: We included 13 pregnant women in our study
(31 3 years old, 6/13 primipara and 2/13 with GD history).
Patients received an IPro CGMS for use over 5 days after an
educational program and dietary advises. This was calibrated at
least 4 times a day. No problem of intolerance occurred during
this trial. The last day of the trial, patients received a standardized
breakfast at hospital.
Results: The postprandial glucose peak was reached after
68 23 min, 79 30 min and 109 28 for breakfast, lunch
and dinner respectively. The postprandial glucose peak was
observed earlier with a standardized breakfast (70 g carbohy-
drates): 52 11 min.
Conclusions: Our results show that the optimal time for
testing in pregnant women with GD is between 45 and 120 min
postprandial. Based on a practical approach, it seems to be easier
to advise a 60-min interval. In real life, results depend on the type
of meals but the earliest peak remains always at breakfast which
could be more discriminant.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
201
FLASH GLUCOSE MONITORING IN NONCOMPLIANT
CHILDREN AND ADOLESCENTS WITH TYPE 1
DIABETES
E. Tirelli1, G. Frontino1, V. Favalli1, C. Bonura1,
A. Rigamonti1, F. Meschi1, R. Bonfanti1
1 above 250 mg/dL (P = 0.006) and glycemic variability (P = 0.01)
San Raffaele Scientific Institute, Pediatrics, Diabetes Research
Institute, Milan, Italy
Background and Aims: Recent data involving adults with
type 1 diabetes (T1D) have shown that Flash Glucose Mon-
itoring (FGM) is effective. However, data regarding children
and adolescents who are noncompliant with regular capillary
blood glucose monitoring (BGM) are lacking. Our aim was to
assess whether FGM could represent a empowering tool and
improve glucose control in children and adolescents who
are noncompliant to regular BGM and treated with multiple
injections.
Methods: We evaluated 13 T1D patients (7 males, 6 females)
with the following characteristics: mean age of 14 years (SD 4.1
years), mean T1D duration of 4.8 years (SD 2.2 years), under-
going multiple injection therapy. HbA1c readings was evaluated
at baseline (FGM insertion) and after 3 months. Average daily
BGM readings were evaluated at FGM placement and average
number of daily FGM scans were evaluated at 3 months. At FGM
insertion the patients were educated on how to interstitial glucose
monitoring management and trend arrow evaluation. Patients
were required to measure at least one BGM to assess FGM ac-
curacy. A paired t-test was used to compare HbA1c means.
Results: Mean HbA1c at FGM placement and after 3 months
were 81 28mmol/mol and 66 19mmol/mol respectively. The
decrease in mean HbA1c of 15mmol/mol was statistically sig-
nificant (p < 0.001). Average number of daily BGM readings in
the 3 months prior to FGM placement: 1.7 1.3. Average number
of daily FGM scans in the 3 months: 10.7 6.6. No episodes of
severe hypoglycemia or DKA were declared.
Conclusions: FGM use may improve glucose control and
motivation in noncompliant children and adolescents with T1D.
202
CGM IN OLDER ADULTS WITH TYPE 1 AND TYPE 2
DIABETES USING MULTIPLE DAILY INJECTIONS
OF INSULIN: RESULTS FROM THE DIAMOND TRIAL
K. Ruedy1, C. Graham2, T. Riddlesworth1, C. Kollman1,
D. Price2, R. Beck1
1
Jaeb Center for Health Research, n/a, Tampa, USA
2
Dexcom Inc., n/a, San Diego, USA
Background and Aims: To determine the effectiveness of
CGM in MDI-using adults >60 years of age with type 1 (T1D) or
type 2 (T2D) diabetes.
Methods: Multicenter, randomized trial conducted in the US
and Canada in which 116 individuals >60 years (mean 67 + 5
years) with T1D (N = 34) or T2D (N = 82) using MDI therapy
were randomly assigned to either CGM (Dexcom G4 Platinum
CGM System with software 505, N = 63) or continued man-
agement with SMBG (N = 53). Mean diabetes duration was
23 + 12 years and mean baseline HbA1c was 8.5 + 0.6%. The
primary outcome, central-lab HbA1c at 24 weeks, was obtained
for 114 (98%) participants.
A-83
Results: HbA1c reduction from baseline to 24 weeks was
greater in the CGM Group than Control Group (-0.9 + 0.7%
versus -0.5 + 0.7%, adjusted difference in mean change =
-0.4 + 0.1%, 95% confidence interval -0.7% to -0.2%,
P < 0.001). More participants in the CGM Group had a relative
reduction in HbA1c >10% (56% versus 26%, odds ratio 4.3, 95%
confidence interval 1.8 to 10.5, P = 0.001). CGM-measured time
were lower in the CGM Group. Among the 61 in the CGM Group
completing the trial, 97% used CGM >6 days/week in month 6.
There were no severe hypoglycemic or diabetic ketoacidosis
events in either group.
Conclusions: In adults >60 years of age with T1D and T2D
using MDI, CGM use was high and associated with improved
HbA1c and reduced glycemic variability. Therefore, CGM should
be considered for older adults with diabetes using MDI.
203
QUALITY OF LIFE BENEFITS ACCRUING FROM CGM
USE IN PATIENTS WITH TYPE 1 DIABETES
ON MULTIPLE DAILY INJECTIONS: RESULTS
FROM A PROSPECTIVE, RANDOMIZED
CONTROLLED TRIAL
W. Polonsky1, D. Hessler2, R. Beck3
1
University of California, San Diego, and Behavioral Diabetes
Institute, Psychiatry, San Diego, USA
2
University of California, San Francisco, Family Community
Medicine, San Francisco, USA
3
Jaeb Center for Health Research, n/a, Tampa, USA
Background and Aims: CGM trials have not consistently
demonstrated positive quality of life (QOL) benefits in adults
with type 1 diabetes (T1Ds). We examined pre-post QOL data
from the DIAMOND trial, which demonstrated glycemic bene-
fits with CGM use in adults withT1D on multiple daily injections
(MDI).
Methods: DIAMOND, a 24-week randomized clinical trial,
randomly assigned adults with T1D (mean age 48 + 13 years,
T1D duration 21 + 14 years, HbA1c 8.6 + 0.6%) to CGM (Dex-
Com G4 Platinum CGM System with software 505, N = 105)
or SMBG only (N = 53). To assess QOL change, subjects com-
pleted, at baseline and week 24, a series of diabetes-related
measuresdiabetes distress (DDS), hypoglycemic fear (HFS-W)
and hypoglycemic confidence (HSC)and generic measures
overall well-being (WHO-5) and health status (EQ-5D). Multiple
regression analyses adjusting for clustering by clinic site and
baseline QOL examined group differences over time.
Results: While there were no significant group differences in
WHO-5 or EQ-5D over time, CGM subjects did evidence greater
improvement than SMBG subjects in all three diabetes-related
QOL outcomes, with greater reductions in DDS (p = .002) and
HFS-W (p = .037), and a larger HSC rise (p = .009). Among DDS
subscales, CGM subjects displayed significantly larger reductions
in diabetes-related emotional burden (p = .046), regimen distress
(p = .017) and interpersonal distress (p = .001). Reductions in total
DDS and regimen distress subscale scores were associated with
decreases in HbA1c (both p < .05). Adjusting for participant
demographic factors did not alter the pattern of effects.
Conclusions: CGM use lowers diabetes distress and hypo-
glycemic fear and raises hypoglycemic confidence in T1D adults
using MDI.
A-84
204
IMPROVEMENT OF GLYCEMIC CONTROL
AND HYPOGLYCEMIA PREVENTION OF SENSOR-
AUGMENTED PUMP THERAPY WITH LOW-
GLUCOSE MANAGEMENT SYSTEM IN TYPE 1
DIABETIC PATIENTS: OMEGA STUDY OUTCOMES
L. Schoumacker-ley1, L. Duchesne2, T. Cuny3, P. Bohme1,
O. Ziegler1, B. Guerci1
1 to manage their diabetes. The study was conducted across 9 UK
CHRU Nancy Brabois, Diabetology, Vandoeuvre-Les-
Nancy, France
2
CHR MERCY, Diabetology, Mercy, France
3
CHRU Nancy Brabois, Endocrinology, Vandoeuvre-
Les-Nancy, France
Background and Aims: The MiniMed 640G sensor-
augmented pump system (SmartGuard system, Medtronic) is
the first system which can automatically suspend insulin delivery
in advance of predicted hypoglycemia and restart it upon re-
covery. This observational study analysed this system on gly-
cemic control, hypoglycemia incidence and quality of life in
uncontrolled T1DM already treated by CSII.
Methods: Twenty-one T1D patients (9W12M) needing CGM
according to the French consensus statement, were recruited.
Baseline characteristics: age = 44 10 yrs, diabetes dura-
tion = 28 12 yrs, BMI = 26.0 4.9 kg/m2, HbA1c = 8.1 0.9%;
symptomatic hypoglycemia incidence was 3.0 2.2 times per
week, severe hypoglycemia (SH) from 0 to 12 events during the
last 6 months. HbA1c levels, hypoglycemia and SH incidences
were recorded at inclusion, at 3 months (M3) and 6 months (M6).
The performance of the system (suspend before low [SBL] and
suspend low [SL] events) was measured with downloaded pump
and sensor data. The quality of life was evaluated using TRIMD
(Treatment Related Impact Measures Diabetes) and TRIMD-
Device questionnaires.
Results: A significant reduction in symptomatic hypogly-
cemia (-1.5 1.6, p = 0.001) at M6 was observed and no epi-
sode of SH or ketoacidosis was reported. No significant change
in HbA1c level (-0.1 0.7%, p = 0.35) at M6 was found. The
frequencies of SBL and SL events for SmartGuard were
1.5 0.9 events/day and 0.1 0.1 events/day, respectively. Fur-
thermore, we found a significant improvement in TRIMD
(+16.9 22.2% p = 0.006), and in TRIMD-Device questionnaires
(+11.2 17.4%, p = 0.013) at M6.
Conclusions: The SmartGuard system reduces significantly
hypoglycemia and SH incidences without any glycemic control
deterioration, increasing comfort and quality of life in a selected
T1D population.
205
ACCURACY EVALUATION OF FREESTYLE LIBRE
FLASH GLUCOSE MONITORING SYSTEM WHEN
USED BY PREGNANT WOMEN WITH DIABETES
E. Scott1, A. Kautzky-Willer2
1
St Jamess University Hospital, Department of Diabetes
and Endocrinology, Leeds, United Kingdom
2
Medical University of Vienna, Department of Internal
Medicine III Division of Endocrinology and Metabolism,
Vienna, Austria
Background and Aims: Accuracy of the FreeStyle LibreTM
Flash Glucose Monitoring System has not previously been
ATTD 2017 E-POSTER VIEWING ABSTRACTS
evaluated in pregnant patients with diabetes. We assessed the
clinical safety and accuracy of the system compared to self-
monitoring of blood glucose (SMBG).
Methods: 74 patients were enrolled into the study and ap-
plied a masked sensor, they were diagnosed with type 1 diabetes
(n = 24), type 2 diabetes (n = 11) or gestational diabetes (n = 39).
Average gestation was 26.6 6.8 weeks (meanSD), average age
was 30.5 5.1 years, duration of diabetes was 13.1 7.3 years for
T1DM and 3.2 2.5 years for T2DM, 49/74 (66.2%) used insulin
sites and 4 in Austria.
Results: Consensus Error Grid analysis showed 88.1%
(4433/5031) of paired FreeStyle Libre sensor and SMBG read-
ings were within zone A (clinically accurate) and 99.8% (5022/
5031) were within zones A&B (clinically acceptable). 87.1% of
results were within 1.1mmol/L (20mg/dL)/20% of SMBG
values. Mean absolute relative difference (MARD) was 11.8%.
Regression analysis demonstrated good agreement with SMBG
(r = 0.92, slope = 1.12, intercept = -0.84 mmol/L [-15.1 mg/dL]).
Clinically accurate results were obtained for each type of dia-
betes.
User satisfaction questionnaires indicated high levels of ac-
ceptance for sensor wear and ease of use of the device. There
were no unanticipated device-related adverse events.
Conclusions: Results show good agreement between the
FreeStyle Libre System and SMBG for pregnant women with
diabetes, indicating the device is safe and accurate for use by this
population.
206
USE OF ACCURACY PROBABILITY CURVES:
A NEW METHOD FOR DISTINGUISHING
DIFFERENCES BETWEEN BLOOD GLUCOSE
MONITORING SYSTEMS MEETING ISO 15197:2013
ACCURACY REQUIREMENTS
S. Pardo1, R. Shaginian1, D. Simmons1
1
Ascensia Diabetes Care, Parsippany NJ, USA
Background and Aims: While blood glucose monitoring
systems (BGMSs) are required to meet ISO 15197:2013 accu-
racy criteria (95% of results within 15 mg/dL [BG <100 mg/
dL] or 15% [BG 100 mg/dL] of the reference result), not all
BGMSs that meet the ISO 15197:2013 criteria have the same
probability of producing accurate results. Here we present a new
methodology for revealing the differences between BGMSs that
meet ISO 15197:2013 accuracy criteria.
Methods: Regression models were fit to BG data (BGMS on
the y-axis; YSI on the x-axis). Weighted least squares was used to
account for the proportional nature of standard deviations (ie,
standard deviation is proportional to the lab value of glucose
concentration). Regression coefficients with statistical estimates
of coefficients of variation (CV) were used to compute the prob-
ability that for any given BG value, the BGMS result would be
within 15% of the lab value; 95% lower confidence limits were
also computed.
Results: As shown in Figures 1A-1C, all 3 BGMSs met ISO
15197:2013 accuracy criteria (ie, 95%; BGMS A, 99.63%;
BGMS B, 99.63%; BGMS C, 99.81%). However, BGMS A
shows the highest accuracy, as all values fall above the 95%
probability line indicating accuracy across all BG ranges; BGMS
B and C show decreased accuracy at low BG ranges.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Conclusions: Results from these probability curves high-
light the importance of BGMS accuracy across the entire
BG range to achieve optimal glycemic control while avoiding
hypoglycemia.
A-85
207
PERFORMANCE OF MEDTRONICS
FOURTH-GENERATION GLUCOSE SENSOR
SYSTEM
A. Sullivan1, M. Johnson1, J. Hall1, K. Nogueira1, T. Engel1
1
Medtronic, Sensor R&D, Northridge, USA
Background and Aims: Medtronics fourth-generation con-
tinuous glucose monitoring (CGM) system is designed to reliably
support an insulin-delivering hybrid closed-loop system, with
flexibility for a standalone CGM system.
This novel 7-day system is comprised of a subcutaneous
glucose sensor, transmitter platforms communicating to insu-
lin pumps via proprietary RF technology or to a mobile display
app via standard Bluetooth low energy (BLE) technology, and
an innovative algorithm designed to drive exceptional sensor
performance and insulin dosing. New features include proac-
tive diagnostics and preventing the display of unreliable sensor
glucose (SG) values.
The improved sensor and algorithm design optimizes signal
stability and consistency, enhancing the performance and min-
imizing variability. The superior sensor performance is main-
tained during extended use of these technologies.
Methods: Clinical studies were conducted with subjects wear-
ing real-time systems with an insulin pump, mobile display app,
and/or a recorder. The studies evaluated sensor performance
during hypoglycemic and hyperglycemia challenges, as well as
continued use in an in-home environment.
Results: Sensor accuracy data were evaluated against YSI
reference points. The mean absolute relative difference
( MARD) between sensors with minimum calibrations and
YSI reference values was 10.45% (23,709 evaluation points)
for the abdomen location and 9.09% (10,526 evaluation
points) for the arm. The MARD for sensors with the re-
commended 3-4 calibrations/day was 9.54% (22,601 evalu-
ation points) for the abdomen and 8.68% (10,771 evaluation
points) for the arm.
Conclusions: Clinical results have demonstrated that the new
sensor and algorithm system is reliable with superior perfor-
mance that is consistent over extended use and periods of gly-
cemic variability.
208
IMPACT OF BLOOD GLUCOSE MEASUREMENT
ERROR ON THE ACCURACY OF MEDTRONICS
4TH GENERATION CGM SYSTEM
A. Varsavsky1, C. Palerm1, N. Parikh2, P. Weydt1
1
Medtronic - Inc., Intensive Insulin Management, Northridge,
USA
2
Medtronic - Inc., Advanced Research, Northridge, USA
Background and Aims: CGM systems that require periodic
blood glucose (BG) measurements for calibration rely on the
integrity of the BG value to ensure accurate sensor glucose
tracings. However, BG meter performance can vary signifi-
cantly, and even the most accurate available BG meter contains
measurement error. We present an evaluation of the impact of
BG errors on the performance of Medtronics 4th Generation
CGM system.
A-86
Methods: Gaussian errors were added to YSI measurements
and used to calibrate 4th Generation sensors. CGM performance
was then evaluated relative to the uncorrupted YSI (*22,500
evaluations).
To simulate the worst case BG error for which the meter would
still comply with the ISO15197:2003 standard, the errors stan-
dard deviation was 10% for YSI 75mg/dL, and 7.5mg/dL for
YSI <75mg/dL. For worst case using ISO15197:2015, the errors
standard deviation was 7.5% for YSI 100mg/dL, and 7.5mg/dL
for YSI <100mg/dL.
Results: For a BG meter that complies to the ISO15197:2015
standard, the worst case impact on CGM performance was small.
Relative to a YSI-calibrated sensor (i.e., zero BG error), MARD
increased by 1.1%; 20/20 and 40/40 agreements decreased
by 2.4% and 0.2%. For a BG meter that complies to ISO15197:
2003, worst case impact on CGM performance remained modest.
MARD increased by 1.9%; 20/20 and 40/40 agreements de-
creased by 5.1% and 0.6%. In both cases average sensor bias was
unaffected.
Conclusions: Performance of Medtronics 4th Generation
CGM system is robust in the presence of large calibration BG
error. The data suggest that the worst performing BG meter that
complies with ISO15197:2003 will have little impact on sensor
performance.
209
IMPROVEMENT OF ACCURACY IN NON-INVASIVE
GLUCOSE MEASUREMENT (NIGM) USING
MID-INFRARED SPECTROSCOPY (MIR)
AND PHOTOACOUSTIC (PA) DETECTION
H.F. v. Lilienfeld-Toal1
1
Elte Sensoric GmbH, Gelnhausen, Germany
Background and Aims: MIR offers the possibility of NIGM
that combines the advantages of high physical and physiological
specificity. In earlier experiments with PA detection in MIR we
showed that such a system is not significantly influenced by
disturbances such as fluid loss, fluid loads, physical activity and
age of the individual. Insufficient accuracy is a major limitation
in the general application of NIGM. We present data towards
sufficient accuracy of our system compared with current invasive
glucose measurement devices.
Methods: Introducing additional features to measurement
and the evaluation of the PA signals we were able to improve
the overall accuracy of the system. To prove the effect on the
in-vivo measurement, we compared the glucose values pre-
dicted by the MIR PA system to values simultaneously mea-
sured with HemoCue during an oral glucose load in tests
with 5 individuals. Datasets had been taken every 5 Min. The
data are calculated with PLS cross-validation analysis for
each test.
Results: For the resulting 174 datasets we found a good cor-
relation (r (pearson) = 0,92) and a MARD of 9%. 91% of the
points are in zone A of error grid.
Conclusions: The non-invasive MIR PA glucose sensor is
work in progress. We have added refinements to the hardware
and software to overcome the limitations of the system and im-
prove its accuracy. Although the mathematical approach to the
data using PLS needs to be improved further, we believe that our
system will be able to achieve a precision comparable to that of
todays standard glucometers.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
210
CONTINUOUS GLUCOSE MONITORING (CGM)
ASSOCIATED WITH LESS DIABETES-SPECIFIC
EMOTIONAL DISTRESS AND LOWER A1C
AMONG ADOLESCENTS WITH TYPE 1 DIABETES
A. Vesco1, J. Weissberg-Benchell1
1
Ann & Robert H. Lurie Childrens Hospital of Chicago,
Department of Psychiatry, Chicago, USA
Background and Aims: CGM psychosocial research is
limited. Aim of the current analysis was to assess association
between diabetes technology (CGM Alone; Pump Alone; CGM+
Pump; or No Technology) and diabetes-specific emotional dis-
tress and A1c.
Methods: 854 adolescents and 1038 parents completed
measures of diabetes-specific distress. ANOVA compared levels
of technology use with distress and A1c. Cohens d values with
Hedges correction provided effect sizes between groups.
Results: For adolescent-reported distress, CGM Alone con-
ferred moderate effect over No Technology (d = 0.59) and small
effects over CGM+Pump (d = 0.26) and Pump Alone (d = 0.29);
Pump Alone and CGM+Pump demonstrated small effects over
No Technology (d = 0.34 and 0.33 respectively). For parent-
reported distress, CGM Alone demonstrated small-medium
effects over No Technology (d = 0.41), over CGM+Pump (d =
0.28), and over Pump Alone (d = 0.23). Pump Alone, although
significant, was associated with small effect (d = 0.23) over No
Technology; CGM+Pump was associated with slight-no effect
over No Technology (d = 0.18). For A1c, CGM Alone demon-
strated small-medium effect size, although statistically non-
significant, over No Technology (d = 0.48) and over Pump Alone
(d = 0.37) and was comparable to CGM+Pump (d = 0.03). Pump
Alone and CGM+Pump were significantly associated with lower
A1c over No Technology (d = 0.24 and d = 0.49 respectively);
CGM+Pump conferred significant advantage over Pump Alone
(d = 0.34).
Conclusions: Technology use is associated with lower ado-
lescent distress than lower parent distress. CGM alone is asso-
ciated with lower adolescent and parent distress than using pump
or CGM+Pump. CGM use is associated with lower A1c than
pump use and has similar effect when used alone or with a
pump. CGM use shows benefit for psychosocial and health
outcomes.
ATTD 2017 E-POSTER VIEWING ABSTRACTS A-87

211
THE TYPE 1 DIABETES PATIENT DECISION-MAKING
MODEL FOR ASSESSING THE INFLUENCE OF HYPO/
HYPER-ALERT SETTINGS ON CONTINUOUS
GLUCOSE MONITORING (CGM) NONADJUNCTIVE
USE
M. Vettoretti1, A. Facchinetti1, G. Sparacino1, C. Cobelli1
1
University of Padova, Department of Information Engineering,
Padova, Italy

Background and Aims: By using a type 1 diabetes patient

decision-making (T1D-DM) model (Vettoretti et al., Proc IEEE
EMBC, 2015) and in silico trials, we recently provided evidence
that CGM nonadjunctive use is safe (Edelman JDST, 2015). A
further step is assessing how customable high alert (HA) and low
alert (LA) thresholds can affect glycemic control when CGM is
used nonadjunctively.
Methods: In silico clinical trials, based on the T1D-DM
model, are designed to determine the impact of alerts settings on
Dexcom G5 Mobile (DG5M) nonadjunctive use. Simulations are
performed on 100 virtual subjects for two weeks with SMBG
treatment and CGM nonadjunctive use, which is repeated for 21
different alerts settings obtained by combining commonly used
thresholds for LA (80, 70 and 55 mg/dl) and HA (180, 200, 250,
300, 350, 400 mg/dl or none). Time in 70-180 mg/dl, below
70 mg/dl, below 50 mg/dl, above 180 mg/dl and above 250 mg/dl
metrics are assessed for the two treatments.
Results: With DG5M, CGM nonadjunctive use, compared to
SMBG use, improves time in 70-180 mg/dl and time above
250 mg/dl if HA 300 mg/dl, improves time above 180 mg/dl if
HA 250 mg/dl, improves time below 70 and 50 mg/dl with all
alert settings. Best performance is achieved with HA = 180 mg/dl
and LA = 80 mg/dl.
Conclusions: The in silico trials show that DG5M non-
adjunctive use is effective in reducing time in hypoglycemia
regardless of the alerts setting and time in hyperglycemia pro-
vided that HA 250 mg/dl.
212
ASSESSMENT OF GLYCEMIC CONTROL
WITH A COMPOSITE METRIC: THE REVISED
GLUCOSE PENTAGON (RGP)
1 2 3 4
R. Vigersky , A. Thomas , J. Shin , B. Jiang , T. Sigmund , 5
C. McMahon4
1
Medtronic Diabetes, Medical Affairs, Northridge, USA
2
Medtronic GmbH, Market Development, Meerbusch, Germany
3 1
Medtronic Diabetes, Clinical Research, Northridge, USA
4 2
Medtronic Diabetes, Engineering, Northridge, USA
5
Diabetes Private Practice, Private Practice, Munich, Germany
Background and Aims: New ways to describe overall diabetes
control are necessary since HbA1c does not reflect the severity/
frequency of hypoglycemia and hyperglycemia nor glycemia
variability. We used continuous glucose monitoring data to update
the previously published composite metric - the Glucose Pentagon
(1) - creating a revised Glucose Pentagon (rGP).
(1) Thomas A, et al. Diabetes Technol Ther 2009;11:399-409.
Methods: The five axes of the rGP describe the area of a pen-
tagon for non-diabetics (green) to which those with diabetes (red)
can be compared (Figure). The intensity of hypoglycemia/hyper-
glycemia are the magnitude of the vectors of area-under-the curve
(AUC) less than 70 mg/dL and time/day less than 70 mg/dL and
AUC greater than 180 mg/dL and time/day greater than 180 mg/dL,
respectively. A prognostic glycemic risk parameter (GPR) based
on the Diabetes Control and Complications Trial can be calculated.
We applied baseline and end-of-study data from the low-glucose
suspend trial (ASPIRE In-Home study) (2) to the rGP and com-
pared the changes in rGP area/PGR to changes in HbA1c.
(2) Bergenstal R et al. N Engl J Med 2013;369:224-232.
Results: We found that the rGP comprehensively describes
overall glycemic control both numerically and visually. It cor-
relates to both long-term and short-term risks and identifies in-
dividuals in whom the changes in HbA1c and rGP/PGR in the
ASPRIE in-Home study are discrepant.
Conclusions: The rGP is a composite metric that provides a
more complete understanding of glycemic control than HbA1c. It
can be used to investigate the effects of a technology, drug or
psycho-educational intervention on glycemic control.
213
SCREEN VIEW FREQUENCY AND ALERT SETTINGS
AFFECT GLYCEMIC CONTROL IN CHILDREN AND
ADOLESCENTS USING REAL-TIME CONTINUOUS
GLUCOSE MONITORING
X. Liu1, J. Welsh2, T. Walker2
Dexcom Inc., Biometrics, San Diego, USA
Dexcom Inc., Clinical Affairs, San Diego, USA
Background and Aims: Behavioral changes prompted by
continuous glucose monitoring (CGM) screen views (SV) and
alerts may improve outcomes. We examined whether the rate of
SV and individualized alert settings were correlated with sensor
glucose (SG) values in children and adolescents.
Methods: Data from 136 children ages 2-11 years and 40
adolescents ages 12-17 years were extracted from an anon-
ymized database of customers using Dexcom CGM systems who
requested technical assistance.
Results: Among children, SV numbered 33 17 per day and
the mean (SD) SG was 10.2 1.8 mmol/L. Among adolescents,
A-88
SV numbered 32 24 per day and the mean SG was
9.2 1.7 mmol/L. In both groups, lower-frequency SV (<16/day)
were associated with higher least-squares mean SG levels than
higher-frequency screen views (>36/day) (children, 10.4 vs.
9.7 mmol/L, respectively; adolescents, 10.0 vs. 9.0 mmol/L, re-
spectively). A separate analysis of 142 children and adolescents
who set hypoglycemia alerts showed an association between
lower (<4.4 mmol/L) thresholds and lower mean SG values (9.3
vs. 10.1 mmol/L). Similarly, those with hyperglycemia alerts set
to <11.1 mmol/L had lower mean SG values than those with
hyperglycemia alerts set to 11.1 mmol/L (8.8 vs. 10.0 mmol/L,
respectively).
Conclusions: In both children and adolescents, more-frequent
SV were correlated with lower mean SG values, suggesting that
real-time CGM data contribute to timely and appropriate treat-
ment decisions. Similarly, lower threshold alert levels for both
hypoglycemia and hyperglycemia were associated with lower
mean SG values. The extent to which device interactions and
alert settings facilitate or reflect treatment decisions warrants
further study.
214
THE NEED FOR UPDATED EVALUATION
APPROACHES FOR EHEALTH AND MHEALTH
INTERVENTIONS A DYNAMIC CONCEPT
FOR MORE EFFICIENT TRIALS
1,2 1 1 1,3
E. Arsand , H. Blixgard , M. Muzny , A. Giordanengo ,
M. Bradway1,2
1 V. Bellido1, C. Tejera2, F. Carral3, G. Ignacio1, A. Soto4,
University Hospital of North Norway, Norwegian Centre
for E-health Research, Troms, Norway
2
UiT The Arctic University of Norway, Department of Clinical
Medicine, Troms, Norway
3
UiT The Arctic University of Norway, Department of Computer
science, Troms, Norway
Background and Aims: Clinical trials are notorious for
falling behind schedule and over budget. In fact, nearly 90% of
clinical trials fail to reach intended outcomes on time. Today,
mobile health (mHealth) technologies, e.g. apps for diabetes self-
management, provide additional challenges by developing faster
than clinical trials are able to evaluate them. Therefore, ap-
proaches to assess mHealth self-management interventions, es-
pecially randomized controlled trials, must adapt.
Methods: A review of traditional eHealth and mHealth as-
sessment studies revealed that tested interventions were often
outdated by the time trials ended, thus reducing their quality and
potential impact. Major bottlenecks were identified and a holistic
platform for electronically supporting study management was
proposed. Specific technological functionalities were designed
through collaboration between researchers, patients, medical
experts, and improved through consultation with our hospitals
research unit, the regional ethical board (REK) and Norwegian
Data Protection Authority (Datatilsynet).
Results: An electronic study-management concept was de-
veloped. Modules with functionalities specific to major trial
stages (Figure 1), several of which have been separately tested
with success, facilitate a new holistic system for evaluation of
eHealth and mHealth trials. The concept is acknowledged by
Datatilsynet and REK (ref. 2013/1906/REK sr-st B), with
planned implementation (autumn 2016) during the Tailoring
Type 2 Diabetes Self-Management project.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Conclusions: We expect this concept to enable researchers to
more efficiently handle the administrational-, patient-, and data-
related tasks of mHealth and eHealth interventions. By utilizing
this concept in an ongoing clinical trial, we will demonstrate the
potential of evaluating mHealth technologies as disease and self-
management treatment interventions.
215
EFFECT OF TELEPHONE COACHING SUPPORT
ON GLYCEMIC CONTROL IN TYPE 2 DIABETES
TREATED WITH GLARGINE INSULIN
J.M. Garca Almeida5, C. Morales6, M. Lopez de la Torre7,
D. Bellido2
1
Hospital Universitario Cruces, Endocrinologia, Barakaldo,
Spain
2
Complejo Hospitalario Universitario de Ferrol,
Endocrinologia, Ferrol, Spain
3
Hospital Universitario Puerto Real, Endocrinologia, Cadiz,
Spain
4
Complejo Hospitalario Universitario de A Coruna,
Endocrinologa, Coruna, Spain
5
Hospital Universitario Virgen de la Victoria, Endocrinologia,
Malaga, Spain
6
Hospital Universitario Virgen Macarena, Endocrinologia,
Sevilla, Spain
7
Hospital Universitario Virgen de las Nieves, Endocrinologia,
Granada, Spain
Background and Aims: eStar program is a telephone
support platform for type 2 diabetes (DM2) on glargine insulin.
This study aimed to evaluate whether this program was effective
in helping patients reach their optimal insulin glargine dose
within 6 months.
Methods: Both DM2 patients who were already receiving
glargine and patients who started receiving it, included in eStar
program from June/2013 to August/2015, were included in the
study. The primary outcome was whether a patient reached his/
her optimal glargine dose within 6 months.
Results: 138 patients consented and were included in eStar
program. Of those, 43 discontinued the telephone follow-up
(control group). The median age was 63 12 years; 56.5% men;
mean duration of diabetes: 15.6 11.6 years. 34% were already
on glargine (37% intervention group/36% control group). The
ATTD 2017 E-POSTER VIEWING ABSTRACTS
mean baseline HbA1c was 8.9 1.7%. A significantly greater
proportion of patients in the intervention group reached their
optimal insulin glargine dose (75.8%, 72/95 vs 23.3%, 10/43;
p < 0.001). The mean change in HbA1c between baseline and 6
months for the intervention group was -1.5 (-1.9 to -1.1,
p < 0.001) and -0.8 (-1.2 to -0.3, p < 0.001) for the control
group. Other differences between the groups at 6 months were
observed in insulin dose and fasting plasma glucose, in favor of
the intervention. No differences in BMI were observed between
the groups.
Conclusions: The eStar program is an effective way to help
patients reach their optimal insulin glargine dose, improves
glycemic control and can be an effective support for diabetes
education.
216
HOME TELEMEDICINE INCREASES THE NUMBER
OF TYPE 1 DIABETES CARE VISITS ATTENDED
BY YOUNG ADULTS
C. Berget1, K.A. Driscoll1, K. Ketchum1, C. Cain1, J. Raymond2
1
University of Colorado Denver, Barbara Davis Center,
Aurora, USA
2
Childrens Hospital Los Angeles, Center for Endocrinology-
Diabetes and Metabolism, Los Angeles, CA, USA
Background and Aims: To determine adherence to essential
components of T1D care: visit attendance, device downloads and
A1C measurement in young adults with T1D enrolled in a home
telemedicine trial (CoYoT1).
Methods: Visits occurred every 3 months for 1 year with 3
home telemedicine visits and 1 in-person clinic visit. Prior to
each visit, participants were instructed to download their T1D
devices from home and obtain A1C at a local laboratory.
Results: 45 young adults (Mage = 19.8 + 1.6 years; 56% fe-
male) with T1D (Mdiabetes duration = 8.6 + 4.6 yrs.) participated. At
least 72% of participants downloaded their T1D devices and
>80% completed A1C (Table 1). In the year prior to study en-
rollment, participants completed 2.5 + 1.2 in person T1D clinic
visits. With access to home telemedicine, participants completed
significantly more T1D clinic visits (M = 3.3 + 1.1; t = -3.563;
p < 0.001) compared to the number of T1D visits attended in the
prior year. The proportion of participants who completed >4 T1D
visits/year, as recommended by ADA, significantly improved
from 22% to 67%; McNemar c2 p < 0.001.
Conclusions: Providing young adults with T1D care visits via
home telemedicine increases visit frequency. Additionally, data
needed for quality T1D care was successfully obtained for the
majority of home telemedicine visits. Offering home tele-
A-89
medicine for young adults may be a successful way to increase
clinical care engagement during this transitional stage.
217
A REVIEW OF MOBILE APPLICATIONS GENERAL
PRACTICE: FORMING A QUESTIONNAIRE
TO EXPLORE CLINICIAN NEEDS
M. Smith1, M. Bradway2,3, E. Arsand2,3
1
University of Aberdeen, School of Medicine and Dentistry,
Aberdeen, United Kingdom
2
University Hospital of North Norway UNN, Norwegian Centre
for E-health Research, Troms, Norway
3
UiT The Arctic University of Norway, Department of Clinical
Medicine, Troms, Norway
Background and Aims: Increasing patient-empowerment
and participation in health-management is critical, especially in
preventative and chronic care domains. While this has tradi-
tionally been facilitated by primary care professionals, more
recently patients are turning toward mobile self-management
tools. While clinicians could better understand patients situa-
tions through these, concerns exist, e.g. safety and efficacy.
Therefore, clinicians, researchers and app-developers must iter-
atively collaborate to synthesize strategic and relatable app-use
in medical practice.
Methods: A literature review searched Embase, MEDLINE
and PubMed using terms related to key concepts of mobile self-
management apps and primary care. The quality of studies was
assed using the NHLBI tools. Data on efficacy, usability and
acceptability of apps was extracted. A brainstorming ses-
sion, involving app developers and a GP with mHealth research
experience, was conducted to develop a questionnaire for
clinicians.
Results: In the review, the search resulted in 960 papers and
12 were finally included. Type 2 diabetes was the most com-
monly targeted disease-case, with apps reportedly impacting
outcomes e.g. HbA1c or self-management domains. Clinicians
and patients were positive about app-usage but, only 2 and 3
studies respectively reported on these outcomes. Cited problems
included: treatment adherence, technical difficulties and ap-
pointment duration. Brainstorming sessions resulted in a ques-
tionnaire (n = 18 questions) with the following sections: GPs
status of app-use in practice, barriers to use, presentation of T2D
apps to address GPs clinical needs.
Conclusions: Additional responses to the questionnaire are
needed to obtain actionable results. We encourage GPs to answer
the questionnaire (http://tinyurl.com/hs6kzt5) to further inform
the society about how GPs can effectively use apps.
A-90 ATTD 2017 E-POSTER VIEWING ABSTRACTS

218
TELEHEALTH CARE MANAGEMENT FOR HIGH
RISK YOUTH WITH DIABETES MELLITUS
E. Burtman1, R. Rapaport1, A. Aluf1, H. Ciporen1, S. Lehrer1
1
Icahn School of Medicine at Mount Sinai, Pediatric
Endocrinology, New York, USA

Background and Aims: Telehealth Care Management

(TMC) is a program offered throughout the New York City
Health & Hospital system that connects patients with diabetes
mellitus to trained nurses using telecommunication technology
and provides remote, interactive healthcare services. Patients
transmit their daily blood glucose (BG) readings from their
OneTouch Ultra meter via wireless modem to TCM. BGs are
reviewed by case-specific nurses who provide care management
and contact the clinic based diabetes team as indicated. The
purpose is to extend the reach of the clinician beyond the medical
visit, enabling patients and their families to remain engaged and
supported in self-management. The TCM program is offered to
youth with poor control due in part to inadequate home super-
vision and who are at high risk for diabetic ketoacidosis.
Methods: The multidisciplinary diabetes care team at our
center selected individuals for TMC intervention. Long term data
were available in four individuals. Hemoglobin A1c (Hba1c) was
measured at enrollment, within the first year and after 1 year of
intervention.
Results: HbA1c decreased by an average of 2.5% in the first
year and remained 0.7% lower than baseline thereafter in those
with T1DM. No improvement in HbA1c was noted in the patient
with T2DM.

randomly varying real-life factors on glucose control for sub-

Conclusions: Our preliminary data suggest that TMC plays a
positive role in improving HbA1c in youth with T1DM. How-
ever, the success of intervention is highly individualized and
dependent on care-givers adherence to the recommended man-
agement. Data in a larger group of TIDM and T2DM patients
followed for longer duration would help validate the value
of TMC.
219
MODELING THE VARIABILITY OF DAILY LIFE
IN-SILICO: EXERCISE, CARBOHYDRATE COUNTING
ERROR, INSULIN DOSING ERROR AND METER
ERROR IN A T1DM POPULATION
M. Weinheimer1, Y.Y. Chang1, S. Riddle1, G. Kongable1
1
The Epsilon Group, Simulation and Modeling, Charlottesville,
USA
Background and Aims: The use of clinical studies would be a
very costly and difficult approach for assessing the effect of
jects with Type 1 diabetes (T1DM). Results would confound
possible direct relationships to clinical outcomes as multiple
factors would occur daily to impact glucose control. We ex-
amined the independent effects of such factors on clinical
outcomes in silico.
Methods: Within the UVA/Padova T1 Diabetes Metabolic
Simulation platform (T1DMS v3.2, 2013; www.tegvirginia
.com), we have modeled lifestyle variabilities in a virtual pop-
ulation of 100 adults with T1DM. Factors included carbohydrate
counting errors, insulin dosing errors, missed dosing, and blind
blousing, as reported in the literature. All 100 subjects experi-
enced the variabilities with identical timing and magnitude, and
all were treated based on readings from identically modeled
SMBG and CGM sensors with errors. Simulations were repeated
with factors selectively included or excluded, allowing assess-
ment of the individual contribution of each, in isolation and in
combination with others.
Results: We successfully implemented lifestyle variability
models and validated each independently against reported results
in the literature. This series of case studies using our lifestyle
variability models demonstrates how in silico simulation allows
examination of factors that disrupt glucose control in ways that
would be difficult to study in a clinical trial (Figure).
Conclusions: Since each varying real-life factor can be con-
trolled independently and is perfectly repeatable, the impact of
each factor can be examined either separately or interdepen-
dently, providing a more meaningful measure of their effects on
glucose control.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
220
SIGNIFICANT IMPROVEMENT OF BLOOD GLUCOSE
CONTROL IN A HIGH RISK POPULATION OF TYPE 1
DIABETES USING A MHEALTH APP,
A RETROSPECTIVE OBSERVATIONAL STUDY
M. Hompesch1, K. Kalcher2, F. Debong3, L. Morrow1
1 day. On 51% of days, patients did not wear their diabetic foot-
Profil Institute for Clinical Research, Inc., Scientific Services,
Chula Vista, USA
2
Medical University of Vienna, Med Statistik, Vienna, Austria
3
mySugr GmbH, Community Relations, Vienna, Austria
Background and Aims: To investigate the impact of mySugr
on blood glucose (BG) control in a less well-controlled popula-
tion. mySugr (registered class-I medical-device application)
was developed to make management and use of metabolic health
data appealing; it is the market leading diabetes-app with over
900,000 registered users (11.2016). It has shown positive effects
in well-controlled populations1, when compared to the previ-
ously published impact of mHealth-tools2.
Methods: A randomly selected group of 440 highly engaged
users (logging 5 days/week for 6 months) with mean(t0)
183 mg/dl (representing eA1c 8%) were included; T1D, age
30.8 15.3 years, 47.3% female.Changes in BG-results (mean,
standard deviation (SD)), HighBloodGlucoseIndex and Low-
BloodGlucoseIndex at baseline (t0), week 2-4 (t1) and month 3-6
(t2) were analyzed. Baseline data (t0) was processed using an
intercept of regression model based on data from first week of use.
Results: Baseline BG was 210.75 69.36 mg/dl, dropping
to 173.08 63.26 mg/dl (t2) reduction in mean of 17.88%
(p < 1*10^-23), SD 8.79% (p < 0.005). HBGI dropped from 5.39
(t0) to 3.36 (from High to Medium risk) (p < 1*10^-10), whereas
LBGI rose from 0.22 (t0) to 0.44 (t2) (p < 1*10^-36).
Conclusions: The results demonstrate that logging alone may
positively impact the quality of blood glucose control. These
findings need to be confirmed in a prospective, controlled clinical
study. We hypothesize that the additions of mySugr Bolus and
CDE-led Coaching may result in further benefits.
221
USING TEMPERATURE SENSORS TO ASSESS
THE COURSE OF ADHERENCE TO CUSTOMISED
DIABETIC INSOLES
D. Ehrmann1, M. Spengler2, M. Jahn2, D. Niebuhr3, T. Haak1,
B. Kulzer1, N. Hermanns1
1
Research Institute Diabetes FIDAM, Research Institute of the
Diabetes Academy Mergentheim, Bad Mergentheim, Germany
2
IETEC foot orthotics GmbH, Research and Development,
Kunzell, Germany
3
University of Applied Sciences, Nursing and Health Sciences,
Fulda, Germany
Background and Aims: Adherence to customised diabetic
footwear is crucial for a preventive effect regarding serious di-
abetic foot problems. However, adherence data often rely on self-
report or cover rather short time spans. The aim of this study was
to objectively assess the course of patients adherence with a
temperature sensor.
Methods: Temperature sensors were incorporated into the
specialized footwear of 26 patients with type-2-diabetes and dia-
A-91
betic foot syndrome. Every 15 minutes, the sensor stored the cur-
rent temperature. A pilot study revealed that a temperature 25C
best predicts wearing. Per patient, wearing time and the percentage
of days the shoe was never worn were calculated; observation time
was divided into quartiles to analyse the course of adherence.
Results: On average, data from 133.5 days per patient could
be analysed. Patients wore their diabetic footwear on 4.2 3.6 h/
wear at all. There was a significant gender*time interaction for
the number of days the footwear was worn: While early adher-
ence was similar between men and women, men showed a sig-
nificant increase in the percentage of days they have worn their
shoes, while women showed a continuous decrease.
Conclusions: Nearly every second day patients did not wear
their footwear at all. Men and women showed a comparable early
adherence but women had more problems with late adherence as
they were more and more unwilling to wear their footwear.
Feedback of the temperature sensors could be used to timely
detect problems with adherence in order to enhance it.
222
CHARACTERIZATION OF THE EFFECT
OF INTERSTITIAL FLUID PH IN PUMP INFUSION
SITE SUBCUTANEOUS TISSUE DUE TO
INFLAMMATORY RESPONSE USING ANIMAL
MODELS
J. Fusselman1, G. Zhang1, S. Chattaraj1, V. Patel1
1
Medtronic Diabetes, Chemistry- Material and Microbiology,
Northridge, USA
Background and Aims: No Delivery alarm is often
found in insulin infusion pumps and one possible source of No
Delivery alarm is occlusion of the infusion set by insulin
aggregates. Insulin (Humalog or Novolog) is supplied at pH
7.0 - 7.8 and has an isoelectric point (pI) of approximately 5.6.
Insulin increasingly forms aggregate precipitates as the pH
decreases and approaches the pI. Insertion of the cannula of
infusion set into the subcutaneous tissue of patients can cause
an immune response inflammatory effect, which can lower
the tissue pH, hence an in-vivo test using an animal model was
designed to verify the hypothesis: inflammatory response caused
the pH lowing effect that triggers the insulin aggregation/
precipitation.
Methods: Two in-vivo studies were performed to verify the
above hypothesis. Both studies used a Type 1 diabetic miniature
swine model.
1. Study 1: In-vivo pH measurement of subcutaneous tissue/
body fluid under various degree of injury and cannula in-
sertion techniques.
2. Study 2: Pump occlusion test designed with various man-
made pH decreasing event.
Results: The experiment has demonstrated that minimal to
mild sub-acute inflammation occurred in association with in-
sertion of the cannula, and the lowing of tissue pH in the inflamed
tissue was also demonstrated in this study.
Conclusions: Although the lower pH due to the inflammatory
response did not precipitate insulin in this study, increased pump
force for more than 30 minutes was observed on several occa-
sions, which is similar to the pump force obtained from the field
returned pump traces.
A-92
223
LONG-TERM USE OF MHEALTH TECHNOLOGY
IN PATIENT WITH TYPE 1 DIABETES LED
TO IMPROVEMENT IN METABOLIC CONTROL:
A CASE STUDY
A. Holubova1,2, J. Muzk1,2, M. Muzny1,3, M. Polacek2, J. Hall1, K. Stephen1, A. Croall2, J. MacMillan3, L. Murray3,
D. Fiala1, E. Arsand3,4, J. Kaspar1,2, K. Hana2, P. Smrcka2,
D. Janckova Zdarska5, M. Kvapil5, J. Broz5 1
1
Charles University, Spin-off company and research results
commercialization center of the First Faculty of Medicine,
Prague, Czech Republic
2
Czech Technical University in Prague, Faculty of Biomedical
Engineering, Prague, Czech Republic
3
Norwegian Centre for E-Health Research, University Hospital
of North Norway, Troms, Norway
4
UiT The Arctic University of Norway, Department of Clinical
Medicine, Troms, Norway
5
Second Faculty of Medicine, Department of Internal Medicine,
Prague, Czech Republic
Background and Aims: Mobile Health (mHealth) tech-
nologies for monitoring and evaluation of data, such as gly-
caemia levels, carbohydrate intake, insulin doses, physical
activity, and others, in patients with type 1 diabetes enable
faster orientation in the current glycaemia and factors influ-
encing them. At the same time, displaying health informa-
tion and clear presentation of important parameters has the
potential to enable more adequate response to glycaemia
changes throughout the day and increase patients self-care
interest.
Methods: During a testing phase of the mHealth system a
22-year old Type 1 diabetes patient was equipped with the
Diabetes Diary smartphone application, glucometer with a
Bluetooth interface, smartwatch and activity tracker, for a
period of 24 months. Values of measured glycaemia, carbo-
hydrate intake, insulin doses and physical activity were au-
tomatically transferred to a secure server where which both
the patient and the clinician had access to the data through a
web application.
Results: During the period of 2 years prior to the com-
mencement, the mean HbA1c value was 80.7 2.3 mmol/mol.
During the period the patient used the devices, the mean
HbA1c value was 65.7 7.36 mmol/mol. The patient did
not observe any increase in frequency of hypoglycemia. He
associates the improved metabolic control with the use of
mHealth system.
Conclusions: When using the above mentioned devices
and applications, there was a significant improvement in the
mean HbA1c values (-18.6%) without a subjective increase
in hypoglycemia values. The patient adapted the technology
in his everyday life and expressed his desire to keep using
them.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
224
IMPACT OF AN INSULIN/CARBOHYDRATE
ADJUSTMENT ALGORITHM APP ON INDIVIDUAL
BLOOD GLUCOSE MANAGEMENT DURING
PLANNED EXERCISE
N. Wiratunga4, S. Massie4, S. MacRury1
University of the Highlands and Islands, Division of Health
Research, Inverness, United Kingdom
2
Diabetes Scotland, Inverness, United Kingdom
3
University of the Highlands and Islands, Educational
Development Unit, Inverness, United Kingdom
4
Robert Gordon University, School of Computing Science and
Digital Media, Aberdeen, United Kingdom
Background and Aims: Risk of hypoglycaemia is a signifi-
cant barrier to undertaking physical exercise among people with
type 1 diabetes. An app based on a personalised prediction al-
gorithm is being developed for people with type 1 diabetes to
optimise blood glucose control associated with physical activity.
Incorporation of case-based reasoning and linkage with online
structured education is being explored for personalisation.
Methods: Physically active people with type 1 diabetes
(n = 10) were recruited using a Facebook forum to test a co-
produced app based on an insulin/carbohydrate adjustment al-
gorithm. Participants wore Actigraph-GT3X activity monitors
and Libre Freestyle blood glucose meters over the eight week
study period. Physical activity, blood glucose and app use time-
lines for individual participants were analysed to assess the im-
pact of the app on planned activity.
Results: A total of 119 app uses were logged, with an average
of 3 uses per week per user across a range of activities. An
example of app use is shown. Once ready to exercise, blood
glucose and activity/intensity were entered. The app indicated
that blood glucose was too low, recommended carbohydrate
consumption and retesting blood glucose before undertaking the
selected exercise intensity. Advice was followed and 30 minutes
later, with low blood glucose treated, the participant had a suc-
cessful exercise session.
Conclusions: Use of the app improved blood glucose levels
during and after exercise for some participants. For other par-
ticipants it highlighted that one-size-fits-all advice may not be
ATTD 2017 E-POSTER VIEWING ABSTRACTS
appropriate, supporting the use of case-based reasoning, even
for people already confident in managing their diabetes during
physical activity.
225
USE OF AN AUTOMATED BOLUS CALCULATOR
BY A TELEMEDICINE SYSTEM FOR THE
MANAGEMENT OF INSULIN THERAPY
IN TYPE 1 DIABETES PATIENTS
A.R. Maurizi1, R. Del Toro1, A. Naciu1, A. Lauria Pantano1,
E. Fioriti1, S. Manfrini1, P. Pozzilli1
1
University Campus Bio-Medico, Endocrinology and Diabetes,
Rome, Italy
Background and Aims: In Type 1 Diabetes (T1D) patients on
multiple daily injections (MDI), adjustments of insulin dose at
meal times must be made by taking into account several parameters
as blood glucose levels, insulin/carbohydrate ratio, carbohydrate
intake at each meal. A bolus advisor system (Accu-Chek Aviva
Connect) developed for the establishment of insulin doses to be
administer, takes into account all above parameters.
Aim of this randomized trial was to evaluate the efficacy of a
bolus advisor system on glycaemic control and patients com-
pliance to Self-Monitoring of Blood Glucose (SMBG), using a
telemedicine system.
Methods: 24 T1D patients were enrolled and HbA1c and
patients compliance were recorded at entry into the trial and at 3
and 6 months follow-up. As secondary end-points Kovatchev
indices were evaluated. Paired t test (two tailed) and analysis of
variance were used to evaluate differences at different time
points.
Results: HbA1c at entry was 7.65% 0.87 (SD) in patients
using bolus advisor system with bolus calculator and data trans-
mission by App on a Smartphone activated and 7.55% 0.98
(SD) in the control group with bolus advisor turned off.
After 6 months of observation, a significant reduction in HbA1c
was observed in active group vs. control subjects (7.32% 0.82 vs.
8.32 1.38 P = 0.04).
A major compliance to SMBG assessed as mean number of
daily measurements (P = 0.03) and as total of the measurements
for each quarter (P = 0.02) was observed in active group vs.
control group.
Conclusions: This bolus advisor system is a friendly wire-
lessly meter that helps to improve glycaemic control and patients
SMBG compliance.
226
INTERPRETING THE DATA FROM SENSOR
AUGMENTED PUMP IN TYPE 1 DIABETES:
A 5-STEP APPROACH IN 10 MINUTES
G. Petrovski1, M. Zivkovic1
1
University Clinic of Endocrinology, Center for Insulin Pump,
Skopje, FYR Macedonia
Background and Aims: We are presenting a simple, sys-
tematic 5 step approach in 10 minutes to interpret the data ob-
tained from Sensor Augmented Pump (SAP) using Carelink Pro
software (Carelink).
A-93
Methods: SAP is changing the life in patients with type 1
diabetes, offering both insulin delivery and continuous glucose
monitoring with automatic suspension (when low or before low
glucose value is achieved). Carelink is a software which allows
evaluation of SAP (basal/ bolus insulin, glucose values, carb
intake, automatic and manual suspension). This robust data re-
quires more time for evaluation, which overwhelms health care
providers (HCP) and can underutilize the benefits of this system
in patients. Time spent for interpreting the results is not recog-
nized by health care authorities. We allocate five segments on the
dashboard page of Carelink in a systematic approach: 1) Basic
statistics with hypo and hyper events; 2) Modal day with insulin
and glucose profile; 3) Postprandial data; 4) Basal/Bolus data;
5) Sensor and suspension statistics, where every segment is an-
alyzed with correlation through others.
Results: Our experience of this approach over 2 years in 142
patients on SAP shows less time spent for interpreting and
greater satisfaction by HCP with improvement of glucose control
in type 1 diabetes patients using SAP.
Conclusions: Our approach is easy and practical and can
be used in everyday practice in type 1 diabetes patients using
SAP.
227
INSULIN PUMP AND CGM DATA TO BE USED
FOR SEARCHING OF NONCOMPLIANT PATIENTS
AND THERAPY MISTAKES
Y. Philippov1, A. Agadzhanyan1, L. Ibragimova1, E. Surkova1,
A. Mayorov1
1
Endocrinology Research Centre, Diabetes Institution,
Moscow, Russia
Background and Aims: In real-life CSII and CGM effec-
tiveness can be affected by several factors, such as low com-
pliance, wrong pump/CGM settings, technical issues, knowledge
deficiency, and so on.
The aim of our study was to use stored in pumps data for
searching patients to be actively supervised (non compliant, with
significant mistakes in settings).
Methods: Cross-sectional observational single-centre study
includes data from type 1 diabetes mellitus patient transferred to
CSII in Endocrinology Research Centre. All participants were
treated in routine outpatient regimen within last year or longer.
We selected only CSII+CGM users (Medtronic Paradigm Real-
Time and Veo pumps) who use sensors in real-life for self-
monitoring.
Results: We included data from 75 patients with long history
of CSII using (3,6 1,7 years) and found several types of issues:
1) Technical issues: hight infusion set use duration; loss of
Fixed Primes; extreme Fixed Prime amount;
2) CGM issues: extreme high/low pump alarms frequency;
manual stop pump due to hypo- exists; hypo- alarms
without actions; sensor self-calibrations; calibrations due to
rapid BG changes;
3) Bolus wizard issues: No of Carbohydrate ratios/day pro-
file; unsuitable BG targets; incorrect Active insulin set-
tings;
4) General diabetes compliance: Carbohydrate under-/
overcounting; low SMBG frequency;
5) Advanced pump functions issues: Dual/Square boluses
use; Temp basal use;
A-94 ATTD 2017 E-POSTER VIEWING ABSTRACTS

6) Pump settings self-adjustment: Basal Rate profile chan- plication convenient and helpful. The largest drawback of the
ges; Bolus Wizard settings changes. application the patients found was the lack of food items in the
build-in food database (which included 2110 items).
We found 2 types of issues in all participants. The study was funded by Russian Science Foundation (project
Conclusions: Low compliance and technical mistakes can No 15-14-30012).
persist in CSII+CGM users very often. Searching and selecting
patients with such issues can be a tool in routine healthcare
system.
229
KALMAN SMOOTHING OF GLUCOSE DATA APPLIED
228 TO PARTIAL LEAST SQUARES MODELING
OF NON-INVASIVE NEAR-INFRARED
REMOTE MONITORING OF DIET FOR PATIENTS
MEASUREMENTS
WITH GESTATIONAL DIABETES USING A
SPECIALIZED MOBILE APP DIARY O.M. Staal1,2, T. Karstang1, S. Slid1, . Stavdahl2
E. Pustozerov1, P. Popova2, Y. Bolotko2, A. Tkachuk2, 1
Prediktor, Medical, Gamle Fredrikstad, Norway
A. Gerasimov2 2
Norwegian University of Science and Technology, Department
1 of Engineering Cybernetics, Trondheim, Norway
Saint-Petersburg Electrotechnical University, Department
of Bioengineering Systems, Saint Petersburg, Russia
2 Background and Aims: Blood and interstitial fluid glucose is
Federal Almazov North-West Medical Research Centre,
measured in people with diabetes using fingerprick and Continuous
Institute of Endocrinology, Saint Petersburg, Russia
Glucose Monitor (CGM) devices. We show that such data can be
homogenized, cleaned and interpolated using a preprocessing al-
Background and Aims: To maintain the appropriate control
gorithm. The algorithm is used to generate a suitable glucose re-
of patients with gestational diabetes throughout the course of
sponse variable from fingerpricks for Partial Least Squares (PLS)
treatment, a specialized software was developed and implemented
modeling of non-invasive near infrared (NIR) transcutaneous
into the clinical practice. It allows physicians to receive stan-
measurement data recorded with a prototype device.
dardized reports on patients diet and glucose monitoring plan in-
Methods: The algorithm is based on Kalman filtering and
between visits and provide patients with a remote feedback.
Rauch-Tung-Striebel smoothing. A discrete-time input sequence
Methods: Patients with diagnosed gestational diabetes were
of fingerprick/CGM data is converted to an interpolated stream
given an application, developed for both mobile devices and
of estimates of the blood/interstitial glucose. The algorithm is
desktop computers, which was used to keep track on the diet,
robust against measurement errors in the input data and can
blood glucose (BG), physical activity, sleep and ketones. The
correct erroneous readings when enough data is present. The
records collected onto a standardized spreadsheet were sent via
algorithm is compared to cubic spline interpolation in simulated
E-mail and stored remotely for further analysis.
and real glucose data sets, and the influence on PLS modeling of
Results: By October 2016, 138 patients were included in the
NIR datasets is investigated.
study. A total of 17820 measurements of BG (in average,
Results: The interpolated output signal from our algorithm
45.4 days of monitoring by patient), and 19527 meals (in aver-
describes the most likely glucose trajectory through the input
age, 36.7 days of monitoring by patient) recorded by patients
dataset of noisy glucose measurements, with a measure of the
were analyzed. The average percent of BG levels for a single
uncertainty (variance) of the estimate at any point along the
patient during fasting (n = 4956) exceeding 5.1 and 5.3 mmol/L
trajectory. This is useful in order to determine when the estimate
were 27.6% and 19.4%; after meal (n = 12864) exceeding 7.0 and
is trustworthy enough to be used in further processing. Use of the
7.6 mmol/L - 20.0% and 8.3% respectively. The average carbo-
algorithm in PLS modeling improves the cross validation cali-
hydrates consumption was distributed during breakfast, lunch,
bration performance and prediction performance compared to
dinner and additional food intakes in the proportion of 27.5%/
cubic spline interpolation.
29.5%/26.0%/17.0%.
Conclusions: The presented algorithm is a useful preproces-
Conclusions: According to the post-study survey, all the pa-
sing step in many applications of automated and manual glucose
tients, who provided the feedback, found the usage of the ap-
data processing, including PLS modeling of NIR data for non-
invasive glucose measurements.

230
SMARTPHONE APP FOR NOCTURNAL
HYPOGLYCEMIA PREDICTION FROM SMBG
MEASUREMENTS
P. Tkachenko1, Y. Sulema2, E. Renard3, S. Pereverzyev1
1
Johann Radon Institute for Computational and Applied
Mathematics, Inverse Problems and Mathematical Imaging,
Linz, Austria
2
National Technical University of Ukraine Igor Sikorsky Kyiv
Polytechnic Institute, Applied Mathematics Department, Kyiv,
Ukraine
ATTD 2017 E-POSTER VIEWING ABSTRACTS
3
Montpellier University Hospital, Department of
Endocrinology, Diabetes, Nutrition, Montpellier, France
Background and Aims: Nocturnal Hypoglycemia (NH) is the
most feared type of hypoglycemia in patients with diabetes
treated by insulin. However, there is still a lack of methods
aiming at the prevention of such cases, especially for patients
performing Self Monitoring of Blood Glucose (SMBG) from
finger sticks.
The aim is to develop a smartphone app DiaSafeNight
equipped with a special tool for predicting Nocturnal Hypogly-
cemia (NH) from SMBG measurements.
Methods: DiaSafeNight incorporates the general function-
ality of commonly used logbook apps (data collection, storing,
analysis and graphical representation) together with the novel
NH predictor. The new mathematical technique introduced by
the authors and staying behind the predicting algorithm allows
an aggregation of the clinical prediction rules known from the
literature in such a way, that the resulting predictor performs at
the level of the best involved one, or even outperforms all of
them. DiaSafeNight has been tested on historical clinical data
collected within the European FP7 project DIAdvisor and
H2020-MSCA-RISE-2014 project AMMODIT. The pre-
diction accuracy observed on these data confirmed the above
statement on the performance and is higher than conventionally
considered as acceptable. The prediction is expressed in terms
of the probability of NH during the forthcoming night (in %)
and categorized into 4 risk zones: low risk, moderate risk, high
risk, and extreme risk.
Results: The beta-version of the smartphone app DiaSafe-
Night has been created.
A-95
Conclusions: The app is being developed in NTUU KPI,
Kyiv, Ukraine. Further improvements and extensions of the app
are planned to create a ready-to-use product.
231
ACCURACY OF CONTINUOUS A1C ESTIMATE
USING ROUTINE MONITORING DATA
P. Vaisanen1, P. Lonnroth2, M. Saraheimo3
1
Tampere University of Technology, Electronics and
Communications Engineering, Tampere, Finland
2
Quattro Folia Oy, Research, Espoo, Finland
3
Neliapila Oy, Clinic, Helsinki, Finland
Background and Aims: The measurement of A1c is the most
well established means to monitor glycemic control in persons
with diabetes. Often A1c measurements are done 2-4 times per
year, although A1c levels can change substantially in 3-4 weeks.
This might lead to unmonitored gaps. To prevent this, we have
introduced an algorithm for continuous A1c estimate (eA1c) to
guide in efficient day-to-day diabetes management. Here, we
evaluate the accuracy and robustness of the algorithm by using
routine monitoring data.
Methods: The accuracy of the algorithm was analyzed with
30 subjects with diabetes. 9 subjects were excluded by having too
little SMBG data or laboratory A1c measurements. In total, 9123
SMBG and 76 A1c measurements were included. The algorithm
adapts to users SMBG measurement habits and individual
metabolic characteristics to estimate A1c. Retrospective analyze
with leave-one-out cross-validation was used for algorithm ac-
curacy evaluation. Mean absolute deviation (MAD), mean ab-
solute relative deviation (MARD) of eA1c from reference A1c,
and correlation (R) between eA1c and reference A1c were cal-
culated. In addition, an error grid analysis was made.
Results: MAD and MARD were 0.34% and 4.45%, respec-
tively. Correlation was strong (R = 0.87). Error grid analysis
showed that 90.14% of eA1c values were within 10% from ref-
erence A1c.
Conclusions: The results show that the adaptive algorithm
can accurately calculate continuous A1c estimate with routine
monitoring data that can be even biased or irregular. Further-
more, the introduced continuous A1c algorithm is one of the best
described in the literature and thus, it can be used to guide in day-
to-day diabetes management.
232
NO ESCAPE: BENEFITS OF DIGITAL RETINAL
SCREENING IN PRISON
C. Wallis1, O. Anderson2
1
Dorset Healthcare, Dorset Diabetic Eye Screening
Programme, Dorset, United Kingdom
2
The Royal Bournemouth and Christchruch Hospitals,
Ophthalmology, Bournemouth, United Kingdom
Background and Aims: To establish levels of diabetic reti-
nopathy in the prison population of Dorset from 2012 - 2016 and
compare to the normal Dorset population with diabetes.
To establish if screening in prisons is a cost effective way of
monitoring referable retinopathy not requiring treatment.
A-96 ATTD 2017 E-POSTER VIEWING ABSTRACTS

Methods: Any retinopathy (R1 background, R2 prepro-

liferative, R3 proliferative and M1 maculopathy using English
National Diabetic Eye Screening criteria) and referable reti-
nopathy rates (R2 preproliferative, R3 proliferative and M1
maculopathy) for the prisoner population (2012-2016) were
compared with normal population (2012-2015).
Results: 171 male prisoners were screened. 99 (57.9%) had no
diabetic retinopathy, 72 (42.1%) had any retinopathy and 18
(10.5%) had referable retinopathy. Of those with referable reti-
nopathy 8 were referred to hospital eye service (HES) and 10
were monitored using digital imaging.
78,112 of the normal diabetic population were screened.
52,951 (67.8%) had no diabetic retinopathy, 25,161 (32.2%) had
any retinopathy and 4,658 (6%) had referable retinopathy.
The prison population had a statistically higher rate of refer-
able retinopathy compared to the normal population (Fishers
exact test p = 0.0186).
Conclusions: The prison population showed higher levels of
referable retinopathy. The cost of taking a prisoner out of prison
for a medical appointment is 300 and an outpatient appointment
in HES is 120. Screening a prisoner in prison costs 33.98. The
total cost of 10 patients attending HES is 4,200 with associated
security risks vs 339.80 using digital imaging screening. Digital
imaging is a cost effective way of monitoring referable diabetic
retinopathy not requiring treatment.

233
INSULIN PUMP IN TYPE 2 DIABETES PATIENTS
WITH INSULIN OPTIMIZATION FAILURE:
RESULTS OF AN OBSERVATIONAL,
MULTICENTRIC TRIAL IN REAL LIFE
J.P. Courreges1, F. Travert2, S. Clavel3, D. Huet4,
E. Ghanassia5, K. Mohammedi2, O. Dupuy4, A. Poussier3
1
Hopital General, Service de Medecine interne et Diabetologie,
Narbonne, France
2
CHU Bichat, Diabetology, Paris, France
3
CH Hotel Dieu, Diabetology, Le Creusot, France
4
CH Saint Joseph, Diabetology, Paris, France
5
Clinique Sainte Therese, Diabetology, Sete, France
Background and Aims: Can type 2 diabetic (T2D) patients
with conventional insulin optimization failure benefit from an
ambulatory insulin pump (AIP) in real life?
Methods: 110 T2D patients (diagnosed for 16.0 8 years, age
: 60.0 9.6 yrs, sex ratio M/F: 1.56) showing insulin optimization
failure (HbA1c8% in spite of 3 injections/d - 0.7 U/kg/d)
undergo AIP treatment in an observational multicentric trial for
12 months.
Results: There were 18 trial discontinuations among which 8
AIP removal. 92 patients (83.6%) reached the end and were
analyzed.
With AIP, HbA1c results improve significantly at T0/T6/T12
(Table 1). At T0, T6 and T12, HbA1c 8% and 10% proportion
evolves (Table 2).
The higher initial HbA1c was, the greater it dropped (Table 3).
No severe hypoglycemia was observed (3 during the multi-
injections year preceding T0).
The weight increased moderately with some heterogeneity 29
patients remained stable, 21 lost weight (3 10%); 30 gained
3%, 18 5% et 5 10% of their initial weight.
Insulin dose dropped significantly by 0.25 U/kg/d (-20%) ;
in 20 patients (22%) it decreased by 30%, in 6 by 50%
(Table 5).
Conclusions: In real life , multicentric results of a 1-year
AIP-treatment confirm its benefit for T2D insulin requiring pa-
tients with insulin optimization failure in spite of very high
insulin doses. It produces a very significant drop in HbA1c
(-1.55%) and in insulin needs (-20%) without any severe hy-
poglycemia or important weight gain.
234
OPPORTUNITIES AND LIMITS OF AN AMBULATORY
INSULIN PUMP TREATMENT IN TYPE 2 DIABETIC
ELDERLY PATIENTS ( 65 YEARS) IN CASE OF
INSULIN OPTIMIZATION FAILURE
D. Huet1, S. Clavel2, F. Travert3, E. Ghanassia4, J.P. Le Berre5,
H. Bonnaure6, V. Cosma7, J.P. Courreges8
1
CH Saint Joseph, Diabetology, Paris, France
2
CH Hotel Dieu, Diabetology, Le Creusot, France
3
CHU BIchat, Diabetology, Paris, France
4
Clinique Sainte Therese, Diabetology, Sete, France
5
HIA Desgenettes, Diabetology, Lyon, France
6
CH Narbonne, Diabetology, Narbonne, France
7
CHU Nmes, Diabetology, Nmes, France
8
Hopital General, Service de Medecine interne et Diabetologie,
Narbonne, France
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Background and Aims: Is ambulatory insulin pump (AIP)
a valuable opportunity (efficacy and safety) for type 2 dia-
betic (T2D) elderly patients in case of insulin optimization
failure?
Methods: 30 elderly T2D patients aged over 65 years (13 70
years) and 75 years (diagnosed for 19 9 years, 69.6 4.8 years
old, sex ratio (M/F) 1.31), consecutively enrolled (E group),
showing glycemic control failure in spite of insulin multi-
injections (3.7 1.1 injections/d) are treated with AIP for 12
months.
Their results are compared with a 54-patient group (NE group)
identical to the previous but younger (<65 years).
Results: The comparative results of E vs NE are collected at
T0, T6 and T12.
Glycemic control evolves as follows:
Weight and insulin doses evolution are not significantly dif-
ferent:
In the E group, 3 AIP treatments (10%) have been suspended
on patient demand (+ 1 death not related with AIP) vs 5 (9.3%) in
the NE group.
No severe hypoglycemia has been noticed in both groups.
The burden of hospitalizations linked with diabetes has been
studied:
Conclusions: These results show the feasibility in real life of
an AIP treatment in elderly T2D patients ( 65 years) with
similar levels of efficiency and safety as in younger patients.
These identical results for both groups confirm the accuracy of an
AIP treatment in elderly T2D patients in case of multi-injections
failure.
A-97
235
WHO WOULD BE THE BEST CANDIDATE
FOR AN AMBULATORY INSULIN PUMP (AIP)
TREATMENT AMONG TYPE 2 DIABETIC (T2D)
PATIENTS WITH INSULIN OPTIMIZATION FAILURE
S. Clavel1, F. Travert2, D. Huet3, E. Ghanassia4, J.M. Andrieu5,
L. Labbe1, R. Zaharia3, J.P. Courreges6
1
CH Hotel Dieu, Diabetology, Le Creusot, France
2
CHU Bichat, Diabetology, Paris, France
3
CH Saint Joseph, Diabetology, Paris, France
4
Clinique Sainte Therese, Diabetology, Sete, France
5
CH Beziers, Diabetology, Beziers, France
6
Hopital General, Service de Medecine interne et Diabetologie,
Narbonne, France
Background and Aims: Insulin optimization failure may lead
to examine the accuracy of an AIP in T2D patients. To whom
may it benefit the most in terms of metabolic results?
Methods: In a multicentric observational trial, 92 T2D pa-
tients (diagnosed for 16.0 8 years, aged 60.0 9.6 yrs, sex
ratio M/F: 1.56, BMI 33.6 4.0 kg/m2) with multi-injections
(n = 3.6 1.1/d) failure (HbA1c 9 .52 1.47%) underwent an AIP
treatment for 1 year.
Results: After 1 year of AIP, patients reached a better glycemic
control (HbA1c 7.96 1.0% - DT0/T12 = -1.56% -p <0.0001).
There were classified into 3 groups according to HbA1c re-
duction between T0 and T12:
The 3 groups were compared on several parameters at T0.
No significant difference was noticed between the 3 groups in
terms of sex ratio, age, duration since diagnosis, weight/BMI,
insulin dose, micro and macro-angiopathy proportion and pre-
existing metformin treatment. Only initial HbA1c level was
significantly different between the groups.
HbA1c reduction according to initial HbA1c level was found
linear until it reached 10% then went exponential.
A-98
Patients have been classified into 4 groups according to
composite endpoint (HbA1c reduction and weight evolution) to
assess more specifically the level of metabolic control they
achieved (no severe hypoglycemia occurred):
Conclusions: 68.5% of highly insulin resistant patients, with
insulin optimization failure, improved their overall metabolic
control with an AIP, while 28 patients improved a composite
endpoint (HbA1c reduction 1% + stable or increasing weight
3%).
No clinical profile has been identified except initial high
HbA1c level both with single or composite endpoint. This may
result from highly heterogenic enrolled patients.
236
DIFFERENCES IN THE METABOLIC CONTROL
IN PEOPLE WITH TYPE 1 DIABETES TREATMENT
WITH SUBCUTANEOUS INSULIN INFUSION VS
SCHEME WITH MULTIPLE DAILY DOSES
A. Dain1, L. Rista2, M.L. Ruiz Morosini3
1
Catedra de Biologia Celular - Histologia y Embriologia,
Facultad de Ciencias Me, Cordoba, Argentina
2
CEDYN Rosario, Rosario, Argentina
3
Hospital Nacional de Clnicas, Buenos Aires, Argentina
Background and Aims: Type 1 diabetes is a complex disease.
Technology has been incorporated offering benefits in metabolic
control and quality of life.
Aim: To analyze the degree of metabolic control in people
treated with SCII vs MDI, assessing glycosylated hemoglobin
(HbA1c) and other parameters of glycemic variability
Methods: We performed a multicenter restrospective analysis
and we included Type 1 DM patients, on SCII or MDI treatment
by 6 months, from 2 years old with at least 1 year from diagnosis
between 2015-16.
We excluded pregnant woman, drug abuse, ketoacidosis,
surgery in the last 3 months or eating disorder.
Data were anonymous and ethical requirements were met.
Blood glucose data were collected through commercial soft-
ware (Glucose average, SD, number and frequency of mea-
surements over 30 days). The HbA1c levels were determined.
We analyzed: t Test, Shapiro-Wilks, Wilcoxon and ANCOVA
(p < 0.05).
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Results: 468 patients were enrolled (female 257) 196 in SCII.
Average age SCII 25.59 3 y and MDI 30.61 4 y. Diagnostic
age 15.76 2 SCII and MDI 11.17 1 y; HbA1c SCII 7.5% 0.89,
MDI 8.32 1.54 (p < 0.0001) frequency of measurements SCII
4.36 2.4, MDI 3.49 1.64 (p < 0.0001) mean glycaemia
SCII162.18 27.3, MDI 179.9 40.88 (p < 0.0001); SD SCII
76.49 18.76, MDI 81.45 23.24 (p < 0.0001) % of Variation SCII
48.17 9.51, MDI 45.88 10.24 (p 0.09).
Conclusions: Based on our results type 1 DM patients on SCII
have better metabolic control, higher frequency of self-monitoring,
lower HbA1c and glycemic less variation than those receiving MDI.
237
BASAL INFUSION RATE SELF-MANAGEMENT IN CSII
AND METABOLIC CONTROL
U. Di Folco1, M.R. Nardone1, M. Timpano1, C. Tubili1
1
S. Camillo Forlanini, Diabetology, Rome, Italy
Background and Aims: Many CSII diabetic patients change
often Basal Infusion Rate (BIR) for short or long periods. It is not
clear if this self-management improves the metabolic control,
more specifically reducing hypoglycemic events.
Aim of this study was to evaluate the correlation between BIR
self-management and metabolic control in CSII type 1 diabetes
subjects in real life.
Methods: 109 outpatients were stratified in 3 groups ac-
cording to HbA1c: 1) < 7% (n = 50; 45.8%); 2) 7.1- 7.9% (n = 29;
26.6%); 3) >8.0% (n = 30; 27.5%). Total and basal insulin re-
quirements (U/day; U/kg); average basal rate (U/h), number of
basal rate daily changes; temporary basal speed frequent usage
( 3 times/week); severe hypoglycemic events (<50 mg/dl) in the
last 4 weeks were analyzed (t test).
Results: Well controlled pts. (group 1) were younger than
groups 2 and 3 (p < 0.005) ones and delivered less basal insulin
(55.5 7.7%, vs. 57.7 13.9% and 56.8 10.8% respectively).
Their insulin requirement and average infusion rate were lower
(0.28 0.1; 0.29 0.09; 0.34 0.14 U/kg; p < 0.03 between
groups 1 and 3; 0.82 0.3; 0.85 0.3; 1.09 0.5 U/h; p < 0.004
between groups 1 and 3).Severe hypoglycemic events were re-
ported by 5 (10%) well controlled patients, 3 (10%) by moder-
ately uncontrolled, 5 (18%) by severely uncontrolled ones. In
group 1 the temporary basal rates usage was more frequent (46%)
than in the other two groups.
Conclusions: Basal rate self-management is an important
component of CSII and seems effective to maintain good HbA1c
levels and to prevent hypoglycemic events.
238
LONG-TERM EFFECT OF CONTINUOUS
SUBCUTANEOUS INSULIN INFUSION
ON GLYCAEMIC CONTROL
A. El-Laboudi1, A.A. Min1, J. Carling1, P. Hammond1
1
Harrogate and District NHS Foundation Trust, Diabetes
and Endocrinology, Harrogate, United Kingdom
Background and Aims: Reduction in HbA1c using contin-
uous subcutaneous Insulin Infusion (CSII) needs to be sustained
to result in reduction of diabetes-related vascular complications.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
For example, the 0.5% reduction in HbA1c, achieved by CSII, in
the meta-analysis of RCTs would need to be sustained for 10
years to result in a 5% decrease in the number of patients de-
veloping retinopathy.
We conducted retrospective review of 207 case-notes of pa-
tients with diabetes who have been treated with CSII from 1998
until 2015 in our centre to assess long-term effect of CSII on
HbA1c.
Methods: HbA1c was collected at baseline (prior to starting
CSII), 3 months, 6 months then yearly after start of CSII.
The changes since baseline for the HbA1c were compared for
each time interval by Wilcoxon signed-rank test or paired t-test
as appropriate.
Results: Notes of 178 CSII treated patients (104 females, 74
males) were analysed with mean age of 43 (range 16-75) years.
Mean SD baseline HbA1c was 8.68 1.55%.
CSII was associated with a statistically significant reduction of
mean HbA1c by 0.88% at three months (P < 0.001). Maximum
improvement in HbA1c was achieved at 6 months with HbA1c
reduction of 0.9% (P < 0.001). Statistically significant reduction
was maintained for the first three years following CSII initiation.
Analysis of patients with pre-pump HbA1c 8.5% (n = 86,
Mean SD baseline HbA1c = 9.88 1.87%) showed clinically
and statistically significant reduction in HbA1c, compared to pre-
pump HbA1c, that was maintained for 15 years (figure 1).
Conclusions: This study demonstrates the long-term meta-
bolic benefits of CSII by achieving sustained HbA1c reduction
over 15 years.
239
COST-UTILITY ANALYSIS OF SENSOR AUGMENTED
PUMP THERAPY WITH LOW GLUCOSE SUSPEND
FUNCTION FOR PATIENTS WITH TYPE 1 DIABETES
AND RECURRENT SEVERE HYPOGLYCEMIA
IN SPAIN
I. Conget1, I. Elas2, F.J. Ampudia-Blasco3,
P. Martn-Vaquero4, M. Alvarez2, A. Delbaere5,
S. de Portu5, S. Roze6
1
Hospital Clnic i Universitari de Barcelona, Diabetes Unit.
Endocrinology Department. IDIBAPS, Barcelona, Spain
2
Medtronic Iberica, S.A, Health Economics & Outcomes
Research, Madrid, Spain
3 5
Clinic University Hospital, Diabetes Reference Unit,
Endocrinology & Nutrition Department, Valencia, Spain
A-99
4
D-medical Clinic, Diabetes Unit, Madrid, Spain
5
Metronic International Trading Sarl, Health Economics
& Outcomes Research, Tolochenaz, Switzerland
6
Heva Heor Sarl, 186 avenue Thiers, Lyon, France
Objective: To estimate the cost-effectiveness of sensor-
augmented pump (SAP) with low glucose suspend (LGS) versus
continuous subcutaneous insulin infusion (CSII) alone for the
treatment of patients with type 1 diabetes (T1D) and recurrent
severe hypoglycemia.
Methods: The CORE Diabetes Model was used to pro-
ject clinical and economic outcomes for the treatment of
hypoglycemic-prone T1D patients. Patient baseline character-
istics and treatment effects were taken from one published
randomized controlled trial, in which severe hypoglycemic
events were observed at 2.2 and 0 per 100 patient-months for
CSII and SAP+LGS, respectively. Unit costs (e,2016) and
utility values were obtained from published sources. The main
analysis was conducted from the National Health Service
(NHS) perspective over a lifetime horizon with costs and health
results discounted at 3%. Furthermore, the societal perspective
was considered in an alternative scenario. Univariate and
probabilistic sensitivity analyses (SA) were performed to assess
the models robustness.
Results: SAP+LGS was associated with improvements in
quality-adjusted life years (QALYs) by 1.877, versus CSII.
SAP+LGS total direct costs were e47,665 higher, leading to an
incremental cost-effectiveness ratio (ICER) of e25,394 per
QALY gained. Likewise, SAP+LGS total direct costs increased
by e41,036 when the societal perspective was considered,
leading to an ICER of e21,862 per QALY gained. SA indicated
the model projections were robust to the various scenarios
tested.
Conclusions: From the NHS and the societal perspective,
SAP+LGS represents a cost-effective option compared with CSII
for the treatment of hypoglycemic-prone T1D patients in Spain
when considering a willingness-to-pay threshold of e30,000 per
QALY gained.
240
MULTI-CENTRIC STUDY RENACED DIABETES TIPO
1: METABOLIC DIFFERENCES BETWEEN INSULIN
PUMP USERS AND THOSE ON BASAL BOLUS
BY INJECTION
R.N. Faradji1, M. Valenzuela-Lara2, J.F. Bustamante-
Martinez3, N.E. De La Garza-Hernandez4,
A.P. Diaz Barriga-Menchaca5, A. Escobedo-Ortiz6,
A. Flores-Camargo5, L. Islas-Ortega7, C. Lopez-Miramontes8,
A. Martinez-Ramos-Mendez9, S. Miracle-Lopez10,
L.A. Ramirez-Toscano8, E. Rodriguez-Sanchez11,
M. Tavera-Hernandez12, J.C. Valenzuela-Montoya13,
M. Vidrio-Velazquez8, R.S. Nino-Vargas14,
E. Sainz-De La Maza-Viadero15, C. Magis-Rodriguez2
1
Instituto Tecnologico de Monterrey/Centro Medico ABC,
Endocrinologia, Mexico, Mexico
2
Centro Nacional para la Prevencion y el Control del VIH y el
Sida- Secretaria de Salud, Epidemiologia, Mexico City, Mexico
3
Hospitale General de Tepic, Departamento de Medicina
Interna, Tepic, Mexico
4
CEMEDIN, Endocrinologia, Monterrey, Mexico
Instituto Tecnologico de Monterrey, Ciencias Medicas Basicas
y Clnicas, Mexico, Mexico
A-100
6
Hospital General Dr. Miguel Silva, Secretaria de Salud,
Endocrinologia, Morelia, Mexico
7
Hospital DIF de la Ninez Hidalguense, Endocrinologia
Pediatrica, Pachuca, Mexico
8
HGR 110 IMSS Guadalajara, Jal, Endocrinologia,
Guadalajara, Mexico
9
HOSPITAL ESPANOL, Endocrinologia Pediatrica,
Mexico City, Mexico
10
Hospital Angeles Lomas, Endocrinologia, Mexico City,
Mexico
11
Hospital Rovirosa- Secretaria de Salud, Diabetes,
Villahermosa, Mexico
12
Centro Medico ABC Santa Fe / Hospital Angeles Lomas,
Endocrinologia Pediatrica, Mexico City, Mexico
13
Hospital De Gineco, Pediatra No. 31 IMSS, Endocrinologia
Pediatrica, Mexicali, Mexico
14
Centro para la Prevencion y Atencion Integral del VIH/SIDA
del Distrito Federal, Secretaria de Salud, Jefatura de Sistemas
de Informacion, Mexico City, Mexico
15
UNIVERSIDAD IBEROAMERICANA, EDUCACION,
Mexico City, Mexico
Background and Aims: There is limited information re-
garding the differences in metabolic control in patients with Type
1 Diabetes (T1D) treated with insulin pump therapy (CSII) or a
basal-bolus (BB) regime by injections in Mexico. We developed
an online system, RENACED Diabetes Tipo 1(DT1), to have a
longitudinal registry of real life data of T1D patients. Our aim is
to evaluate the differences in metabolic control between patients
treated with CSII or BB.
Methods: Multi-centric study where a bivariate analysis
(alfa = 0.05) was performed in 363 T1D patients, that use CSII or
BB, registered in the RENACED DT1 system up to 10/5/2016.
Results: Of the 363 patients, 121 are on CSII and 242 on BB.
Patients on CSII had lower HbA1c levels (7.9;CI 95% 7.68.1)
than those on BB (8.8;IC 95% 8.59.1) (p < 0.05). The total in-
sulin daily dose was lower on CSII (0.60 IU/kg; CI 95% 0.5-0.6),
than on BB (0.76 IU/kg; CI 95% 0.7-0.8) (p < 0.05). (Table 1).
CSII was associated with higher SMBG (self monitor of capillary
blood glucose) per day, as well as use of continuous glucose
monitor (CGM) (p < 0.01). A significantly higher event rate of
mild/moderate hypoglycemia/week was observed in the CSII
group (4.3 vs. 2.5; p = 0.02). An interesting finding is that those
patients on CSII exercise more.
Conclusions: According to the literature, CSII use, higher
number of SMBG/day and CGM is associated with better gly-
cemic control. It is interesting that those on CSII exercise more, a
finding that will need to be confirmed with higher number of
patients in the registry.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
241
EVALUATION OF CORRELATION BETWEEN
INCREASED BLOOD GLUCOSE LEVELS AND
INCREASED PUMP FORCE (SYSTEM PRESSURE)
MEASUREMENTS
J. Fusselman1, S. Chattaraj1, J. Shin2, B. Grosman3
1
Medtronic Diabetes, Chemistry- Material and Microbiology,
Northridge, USA
2
Medtronic Diabetes, Clinical Research, Northridge, USA
3
Medtronic Diabetes, Close-loop Development, Northridge,
USA
Background and Aims: The Medtronic insulin infusion
pump is a positive displacement design, designed to overcome
the tissue or system pressure for assured delivery of a known
volume with each pump stroke. Recently, several publications
have speculated a pump wearer pumping with a partial or
completely occluded infusion set might experience temporary
flow interruptions or silent occlusions. These publications
speculated that the silent occlusion was a potential factor for
unexplained hyperglycemia in insulin pump users. To date,
none of these publications showed clinical evidence establish-
ing a correlation between rising system pressure and glycemic
effects. Therefore, the silent occlusion theory remains hypo-
thetical, with no supporting data. However, these publications
did trigger our interest to evaluate the potential correlation
between increased blood glucose levels and increased pump
force (system pressure) measurements, therefore, a total of
204 days of patient data from different clinical sites were an-
alyzed for the pump force sensor data versus the continuous
glucose sensor data.
Methods: The effect of the mean normalized force on the
sensor glucose (SG) value was examined on a total of 204 days
of patient data during the study under both fasting and bolus
conditions.
Results: Both Fasting and Bolus evaluation results show no
significant correlation between pump force sensor data and
sensor glucose drop (DSG). In fact, the majority of SG drops less
than 50 mg/dL (potential hyperglycemia) are in the low nor-
malized pump force region.
Conclusions: Both evaluation methods show that there is no
correlation between the unexplained hyperglycemia and high
pump system pressure.
242
INSULIN PUMPS THE KENYAN EXPERIENCES
G.A.M. Gaman1, F. Sherdel1
1
Comprehensive Diabetes Centre, OPD, Nairobi, Kenya
Background and Aims: Information on pump usage is scarce
in Africa. Pump usage (CSII) is still rare due to the relatively high
costs and lack of trained personnel and support services. We
embarked to review our clinical experiences with patients on
sensor augmented pumps at the Comprehensive Diabetes Centre
in Nairobi, Kenya.
Methods: A survey was carried out on 32 patients 27 type 1
and 5 type 2 previously on MDI and switched to Sensor aug-
mented pump therapy. Mean age of patients in the study was
24 yrs. Basic Demographic data including HbA1c was collected,
A questionnaire was administered to assess Quality of life
ATTD 2017 E-POSTER VIEWING ABSTRACTS
retrospectively pre and one year post pump usage. Follow up
HbA1c was thereby done for all patients and for up to 20 patients
HbA1c data was collected reaching 4 years.
Results:
Conclusions: Our survey suggested improvement in HbA1c
when comparing CSII to MDI with an greater QOL and im-
provement in treatment satisfaction while on pump therapy.
While the survey was basic with several limitation, they mimic
results of pump therapy that has been seen in countries with vast
insulin pump experience and more resources available. This
would suggest that these benefits can also be replicated in
countries with limited resources with small dedicated pump
training centres.
243
AUTOMATIC SUPER-BOLUS AND BOLUS SHAPING
FEATURES FOR INSULIN PUMPS
1 1 2
F. Garelli , N. Rosales , J. Veh , H. De Battista 1 Diabetes, Moscow, Russia
1
LEICI, EE, La Plata, Argentina
2 3
UdG, EE, Girona, Spain
Background and Aims: This work presents a method for
automatic insulin bolus shaping based on residual insulin or
insulin-on-board (IOB) estimation as an extra feature for com-
mercial insulin pumps. Among other potential applications, this
methodology allows the pump to automatically generate the so-
called super-bolus for the compensation of high glycemic index
meals, which has been recently related to the best theoretical
basal-bolus combination for the reduction of glucose excursions
under open-loop treatment.
Methods: The method computes the individual extra amount
of bolus and basal cutoff time from the duration of insulin
action (DIA) of the patient using a physiological compart-
mental model for subcutaneous insulin absorption. Then, by
means of a simple switching law, it automatically reestablishes
basal insulin when IOB reaches its basal level, thus avoiding
unnecessary detrimental transients generated with manual or
a-priori computations.
A-101
Results: The potential of this method, registered on patent and
priority requests, are illustrated via in-silico trials including
intra-patient variability and mixed meals. The table below shows
the time in hyper and hypoglycemia reduction achieved with the
proposed automatic SB with respect to standard treatment for a
cohort of 30 patients facing a high glycemic index mixed meal of
25g, a mixed meal of 50g, and a 75g and 100g of CHO meal.
Conclusions: A novel automatic algorithm for open-loop
treatment is introduced, based on the super bolus treatment and
the IOB profile of the patient. This algorithm can be easily loaded
into any medical device software and depends only on the DIA of
the patients.
244
EFFECT OF DIFFERENT TYPES OF INSULIN
THERAPY ON TRANSPLANT STATE, METABOLIC
CONTROL IN PATIENTS WITH TYPE 1 DIABETES
AFTER KIDNEY TRANSPLANTATION
A. Glazunova1, E. Tarasov1, M. Shamkhalova1, G. Musaeva2,
M. Shestakova1,3, Y. Moysyuk4
1
Federal Endocrinology Research Centre, Institution of
2
I.M. Sechenov First Moscow State Medical University,
Institution of Ophthalmology, Moscow, Russia
I.M. Sechenov First Moscow State Medical University,
Institution of Diabetes, Moscow, Russia
4
Moscow Regional Research and Clinical Institute MONIKI,
Institution of Trasplantology, Moscow, Russia
Background and Aims: To evaluate the impact of different
types of insulin therapy (continuous subcutaneous insulin infusion
(CSII) using insulin pump or multiple insulin injections (MII)) on
carbohydrate metabolism, the state of the transplant in patients with
type 1 diabetes (DM1) after kidney transplantation (KT).
Methods: The study included two groups of patients with DM1
after transplantation: 1) 21 patients treated with CSII; 2) 20 with MII.
Mean duration of diabetes in the first group was 25 years[20.5;34.5],
the second group - 24.5 years [20;30]. Posttransplantation period
in both groups was comparable: 8.0[7.0;36.0] and 7.5 [7.0:19.0]
months.
Results: The mean level of glycated hemoglobin (HbA1c)
in groups before the study did not differ: 9.0%[8.0;9.6] and
9.0%[8.7; 9.8]. When patients were transfer into CSII-HbA1c
A-102
was significantly lower in this group after 12 months: 7.3% [7.3;
8.6] (p < 0.00001), while in the MII group: 8.1%[7.5;8.7]
(p < 0.03). Recurrent diabetic nephropathy at the stage of
microalbuminuria was diagnosed in 20% in the MII-group
with continuing poor glycemic control (ratio albumin/creatinine
>30mg/g). All patients, treated CSII had normal albuminuria.
GFR(CKD-EPI): 86 [68.4;101]ml/min/1.73 m2 in CSII-group
107[91;130]ml/min/1.73 m2 - MII group (p < 0.05). Positive of
hemoglobin, parathyroid hormone and blood pressure dynamics
did not differ in the groups after KT.
Conclusions: The CSII using insulin pump allows to reach
target values faster and more efficiently, CSII seems to be more
effective than MII in reducing glycemic variability (Table 1), and
this improving the control of complications and overall prog-
nosis in patients with DM1 after KT.
245
EFFICACY, SAFETY AND MATERNOFETAL
OUTCOMES IN 34 PREGNANT WOMEN WITH TYPE 1
DIABETES (T1D) IN SENSOR AUGMENTED PUMP
THERAPY (SAPT)
A.M. Gomez Medina1, D.C. Henao Carrillo1, L.M. Marn
Carrillo1, M. Rondon1, J.L. Silva Herrera1
1
Pontificia Universidad Javeriana, Hospital San Ignacio-
Unidad de Endocrinologa, Bogota, Colombia
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Background and Aims: Pregnancy in women with T1D is
associated with increased risk of maternal complications, neo-
natal morbidity and mortality. Optimizing glycemic control
improves all of these outcomes.
Objective: To assess the efficacy and safety of SAPT in
pregnant women with type T1DM and to describe maternofetal
outcomes
Methods: Observational prospective cohort from August
2009 until November 2015 of 34 pregnant women with T1D who
started SAPT before or during pregnancy. The main indication
was severe hypoglycemia and poor glycemic control.
Results: 34 pregnant women with T1D on SAPT were in-
cluded. Mean preconceptional A1c was 8.24% 2.02. 20% of
pregnancies were planned. 17 patients started SAPT at 17.6 8.3
weeks. Absolute reduction of A1c level from pre-pregnancy to
third trimester was -1.72% (p < 0.0001), without differences
between the women who initiated SAPT during the pregnancy.
52% of patients in second trimester and 66.6% in third trimester
achieved A1c <6.5% respectively. Maternal and fetal outcomes:
91.1% underwent cesarean section. The main reasons were it-
erative cesarean (30%), fetal distress (20%), and pre-eclampsia
(16%). 35.9 weeks was the mean gestational age at delivery
and 15 pregnancies resulted in preterm delivery. There were no
maternofetal mortalities and no severe hypoglycemic episodes.
Two patients had diabetic ketoacidosis (DKA), none of them
required hospitalization in ICU.
Conclusions: SAPT is a safe alternative of treatment in
pregnant patients with T1D, which allows achieving goals of A1c
without severe maternal hypoglycemia or increase in DKA, no
matter the time of the beginning of the therapy.
246
HISTOPATHOLOGICAL AND MOLECULAR
ANALYSIS OF ADIPOSE TISSUE AFTER CSII
CATHETER IMPLANTATION: STEEL VERSUS
TEFLON
J.R. Hauzenberger1, J. Munzker1, P. Kotzbeck1, M. Asslaber2,
V. Bubalo3, J.I. Joseph4, T.R. Pieber1
1
Medical University of Graz, Internal Medicine, Graz, Austria
2
Medical University of Graz, Pathology, Graz, Austria
3
Medical University of Graz, Biomedical Research, Graz,
Austria
4
Thomas Jefferson University, Anesthesiology, Philadelphia,
USA
Background and Aims: Choice of CSII catheter material is
mostly based on personal experience or preference, since pro-
found molecular studies of tissue response are lacking. Previous
studies have used patient questionnaires to evaluate the ad-
vantages of Teflon over steel or vice versa. In this study we
evaluated the adipose tissue response over 7 days of wear time
to commercially available Teflon and steel insulin infusion
catheters using standard histopathological staining methods
and qPCR.
Methods: CSII catheters (Quick-set and SureT) were inserted
into the subcutaneous adipose tissue of 10 swine for 7 days,
4 days and 1 day of wear-time. Tissue surrounding catheters was
excised and stained to determine morphological changes, fibrosis
and mononuclear cell infiltration. Quantitative real-time PCR
was carried out to determine changes in cytokine and inflam-
matory cell marker gene expression.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Results: Steel causes substantially more bleeding and there-
fore fibrin deposition compared to Teflon. Infiltration of
neutrophils is significantly higher and the inflamed area is
40% larger around steel than around Teflon. IL-6 is immedi-
ately upregulated inducing macrophage differentiation, that
constantly increase in number over 7 days independent of
material.
Conclusions: Our study design allowed for an adequate trend
analysis beyond the clinically recommended wear-time of CSII
catheters. Data showed a trend towards worse immunological
outcomes for steel sets for all characteristics analyzed. However,
more research is needed to confirm our findings.
247
PSYCHOSOCIAL RISK AND INSULIN PUMP THERAPY
IN CHILDREN WITH TYPE 1 DIABETES IN IRELAND
E. Hennessy1,2,3, C. Cronin1, A. Bradfield1, O. Neylon4,
A. Khan5, D. Bux6, P. Leahy3, S. OConnell1, S. ORiordan1,2,3
1
Cork University Hospital, Paediatrics and Child Health, Cork,
Ireland
2
HRB, Clinical Research Facility - Cork, Cork, Ireland
3
University College Cork, Department of Paediatrics, Cork,
Ireland
4
Sligo General Hospital, Department of Paediatrics, Sligo,
Ireland
5
Tralee General Hospital, Department of Paediatrics, Tralee,
Ireland
6
Waterford University Hospital, Department of Paediatrics,
Waterford, Ireland
Background and Aims: Psychosocial factors may be essen-
tial in explaining poor glycaemic control in children with Type 1
diabetes (T1D).
Aim is to examine the psychosocial risk and the risk for
emotional distress in children with T1D.
Methods: The Risk Index for Poor Glycaemic Control
(RI-PCG) is the screening tool to assess psychosocial risk
(low risk score 0-1, moderate = 2, high risk 3), contains so-
cial and psychological subscales. The Paediatric Index of
Emotional Distress (PI-ED) was used for emotional distress
assessment.
Results: 103 children with T1D (53 males) aged 318 years
(mean 12.3 3.4) were analysed. 63.5% of patients had low risk
on the RI-PGC, moderate - 15.7%, high - 20.8%. 8.7% of patients
were at high risk for emotional distress, mainly female (91.3%),
p < 0.03. There was a significant correlation between higher RI-
PGC scores and higher PI-ED scores, p < 0.002.
30% of patients were on continuous subcutaneous insulin in-
fusion (CSII): age 11.5 4, duration of T1D 5.3 3.3, HbA1c
64.1 9.6. 72.4% of CSII patients had a low risk on the RI-PGC,
27.6% were at moderate and high risk. 8.3% of CSII patients
were at high risk for emotional distress. Psychological subscale
of RIPGC showed lower risk in CSII patients compare to patients
on multiple daily injections (p < 0.05).
Conclusions: High psychosocial risk is associated with
emotional distress. Risk for emotional distress is higher in
females with T1D. Psychological risk for poor control is re-
duced in children on CSII. The ability to predict higher risk of
diabetes related complications and psychological distress
would allow for early intervention by trained clinical Psy-
chologist.
A-103
248
USE OF TECHNOLOGICAL FEATURES OF INSULIN
PUMPS AS PREDICTORS OF GLYCAEMIC CONTROL
IN PATIENTS WITH CSII THERAPY
N. Hermanns1, B. Kulzer1, T. Haak1, D. Ehrmann1
1
Research Institute Diabetes FIDAM, Research Institute of the
Diabetes Academy Mergentheim, Bad Mergentheim, Germany
Background and Aims: Technological features of CSII
therapy comprise temporal basal rates, different basal rate pro-
files, use of bolus calculators, and bolus variants. In addition,
real-time CGM data as well as computerized analysis of glucose
data can be used to adjust insulin pump therapy. In this study, the
associations between the frequency of use of these technological
features and glycaemic control were analysed.
Methods: Stepwise linear regression analysis with HbA1c as
dependent variable was performed. Independent variables were
the frequency of use of the technological features mentioned
above. Patients indicated the frequency of use per week of those
features on a five-point Likert scale (0-not at all, 1-less than once
per week, 2-at least once a week, 3-several time per week, 4-
every day).
Results: 150 patients participated in the study (99.3% with
type 1 diabetes, mean HbA1c: 8.3 0.8%). The most frequently
used feature was the bolus calculator with a mean score of
2.7 1.8, followed by use of bolus variants (1.6 1.5); temporal
basal rates (1.4 1.3) and basal profiles (0.6 1.5) were rarely
used. The stepwise regression retained only use of basal rate
profiles as well as computerised analysis of glucose as significant
predictors of glycaemic control (b = -0.17, p = .04; b = -0.20,
p = .02).
Conclusions: Patients used the technological features of their
insulin pump rather rarely. More frequent use of different basal
rate profiles and systematic analysis of glucose profiles were
associated with better glycaemic control. Patients should be
better educated how to interpret their glucose data and make use
of the benefits of the technological features of their insulin pump.
249
DOSING ACCURACY AND BOLUS DELIVERY TIME
OF SIX DIFFERENT INSULIN PUMPS
U. Kamecke1, G. Freckmann1, C. Haug1, R. Ziegler2
1
Institut fur Diabetes-Technologie Forschungs, und
Entwicklungsgesellschaft mbH, an der Universitat Ulm, Ulm,
Germany
2
Diabetes Clinic for Children and Adolescents, Diabetes Clinic
for Children and Adolescents, Munster, Germany
Background and Aims: In insulin pump therapy, bolus doses
are delivered to cover meals and to correct high glucose values.
The aim of this study was to assess precision and trueness of a
10 U bolus delivery and to measure the delivery time of this
bolus.
Methods: In an experimental setting following EN 60601-2-
24, six insulin pumps with different insulin infusion sets (IIS)
were evaluated, Accu-Chek Insight with Accu-Chek Insight
Flex [1] and Accu-Chek Insight Rapid [2], Accu-Chek Spirit
Combo with Accu-Chek FlexLink [3] and Accu-Chek Rapid-
D Link [4], Animas Vibe with Inset II [5], MiniMed
640G with MiniMed Quick-set [6], mylife OmniPod [7],
A-104
Paradigm Veo with MiniMed Mio [8], MiniMed Quick-
set [9], and MiniMed Sure-T [10]. Insulin pumps were in-
stalled with the tip of the cannula in a water-filled beaker placed
on an electronic balance. To avoid evaporation, an oil film was
applied. After a run-in period, 12 successive 10 U boluses were
delivered and weighed individually. Each combination of insulin
pump and IIS was tested 9 times. In addition, time for insulin
delivery was recorded with a stopwatch. For insulin pumps with
adjustable speed, all possible settings were tested.
Results: The accuracy assessment showed deviations from the
target dose from -4% to +8% for discrete single boluses. Time to
deliver 10 U bolus doses ranged from 19 sec to 6:39 min for the
different models.
Conclusions: For 10 U bolus doses, delivery accuracy was
reliable for all tested insulin pump systems. Delivery time,
however, strongly varied among the different insulin pumps.
250
CONTINUOUS INSULIN DELIVERY IN A PATIENT
WITH MAURIAC SYNDROME
M. Kocova1, E. Sukarova-Angelovska1, L. Gigova1
1
University Childrens Hospital, Endocrinology & Genetics,
Skopje, FYR Macedonia
Background and Aims: Introduction. Mauriac syndrome is
rare in children with type 1 diabetes who are under inappropriate
control. It consists of dwarfism, hepatomegaly and cushingoid
appearance. We present a boy at 13.5 years with a typical clinical
presentation of Mauriac syndrome.
Methods: Case report. The boy was diagnosed with diabetes
at 5 years of age. He was started on multiple injection therapy
with insulin. However, due to the social circumstances, the boy
start early self- injecting insulin, receiving many additional
doses in order to eat frequent meals. His visits to the diabetol-
ogist were rare. At the age of 13.5 years he was evaluated for the
short stature falling from 25%o to -3SD. Moon face, prominent
abdomen, hepatomegaly (6 cm) was noticed. He was pre-
pubertal.
Results: His HbA1c was 11.87% (106 mM/mol). CGM showed
large glucose variations. Fundoscopy revealed normal retina.
Thyroid hormones and antibodies as well as transglutaminase an-
tibodies showed normal values. Hepatic enzymes AST, ALT and
ATTD 2017 E-POSTER VIEWING ABSTRACTS
GGT were all elevated (265, 188 and 74 U/L respectively). Bone
age was delayed (-3.2 SD). GH was low (peak 1.48 ng/ml). GnRH
test was normal. After extensive education continuous insulin de-
livery was initiated. Hepatomegaly disappeared after 3 months and
CGM showed improved glucose measurements. After 6 months
HbA1c decreased to 7.1% and he gained 6 cm in height. cushingoid
appearance completely resolved.
Conclusions: Although the knowledge about the etiology of
Mauriac syndrome is limited, careful continuous insulin delivery
via insulin pump can be a solution. Close follow up of this patient
is warranted.
251
IDENTIFYING PATIENTS WITH TYPE 2 DIABETES
AT RISK FOR HYPOGLYCEMIA, AMONG THOSE
TREATED WITH LONG-ACTING INSULIN ANALOGS
B. Kovatchev1, Z. Meng2, M. Breton1, B. Leroy3, A. Cali3
1
Center for Diabetes Technology, University of Virginia,
Charlottesville, VA
2
Sanofi, Bridgewater, NJ
3
Sanofi, Paris, France
Hypoglycemia does occur in type 2 diabetes, particularly in
patients using insulin. Twenty years ago we introduced the Risk
Analysis of blood glucose (BG) data1 to quantify the extent and
frequency of hypo- and hyperglycemia. Over the years, its utility
has been repeatedly confirmed, and the Low BG Index (LBGI)
was established as a powerful predictor of severe hypoglyce-
mia2. The objective of this reanalysis is to identify patients re-
porting symptomatic hypoglycemia (SH) during pivotal trials of
Toujeo (insulin glargine 300 Units/mL).
Self-monitoring (SMBG) daily profiles were available from
two multicenter trials: EDITION 2 (N = 802 patients, 44,787
SMBG readings, 699 SH episodes) and EDITION 3 (N = 869
patients, 47,817 SMBG readings, 236 SH episodes). Both ran-
domized their participants to Toujeo or Lantus (insulin glar-
gine 100 Units/mL); for this analysis, the data was pulled across
the two types of insulin. The LBGI was computed for each person.
Among several measures of glucose variability (e.g. Standard
Deviation, Coefficient of Variation), the LBGI was the only metric
significantly correlated with SH: r = 0.38, p1.1) experienced 6-fold
more symptomatic hypoglycemia than those at minimal risk
(LBGI 1.1): 3.74 vs. 0.63 SH episodes per person.
While EDITION 2 and EDITION 3 had different frequencies
of hypoglycemia, the LBGI detected patients at risk uniformly
well across the two studies. Thus, symptomatic hypoglycemia is
predictable during treatment with long-acting insulin.
252
PAQ, A SIMPLE, WEARABLE THREE-DAY BASAL/
BOLUS INSULIN DELIVERY DEVICE, DESIGNED
FOR DISCREETNESS
C. Kuerschner1, L. Lilly1, J. Warner1
1
CeQur, Marlborough, USA
Background and Aims: Peyrot, et. al. revealed that >50%
of patients on insulin reported skipping injections. Embarrassment
was one of the most common factors contributing to these
ATTD 2017 E-POSTER VIEWING ABSTRACTS A-105

omissions. To decrease this, as well as other barriers to insulin devices on intended users to confirm these findings and their
therapy, CeQur designed a body worn device, PAQ, to deliver effect on user acceptance.
both basal and bolus insulin for 3-days. Feedback received from
adults with diabetes during PAQ development was the importance
of discreetness and a key variable to consider was non-detectability 253
under clothing. To this end different colors of the PAQ device were
tested for detectability when worn under clothing. WHOSE DECISION IS IT? DECISION COACHING
Methods: A white colored PAQ and a gray colored PAQ were WITH A PATIENT DECISION AID IN YOUTH AND
placed on a body form with a dark and a medium skin tone. A THEIR PARENTS TO IDENTIFY THE RIGHT INSULIN
thin, white t-shirt was placed on the body form covering the DELIVERY METHOD FOR THEM
devices. Participants were shown the forms and asked to choose M. Lawson1, A.L. Shephard2, B. Feenstra3, L. Boland3,
the most noticeable device color. The device labels were dif- N. Sourial4, D. Stacey5
ferent for each skin tone to prevent selection bias.
1
Childrens Hospital of Eastern Ontario, Endocrinology
and Metabolism, Ottawa, Canada
2
Childrens Hospital of Eastern Ontario Research Institute,
Clinical Research Unit, Ottawa, Canada
3
University of Ottawa, Faculty of Health Sciences, Ottawa,
Canada
4
McGill University, Epidemiology, Montreal, Canada
5
Ottawa Hospital Research Institute, Clinical Epidemiology,
Ottawa, Canada

Background and Aims: To evaluate the effect of decision

coaching with a decision aid on decisional conflict and satis-
faction for youth and parents considering a change in insulin
delivery method (standard regimen vs. MDI vs. CSII).
Methods: Pre-post test design. Pediatric diabetes social work-
ers were trained to provide decision coaching through an online
tutorial and skill-building workshop. Youth and parent(s) con-
sidering a change in the youths insulin delivery method were
referred for decision coaching by their physician. Decision
coaches used the Ottawa Family Decision Guide pre-populated
for insulin delivery options. Data were collected prior to decision
coaching (T1) and 10-14 days post (T2). Primary outcome was
decisional conflict measured with the Decisional Conflict Scale
(DCS), compared at T1 and T2 using a paired t-test. Other out-
comes: choice predisposition vs. actual choice (T1&T2) and
satisfaction with coaching questionnaire (T2).
Results: 45 families participated, each consisting of 1 youth and
1-2 parents. Youth (n = 45), 56% male, mean age 12.5 2.9 (SD)
years (range 6.3-17.7). Parents (n = 66), 38% fathers. Coaching
sessions averaged 54.8.2 8.8 minutes. Mean youth DCS de-
creased from 32.0 19.7 (T1) to 6.6 12.2 (T2) (p < 0.0001).
Parent DCS decreased from 37.6 20.7 (T1) to 3.5 7.4 (T2)
(p < 0.0001). Between T1 and T2, there were changes in choice
predisposition for parents and youth. 89.2% of youth and 94.3% of
parents rated the coaching session as balanced and 94.6-98.1%
would probably/definitely recommend it to others.
Conclusions: Decision coaching with a decision aid reduced
decisional conflict for youth and parents facing a preference-
sensitive insulin delivery decision with high satisfaction ratings
from youth and parents.

254
Results: Thirty adults with diabetes taking at least two in- PAQ INSULIN DELIVERY DEVICE SIGNIFICANTLY
jections per day of insulin participated, 55% male, mean age 52 INCREASES THE PERCENTAGE OF TIME IN TARGET
years with a BMI of 31.7 kg/m2. The majority of the participants RANGE
(28/30, 93%) chose the white PAQ as more noticeable on both L. Lilly1, J. Mader2, F. Aberer2, J. Warner1, T. Augustin3
the dark and medium skin tone.
1
Conclusions: A gray colored PAQ may provide a more dis- CeQur, Clinical Research, Marlborough, USA
2
creet insulin delivery option for adults with diabetes with dif- Medical University of Graz, Department of Internal Medicine,
ferent skin tones. Additional studies will be conducted with Graz, Austria
A-106 ATTD 2017 E-POSTER VIEWING ABSTRACTS

3
JOANNEUM RESEARCH Forschungsgesellschaft mbH,
HEALTH - Institute for Biomedicine and Health Sciences, Graz,
Austria

Background and Aims: Data suggest not only is HbA1c <

7.0% desirable, but increasing time in target range and mini-
mizing glycemic variability is of importance.
Methods: Twenty adults with type 2 diabetes with HbA1C
7.0 11.0% on established regimen of insulin therapy (2
injections/day) other glucose lowering agents were enrolled
into a single center, single arm, treat to target study evaluat-
ing PAQ. PAQ is a simple body worn 3-day insulin deliv-
ery device which provides continuous basal and bolus insulin
on demand. The study comprised three periods: baseline
(insulin injections), transition to PAQ and PAQ treatment
(12-weeks). Five subjects wore a continuous glucose moni-
toring device for 1 and 2 weeks during baseline and PAQ
treatment periods; respectively. Endpoints HbA1c, per-
centage of time (%oT) in target, and glucose variability (SD Results: Changing the insulin preparations and increasing the
and rate of change). insulin dosage up to 160 U/day failed to decrease the skin reac-
Results: Mean HbA1c decreased from 8 to 7.1% following 12 tions, nor improved glycemic control. Once intervention with an
weeks of PAQ. After Week 8 of PaQ the %oT in target range [70- insulin pump (MiniMed Paradigm VEO) started, the skin le-
180 mg/dL] increased from 50.8% to 70.4% (P < 0.001), the %oT sions disappeared. Also a dramatic improvement with HbA1c
<70 mg/dL was unchanged from 0.24% to 0.38% (P < 0.085), resulted with a decrease in insulin dosage (Fig. 2).
mean SD of all glucose readings decreased from 181 (17) mg/dL
to 161 mg/dL (14) (P = 0.041), and the rate of change in glucose/
hour (07:00-21:50) decreased from 18.50 (5.26) to 13.19 (2.10)
(P = 0.058).
Conclusions: Insulin delivery with PAQ resulted in a decrease
in HbAc, an increase in the percentage of time in target, reduced
glycemic variability and did not result in increased hypoglyce-
mia. Additional studies are needed to confirm this effect.

255
INSULIN SKIN REACTION AND SUBCUTANEOUS
INSULIN RESISTANCE SOLVED BY INSULIN PUMP
(CSII) IN A 63-YEAR-OLD FEMALE WITH TYPE 2
Conclusions: While the mechanisms are not fully understood,
DIABETES MELLITUS: A CASE REPORT
this case report findings suggest that CSII, by delivering smaller
P. Massucco1, L. Spadafora2, K. Bonomo1, O. Cohen3, intermittent boluses of insulin, may be more rapidly and con-
F. Cavalot1, A. Guerrasio1 tinuously absorbed increasing efficiency of the insulin and de-
1 creasing the allergic skin reaction. Another plausible explanation
S. Luigi Gonzaga University Hospital- Orbassano Turin,
is that pump therapy might decrease insulin degradation at the
Department of Internal Medicine- Diabetes Unit-, Orbassano
inflamed site, decreasing subcutaneous insulin resistance. Here,
Turin, Italy
2 CSII resulted in a dramatic and persistent reduction in HbA1c,
Internal Medicine School, University of Turin- Italy, Turin,
far beyond the expected improvement deriving only from
Italy
3 switching to CSII, indicating that this injection modality might
Institute of Endocrinology, Ch. Sheba Medical Center, Tel
have an effect both on the local inflammatory response and the
Hashomer, Israel
responsiveness to insulin.
Background and Aims: While insulin-induced skin reac-
tions have become less common, since the advent of recombinant
insulin, the use of modified insulins may still induce adverse 256
local/systemic reactions. CSII has been described in several case
reports and has shown many beneficial effects, therefore, be- ONLINE SURVEY ON PERCEPTIONS AND ISSUES
coming a recommended therapeutic option. The following de- WITH CONTINUOUS SUBCUTANEOUS INSULIN
scribes the effect intervention with an insulin pump on one Type INFUSION THERAPY IN ADULTS WITH TYPE 1
2 Diabetic mellitus (T2D) patients skin reaction and glycaemic DIABETES
control. N. Taleb1, V. Messier1, J. Rene1, S. Ott-Braschi2, J. Pickup3,
Methods: A delayed local cutaneous reaction at insulin in- J.L. Ardilouze4, R. Rabasa-Lhoret1
jection sites with concurrent central necrosis (Fig.1) is described
1
in a 63-year-old female with poorly controlled T2D on warfarin Institut de recherches cliniques de Montreal, Metabolic
treatment for atrial fibrillation. Diseases, Montreal, Canada
ATTD 2017 E-POSTER VIEWING ABSTRACTS
2
Centre Hospitalier de lUniversite de Montreal,
Endocrinology, Montreal, Canada
3
Kings College London, Diabetes & Nutritional Sciences,
London, United Kingdom
4
Universite de Sherbrooke, Medicine, Sherbrooke, Canada
Background and Aims: We conducted an online survey to
identify the perceptions and problems experienced by adults with
type 1 diabetes (T1D) who use continuous subcutaneous insulin
infusion therapy (CSII).
Methods: Participants (n = 86, women: 76%, age: 41 13 years,
T1D for 22 12 years, CSII use for 6 4 years, mean catheter
replacement every 3.3 days) completed a 39-item questionnaire.
Results: With CSII usage, improved glucose control and de-
creased number/severity of hypoglycemic episodes were per-
ceived by 79% and 68%/50% of patients, respectively. In the last
year: 1) most participants reported no increase in anxiety/worry
(89%), no negative impact on life or family schedule (95%) or on
time off from work/school (86%) related to CSII; 2) however,
participants reported numerous technical problems at infusion site
[pain (49%), irritation/itchiness (40%), build-up of fat/lumpiness
(34%), infection/inflammation (16%)] and with catheters [block-
age (39%), kinking (38%), bubbles/air pockets (26%), and leakage
(11%)]. Only 11% of patients did not report any catheter related
problems in the last year.
Conclusions: Patients using CSII positively perceived key
aspects of diabetes control but also reported a high frequency of
infusion site/catheter issues. The frequency of CSII infusion site/
catheter issues is probably underestimated and warrants further
attention by health professionals and manufacturers.
257
TIMING OF PRE-EXERCISE BASAL INSULIN
INFUSION RATE REDUCTION TO PREVENT
EXERCISE-INDUCED HYPOGLYCEMIA IN ADULTS
WITH TYPE 1 DIABETES USING INSULIN PUMP
THERAPY
V. Messier1, A. Roy-Fleming1, C. Suppere1,
C. Cameli2, S. Elbekri3, M. Smaoui4, L. Legault5,
R. Rabasa-Lhoret1
1
Institut de recherches cliniques de Montreal, Metabolic
diseases, Montreal, Canada
2
Universite de Rennes 1, Medicine, Rennes, France
3
Universite de Montreal, Medicine, Montreal, Canada
4
McGill University, Biomedical engineering, Montreal, Canada
5
Montreal Childrens Hospital, Endocrinology, Montreal,
Canada
Background and Aims: Regular exercise should be encour-
aged in most patients with type 1 diabetes (T1D) but is mainly
limited by fear of hypoglycemia. To reduce the risk of exercise-
induced hypoglycemia, two types of adjustment may be con-
sidered: insulin dose reduction and/or carbohydrate supplements.
Insulin pump therapy (CSII) offers flexibility using temporary
insulin infusion rate reduction. Few studies have investigated the
pre-exercise optimal timing at which patients should implement
insulin infusion reduction to prevent exercise-induced hypogly-
cemia. The objective of this study was to compare the efficacy of
different pre-exercise timing for an 80% insulin infusion rate
reduction to prevent exercise-induced hypoglycemia in adults
with T1D using CSII.
A-107
Methods: Participants performed an afternoon 45-minute
exercise at 60% of VO2peak on an ergocycle 3 hours after the last
meal. In a random order, insulin infusion rate was reduced at the
time of exercise, 20 minutes or 40 minutes before. Capillary
glucose levels were measured at the onset of exercise, 15 minutes
after the onset of exercise and then every 5 minutes until the end
of exercise.
Results: There was no significant difference between the
three strategies for time spent below 4 mmol/L, time spent be-
tween 4 and 10 mmol/L and decrease in glucose levels. The
number of hypoglycemic events below 3.5 mmol/L was 2, 7 and
5 when insulin infusion rate was reduced 40 minutes before
exercise, 20 minutes before exercise and at the time of exercise,
respectively.
Conclusions: Earlier timing and/or larger insulin infusion rate
reduction should be tested in a larger group of patients.
258
IMPROVING PATIENTS CARE IN DIABETES
USING TECHNOLOGY-INSULIN PUMP
SERVICE, THE DARENT VALLEY
HOSPITAL EXPERIENCE
G. Mlawa1,2, D. Affam1, A. Ogunko1, C. Eboh1
1
Darent Valley Hospital, Endocrinology & Diabetes, Kent,
United Kingdom
2
Queens Hospital, Acute Medicine/Endocrinology & Diabetes,
London, United Kingdom
Background and Aims: Diabetes patients have to be offered
high quality care and evidence-based diabetes treatment in-
cluding insulin pumps.
Insulin pump therapy is recommended for adults and children
over the age of 12, with type 1 diabetes with recurrent disabling
hypoglycaemia or poorly controlled diabetes despite being on
multiple daily injections.
The aim of this study was to measure the practice in our
Hospital in the use of insulin pumps for treatment of diabetes and
whether it is in keeping with NICE guidelines.
Methods: This was a retrospective study from November
2015 to January 2016.
The following demographic data were recorded: Age, Gender,
Duration on insulin pump. Patients commenced on insulin
pump at the preconception clinic, during pregnancy and paedi-
atric clinics.
INCLUSION CRITERIA:
Disabling hypoglycaemia
Poorly controlled diabetes with persistent high HbA1c
>8.5%(69mmol/mol) despite multiple daily injections
Insulin initiated by trained specialist team
Structured education to patient
Results: 80 patients were identified, aged 16 or over
Data source: patients notes, Diabeta3 (vectra) software
available in the diabetes department
98%(79) had type 1 diabetes, 1.25%(1) type 2 diabetes
13%(11) commenced insulin pumps from other European
countries, or other Hospitals in UK.
12%(10) commenced insulin pumps in pediatric age for poor
glycaemic control.
5%(4) started insulin pump during pregnancy (poor control/
hypoglycaemia).
34 were females, and 46 males.
A-108 ATTD 2017 E-POSTER VIEWING ABSTRACTS

Conclusions: Insulin pump therapy at Darent Valley Hos-
pital was initiated by specialist team and in keeping with the
guidelines.
Insulin pump therapy resulted in improvement in hypogly-
caemic episodes in 50% of patients, while 36%% had sustained
improvement in HbA1c.
Insulin pump may be offered in type 2 diabetes patients with
high insulin requirements.
Methods: Observational prospective study conducted on a
group of 28 type 1 diabetic patients (14 men), with an average age
of 42.6 9.4 years, treated with CSII, and with 5 years of follow up.
We compared the change in metabolic control, glycemic var-
iability (defined by standard deviation), hypoglycemic events and
insulin dose at baseline, 1 and 5 years after initiation of treatment.
Descriptive statistic was expressed as mean SD. A p value
<0.05 defined the level of statistical significance.
Results:

259 Baseline 1 year Sig* 5 years Sig**

FOUR-YEARS BASAL BOLUS THERAPY HbA1c (%) 8,7 1,7 7,9 1,1 p = 0,05 7,8 0,9 ns
Mean Glucose 175,9 44,3 169,6 39,6 ns 171,3 36,6 ns
IN PEDIATRIC PATIENTS WITH TYPE 1 (mg/dl)
DIABETES MELLITUS Standard 97,4 40,5 75,1 19,9 p = 0,032 79,1 22,6 ns
Deviation
1 1 1 1
E. Mozzillo , P. Buono , A. Casertano , A. De Matteis , (mg/dl)
S. Mobilia1, V. Fattorusso1, A. Franzese1 Hypoglycemic 13,8 8,9 11,4 6,2 ns 9,1 6,2 ns
events
1
Federico II University of Naples, Translational Medical 1 month (%)
Severe 28 6 ns 2 ns
Science, Naples, Italy hypoglycemia
1 year (n)
Background and Aims: Basal-bolus insulin therapy simulates Total insulin 49,7 21,6 40,8 18,1 p = 0,015 43,7 17,9 ns
dose (IU)
physiological pancreatic secretion of the hormone. Aim of this
study is to analyze the effects of a four-years basal-bolus insulin- * Baseline 1 year ** 1 year 5 years
therapy in T1DM pediatric patients treated by insulin pump (CSII
group) or multiple daily injection therapy (MDI group: 3 injections
Conclusions: After 1 year of follow up we observed that CSII
of rapid/analogue insulin as bolus, glargine at bed-time as basal).
therapy has provided a significant improvement in metabolic
Methods: 82 T1DM outpatients (M 40, age 10.5 3.7 years, 41
control, glycemic variability and decrease insulin dose. Hy-
CSII-group), in Pediatric Diabetes Center of University of Naples
poglycemia, events have been reduced during the first year of
Federico II, were enrolled in the study; patients with onset of
treatment.
T1DM <1 year have been excluded. Glycated hemoglobin
The improvements obtained with CSII during first year remain
(HbA1c%), Body Mass Index (BMI) z-score, Units/Kg/day of in-
without significant changes after 5 years of follow-up.
sulin administered as basal and Units/Kg/day of insulin adminis-
tered as bolus were evaluated at the beginning of the study and after
1, 2, 3 and 4 years of the same therapy. No patient dropped.
Results: Mean HbA1c% value remains stable in both groups; 261
Mean BMI z-score increases during follow-up in both groups;
Units/Kg/day of basal insulin show statistically significant in- GLYCEMIC CONTROL AMONG CSII USERS
crease in MDI-group; while only during first two years of follow- AFTER 5 YEAR SUPERVISION IN ROUTINE
up in CSII-group; Units/Kg/day of bolus insulin remain stable CLINICAL PRACTICE
during follow-up in MDI-group and increase in CSII-group. L. Ibragimova1, Y. Philippov1, A. Mayorov1
Conclusions: In conclusion CSII-long term therapy doesnt
1
seem to show advantages compared to MDI therapy. Endocrinology Research Centre, Institute of Diabetes,
Moscow, Russia

Background and Aims: In clinical studies continuous sub-

260
SUBCUTANEOUS CONTINUOUS INSULIN INFUSION
IN TYPE 1 DIABETIC PATIENTS: GLYCEMIC
CONTROL AFTER 5 YEARS OF FOLLOW-UP
M. Pazos-Couselo1, M. Gonzalez-Rodrguez1, F. Casanueva1,
J.M. Garca-Lopez1
1
University Hospital Santiago de Compostela, Endocrinology
and Nutrition Service, Santiago de Compostela, Spain
Background and Aims: Subcutaneous continuous insulin
infusion (CSII) therapy has been associated with an improvement
in the HbA1c, lowering glycemic variability and hypoglycemic
events. This improvement is achieved approximately after 1 year
of treatment.
The aim of our study is to measure if the improvement of the
metabolic control remains after 5 years of treatment.
cutaneous insulin infusion (CSII) leads diabetes mellitus patients
to have better glycaemic control. But in real-life routine clinical
practice positive effects of CSII can disappear.
The aim of the study was to assess glycaemic control among
CSII users in routine clinical practice.
Methods: This 5 years observational study included type 1
diabetes mellitus users of CSII. We selected patients who were
transferred from multiple daily injections to CSII in our research
centre with special education and long-term supervision by en-
docrinologist (during 4 months after transferring to CSII). The
next 5 years all patients were followed up by endocrinologists in
routine clinical practice and didnt come to our research centre or
insulin pump specialists. We have analyzed glycaemic control:
before CSII initiation, after 4 months of supervision and after 5
years of routine real-life care.
Results: In preliminary part of our study we have analyzed
data from 17 patients. 4 months after transferring to CSII HbA1c
was significantly lower compared to a basic level (7.8% [7.0;
ATTD 2017 E-POSTER VIEWING ABSTRACTS
8.1] vs 8.5% [7.5; 9.5]) p < 0.0001. 5 years later the HbA1c was
significantly higher compared HbA1c 4 months after transfer-
ring to CSII (8.1% [7.7;9.1] vs 7.8% [7.0; 8.1], p < 0.01), and we
did not find significantly differences between basic HbA1c and
HbA1c 5 years after transferring to CSII (p > 0,05). In contrast,
glucose variability (SD) didnt change significantly between 4
months and 5 years points: 3.3[2.8; 3.7] vs 3.3[2.7;3.5],
p > 0.05.
Conclusions: Using CSII without regular re-education and
special supervision can damage positive effects of CSII.
262
ROUTINE USE OF CONTINUOUS SUBCUTANEOUS
INSULIN INFUSION IN A COHORT OF TYPE 1
DIABETES PATIENTS ATTENDED IN A DIABETES
REFERENCE UNIT
C. Quiros1, C. Vinals1, V. Pane1, D. Roca1, I. Conget1,
M. Gimenez1
1 engagement, in comparison to previous insulin administration;
Hospital Clnic de Barcelona, Diabetes Unit. Endocrinology
Department, Barcelona, Spain
Background and Aims: Continuous subcutaneous insulin
infusion (CSII) is an increasingly common effective option in
Type 1 Diabetes (T1D) management. Data on its efficacy, safety
and use comes frequently from clinical trials or retrospective
controlled studies. We aimed to analyse the characteristics of the
routine use of CSII in a large cohort of patients attended in a
Diabetes Reference Unit and its relationship with glycaemic
control.
Methods: T1D patients using CSII with either a Veo or
640G Medtronic-Minimed pump linked to a glucometer (Con-
tour Next Link/2.0, Bayer) were included (10% using sensor-
augmented-pump). Data from 14 consecutive days were collected
from uploads in CareLink  software and HbA1c was obtained
from medical records.
Results: Data from 338 subjects with T1D were included (age
43.4 13.1 years; 64.5% females; diabetes duration 27.1 9.9
years, 9.3 4.8 years on CSII, HbA1c 7.7 1.0%). Average daily
basal/bolus insulin ratio was 52.5/47.5%, with a mean of 4.9 3.4
bolus/day (78.9% advised bolus), 6.0 1.8 basal segments/day Hopital Sud-Francilien, Endocrinology and Diabetes, Corbeil
and 3.4 1.5 insulin/CH ratios/day. The number of capillary blood
glucose readings/day (CBG) was 4.4 2.1 (37.9 15.6% <180mg/
dL and 11.4 9.2% <70 mg/dl). Those subjects with an HbA1c
7.5% (55%) performed more CBG (4.9 2.1 vs. 4.0 2.0; p <
0.001), more boluses (5.4 1.9 vs. 4.6 2.2; p < 0.05) and used
more basal segments/day (6.3 2.0 vs. 5.8 1.7; p = 0.002)
Conclusions: CSII use by subjects with T1D in routine clin-
ical care is not far from expected and usually recommended. The
frequency of CBG, bolus and number of basal segments/day
were associated with a better glycaemic control in terms of
HbA1c.
263
WHAT ARE THE FACTORS THAT ENABLE PEOPLE
TO INCORPORATE THE INSULIN PUMP INTO THEIR
EVERYDAY LIVES?
C. Reidy1, A. Rogers1, M. Bracher1, A. Kennedy1, I. Vassilev1
1
University of Southampton, Health Sciences, Southampton,
United Kingdom
A-109
Background and Aims: Insulin pumps, or Continuous Sub-
cutaneous Insulin Infusion (CSII), have been cited as a tech-
nological advancement which can improve quality of life and
biomedical outcomes of people with Type 1 diabetes. A concern is
that such devices may widen health inequality, particularly if up-
take is mostly seen in motivated patients who demonstrate good
self-care behaviours. Understanding factors which enable people to
incorporate CSII could provide an exemplar for the implementa-
tion of new technologies, with an impact on how people manage
their condition and the health service implications.
Methods: A systematic search of seven databases was con-
ducted to identify studies reporting patient experiences of living
with CSII. A critical interpretative synthesis of the evidence was
used to identify domains that are key to successfully incorpo-
rating CSII.
Results: A total of 4,998 titles were identified. We viewed 274
abstracts, reviewed 39 papers and included 21. Studies show that
CSII offers a level of choice, control and flexibility which is
unmet by multiple daily injections. However, CSII is a complex
technology where there is a leap in terms of expectations in
physiologically, practically, psychologically and socially.
Conclusions: Our findings suggest that there are many ben-
efits, but also complex issues to consider when CSII is intro-
duced. There is a potential encumbrance on self-care when
balancing the burdens of a technologically-advanced, intensified,
regimen against its benefits. In order to successfully incorporate
CSII, people need to be able to utilise and access social support
and navigate resources that are tailored to their needs.
264
USE OF REGULAR U-500 INSULIN IN TYPE 2
DIABETES TREATMENT WITH PUMP THERAPY:
A FRENCH TWO CENTER LONG TERM EXPERIENCE
IN 43 PATIENTS
D. Emilie1, H. Juliette1, P. Alfred2, M. Julia1, R. Anne1,
J. Michael1, R. Yves1
1
CHU de Caen, Endocrinology and Diabetes, Caen, France
2
Essonnes, France
Background and Aims: Insulin therapy intensification by
insulin pump is helpful in insulin resistant type 2 diabetes. The
use of concentrated insulin may help improving glycemic control
but few studies are available.1 We report on the utilization of
regular insulin 500 U/ml (Eli Lilly, France) in a pump device
over a 6-yr period.
Methods: Patients on pump therapy with U-100 insulin rapid
acting analogs were recruited in two circumstances: i)
HbA1c>8% and/or insulin dose >100 UI/d. After U-500 therapy
initiation, follow up was performed at 1 week, 3, 6, 12, 18, 24
months then annually for HbA1c, total daily dose (TDD), body
weight, incidence of hypoglycemia, treatment drop off.
Results: 43 patients were included, M/F ratio 24/19, age
62.9 8.3, diabetes duration 19 8 yrs, TDD 205 61 UI/d, BMI
39 6 kg/m2, HbA1c 8.9 1.4%. Mean follow up on U-500 was
21 15 months with 5 drop off. HbA1c decreased by -0.77%
(p = 0.0002), -1.07% (p < 0.0001), -0.94% (p = 0.0009), -0.84%
(p = 0.045) and -1.9% (p = 0.046) at 3, 6, 12, 18, 24 and 36 months.
Body weight and TDD were stable. Non severe hypoglycemia oc-
curred in 23% subjects before U500 and in 48.6%, 45.5% and
A-110
70.6% subjects at 3, 12 and 18 months on U500. No severe hypo-
glycemia occurred.
Conclusions: When insulin resistant type 2 diabetes remains
uncontrolled on pump therapy delivering TDD, U-500 regular
insulin may durably improve glycemic control. Hypoglycemia
may be prevented by careful education of U-500 users.
1. Lane WS. Endocr Pract 2010;16:181-6.
265
CONTRIBUTIONS OF BASAL AND POSTPRANDIAL
HYPERGLYCEMIA IN TYPE 2 DIABETES PATIENTS
TREATED BY AN INTENSIFIED INSULIN REGIMEN:
IMPACT OF PUMP THERAPY IN OPT2MISE TRIAL
Y. Reznik1, A. Habteab2, J. Castaneda2, J. Shin3, M. Joubert1
1
Caen University Hospital, Endocrinology and Diabetes, Caen,
France
2
Medtronic, Bakken Research Center, Maastricht,
The Netherlands
3
Medtronic, Diabetes, Northridge, USA
Background and Aims: The Relative contribution of fasting
and postprandial hyperglycemia in type 2 diabetes subjects
treated by an intensified insulin regimen using multiple daily
injections (MDI) is poorly documented. Our aim was to measure
fasting and postprandial hyperglycemia (HG) in type 2 diabetes
subjects on MDI before randomization in the OPT2MISE study.
We also analyzed the predictive value of these variables on the
metabolic response to CSII.
Methods: We performed an analysis of continuous glucose
monitoring (CGM) recordings after 8-week run-in period in 259
MDI patients. Area under curve (AUC) HG was calculated in the
basal (AUC-B), nocturnal (AUC-N) and postprandial (AUC-PP)
periods according baseline HbA1c level (Gr1 :<8, Gr2 :8-8.5,
Gr3 :8.5-9, Gr4 :9-9.5, Gr5 :>9.5%). Changes were analyzed in
131 subjects switched from MDI to CSII. Analysis of variance
was used for comparisons between groups.
Results: AUC-B was 27.5% to 121% higher in Gr5 vs Gr4 to
Gr1 (p = 0.0001). AUC-N was 18.5% to 93% higher in Gr5 vs
Gr4 to Gr1 (p = 0.0001). Conversely, AUC-PP did not differ
between groups HbA1c9.5% vs <9.5% (p = 0.72). HbA1c cor-
related with AUC-N (R = 0.32, p = 0.001) AUC-B (R = 0.31,
p = 0.0001) and AUC-PP (R = 0.12, p = 0.048). After switch from
MDI to CSII, AUC-B, AUC-N and AUC-PP decreased signifi-
cantly (-21%, -19% and -18.5%. When comparing responders
to non responders to CSII, the latter had higher AUC-B, AUC-N
and AUC-PP, but differences were not significant.
Conclusions: Fasting and nocturnal HG are the major determi-
nants of poor glucose control in type 2 diabetes with MDI failure.
266
THE OXIDATIVE STRESS IN TYPE 1 DIABETES
PEOPLE WITH CONTINUOUS SUBCUTANEOUS
INSULIN INFUSION VERSUS MULTIPLE DAILY
INJECTIONS TREATMENT
M.S. Ruiz de Adana1, N. Colomo1, E. Rubio-Martin2,
M.E. Dominguez-Lopez1, E. Garcia-Escobar3, J. Abuin-
Fernandez1, J. Morillas1, F. Sanchez-Torralvo1, M. Guerrero1,
G. Rojo-Martinez1
ATTD 2017 E-POSTER VIEWING ABSTRACTS
1
IBIMA. Hospital General Universitario de Malaga. Ciberdem,
Diabetes Unit. Endocrinology and Nutrition, Malaga, Spain
2
IBIMA. Hospital Regional Universitario de Malaga.
Ciberdem, Malaga, Spain
3
IBIMA. Hospital General Universitario de Malaga. Ciberdem,
Diabetes Unit, Malaga, Spain
Background and Aims: To measure oxidative stress markers
in patients with type 1 diabetes (T1DM), type 2 diabetes
(T2DM) and healthy subjects and to compare these markers
in patients with T1DM according to insulin treatment (multi-
ple daily injections MDI- vs. continuous subcutaneous insu-
lin infusion CSII-) and the presence of diabetes related
complications.
Methods: Cross-sectional study that included 205 subjects with
similar age and sex: 123 with T1DM (64 on MDI and 57 on CSII),
39 with T2DM and 43 healthy subjects. Study variables in patients
with T1DM: insulin treatment, diabetes related complications, di-
abetes duration, anthropometric measures, metabolic data. Total
antioxidant capacity (TAC) (Cayman ELISA, ABTS method) and
oxidized LDL (ELISA kit) were measured in blood samples in all
study subjects.
Results: Subjects with T1DM had lower TAC values than
subjects with T2DM and healthy controls (1.4 0.67 vs. 2.6 1.2
vs. 2.8 1.3 mM; p < 0.05). No significant differences in TAC
levels were found in patients with T1DM according to insulin
therapy (MDI/CSII). We found lower TAC values in patients
who reported diabetes related complications than in those who
did not (1.2 0.6 vs. 1.5 0.7 mM; p = 0.05). There were no
differences in oxidized LDL adjusted for LDL in any of the
groups.
Conclusions: Subjects with T1DM had lower TAC levels than
those with T2DM and healthy controls. In subjects with T1DM
and any diabetes related complications TAC values were de-
creased. We did not find significant differences in TAC values
according to the use of CSII or MDI. Further studies are needed
to confirm these findings.
267
SHORT TERM CONTINUOUS SUBCUTANEOUS
INSULIN INFUSION THERAPY (CSII)
SIGNIFICANTLY IMPROVES ERECTILE
DYSFUNCTIONS IN PATIENTS WITH TYPE-2
DIABETES MELLITUS
K. Singh1, P.E. Rai2, S. Karol1, P. Gupta1
1
Fortis Hospital Mohali, Endocrinology, Chandigarh, India
2
Fortis Hospital/ Pharmacovigilance Parexel- Chandigarh,
Endocrinology, Chandigarh, India
Background and Aims: To determine the efficacy of 12
weeks CSII vs MSI (multiple subcutaneous injection) among
uncontrolled T2D patients with ED.
Methods: This is a 12 week comparative study on 46 T2D
patients (mean age 43.8 y) with uncontrolled hyperglycemia
(HbA1C>10.0%) & ED and were on multiple oral hypoglycemics.
These patients had ED as graded on the Erectile Hardness Grading
Scale 1- 4 (EHGS) [European Association of Urology]. All the
study patients had EHGS grading of 1 to 2 only. The patients were
randomized into 2 treatment groups, 23 on MSI while another 23
on CSII. Patients in both the groups were matched in terms of
ATTD 2017 E-POSTER VIEWING ABSTRACTS
duration of diabetes & complications, BMI, HbA1c, creatinine
clearance, S testosterone, FT4 TSH & prolactin levels. Stamp test
& International Index of Erectile Function (IIEF-5) were recorded.
EHGS scale was recorded by patients in their diary at -7 day,
baseline & weekly till the end of study.
Results: Baseline HbA1c in CSII group was 11.2% and 8.7%
at the end of study while in MSI group it was 11.1% and 9.1%
respectively. In CSII group,4 patients achieved Grade 4 erec-
tions,5 achieved Grade 3 erections (response rate 39.1%) while
in MSI, one achieved Grade 4 & three recorded Grade 3 re-
sponse(17.3%).
Conclusions: Short Term CSII therapy significantly im-
proved ED as achievement of Grade 4 erections was four times
higher in this group (4/23 patients) compared to MSI (1/23) as
well as the overall response rate(Grade 3 and 4 erections) was
2.25 times higher in CSII group. Marked reduction in HbA1c
in CSII.
268
DIFFERENT STRATEGIES FOR PREVENTION
OF HYPOGLYCEMIA INDUCED BY PHYSICAL
ACTIVITY IN TYPE 1 DIABETES (T1D) PATIENTS
E. Patrakeeva1, K. Solovyova2, A. Mosikian1
1 20.5 11.8 vs 21.1 11.7 years, p = NS; BMI: 23.4 3.6 vs
Saint-Petersburg Medical University, Endocrinology, Saint-
Petersburg, Russia
2 46.5 28.5, p = NS)]. The effectiveness of these two sensor-
Federal Almazov North-West Medical Research Centre, Saint-
Petersburg, Russia
Background and Aims: Potential hypoglycemia is a sig-
nificant barrier to physical activity (PA) in T1D patients.
We investigate different strategies for prevention of exercise
induced hypoglycemia to find links between prevention
methods and hypoglycemia frequency or quality of glycemic
control.
Methods: We asked 53 regularly exercised T1D patients (age
28.5 7.2 years, HbA1c 7.08 1.15%) using anonymous ques-
tionnaire in Google Forms spread by specialised social media
group Diabet Connect. Patients described their main strategies
using to prevent exercise induced hypoglycemia and gave in-
formation about frequency of hypoglycemia during and after the
exercise (including nighttime). The data were processed using
Fishers criteria.
Results: There were no difference in HbA1c between subjects
who had prepared for PA and who didnt use any strategy to
prevent hypoglycemia (p = 0.87). Also there were no links be-
tween hypoglycemia frequency (including late and nighttime
episodes) and the method of insulin therapy (CSII p = 0.95; MDI
p = 0.61). The frequency of late hypoglycemia didnt differ be-
tween subjects with low blood glucose level just after the exer-
cise comparing with subjects with normal or high blood glucose
level at the same moment. Subjects used temporal basal rate
(including its combination with additional CHO intake or addi-
tional intake and bolus dose reduction) had no preferences
in hypoglycemia prevention comparing with other strategies
(p = 0.29, p = 0.29, p = 0.30 respectively)
Conclusions: There is still no clear dependence upon the
method of exercise induced hypoglycemia prevention and
frequency of hypoglycemic episodes (including late and
nigthtime hypoglycemias). It can be the object for the future
research.
A-111
269
THE BENEFICIAL EFFECT OF THE PREDICTIVE
LOW GLUCOSE MANAGEMENT SYSTEM
ON HYPOGLYCAEMIA INCIDENCE
AND GLYCAEMIC CONTROL IN TYPE 1
DIABETES MELLITUS
P. Thomakos1, A. Mitrakou2, O. Kepaptsoglou1, I. Taraoune1,
C. Baretto1, C. Zoupas1
1
Hygeia, Diabetes Center and Clinic, Athens, Greece
2
Alexandra Hospital, Department of Clinical Therapeutics,
Athens, Greece
Background and Aims: The aim of our study was to assess
the effect of the Predictive Low Glucose Management System of
the MiniMed 640GR Insulin Pump, compared to the Low Glu-
cose Suspend System of the MiniMed VeoR Insulin Pump, on
hypoglycaemia frequency and glycaemic control in people with
Type 1 Diabetes Mellitus (T1DM).
Methods: A cross-sectional study was conducted in 30 T1DM
patients using the MiniMed 640G vs 30 using the MiniMed
Veo sensor-augmented Insulin Pump for a minimum of 3
months. The patients were matched for Age and duration of
Diabetes. [(MeanSD) age: 33.4 11.5 vs 34.2 11.4 years,
p = NS; gender: 50 vs 53% males, p = NS; duration of diabetes:
24.5 3.4 kg/m2, p = NS; total daily insulin dose: 44.9 29.5 vs
augmented pumps was evaluated using CareLink software data.
Hypoglycaemia was defined as an episode of interstitial glucose
54mg/dl for 20 minutes and expressed as episodes per week.
Results: Patients used the 640G system exhibited significantly
lower hypoglycaemia episodes/week (1.9 1.3 vs 3.6 1.9, p =
0.0004) as well as better glycaemic control (HbA1c: 6.9 0.6 vs
7.3 0.9%, p = 0.03). There was only one episode of severe hy-
poglycaemia in the Veo group. 640G group had better hy-
poglycaemia awareness status (Gold Score: 1.8 0.8 vs 2.6 1.6,
p = 0.01). The mean activation of the Suspend before low
feature of the 640G pump was 2.2 1.6 times/day.
Conclusions: Our results demonstrate that the use of the
MiniMed 640G sensor-augmented pump system can help to re-
duce the frequency of hypoglycaemia, in combination with better
glycaemic control.
270
REAL-TIME BASAL INSULIN ATTENUATION BASED
ON CONTINUOUS GLUCOSE MONITORING (CGM):
ASSESSMENT OF STATE-OF-ART ALGORITHMS
IN 14-DAY IN SILICO SCENARIO
M. Vettoretti1, C. Fanton1, A. Facchinetti1, L. Meneghetti1,
G. Sparacino1, C. Cobelli1
1
University of Padova, Department of Information Engineering,
Padova, Italy
Background and Aims: Automatic attenuation of insulin
pump basal delivery is employed as a safety measure against hy-
poglycemia in open- and closed-loop type 1 diabetes (T1D) ther-
apies. So far, three algorithms were proposed: brakes (B) and
power brakes (PB), based on hypoglycemia risk index calculated
from original and predicted CGM data, respectively (Hughes et al.,
A-112
JDST 2010), and PB with insulin on board (IOB-PB) (Patek et al.,
IEEE TBME, 2012). B and PB were tested on short scenarios in
absence of meals. IOB-PB was assessed on a single-day scenario.
Here, we compare these algorithms on a 14-day scenario.
Methods: B, PB and IOB-PB algorithms are tested in silico in
a 14-day scenario reproducing open-loop insulin pump therapy in
100 virtual subjects. The T1D patient decision-making model of
(Vettoretti et al., Proc IEEE EMBC, 2015) is used for simulation,
which includes the UVA/Padova T1D simulator (2013 release),
insulin sensitivity variability (Visentin et al., IEEE TBME, 2015),
CGM error (Facchinetti et al., MBEC, 2015) and patients be-
haviour in making treatment decisions, also considering possible
patients mistakes, e.g. in carb-counting.
Results: Time in hypoglycemia (Thypo) is 24.4 min/day with B,
23.1 min/day with PB and 9.0 min/day with IOB-PB, reduced
compared to no-attenuation scenario (Thypo = 26.9 min/day). As
a drawback, time in hyperglycemia (Thyper) is increased with B
(Thyper = 9 h/day), PB (Thyper = 9 h/day) and IOB-PB (Thyper = 10.4 h/
day) compared to no-attenuation scenario (Thyper = 8.5 h/day).
Conclusions: In a multiple-day in silico scenario IOB-PB
shows the best performance in reducing Thypo, albeit Thyper in-
creases by almost 2 h/day.
271
INSULIN PUMP SATISFACTION IN PEDIATRICS
M. Yafi1, M. Silva1, C. Bowden1, C. Hughes1, S. Ohland1,
R. Yetman2
1
University of Texas at Houston Health Science Center,
Pediatric Endocrinology, Houston, USA
2
University of Texas at Houston Health Science Center,
Pediatrics, Houston, USA
Background and Aims: Insulin pump therapy or Continuous
Subcutaneous Insulin Infusion (CSII) offers many benefits for
pediatric patients living with Type 1 Diabetes Mellitus (TIDM)
including potential improvement of Hemoglobin A1C, flexibility
with physical activity and exercise, prevention of fluctuation of
blood glucose levels and improvement of quality of life. CSII use
can be effective in very young children, competitive athletes,
children with needle phobia and children with severe fluctuation
of blood glucose levels.
Methods: We surveyed 30 families who have children with
TD1M utilizing CSII. The project was approved by the Institu-
tional Review Board in our university.
Results: Sixty three percent of the children using CSII were
between the age of 13 and 18 years. Fifty six percent of the total
patients had the CSII for more than 5 years. All of the families
felt that CSII gave their children more flexibility in their lives,
made managing diabetes easier and reported that they would
recommend it to other families with children with diabetes. We
didnt evaluate HbA1C improvement but 87% of the families
believed that CSII improved the HbA1C.
The frequency of reported problems in 1 year using CSII was:
Diabetes ketoacidosis episodes 23%, pump failure 60% and se-
vere hypoglycemia 13%
Conclusions: CSII offers a great satisfaction rate among pe-
diatric patients with TDIM and their families. The best areas of
satisfaction are related to improving flexibility in lifestyle.
This small survey confirms the reported satisfaction in the
medical literature that patients and families get from CSII use.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
272
HYPOGLYCEMIA AS A FUNCTION OF HBA1C
IN TYPE 2 DIABETES (T2DM): INSULIN GLARGINE
300 U/ML IN A PATIENT-LEVEL META-ANALYSIS
OF EDITION 1, 2 AND 3
P. Choudhary1, R. Bonadonna2, J.F. Yale3,
C. Brulle-Wohlhueter4, E. Boelle-Le Corfec5, T. Bailey6
1
Department of Diabetes, Kings College London, London,
United Kingdom
2
Department of Clinical and Experimental Medicine, University
of Parma, Parma, Italy
3
McGill University, Department of Medicine, Montreal,
Canada
4
Sanofi, Diabetes Division, Paris, France
5
Sanofi, Biostatistics and Programming, Paris, France
6
AMCR Institute, Escondido, CA, USA
Background and Aims: Basal insulin therapy can be a
compromise between achieving glycemic targets and avoiding
hypoglycemia, dependent on how intensively insulin is titrated.
In the phase 3a EDITION 1, 2 and 3 studies, insulin glargine
300 U/mL (Gla-300) provided equivalent glycemic control to
insulin glargine 100 U/mL (Gla-100) with less hypoglycemia in
people with T2DM. The objective of the current analysis was to
evaluate rates of confirmed (70 mg/dL) or severe hypoglycemia
over 6 months of treatment with Gla-300 or Gla-100 in these
EDITION studies, as a function of HbA1c.
Methods: Meta-analysis was performed on patient-level
data, and annualized hypoglycemia rate as a function of HbA1c
at month 6 was fitted using a negative binomial regression
model.
Results: Adding a treatment-by-HbA1c interaction term to the
model did not significantly improve the goodness of fit (inter-
action p-value 0.937 and 0.829 for anytime [24 h] and nocturnal
[00:0005:59 h] hypoglycemia, respectively). Therefore the
model without interaction describes the data accurately: people
treated with Gla-300 experienced a consistently lower rate of
confirmed (70 mg/dL) or severe hypoglycemia vs those treated
with Gla-100, regardless of HbA1c at month 6 (Figure).
Conclusions: These results suggest that treatment with Gla-
300 vs Gla-100 could allow people with T2DM to achieve
equivalent glycemic control with less hypoglycemia.
Studies sponsored by Sanofi (NCT01499082, NCT01499095,
NCT01676220).
ATTD 2017 E-POSTER VIEWING ABSTRACTS
273
CLINICAL PERSPECTIVES FROM THE BEGIN
AND EDITION PROGRAMS: TRIAL-LEVEL META-
ANALYSES OUTCOMES WITH EITHER DEGLUDEC
OR GLARGINE 300 U/ML VS GLARGINE 100 U/ML
IN T2DM
R. Roussel1, R. Ritzel2, S. Chevalier3, B. Balkau4,
J. Rosenstock5
1 Gla-300 vs Gla-100, nocturnal and anytime, closely reflected
Assistance Publique Hopitaux de Paris, Bichat Hospital, Paris,
France
2
Klinikum Schwabing, Stadtisches Klinikum Munchen GmbH,
Munich, Germany
3
Sanofi, Biostatistics and Programming, Paris, France
4
INSERM U1018, Center for Research in Epidemiology
and Population Health, Villejuif, France
5
Dallas Diabetes Research Center, Medical City, Dallas, USA
Background and Aims: The BEGIN and EDITION pro-
grams, including adults with T2DM on basal-bolus or basal-oral
therapy and those who were insulin nave, evaluated efficacy
and safety of insulin degludec (IDeg; BEGIN) and insulin glar-
gine 300 U/mL (Gla-300; EDITION) versus glargine 100 U/mL
(Gla-100).
Methods: HbA1c, fasting plasma glucose (FPG) and hypo-
glycemia incidence with IDeg or Gla-300 vs Gla-100 were ex-
plored in 2 trial-level meta-analyses.
Results: HbA1c reduction was significantly greater for Gla-
100 vs IDeg despite significantly more pronounced FPG reduc-
A-113
tion with IDeg. HbA1c reduction was comparable with Gla-300
and Gla-100, whereas FPG reduction was significantly greater
with Gla-100 in the fixed but not random effect model. Risk of 1
confirmed (<56 mg/dL) or severe hypoglycemic event was lower
with IDeg vs Gla-100 at night (00:0105:59 h) but comparable at
any time (24 h). Risk of 1 confirmed (<54 mg/dL) or severe
hypoglycemic event (nocturnal [00:0005:59 h] and anytime)
was lower with Gla-300 vs Gla-100. Risk of 1 documented
symptomatic (70 mg/dL) hypoglycemic event with IDeg or
confirmed or severe events. Risk of 1 severe hypoglycemic
event was comparable with IDeg or Gla-300 vs Gla-100.
Conclusions: In trial-level meta-analyses in T2DM, Gla-100
reduced HbA1c more than IDeg despite IDeg having a greater
FPG-lowering effect. Hypoglycemia risk was lower with IDeg vs
Gla-100 for nocturnal but not anytime events. Gla-300 provided
comparable glycemic control to Gla-100 with lower risk of any-
time and nocturnal hypoglycemia. Head-to-head trials of IDeg vs
Gla-300 are warranted.
Trial-level meta-analyses supported by Sanofi.
274
DRIVERS OF AND BARRIERS TO OPTIMAL BASAL
INSULIN (BI) TITRATION: RESULTS OF A
QUANTITATIVE SURVEY
L. Berard1, M. Bonnemaire2, M. Mical2, S. Edelman3,
K. Khunti4
1
Winnipeg Regional Health Authority, Health Sciences Centre,
Winnipeg, Canada
2
Sanofi, Diabetes Division, Paris, France
3
University of California, San Diego, CA, USA
4
Diabetes Research Centre, University of Leicester, Leicester,
United Kingdom
Background and Aims: Evaluation of drivers of and barriers
to optimal BI titration in the USA, France, and Germany.
Methods: Online survey of 386 healthcare professionals
(HCPs) and 318 people with type 2 diabetes (T2DM) on long-
acting BI for 636 months, including 243 current BI users
(currently self-titrating n = 95), and 75 users who had dis-
continued BI for <12 months.
Results: Not all HCPs used fasting self-monitored plasma
glucose (SMPG) targets recommended in country-specific guide-
lines and preferred higher fasting SMPG targets. For current BI
users, mean start dose was 15 U and mean current dose was 25 U.
By 27 months, dose increases were <10 U for 62% of current BI
users, despite 49% reporting not reaching HbA1c target. Main
barriers to optimal titration for current BI users were concerns
over weight gain (52%), the time to reach goal (43%), perception
that dose increase meant worsening of disease (38%) and fear of
hypoglycemia (37%). HCPs perceived the main barriers to target
attainment in self-titrating patients to be fear of hypoglycemia
(74%) and low patient involvement/motivation (63%). Self-
titration was preferred by 26% of current BI users; 39% of cur-
rent BI users were self-titrating.
Conclusions: Generally, HCPs prefer a slower, safer ap-
proach to titration to higher glucose targets than recommended to
avoid hypoglycemia. However, patients not at target are frus-
trated about time taken to reach target and are less concerned
A-114 ATTD 2017 E-POSTER VIEWING ABSTRACTS

28.4% (EDITION) of patients, with a similar mean HbA1c (SD)

of 7.6% (0.9) at Week 12. Number of patients experiencing
nocturnal hypoglycemia (INSIGHT = 28.7%; EDITION =
27.5%), mean (SD) insulin dose at Week 12 (INSIGHT = 67.0 U
[37.8]; EDITION = 70.0 U [43.1]), and weight change from
baseline (INSIGHT = 0.41 kg [3.3]; EDITION = 0.15 kg [2.4])
were similar between groups. No between-group differences in
adverse events were noted.
Conclusions: Application of a 1 U/day self-titration algorithm
with Gla-300 is well-tolerated, effective and comparable to the
previously tested EDITION algorithm.
Study sponsored by Sanofi (NCT02401243).

276
WIDER WINDOWS FOR EVALUATING NOCTURNAL
HYPOGLYCEMIA CAPTURE MORE EVENTS
AND CONFIRM LOWER NOCTURNAL
about hypoglycemia than HCPs. Preference for self-titration HYPOGLYCEMIA RISK WITH INSULIN
needs improvement and patients need encouraging to self-titrate. GLARGINE 300 U/ML VERSUS 100 U/ML IN T2DM
Market survey project conducted by Hall & Partners US LLC,
funded by Sanofi. G. Bolli1, C. Wysham2, M. Fisher3, S. Chevalier4, A. Cali5,
B. Leroy5, M. Riddle6
1
University of Perugia, School of Medicine, Perugia, Italy
2
Diabetes and Endocrinology Center, Rockwood Clinic,
275 Spokane, USA
3
A PRAGMATIC SELF-TITRATION 1 UNIT/DAY Glasgow Royal Infirmary, University of Glasgow, Glasgow,
(INSIGHT) ALGORITHM FOR INSULIN GLARGINE United Kingdom
4
300 U/ML (GLA-300) IS WELL-TOLERATED Sanofi, Biostatistics and Programming, Paris, France
5
AND EFFECTIVE Sanofi, Diabetes Division, Paris, France
6
Oregon Health & Science University, Portland, OR, USA
J.F. Yale1, S. Harris2, L. Berard3, M. Groleau4, P. Javadi5,
J. Stewart4 Background and Aims: The EDITION clinical trials in
1
McGill University, Department of Medicine, Montreal, T2DM show comparable glycemic control with less nocturnal
Canada (00:0005:59 h) and anytime (24 h) hypoglycemia for insulin
2
Schulich School of Medicine & Dentistry, The University glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL
of Western Ontario, London, Canada (Gla-100). However, the predefined nocturnal window may not
3
Winnipeg Regional Health Authority, Health Sciences Centre, capture all clinically relevant hypoglycemic events during the
Winnipeg, Canada true fasting period (i.e. late evening to prebreakfast).
4
Sanofi, Laval, QC, Canada Methods: Post hoc patient-level meta-analyses of pooled 6
5
Sanofi, Diabetes Division, Paris, France months data from EDITION 2, EDITION 3 and EDITION JP
2 (N = 1922; Fig) compared hypoglycemia using predefined
Background and Aims: Gla-300 provides comparable gly- (00:0005:59 h) and broader nocturnal windows (22:0005:59 h,
cemic control and less hypoglycemia versus insulin glargine
100 U/mL (Gla-100). In the phase 3 EDITION trials, insulin was
titrated once weekly (no more than every 3 days) by the HCP,
based on the median of the last three fasting prebreakfast SMPGs.
In Canada, the INSIGHT pragmatic 1 U/day self-titration protocol
is widely used with Gla-100.
Methods: This 12-week, randomized pilot study compared
safety and efficacy of the INSIGHT and EDITION titration al-
gorithms with Gla-300 in people with T2DM (insulin-nave or on
basal insulin OAD).
Results: 212 participants were randomized (37.0% insulin-
nave). Mean baseline characteristics: age 62.3 years, BMI
34.2 kg/m2, HbA1c 8.4%, prior basal insulin dose 57.2 U. Com-
parable numbers of patients in each titration group reached the
primary endpoint, fasting SMPG 5.6 mmol/L without nocturnal
(0:006:00 h) hypoglycemia (confirmed: SMPG 3.9 mmol/L or
symptomatic or severe) at 12 weeks (INSIGHT = 22.8%; EDI-
TION = 20.6%). No between-treatment differences in severe
hypoglycemic episodes were noted (INSIGHT = 1; EDITION =
3). HbA1c 7% was achieved by 28.7% (INSIGHT) versus
ATTD 2017 E-POSTER VIEWING ABSTRACTS
00:0007:59 h, 22:00 h to prebreakfast self-monitored plasma
glucose [SMPG]).
Results: Total numbers of events were consistently greatest
for 22:00 h to prebreakfast SMPG versus other windows, and
absolute differences (favoring Gla-300) were greater for windows
extending beyond 05:59 h (Fig). Risk of 1 confirmed (70 mg/
dL) or severe event was lower for Gla-300 versus Gla-100 using
the predefined and broader windows. Corresponding annualized
rates were also lower with Gla-300 for all windows (predefined
41%, 22:0005:59 h 34%, 00:0007:59 h 30%, 22:00 h to pre-
breakfast SMPG 29% lower). A similar pattern of lower risk for
Gla-300 versus Gla-100 was seen with other hypoglycemia types.
Conclusions: Nocturnal hypoglycemia risk was consistently
lower for Gla-300 versus Gla-100 irrespective of hypoglycemia
definition or nocturnal window.
Studies sponsored by Sanofi (NCT01499095, NCT01676220,
NCT01689142).
277
ACTION PROFILES OF GLARGINE 300 AND
GLARGINE 100 IN TYPE 2 DIABETES: AN EA1C
COMPARISON OF THE FASTING AND PRANDIAL
COMPONENTS OF AVERAGE GLYCEMIC CONTROL
M. Breton1, B. Kovatchev1, Z. Meng2, B. Leroy3, A. Cali3
1 a common notion that more frequent hypoglycemia is a disadvan-
UVA, Center for Diabetes Technology, Charlottesville, USA
2
Sanofi, Diabetes Division, Bridgewater, USA
3
Sanofi, Diabetes Division, Paris, France
Background and Aims: Insulin glargine 300U/mL (Gla-300)
is a long-acting insulin analog indicated for adults with diabetes
mellitus. Pivotal clinical trials compared Gla-300 vs. insulin
glargine 100U/mL (Gla-100), showing that Gla-300 and Gla-100
achieve similar HbA1c outcomes. As HbA1c represents a sur-
rogate measure for average glycemia through hemoglobin gly-
cation, it may deviate substantially from average glucose levels;
estimated A1c (eA1c) also indirectly measures average glycemia
using a dynamical model with self-monitored blood glucose
(SMBG) as input. We propose to study differences in average
glycemia between Gla-300 and Gla-100 using eA1c, calibrated
with both reference HbA1c and SMBG day profiles.
Methods: SMBG data from the EDITION-2 study (NCT0
1499095) - a multicenter, open-label, clinical trial, which ran-
domized N = 811 participants to Gla-300 or Gla-100 once daily for
12 months (6m + 6m extension) were analyzed. N = 440 subjects
with enough SMBG data for eA1c assessments at 0, 3, 6 and 12
months (completers) were selected, and the fasting and prandial
A-115
components of eA1c were computed separately, distinguishing
between contributions of fasting and postprandial SMBG values to
overall eA1c estimates.
Results: Accounting for baseline differences, Gla-300 low-
ered fasting BG more than Gla-100, by -30mg/dl vs. -21.3mg/dl,
p < 0.001. As seen in Figure 1, the improvements of both the
fasting and the prandial components of eA1c were more pro-
nounced on Gla-300 than on Gla-100.
Conclusions: In conclusion, while the EDITION 2 study has
demonstrated that Gla-300 was similarly effective to Gla-100 in
terms of HbA1c lowering, Gla-300 achieved better overall eA1c
control than Gla-100 in completers, and for both fasting and
prandial components.
278
NEW INSULIN DEGLUDEC REDUCES
HYPOGLYCEMIA IN PATIENTS WITH TYPE 1
DIABETES AT HIGH RISK OF HYPOGLYCEMIA
M. Cokolic1
1
University Clinical Centre Maribor, Department of
Endocrinology and Diabetology- Internal Clinic, Maribor,
Slovenia
Background and Aims: Intensive Insulin Therapy (IIT) is a
therapeutic regimen for the treatment of type 1 diabetes (T1D). It is
tage of intensive regimens. Many patients, who have had diabetes
for a long time, do not notice the signs of hypoglycemia or they do
not recognize the condition as it occurs without associated symp-
toms or during sleep. Severe hypoglycemia can be life-threatening.
Methods: In 10 T1D patients suffering from frequent severe
hypoglycemia receiving treatment in the form of conventional
IIT. We have replaced their conventional basal insulin with a
new ultra-long-acting basal insulin analogue degludec (IDeg).
Results: This exploratory analysis included 10 T1D patients
(30% female) with frequent low glucose concentrations and the
following baseline characteristics: mean (SD) age 49.9 11.8
years, duration of T1D 17 8.5 years, HbA1c <8.52 1.5%, BMI
25.5 4.6kg/m2, waist 94.7 10.1 cm, weight 77.3 12.1 kg.
HbA1c decreased from 8.52% to 8.07% after 10 months without
any changes in other parameters without hypoglycemia in the
total treatment period with IDeg.
Conclusions: Hypoglycemia represents a great challenge for
both the patient and the healthcare professional; however, hy-
poglycemia can be successfully managed. After replacing the
conventional basal insulin with an ultra-long-acting basal insulin
analogue degludec this resulted in a consistent reduction in hy-
poglycemia with improved glycemic control in T1D on IIT pa-
tients at high risk of hypoglycemia.
279
SAFETY AND EFFICACY OF INSULIN DEGLUDEC
IN PATIENTS WITH TYPE 1 DIABETES MELLITUS
AFTER ONE YEAR OF TREATMENT
T. Didangelos1, K. Tziomalos1, A. Mourouglakis1, E. Karlafti1,
D. Stogianou1, S. Alkayiet1, A. Sofogianni1, A. Hatzitolios1
1
AHEPA University Hospital, 1st Propeudetic Department
of Internal Medicine, Thessaloniki, Greece
Background and Aims: To evaluate the safety and efficacy of
insulin degludec in patients with type 1 diabetes mellitus (T1DM).
A-116 ATTD 2017 E-POSTER VIEWING ABSTRACTS

Methods: We studied 31 patients with T1DM (61.3% males,

mean age 45.5 17.6 years), who were switched to insulin de-
gludec after at least two years of treatment with another basal
insulin. Patients were followed up another year after switching to
insulin degludec.
Results: Patients were previously treated with insulin glargine
(77.4%) or detemir (22.6%). During the 24 months prior to the
switch to insulin degludec, 29 patients (93.5%) experienced at
least 1 non-severe hypoglycemic episode (mean 12.7 3.7 epi-
sodes, among which 4.6 1.9 occurred during nighttime). During
the 12 months after the switch to insulin degludec, 4 patients
(12.9%) experienced a non-severe hypoglycemic episode (1, 2, 1
and 3 episodes, respectively, among which none occurred dur-
ing nighttime). At the time of switch to insulin degludec, HbA1c
and plasma glucose levels were 7.0 0.6% and 130 15 mg/dl,
respectively, and after 12 months decreased to 6.1 0.2% and
100 9 mg/dl, respectively (p < 0.001 for both comparisons). No
change observed on body weight, on dose of insulin degludec vs
previously administered insulin and on the prandial insulin,
during treatment with insulin degludec.
Conclusions: In patients with T1DM, switching from other
basal insulins to insulin degludec reduces the risk of hypogly- and Gla-100 regardless of renal function; no evidence of het-
cemia and improves glycemic control without body weight gain erogeneity of treatment effect was demonstrated across sub-
and without a need to increase insulin doses. groups (p = 0.46; Table). Risk of confirmed (70 mg/dL) or
severe hypoglycemia was significantly lower for nocturnal
(00:0005:59 h) events and comparable or lower for anytime
(24 h) events for Gla-300 versus Gla-100 across subgroups. Re-
280 nal function did not affect the lower rate of nocturnal or any time
hypoglycemia (no evidence of heterogeneity of treatment effect
GLYCEMIC CONTROL AND HYPOGLYCEMIA across subgroups: p = 0.73, p = 0.27).
BENEFITS WITH INSULIN GLARGINE 300 U/ML Conclusions: Gla-300 provided comparable glycemic control
(GLA-300) EXTEND TO PEOPLE WITH TYPE and consistently reduced nocturnal hypoglycemia versus Gla-
2 DIABETES (T2DM) AND MILD-TO-MODERATE 100 in participants with T2DM regardless of renal function, with
RENAL IMPAIRMENT no increase in any time hypoglycemia.
Studies sponsored by Sanofi EDITION 1 (NCT01499082),
J. Escalada1, S. Halimi2, P. Senior3, M. Bonnemaire4, A. Cali4,
EDITION 2 (NCT01499095), EDITION 3 (NCT01676220).
S. Chevalier5, J. Karalliedde6, R. Ritzel7
1
Clnic University of Navarra, Endocrinology and Nutrition, 281
Pamplona, Spain
2
Department of Diabetology, Endocrinology and Nutrition, INSULIN GLARGINE (IGLAR) AND INSULIN
Grenoble University Hospital Center, Grenoble, France DETEMIR (IDET) IN PATIENTS WITH TYPE 2
3
Division of Endocrinology, University of Alberta, Edmonton, DIABETES IN RUSSIA: A RETROSPECTIVE
Canada PRAGMATIC STUDY
4
Sanofi, Diabetes Division, Paris, France E. Patrakeeva1, O. Martyanova2, A. Mosikian1,
5
Sanofi, Biostatistics and Programming, Paris, France M. Zakharchenko1
6
Cardiovascular Division, Faculty of Life Sciences & Medicine,
1
Kings College London, London, United Kingdom Saint-Petersburg Medical University, Endocrinology,
7
Klinikum Schwabing, Stadtisches Klinikum Munchen GmbH, Saint-Petersburg, Russia
2
Munich, Germany Saint-Petersburg Outpatient Clinic No 27, Saint-Petersburg,
Russia
Background and Aims: EDITION 1, 2 and 3 showed that
over 6 months, Gla-300 provided comparable glycemic control Background and Aims: Meta-analyses of randomized clin-
to glargine 100 U/mL (Gla-100) and less hypoglycemia in people ical trials comparing IGlar and IDet show no difference in
with T2DM. As renal impairment increases the risk of hypo- their treatment efficacy, but the equality of its effectiveness
glycemia in people with T2DM, the aim was to investigate the in real-life clinical settings in Russia remains questionable.
impact of renal function on HbA1c reduction and risk of hypo- We aimed to provide this comparison in a retrospective prag-
glycemia in participants treated with Gla-300 and Gla-100. matic study.
Methods: The effects of Gla-300 versus Gla-100 on HbA1c Methods: We have analyzed 2000 existed medical records of
reduction and hypoglycemia were assessed in renal function patients with diabetes in an outpatient department for people older
subgroups (baseline eGFR 30 to <60, 60 to <90 and 90 mL/ than 18 y.o. All the records of patients who met the inclusion
min/1.73 m2) in a post hoc patient-level meta-analysis of data criteria (T2D for more than 6 month, IGlar of IDet treatment for
from EDITION 1, 2 and 3. more than 6 month) were included into analysis. Groups were
Results: Most participants (56%) had baseline eGFR 60 to compared with the use of Wilcoxon test or continuity-corrected
<90 mL/min/1.73 m2 (Table). Non-inferiority for HbA1c reduc- Chi-Squared test (were appropriate). Factors, which possibly in-
tion (defined in the EDITION studies) was shown for Gla-300 fluence on HbA1c level, were analyzed via two-way ANOVA.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Results: We included 133 medical records (70% IGlar, 53%
women) into analysis. HbA1c was (meanSE) 7.86 0.14% and
7.72 0.22% in IGlar and IDet groups, respectively (p = 0.54).
Average dose of basal insulin was 0.31 0.01 U/kg and 0.32
0.02 U/kg in IGlar and IDet groups, respectively (p = 0.31). There
was no between-group difference in percent of patients, reached
a target goal of HbA1c 7.5%. There was no between-group
difference for a target goal of HbA1c 7.0% neither.
Conclusions: No difference between IGlar and IDet effec-
tiveness for T2D treatment was shown in real-life clinical
settings in Russia. These results conform to ones shown in ran-
domized clinical trials meta-analyses. Thus, we propose to base a
choice mainly on the quality of patients life (frequency of in-
jections, hypoglycemic events and other adverse reactions).
282
SWITCH FROM GLARGINE TO DEGLUDEC:
EFFICACY AND SAFETY IN CHILDREN
AND ADOLESCENTS WITH TYPE 1 DIABETES
L. Iughetti1, P. Bruzzi1, C. Toffoli1, S. Poluzzi1, F. Leo1,
G. Maltoni2, T. Suprani3, S. Zucchini2, B. Predieri1
1
University of Modena and Reggio Emilia, Department
of Medical and Surgical Sciences of the Mother, Children
and Adults, Modena, Italy
2
S. Orsola-Malpighi Hospital, Department of Pediatrics,
Bologna, Italy
3
Bufalini Hospital, Department of Pediatrics, Cesena, Italy
Background and Aims: Insulin degludec (IDeg) is a new
basal insulin that induces a flat and stable action profile with low
variability. Few data have been published on IDeg effects in
chilhood. Aim of this study was to assess the efficacy and the
safety of IDeg in children and adolescents with type 1 diabetes
(T1D) previously treated with IGlar.
Methods: Twenty patients (15.1 4.0 yrs; 9 males; T1D du-
ration 7.2 3.7 yrs; IGlar treatment at least 1 year) were switched
to IDeg once daily. z-score BMI, HbA1c, fasting plasma glucose
(FPG), severe hypoglycaemia rates, and insulin dose (IGlar or
IDeg plus short-acting or regular) were collected at baseline (T0,
during IGlar treatment), 3 months (T1), and 6 months (T2) after
IDeg was started.
Results: The switch from IGlar to IDeg allowed a significant
reduction in doses of both basal (p = 0.018; Figure 1a) and short-
A-117
acting or regular mealtime (MT) (p = 0.033; Figure 1b) insulin.
Despite the lack of statistical significance, during IDeg treatment
HbA1c values decreased by -0.35% (T1) and -0.20% (T2)
points and FPG improved by 37.6%. z-score BMI did not change
and no episode of severe hypoglycaemia was reported.
Conclusions: IDeg seems to improve the glycemic control
than therapy with IGlar. Despite data from adults with T1D, our
results in childhood suggest that the dose of IDeg should be
reduced by median 5% and the meal-time insulin appropriate
replacement doses should be lowered by 10% for patients who
previously received IGlar. IDeg might be considered a useful and
well tolerated basal insulin also in childhood.
283
TO STUDY THE FREQUENCY OF NOCTURNAL
HYPOGLYCEMIA IN T2DM PATIENTS
ON GLARGINE VS. DEGLUDEC USING
THE FLASH GLUCOSE MONITORING SYSTEM
BY THE LIBRE PRO
M. Saiyed1, B. Saboo1, H. Chandarana1,
D. Hasnani1, F. Patel1
1
Dia Care Diabetes Care and Hormone Clinic, Diabetology,
Ahmedabad, India
Background and Aims: To find out the frequency of occur-
rence of nocturnal hypoglycemia in T2DM patients on Glargine
vs Degludec once daily using the Libre Pro sensor.
Methods: 30 adult T2DM Indian subjects who were on basal
insulin (Glargine) OHA (non SU) were studied.
Inclusion Criteria: HbA1c 7 - 8.5%.
Exclusion criteria: patients with symptomatic and documented
hypoglycemia and with renal dysfunction.
The Libre Pro flash monitoring sensor was applied to them
after taking consent. They were called on the 4th & 7th days after
application of sensor and the readings were taken and the diet and
doses of the basal insulin were optimised. The patients who had
nocturnal hypoglycemia after optimization of glargine doses to
achieve target fasting were shifted over to degludec.
On the 11th & 14th days, all the patients were again followed
up for optimization of therapy.
A-118
Results: Despite multiple optimization of glargine doses, 18 out
of 30 patients had nocturnal hypoglycemia and had to be shifted
over to degludec. Also, up titration of glargine failed to achieve the
fasting glucose target. Insulin requirement of the patients on
degludec reduced by 8% from the initial dose of glargine.
Conclusions: We could observe that the patients on Degludec
had less frequency of nocturnal hypoglycemia in comparison to
glargine.
284
MODELING SUBCUTANEOUS ABSORPTION
OF U100 AND U300 INSULIN GLARGINE
IN TYPE 1 DIABETES
M. Schiavon1, R. Visentin1, C. Dalla Man1, T. Klabunde2,
C. Cobelli1
1 Porto, Portugal
University of Padova, Department of Information Engineering,
Padova, Italy
2 Universidade do Porto, Porto, Portugal
Sanofi-Aventis Deutschland GmbH, Drug Design, Science
& Medical Affairs, Frankfurt am Main, Germany
Background and Aims: Subcutaneous administration of long-
acting insulin analogs are often employed in multiple daily injec-
tion (MDI) therapy of type 1 diabetes (T1D) to cover patients
basal insulin needs. Among these, U300 and U100 are formulations
of insulin glargine indicated for once daily subcutaneous admin-
istration in MDI therapy of type 1 diabetes (T1D). U300 is a new
formulation with a different absorption kinetics with respect to
U100 resulting in less hypoglycemia in clinical trials. Some models
have already been proposed but were not assessed under controlled
experimental conditions for both formulations. The objective is to
develop a model of subcutaneous absorption of U100 and U300
glargine insulin formulations in T1D.
Methods: The database consists of 24 T1D subjects who
underwent a randomized, 4-sequence, cross-over, double-blind,
dose-response euglycemic clamp study, receiving single subcu-
taneous injections of 0.4, 0.6 and 0.9 U/kg U300 and 0.4 U/kg
U100. Plasma insulin concentrations were measured for 36 hours
using a validated radioimmunoassay. Model identification was
performed on U100 and U300 data using a Bayesian Maximum a
Posteriori technique.
Results: The model well fits the data and provides precise
parameter estimates for both insulin formulations. The model
describes the gradual dissolution from the precipitate to soluble
states and model parameters allow to characterize the different
rates of absorption between U100 and U300.
Conclusions: The model will be incorporated into the UVA/
Padova T1D simulator together with the joint parameter distri-
butions. This will open the door to perform in silico clinical trials
for testing novel up-titration and insulin glargine switching rules.
285
THE EFFECT OF EXTRACELLULAR MATRIX
COMPONENTS IN ALGINATE HYDROGELS
FOR BIOARTIFICIAL PANCREAS: AN IDEAL
NICHE TO IMPROVE INSULIN SECRETION
AND DIABETIC GLUCOSE PROFILE
J. Crisostomo1, A.M. Pereira1, S.J. Bidarra2,3,
A.C. Goncalves4,5,6, P.L. Granja2,3,7, C.C. Barrias2,3,8,
R. Seica1
ATTD 2017 E-POSTER VIEWING ABSTRACTS
1
IBILI - Institute for Biomedical Imaging and Life Sciences,
Faculty of Medicine, University of Coimbra, Laboratory
of Physiology, Coimbra, Portugal
2
i3S - Instituto de Investigacao e Inovacao em Saude,
Universidade do Porto, Biomaterials for Multistage Drug
and Cell Delivery, Porto, Portugal
3
INEB - Instituto de Engenharia Biomedica, Biocarrier, Porto,
Portugal
4
Faculty of Medicine, University of Coimbra, Laboratory
of Oncobiology and Hematology, University Clinic
of Hematology and Applied Molecular Biology Unit,
Coimbra, Portugal
5
CNC.IBILI - Center for Neuroscience and Cell Biology,
University of Coimbra, Coimbra, Portugal
6
CIMAGO - Centre of Investigation in Environment Genetics
and Oncobiology, Faculty of Medicine, University of Coimbra,
Coimbra, Portugal
7
FEUP - Faculdade de Engenharia, Universidade do Porto,
8
ICBAS - Instituto de Ciencias Biomedicas Abel Salazar,
Background and Aims: The bioartificial pancreas is the most
complex insulin-delivery system and presents a promising meth-
odology to treat diabetes. To ameliorate the function of hydrogel-
encapsulated beta cells, we describe a strategy aiming to mimic
the in vivo cellular microenvironment by the establishment of
interactions between cells and extracellular matrix (ECM)
components.
Methods: We chemically modified alginate hydrogels by
using carbodiimide chemistry to incorporate ECM components,
namely the tripeptide Arg-Gly-Asp (RGD). After beta cell en-
capsulation in RGD-alginate hydrogels, we analysed the effect of
these adhesive peptides on cells performance both in vitro and
in vivo.
Results: The proposed RGD-alginate model demonstrated to
be a good in vitro niche for supporting beta cells viability, pro-
liferation and activity, namely by improving the key feature of
insulin secretion. The presence of RGD peptides promoted cell-
matrix interactions, enhanced the expression of endogenous
ECM components and favoured the assembly of individual cells
into multicellular spheroids, an essential configuration for proper
beta cell survival and functioning. In vivo, our pivotal model for
diabetes treatment showed to improve glycaemic profile of type 2
diabetic rats, where insulin secreted from encapsulated cells was
more efficiently used.
Conclusions: The RGD-alginate system stands out as a
promising approach to improve beta cell survival and function
and increase the success of this therapeutic strategy that could
greatly improve the quality of life of an increasing number of
diabetic patients worldwide.
286
PHYSIOLOGICAL EFFECTS OF INTRAPERITONEAL
VERSUS SUBCUTANEOUS INSULIN DELIVERY
IN PATIENTS WITH DIABETES MELLITUS TYPE 1:
A SYSTEMATIC REVIEW
I. Dirnena-Fusini1,2, M.K. Am1,2,3, S.C. Christiansen1,2,4,
A.L. Fougner2,3,5, S.M. Carlsen1,2,4
1
Norwegian University of Science and Technology, Department
of Cancer Research and Molecular Medicine, Trondheim,
Norway
ATTD 2017 E-POSTER VIEWING ABSTRACTS A-119

2
Norwegian University of Science and Technology, Artificial
Pancreas Trondheim APT, Trondheim, Norway
3
Central Norway Regional Health Authority, RHA, Trondheim,
Norway
4
St. Olavs University Hospital, Department of Endocrinology,
Trondheim, Norway
5
Norwegian University of Science and Technology, Department
of Engineering Cygernetics, Trondheim, Norway
Background and Aims: Intraperitoneal (IP) insulin admin-
istration in patients with diabetes mellitus type 1 (DM1) may
have physiological advantages but also carry potential risks
according to the invasive route of administration. It is impor-
tant to weigh risks and advantages before initiating IP insulin
infusion.
Several studies have compared IP with subcutaneous (SC) in-
sulin administration. However, no comparative summary of these
observations has been performed. Therefore, we initiated a sys-
tematic review to identify the possible different physiologic effects
of IP versus SC insulin administration in patients with DM1.
Methods: Specific search strategies in PubMed, Scopus,
CENTRAL and Embase databases identified 1,517 publications
and 106 of these were recognized as important for the review.
After screening the references of the included publications
complementary materials were added to the research materials.
All results were analyzed, combined and calculated using sta-
tistical software Rev Man 5.3.
Results: The HbA1c levels of participants in the included
studies were compared at the beginning of IP insulin adminis-
tration and after 3, 6, 12 and 24 months.
Our preliminary analyses of patients crossing over from SC to
IP treatment indicate a mean HbA1c decrease over time, with
some exceptions where mean HbA1c levels increased. Contrary,
case-control studies indicate minimal superiority of IP delivery
evaluated by HbA1c changes.
Conclusions: In patients switching from SC to IP insulin,
there was tendency towards improved blood glucose control
based on changes of HbA1c. Metabolic improvements will be the
scope of ongoing analyses, as will results according to metabolic
complications.
287
PAQ INSULIN DELIVERY DEVICE IMPROVES
GLYCEMIC CONTROL AND DIABETES
TREATEMENT SATISFACTION IN ADULTS
WITH TYPE 2 DIABETES
J. Mader1, N. Hermanns2, L. Lilly3, F. Aberer1, T. Poettler1,
C. Lanz1, J. Warner3, T. Pieber1
1
Medical University of Graz, Internal Medicine,
Graz, Austria
2
Diabetes Zentrum, Forschungsinstitut Diabetes-
Akademie Bad Mergentheim FIDAM GmbH, Bad
Mergentheim, Germany
3
CeQur, Clinical Research, Marlborough, USA
center, single arm, treat to target study. The study comprised three
periods: baseline (conventional insulin injections), transition to
PAQ and PAQ treatment (12-weeks). Endpoints included: HbA1c,
7-point self-monitored blood glucose (SMBG), Barriers to Insulin
Treatment (BIT), Diabetes Treatment Satisfaction Questionnaire
(DTSQ) and Short Form-36 (SF-36) survey.
Results: Mean age 63 7 years, 85% male, BMI 32.2 3.7 kg/
m2, diabetes duration 15 7 years, HbA1c 70 12 mmol/mol.
Seventeen patients completed the study. After 12 weeks of PAQ
treatment, significant reductions in HbA1c, -16 10 mmol/mol
(p 0001), and all 7-point SMBG values (p < 0.05) were seen. A
moderate reduction in the total BIT score, -4.5 11.6 (p = 0.09) was
observed. The DTSQ total score significantly increased, 3.0 6.3
(p<0.05), the hyperglycemia and hypoglycemia scores decreased,
-2.10 2.8 (p = 0.0041) and -0.50 2.5 (p = 0.3748), respectively.
The mental health score in the SF-36 increased 5.5 14.7 (p = 0.11)
while all other parameters were similar to baseline.
Conclusions: People with T2D who utilized PAQ achieved
significantly better glycemic control, had a trend toward a re-
duction of BIT and had an increase in their DTS compared to
their baseline insulin therapy.
288
SMARTCAP FOR TRACKING DISPOSABLE INSULIN
INJECTION PENS
B. Peters1, A. Lepple-Wienhuese2, S. Rigante3, S. Joly3,
R. El Hage Ali3
1
Valtronic Technologies Holding SA, Corp Business
Development & Innovation, Les Charbonnieres, Switzerland
2
Valtronic Technologies Holding SA, Innovation, Lausanne,
Switzerland
3
Valtronic Technologies Holding SA, Innovation,
Les Charbonnieres, Switzerland
Background and Aims: 80% of diabetic patients use dis-
posable insulin pens lacking data recording capability.
Methods: We present Smartcap, a novel intelligent cap re-
cording dose and time of injections automatically without user
input. Wireless data transfer helps caretakers and patients to
improve treatment. Dangerous dosing errors can be recognized
and alerted. Figure 1 shows Smartcap on a commercial insulin
pen. The device can be easily adapted to other pens. The insulin

Background and Aims: PAQ is a patch on device which

provides set basal rates and bolus insulin on demand.
Methods: Twenty adults with type 2 diabetes (T2D) with
HbA1C 53 97 mmol/mol on an established regimen of basal-
bolus insulin therapy (2 injections per day) oral and/or in-
jectable glucose lowering agents were enrolled in this single
A-120 ATTD 2017 E-POSTER VIEWING ABSTRACTS

might be a good, less invasive, alternative way to implanted

pumps. Here we report the first Italian experience on patients
with the DiaPort system.
Methods: five patients (nos. 1-4 from Olbia and no. 5 from
Partinico) using the DIA, all patients were implanted after a
period in MDI and CSII
Results:

MDI MDI CSII CSII CIPII CIPII CIPII

PZ BM1 INSULIN HbA1c/HYP INSULIN HbA1c/HYP IMPL. INSULIN HbA1c/HYP

IU IU DATE IU
1 OLBIA 48.3 108 10.3% /NO 73 8.6% /NO SEPT 44 7.4% / NO
2015
2 OLBIA 26.6 82 8.4% /YES 54 6.9% / YES SEPT 40 6.5% /NO
2015
3 OLBIA 44.4 125 9.9% / NO 102 8.9% /NO SEPT 60 NA/ NO
2016
4 OLBIA 20.1 60 10.4%/ YES 45 8.6% /YES SEPT 35 NA/ NO
2016
5 PARTINICO 21.9 71 7.8% /YES 59 7.0% /YES JUNE 46 6.6% /NO
2016

Conclusions: A better metabolic control with less glycaemic

dose measurements are possible through electrodes in the cap,
connected to a capacitance to digital converter circuit including a
Bluetooth module for data transmission. The capacitance is a
function of remaining volume in the drug container.
Results: The precision is comparable to the analytical balance
determined weight for assessing the dispensed drug. An un-
equivocal identification of dialed-in dosing events is possible
solely based on capacity data, as demonstrated in Figure 2. In the
graph presented, a second order polynomial was fitted to the
capacitance data. The red boxes indicate the confidence interval
for C measurements with each dosing step (as if the pen was
emptied at 1 U steps).
The measured C values allow to accurately detect each real
dosing event, except 1 point at the full and 2 points at the empty
end where fringe effects of the field are not yet addressed in the
current prototype.
This is including and not corrected for factual inaccuracies of
the mechanic-hydraulic delivery system and errors in the ca-
pacity measurement.
Conclusions: Capacitance changes can be recorded with good
linearity and precision down to less than 1 U.
289
FIRST ITALIAN EXPERIENCE WITH CONTINUOUS
INTRAPERITONEAL INSULIN INFUSION (CIPII)
VIA DIAPORT SYSTEM
variability was evident. After 9 months implantation pz 2 ex-
perienced a reduction in catheter flow (obstruction for bolus of
10 U or more) restored in the radiology unit. The diaport system
is a good and easy to manage device in dedicated patients with
improvement of clinical condition and excellent acceptability by
the patient. Rescue manoeuvres are less invasive than with the
implantable pumps.
290
OBSERVATIONAL STUDY OF SAROGLITAZAR ON
METABOLIC PARAMETERS IN INDIAN PATIENTS
WITH DIABETIC DYSLIPIDEMIA: 43 WEEKS
OF CLINICAL EXPERIENCE
S. Chatterjee1, A. Majumder2, S. Ray1
1
Apollo Gleneagles Hospital, Diabetes and Endocrinology,
Kolkata, India
2
KPC Medical College, Endocrinology, Kolkata, India
Background and Aims: Control of both glycemic and lipid
parameters are important for management of diabetic dyslipi-
demia (DD). Saroglitazar, the only dual peroxisome proliferator-
activated receptor (a/c) agonist available for clinical use, is
marketed in India for the treatment of DD since September 2013.
Objective of this study was to evaluate the efficacy and safety of
saroglitazar in Indian DD patients and also to compare our results
with our previous findings.

I. Carta1, M.S. Ledda1, A. Carboni1, G. Giorgi1,

A. Scorsone2, D. Brancato2, S. Cherchi1, V. Provenzano2,
G. Tonolo1
1
SC Diabetologia aziendale, San Giovanni di Dio, Olbia, Italy
2
Struttura complessa diabetologia, Partinico Hospital,
Partinico, Italy

Background and Aims: CIPII is an alternative route of in-

sulin delivery when injection site issues make difficult subcuta-
neous insulin administration. In order to bypass the subcutaneous
tissue, the second generation Diaport system (DIA), allowing
intraperitoneal insulin infusion by an external insulin pump
ATTD 2017 E-POSTER VIEWING ABSTRACTS A-121

Methods: This study is a retrospective analysis of 75 patients

with type 2 diabetes mellitus and dyslipidemia, who were re-
ceiving saroglitazar 4 mg once daily as per the approved indi-
cation and prescribing information of saroglitazar.
Results: Baseline demographics were: age 52.77 9.59
years (mean SD), body weight 68.24 10.50 kg; 64% par-
ticipants were males. At baseline, all patients were on anti-
hyperglycemic medication and 48 (64%) patients were on
statin therapy. Mean duration of follow-up was 42.36 weeks.
Compared to baseline values, there were statistically signifi-
cant changes observed in lipid and glycemic parameters
(table). Liver enzyme, alanine aminotransferase (ALT) was
significantly reduced from 42.61 24.03 U/L to 30.93 18.9 U/L
(mean SD; p < 0.0001). No serious adverse event was reported
during entire study follow-up. Adverse events reported were
mild and transient. No significant change was observed in se-
rum creatinine level. These results are consistent with our
previous reports with lesser number of patients and smaller
duration of study.
Conclusions: Our results showed that saroglitazar is effective
and safe for the treatment of type 2 diabetes with dyslipidemia.

291
EFFECTS ON METABOLIC PARAMETERS OF
ADDITION OF SGLT-2 INHIBITORS ON PATIENTS
WITH TYPE 2 DIABETES INADEQUATELY
CONTROLLED WITH DPP-IV INHIBITORS AND
METFORMIN.
S. Chatterjee1, S. Ray1, A. Mazumdar2,
K. Bhattacharjee3 Results: Results showed that addition of SGLT-2 inhibitors
produced favorable effects on all metabolic parameters studied
1
Apollo Gleneagles Hospital, Diabetology & Endocrinology, (Table 1 to Table 3).
Kolkata, India Conclusions: Our study shows that addition of SGLT-2 in-
2
K.P.C Medical College, Endocrinology Unit- Department of hibitors on existing therapy with DPP-IV inhibitors and metformin
Medicine, Kolkata, India produces favorable effects on metabolic parameters with the ad-
3
Assistant Manager, Biocon Ltd, Medical Services, Bangalore, vantage of weight loss and without producing major hypoglycemic
India events.

Background and Aims: Practice guidelines are open re-

garding choice of therapy after metformin. Insulin(INS), sul-
phonylureas(SU) and thiazolidinediones(TZD) may cause
hypoglycemia or weight gain. Dipeptidyl peptidase-IV (DPP-IV)
inhibitors are unlikely to produce that. Sodium-glucose
transporter-2 (SGLT-2) inhibitors are newer agents with the
advantage of weight loss. We have used SGLT-2 inhibitors
canagliflozin or, dapagliflozin, or, empagliflozin on T2D patients
inadequately controlled (HbA1c 7%) with DPP-IV inhibitors
plus Metformin and analyzed the results on glycemic and other
metabolic parameters. Since Indian data of such therapy is
scanty, this study is relevant because of the number of patients
studied, duration of study, study variables and effects of three
SGLT-2 inhibitors analyzed separately.
Methods: Data of 101 T2D patients inadequately controlled
(HbA1c 7%) with DPP-IV inhibitors plus Metformin who were
prescribed canagliflozin 100 mg or, dapagliflozin 5 or, 10 mg, or
empagliflozin 10 mg or, 25 mg once daily with mean follow-up
duration of 23 weeks were analyzed. Subjects receiving INS, SU
and TZD were excluded from analysis. Changes in weight, blood
pressure, glycemia, lipids, renal and hepatic parameters were
studied. Subgroup analyses were done to see effects of three
SGLT-2 inhibitors separately.
A-122
292
LACK OF GLUCAGON EFFECT OF GLP-1 RECEPTOR
AGONISTS: ASSESSMENT DURING A MIXED MEAL
TOLERANCE TEST
A. Galderisi1,2, J. Sherr1, N. Patel1, M. Van Name1, E. Cengiz1,
L. Carria1, K. Weyman1, M. Zgorski1, S. Weinzimer1,
W. Tamborlane1
1 junctive treatment for T1D are mediated by its effects on satiety,
Yale University, Pediatric Endocrinology, New Haven, USA
2
University of Padova, Department of Womans and Childs
Health, Padova, Italy
Background and Aims: Postprandial hyperglycemia remains
challenging in type 1 diabetes (T1D) due, in part, to dysregulated
glucagon secretion. While acute GLP-1 receptor agonist infusion
studies suggested suppressed glucagon after mixed-meal feed-
ing in T1D, more recent GLP1 treatment studies demonstrate
conflicting results. In this study, mixed-meal tolerance tests
(MMTT) explored how the GLP1 receptor agonist, liraglutide,
effects meal-stimulated excursions in plasma glucose (PG) and
glucagon in patients with T1D.
Methods: Eleven participants (aged23 3 yrs, A1C7.6 0.9%)
underwent two MMTTs, before and after treatment with liraglu-
tide. During the 3-4-wk outpatient period, liraglutide doses were
titrated to 1.8mg/day and insulin adjusted, as needed. The MMTTs
utilized Boost High Protein Energy Drink. PG and glucagon were
measured for 5-hrs. Normal fasting PG levels were achieved by
overnight closed-loop insulin delivery.
Results: Plasma glucose and glucagon were nearly identical in
both studies at baseline and following Boost ingestion (Figure).
ATTD 2017 E-POSTER VIEWING ABSTRACTS
The mean plasma glucagon AUC observed during the control
study was not suppressed after treatment with liraglutide (control:
2352 997 vs. lira: 2705 1473 pg/ml*min, p = ns). Despite the
short duration of treatment, there was a reduction in both body
weight (4.8 2.4%, p = 0.001) and insulin dose (*25%, p = 0.001)
with liraglutide.
Conclusions: Unlike the results of earlier acute infusion stud-
ies, dysregulated plasma glucagon responses to mixed meal feed-
ings in T1D are not suppressed after 3-4-wks of treatment with
liraglutide. This suggests that the benefits of liraglutide as an ad-
leading to weight loss and reductions in insulin requirements.
293
NASAL GLUCAGON (NG) FOR THE TREATMENT
OF MODERATE TO SEVERE HYPOGLYCEMIA
(HYPO) EPISODES IN CHILDREN AND
ADOLESCENTS WITH TYPE 1 DIABETES (T1D)
L. Deeb1, H. Dulude2, X.M. Zhang3, S. Zhang4, B. Reiner5,
C. Piche2, C.B. Guzman6
1
Florida State University College of Medicine, Department of
Pediatrics, Tallahassee, USA
2
Locemia Solutions, Clinical Development, Montreal, Canada
3
Eli Lilly and Company, Medical Development- Diabetes
Business Unit, Toronto, Canada
4
Eli Lilly and Company, Statistics, Indianapolis, USA
5
Pediatric Endocrine Office, Private Practice, Baltimore, USA
6
Eli Lilly and Company, Medical Development, Diabetes
Business Unit, Indianapolis, USA
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Background and Aims: This multi-center, open-label study
evaluated the effectiveness and ease of use of NG in treating
moderate or severe hypo episodes in patients (pts) with T1D,
aged 4 to <18 yrs.
Methods: Pts and caregivers (CGs) were taught how to use
NG. During naturally occurring symptomatic episodes of mod-
erate or severe hypo in real world settings, CGs administered
3 mg NG and measured blood glucose (BG) levels over time.
Adverse events (AEs), recovery of symptoms, and ease of use
were solicited by questionnaires.
Results: Fourteen pts, who experienced 33 moderate hypo ep-
isodes with neuroglycopenic symptoms and a BG level 70 mg/dL,
were included in the efficacy and main safety analyses. Mean
number of episodes per pt was 2.4 (range 1 to 4). In all episodes, pts
returned to normal status within 30 minutes after NG dose. No calls
to 911 (emergency medical services) were needed. Mean baseline
BG level was 56 (range 42-70) mg/dL. Within 15 minutes after NG
dose, mean BG level increased to 114 (range 79-173) mg/dL, and
continued to increase (Figure). No serious AEs occurred. For most
episodes (61%), CGs administered NG in <30 seconds; in all cases,
administration took <2 minutes. CGs were either satisfied or very
satisfied with NG after most episodes (91%).
Conclusions: NG increased BG and resolved symptoms in all
reported episodes of hypo among children and adolescents with
T1D. The majority of CGs were highly satisfied with NG. Data
suggest that NG is a viable alternative to currently available
injectable recombinant glucagons.
294
EFFECTS OF NASAL CONGESTION FROM
COMMON COLD ON THE PHARMACOKINETICS
(PK) AND PHARMACODYNAMICS (PD)
OF NASAL GLUCAGON
H. Dulude1, E. Sicard2, M. Rufiange3, A. Sadoune4,
D. Carballo5, M. Triest6, M. Tafreshi7, E. Rampakakis7,
C. Piche1, X.M. Zhang8, C.B. Guzman9
1
Locemia Solutions, Clinical Development, Montreal, Canada
2
Altasciences/Algorithme Pharma, Principal Investigator,
Montreal, Canada
3
Altasciences/Algorithme Pharma, Scientific and Regulatory
Affairs, Montreal, Canada
4
Altasciences/Algorithme Pharma, Clinic Department,
Montreal, Canada
5
Locemia Solutions, Operations, Montreal, Canada
A-123
6
Locemia Solutions, Pharmaceutical Product Development,
Montreal, Canada
7
JSS Medical Research, Scientific Affairs, Montreal, Canada
8
Eli Lilly and Company, Medical Development- Diabetes
Business Unit, Toronto, Canada
9
Eli Lilly and Company, Medical Development- Diabetes
Business Unit, Indianapolis, USA
Background and Aims: Nasal glucagon (NG), a needle-free
glucagon that is absorbed through the nasal mucosa, is being
developed to treat severe hypoglycemia. This single center, open-
label study evaluated the safety, pharmacokinetics (PK) and
pharmacodynamics (PD) of NG in 36 otherwise healthy subjects
with nasal congestion from common cold with or without con-
comitant nasal decongestant.
Methods: Cohort 1 (N = 18) received 2 NG doses: a 3 mg dose
while suffering from common cold and a second 3 mg dose after
return to normal health. Cohort 2 (N = 18) received a single 3 mg
dose of NG 2 hours after receiving the nasal decongestant oxy-
metazoline while suffering from common cold.
Results: There were no serious adverse events (AE); the most
common AEs were transient lacrimation, nasal discomfort, rhi-
norrhea and nausea with reduced nasal symptoms and nausea in
participants with normal health versus those with cold symp-
toms, with or without decongestant. Glucagon and glucose levels
increased rapidly after treatment to peak glucagon levels at 20
minutes post dose and peak glucose levels at 30 to 40 minutes
post dose for all groups (Figure).
Conclusions: Nasal congestion, with or without concomitant
use of a nasal decongestant, did not significantly affect the PK
and PD of NG although transient AEs were more frequent in
participants with common cold than in healthy participants.
These data suggest that NG can be used to treat severe hypo-
glycemia in patients with nasal congestion.
A-124
295
NEEDLE-FREE NASAL DELIVERY
OF GLUCAGON IS SUPERIOR TO INJECTABLE
DELIVERY IN SIMULATED HYPOGLYCEMIA
RESCUE
J.F. Yale1, M. Egeth2, C. Piche3, M. Lafontaine4, R. Margolies2,
E. Dissinger2, D. Carballo5, A. Shames2, N. Kaplowitz2,
C.B. Guzman6, H. Dulude3
1
McGill University, Department of Medicine, Montreal,
Canada
2
CORE Human Factors, Research, Bala Cynwyd, USA
3 T. Lu1, X.L. Wang1, X. Sun1, H.C. Lee1
Locemia Solutions, Clinical Development, Montreal, Canada
4 1
Locemia Solutions, Commercial, Montreal, Canada
5
Locemia Solutions, Operations, Montreal, Canada
6
Eli Lilly and Company, Diabetes Business Unit. Development,
Indianapolis, USA
Background and Aims: This study evaluated the ease of use
of needle-free nasal glucagon (NG) devices versus injectable
glucagon (Glucagon Emergency Kit GEK) in treating a sim-
ulated severe hypoglycemia (SH) episode.
Methods: The caregiver arm included 16 adult persons with
diabetes (PWD) and their caregivers. The PWDs were taught
how to use one of the devices and they, in turn, instructed
their caregivers. The acquaintance arm had 15 adults who
were not trained on device use. Acquaintances were shown the
device before the simulation. During the simulation, each
caregiver and acquaintance treated a manikin representing a
PWD with SH using both GEK and NG devices at different
time-points.
Results: Fifteen of 16 caregivers and 14 of 15 acquaintances
administered a full dose of NG (average time 0.27 and 0.44 min,
respectively).
Eight of 16 caregivers injected glucagon (average time
1.89 min); of which 2 gave the full dose. Failures included in-
jection of diluent only (n = 4), insulin injection (n = 3), and bent
needle (n = 1).
Three of 15 acquaintances injected glucagon (average time
2.4 min); none gave the full dose. Failures included injection of
diluent only (n = 9), insulin injection (n = 1), refusal to inject
(n = 1) and injection with empty syringe (n = 1).
Conclusions: During simulated SH, caregivers and ac-
quaintances used GEK with low success rates and numerous
errors; however, they administered NG successfully and in
less time. This suggests that NG delivery is easier and faster
ATTD 2017 E-POSTER VIEWING ABSTRACTS
for non-medical people and use of a different route of ad-
ministration for glucagon may reduce the risk of accidental
insulin injection.
296
NRF2 ACTIVATOR PROTECTS CORONARY BK
CHANNEL FUNCTION AND CORONARY
VASODILATION IN HIGH FAT DIET-INDUCED
DIABETIC MICE
Mayo Clinic, Cardiovascular Diseases, Rochester- MN, USA
Background and Aims: Vascular large conductance Ca2+-
activated K+ (BK) channels, composed of four pore-forming
subunits (BK-a) and four regulatory subunits (BK-b1), are the
key determinant of coronary vascular tone. However, BK
channel function is impaired in diabetic vessels. The nuclear
factor erythroid-2-related factor 2 (Nrf2) signaling is cytopro-
tective against oxidative stress, but little is known about the role
of Nrf2 on regulating BK channel function.
Methods: Combining patch clamp and cellular biological
techniques, we examined the protective effects of Nrf2 on cor-
onary BK channel function in diabetes.
Results: We found that BK currents were diminished in the
coronary smooth muscle cells (SMCs) of mice 6 months after
feeding with high 60% fat-diet (HFD), compared to mice feeding
with 10% low fat-diet (LFD), which was accompanied by a re-
markable reduction of Nrf2, BK-a and BK-b1 protein expres-
sions. Adenoviral delivery of Nrf2 gene (50 MOI, 48 h) produced
a 2.9-fold and 3.4-fold upregulation of BK-a and BK-b1 protein
expressions in coronary SMCs respectively. The regulation of
BK-a protein expression by Nrf2 was attributed to increased BK-
a mRNA level, while that of BK-b1 expression by Nrf2 was
associated with inhibited ubiquitin-dependent BK-b1 prote-
olysis. Oral administration of dimethyl fumarate (a FDA-
approved Nrf2 activator, 25 mg/kg/day, 10 days) enhanced Nrf2,
BK-a and BK-b1 protein expressions, and preserved coronary
BK channel function and coronary vasodilation in HFD mice.
Conclusions: Our results indicate that Nrf2 signaling plays a
critical role in coronary BK channelopathy and vasculopathy in
HFD mice. Activation of Nrf2, therefore, may have a therapeutic
potential for diabetic cardiovascular complications.
297
SAFETY OF SGLT2 INHIBITOR TREAMENT
IN TYPE 1 DIABETES: CHANGE IN THE PATTERN
OF EARLY METABOLIC DECOMPENSATION
FOLLOWING BASAL INSULIN SUSPENSION
N. Patel1, M. Van Name1, L. Carria1, E. Cengiz1,
S. Weinzimer1, W. Tamborlane1, J. Sherr1
1
Yale School of Medicine, Pediatric Endocrinology, New
Haven, USA
Background and Aims: Enthusiasm for the benefits of
SGLT2 inhibitors (SGLT2i) as adjunctive treatments in type 1
diabetes (T1D) has been offset by the possible increased risk of
diabetic ketoacidosis (DKA). Since pump-treated T1D patients
ATTD 2017 E-POSTER VIEWING ABSTRACTS
are susceptible to DKA due to infusion site problems, this study
was undertaken to assess how treatment with SGLT2i affects
patterns of early metabolic decompensation following suspen-
sion of basal insulin.
Methods: 10 participants with T1D [age 19-35y, duration
10 8y, A1c 7.4 0.8%) underwent an overnight pump sus-
pension study before and after *3wks of SGLT2i treatment.
On both study nights, basal insulin was suspended at 3AM and
plasma glucose (PG) and b-hydroxybutyrate (BHB) were
measured every 30 minutes. Studies were terminated 6 hours
after suspension, or sooner if PG rose >350mg/dL or BHB
>2.5mmol/L.
Results: At the start of suspension, PG was similar in the two
studies (Figure). Rate of rise in PG was markedly blunted by
SGLT2i treatment, with PG at end of suspension in control
301 21mg/dL vs. SGLT2i 195 14mg/dL, (p = 0.002). In con-
trast, rise in BHB and BHB at end of suspension was similar
(control 1.4 0.2mmol/L vs SGLT2i 1.8 0.3mmol/L, p = 0.06).
Differences in BHB were not considered clinically significant.
Conclusions: In insulin-pump treated T1D patients receiving
SGLT2i, difficulty recognizing early DKA following interrup-
tion of basal insulin is primarily due to the more gradual increase
in PG rather than to more rapid increases in BHB. T1D patients
using SGLT2i should test for ketones based on symptoms of
illness rather than relying on persistent elevations of glucose to
identify impending DKA.
298
CANAGLIFLOZIN (CANA) IMPROVES GLYCEMIC
CONTROL AND REDUCES GLYCEMIC VARIABILITY
IN PATIENTS WITH TYPE 1 DIABETES MELLITUS
(T1DM) INADEQUATELY CONTROLLED
WITH INSULIN
1 2 3 3
H.W. Rodbard , A.L. Peters , A. Cao , M. Alba
1
Endocrine and Metabolic Consultants, Rockville, MD, USA
2
Keck School of Medicine of the University of Southern
California, Los Angeles CA, USA
3
Janssen Research & Development LLC, Raritan, NJ, USA
Background and Aims: CANA, a sodium glucose co-
transporter 2 (SGLT2) inhibitor, provided glycemic improve-
ments in a randomized Phase 2 study in adults with T1DM as
A-125
add-on to insulin. The effects of CANA on daily mean glucose,
glycemic variability, and time spent in glycemic ranges were
assessed.
Methods: At baseline (week prior to randomization) and at
the end of the study (Week 17-18), all patients (N = 351) were to
record 9-point self-monitoring blood glucose (SMBG) mea-
surements; a subset of 89 patients also underwent continuous
glucose monitoring (CGM).
Results: At Week 18, reductions in daily mean glucose and
standard deviation measured by 9-point SMBG were seen with
CANA 100 and 300 mg vs placebo (PBO; Table). Consistent
with this, reductions in mean glucose and measures of gly-
cemic variability assessed by CGM were seen with CANA 100
and 300 mg vs PBO (Table). Both CANA doses were asso-
ciated with increases in the time patients spent within target
(glucose >70 to 180 mg/dL) and commensurate reductions in
time spent above target (glucose >180 mg/dL) vs PBO at the
end of the study. There were no meaningful changes in the
time patients spent below target (glucose 70 mg/dL) across
groups. CANA was generally well tolerated, with an increase
in ketone-related AEs.
Conclusions: In summary, CANA improved indices of gly-
cemic variability and increased the time spent in target without
increasing time spent below target vs PBO in T1DM patients.
299
ENDOSCOPIC INSERTION OF A SOFT
POLYURETHANE TUBE INTO THE JEJUNUM
TO DISSOCIATE MEAL FROM MUCOSA
AS A SUBSTITUTE FOR BARIATRIC SURGERY
K. Khodabakhshi Pirkalani1, Z. Talaeerad1
1
Mehr Medical Group, Internal Medicine/Gynecology, Tehran,
Iran
Background and Aims: To reduce side effects and cost of
bariatric surgery which is a complex, irreversible and hazardous
procedure as many of the mechanism are still ill define we have
developed the following.
Methods: Based on the physiological function of the small
intestine we have designed a very soft polyurethane tube that
can be inserted via endoscopy as a small 3cmX3cmX3cm clump
into the upper GI and inflated there so that it can cover about
90% of the jejunum mucosa and possibly 30% of the ileum. This
reduces the absorptive surface of the small intestine and causes
reduced absorption of the major nutrients just like a bariatric
surgery but without its drawbacks, side effects and irrevers-
ibility character. The 25mm diameter tube is double layer and
has a wall thickness of 0.3mm, completely impermeable to
water and is inflated via a second 2mm Archimedes Arc tube
filled with water during the procedure. The upper end of the
tube is fixed in the stomach via a larger ring in continuity with
the Archimedes Arc. The real beginning of the tube is at the
second part of the duodenum where bile and pancreatic juice are
drained into the tube as well.
Results: The design is completely successful and though
simple extremely effective. Preliminary results in dogs have
shown 88% reduction of different nutrient absorption.
Conclusions: To our knowledge this is the most effective
and simple substitute for bariatric surgery both in diabetic and
obesity setting with a cost of around 10% of it. Human trial is
underway.
A-126
300
LIPID STATUS IN PATIENTS WITH DIABETES
MELLITUS TYPE 1 FROM VARIOUS ETHNIC GROUPS
L.I. Kolesnikova1, S.I. Kolesnikov1, M.A. Darenskaya1,
L.A. Grebenkina1, S.V. Gnusina1
1 Outcomes were assessed via surveys both before and after the
Scientific Centre for Family Health and Human Reproduction
Problems, Department of Pathophysiology, Irkutsk, Russia
Background and Aims: Diabetes mellitus type 1 (T1DM) is
the most severe form of Diabetes mellitus with clear clinical
presentation and metabolic disturbances. Some studies reported
low T1DM morbidity rate among the aboriginal people in Arctic
and Siberian peoples resulted from the presence of the protective
alleles for this nosology. The aim of this study was to compare
lipid status in Mongoloids and Caucasians with T1DM.
Methods: The study recruited the patients with T1DM: Mon-
goloids (n = 38, mean age 34.4 1.9 years, disease duration 12.0
1.5 years) and Caucasians (n = 27, mean age 32.7 2.3 years,
disease duration 12.9 2.0 years), which were the residents of
Siberian. The control group was comprised of practically healthy
persons that had no congenital diabetic history: Mongoloids
(n = 34, mean age 30.3 1.3 years) and Caucasians (n = 23, mean
age 27.1 1.9 years).
Results: Thus, T1DM Mongoloid patients had significantly
lower total lipids value in comparison with Caucasian patients. In
addition, T1DM Mongoloid patients were characterized with
significantly lower levels of triglycerides, total cholesterol and
low-density lipoproteins in comparison with Caucasian patients.
It should be stressed that despite the absence of significant dif-
ferences in atherogenic coefficient between the patients in two
ethnic groups, atherogenic coefficient in Caucasian patients
surpassed the normal value. Elevation of this parameter is an
important prognostic factor for the course of diabetes, because
dislipidemia promotes the development of morphological alter-
ations in the basal vascular membrane and the hemodynamic
disturbances leading to generalized angio - and neuropathies.
Conclusions: We can conclude a more favorable course of
the lipid metabolic processes in Mongoloids in comparison
with Caucasians.
301
VISUAL FOOD DIARY FOR SOCIAL SUPPORT,
DIETARY CHANGES AND WEIGHT LOSS
H. Salmenius-Suominen1, M. Lehtovirta2, H. Vepsalainen1,
H. Konttinen3, M. Erkkola1
1
University of Helsinki, Department of Food and Environmental
Sciences- Division of Nutrition, Helsinki, Finland
2
University of Helsinki, FiMM- Institute for Molecular
Medicine Finland, Helsinki, Finland
3
University of Helsinki, Department of Social Research,
Helsinki, Finland
Background and Aims: Behaviour changes in diet may
prevent or delay onset of chronic diseases. Social support is a
known predictor of successful behaviour change.
To find out whether virtual peer support groups moderated by
a nutrition professional using a mobile application can be used to
promote healthy eating.
ATTD 2017 E-POSTER VIEWING ABSTRACTS
Methods: In this 4-week feasibility study, volunteering adult
(n = 26) overweight (BMI >25 kg/m2) men and women were re-
cruited from a diabetes outpatient clinic and from an occupational
health care unit. Participants used a smartphone application to
keep a visual food journal, share their meals and activity with peer
group members and receive virtual coaching.
intervention using a food frequency questionnaire (FFQ), group
environment and social support scales. Height, weight and waist
circumference were measured. Also frequency of the application
use was analysed.
Results: After the intervention the daily use vegetables and
fruits had increased by 2.15 (SD 2.64) portions (p < 0.001) com-
pared to baseline. Mean weight loss after the intervention was
1.5 kg (SD 1.82, p = 0.001). Mean reduction in waist circumference
was 2.4 cm (SD 2.418, p = 0.001). 84% of participants agreed that
they got support from other group members. The use of application
was high: average user uploaded 5.2 (SD 2.24) meals per day and
used the application total of 9.3 (SD 4.41) times per day.
Conclusions: Smartphone based virtual peer support can be
used as a tool to promote healthy eating both in outpatient clinic
and occupational health settings.
302
CONTINUOUS GLUCOSE MEASUREMENT,
A TECHNICAL TOOL TO FACILITATE
OVERWEIGHT INDIVIDUALS TO ADHERE
TO A LOW CARB DIET PROGRAM
H.F. v. Lilienfeld-Toal1, D. Tews2
1
Elte Sensoric GmbH, Gelnhausen, Germany
2
Diabetes Zentrum Gelnhausen, Outpatient Clinic,
Gelnhausen, Germany
Background and Aims: It is difficult to keep motivation up
during attempts to reduce weight. After it became clear that dietary
reduction of carbs - especially with a high glycemic index - is an
essential part of a weight reduction project by avoiding insulin
peaks the measurement of glucose offers a technological tool for
instant monitoring of the correctness of the diet. Theoretically, this
enables the individual to collect experience with his favorite food
and allows for correction so that for him it becomes clear how his
personal diet can be composed without losing palatability.
Methods: To test this possibility we have studied normal di-
etary situations while monitoring the subcutaneous glucose
concentration (FreeStyle Libre, Abbott). These situations in-
cluded comparison meals with different amounts of carb content
and glycemic index, fruits, nuts and the effects of different drinks
(orange juice, apple juice, cola, beer, wine).
Results: Parts of the diet induced high glucose peaks. Espe-
cially in fruits with high glucose content, the effects of high in-
crease and fast decrease of tissue glucose combined with sudden
attacks of hunger were impressive. The combination with fiber
rich parts of the meal showed that a total restriction of sweet
components in the diet was not necessary. It was possible to create
a dietary composition which was well tolerated by the individual
and resulted in glucose values constantly below 140 mg/dl.
Conclusions: Through this approach the individual learns to
take the right measures for palatable diet. This will probably lead
to better results in the project of weight reduction.
ATTD 2017 Read By Title
303 COMMERCIALIZING THE FIRST HYBRID CLOSED-
LOOP ARTIFICIAL PANCREAS SYSTEM
L. Lintereur1, N. Kurtz2, A. Roy2, B. Grosman2, N. Parikh2,
G. Voskanyan2
1
Medtronic Diabetes, Systems Engineering, Northridge, USA
2 3
Medtronic Diabetes, Advanced Research, Northridge, USA
304 SOME SUCCESSFUL EXPERIENCES IN MAGGOT
THERAPY IN BABOL, IRAN
E. Shojaeizadeh1, B.D. Rahman2, S. Ali Asghar2, A. Kamran3,
N. Mahbobeh3, S. Davoud3
1
School of Public Health, Tehran, Iran
2
Faculty of Medicine, University of Medical Sciences-Babol,
Babol, Iran
3
Tehran University of Medical Sciences, School of Public
Health, Tehran, Iran
305 THE INFLUENCE OF HEALTH BELIEF MODEL
COMPONENT ON SELF EFFICACY AMONG
PATIENTS WITH TYPE 2 DIABETES
D. Shojaeizadeh1, S. Esmaeil2, S. Maedeh3, G. Nahid4,
S. Motahareh5
1
Tehran University of Medical Sciences, Tehran, Iran
2
School of Public Health- Tehran University of Medical Sciences,
Department of Health Education & Promotion, Tehran, Iran
3
Shahid Beheshti university of Medical Sciences, community
health nursing education- Treatment Affairs, Tehran, Iran
4
School of Public Health- Tehran University of Medical Sci-
ences, Public Health, Tehran, Iran
5
School of Public Health, Tehran, Iran
306 DIABETES MELLITUS IN STRUCTURE
OF PATIENTS WITH TERMINAL CHRONIC
RENAL FAILURE RECEIVING HEMODIALYSIS
IN THE SAKHA REPUBLIC (YAKUTIA)
M. Petrova1, E. Unarova2
1
North-Eastern Federal University, Institute of Medicine,
Yakutsk, Russia
2 Saudi Arabia
State Autonomous Institution of the Republic of Sakha Yakutia
Republican Hospital No 1 - National Medical Center, De-
partment of chronic hemodialysis n.a. Pavlov E.G., Yakutsk,
Russia
307 NET GLYCEMIC VARIABILITY AND COPING
STRATEGIES: A POSSIBLE RELATIONSHIP
A. Bisio1, E. Campos-Nanez2, E. Gamarra1, P. Leombruni3,
G. Grassi1
1 2
A.O.U. Citta della Salute e della Scienza di Torino,
A-127
S.C.D.U. Endocrinologia- Diabetologia e Metabolismo,
Torino, Italy
2
Center for Diabetes Technology, Dept. of Psychiatry and
Neurobehavioral Science- University of Virginia, Charlottes-
ville, USA
A.O.U. Citta della Salute e della Scienza di Torino, S.C.U.
Psicologia Clinica e Oncologica, Torino, Italy
308 THE EFFECT OF CSII ON GLYCEMIC
CONTROL INT2DM: A RETROSPECTIVE STUDY
IN 60 PATIENTS WITH T2DM WITH A FOLLOW
UP OF 24 MONTHS
R.K. Gonera1
1
, Rolde, The Netherlands
309 REDUCED FORM OF GLUTATHIONE PROTECT
B-CELLS FROM DESTRUCTION CAUSED
BY XANTHURENIC ACID
G. Meyramov1, A. Shaybek1, E. Laryushina2, G. Kartbaeva1,
O.N. Dupont3, A. Alina2, A. Abdraimova-Meyramova4,
A. Embergenova1, Z. Zhumagalieva1, A. Tulieva5
1
Buketov Karaganda State University, Biology, Karaganda,
Kazakhstan
2
Karaganda State Medical University, Internal Diseases N2,
Karaganda, Kazakhstan
3
Hymnasium N3, Biology, Karaganda, Kazakhstan
4
Karaganda State Medical University, Physiology, Karaganda,
Kazakhstan
5
Astana Medical University AG, Histology and Cytology,
Astana, Kazakhstan
310 FEAR OF SELF-INJECTING AND SELF-TESTING
AND ITS ASSOCIATED RISK FACTORS AMONG
ADOLESCENTS WITH TYPE 1 DIABETES : A CROSS
SECTIONAL STUDY
K. Almonaei1, A. Al Hayek1, A. Asirvatham1
1
PSMMC, Endocrinology and Diabetes, RIYADH,
311 COMPARING AUTOMATED SEGMENTATION
FOR AUTOMATED CHC IN SELF-MANAGEMENT
OF DIABETES
C. Baptista1, I. Cruz2, D. Martins1, P. Martins2, J. Cecilio2,
F. Carrilho1, P. Furtado2
1
CHUC, Endocrinology and Diabetes, Coimbra, Portugal
Universidade de Coimbra, DEI/CISUC, Coimbra, Portugal
A-128
312 DENSITY SEGMENTATION IN DETECTION
OF DIABETIC RETINOPATHY
C. Baptista1, C. Travassos2, R. Monteiro2, S. Oliveira2,
D. Martins1, F. Carrilho1, P. Furtado2
1 1
Centro Hospitalar e Universitario de Coimbra,
Endocrinology- Diabetes and Metabolism, Coimbra,
Portugal
2
Universidade de Coimbra, DEI/CISUC, Coimbra,
Portugal
313 ARACHIDONIC ACID (AA) AS A POTENTIAL
ANTI-DIABETIC MOLECULE: AN IN VITRO
AND IN VIVO STUDY
D. Undurti1
1
UND Life Sciences, R & D, Federal Way, USA
314 ACACIA NILOTICA (L.) DELILE COULD BE
A POTENTIAL DRUG COMBATING DIABETES:
AN EVIDENCE-BASED AND IN-SILICO APPROACH
M.R. Saha1, P. Dey2, I. Sarkar1, P. Kar1, D.D. Sarker3, S. Das4,
B. Haldar5, T.K. Chaudhuri2, A. Sen1
1
University of North Bengal, Molecular Cytogenetics
Laboratory, Department of Botany, Siliguri, India
2 INSULIN PUMP IN TYPE 2 DIABETES PATIENT
University of North Bengal, Cellular Immunology Laboratory,
Department of Zoology, Siliguri, India
3 A CASE REPORT
Raiganj University, Department of Botany, Raiganj, India
4
University of North Bengal, Department of Chemistry, Siliguri,
India
5
North Bengal Medical College, Department of Pathology,
Siliguri, India
315 ADDITION OF FASTER-ACTING INSULIN ASPART
TO BASAL INSULIN SIGNIFICANTLY IMPROVES
GLYCAEMIC CONTROL IN ADULTS WITH TYPE 2
DIABETES: THE ONSET 3 TRIAL
H. Rodbard1, D. Tripathy2,3, M. Vidrio-Velazquez4,
M. Demissie5, S.C. Tamer5, M. Piletic6
1 2
Research Center, Endocrine and Metabolic Consultants,
Rockville, USA
2
Texas Diabetes Institute, University of Texas Health Science
Center, San Antonio, USA
3 322 THE EFFECT OF THE BOLUS CALCULATOR USE
Audie L Murphy VA Hospital, South Texas Veterans Health
Care System, San Antonio, USA
4 PUMP THERAPY
Endocrinology- Metabolism and Nutrition, Hospital General
Regional 110, Guadalajara, Mexico
5 University Clinical Center of Republic of Srpska, Department
Novo Nordisk A/S, Sborg, Denmark
6 for Endocrinology, Clinic for Internal Diseases, Banja Luka,
Nutritional Biochemistry, Nutrition and Dietetics, Diabetol-
ogy, General Hospital, Novo Mesto, Slovenia
316 EFFICACY AND SAFETY OF MINIMED 640G
INTEGRATED SENSOR-AUGMENTED PUMP
THERAPY (SAPT) SYSTEM WITH SMARTGUARD
IN PATIENTS WITH TYPE 1 DIABETES PREVIOUSLY
TREATED WITH PARADIGM VEO
A.M. Gomez Medina1, D.C. Henao Carrillo1, L. Kattah1,
J.P. Llano1, A. Carol1, M. Rondon1
1
Pontificia Universidad Javeriana, Hospital San Ignacio,
Unidad de Endocrinologa, Bogota, Colombia
ATTD 2017 READ BY TITLE
317 PERSONAL VS PROFESSIONAL CONTINUOUS
GLUCOSE MONITORING IN TYPE 1 DIABETES: CAN
WE MAKE A DIFFERENCE?
G. Petrovski1, M. Zivkovic1
University Clinic of Endocrinology, Center for Insulin Pump,
Skopje, FYR Macedonia
318 CONTINUOUS SUBCUTANEOUS INSULIN
INFUSION (CSII) THERAPY: A COST EFFECTIVE
AND EFFICIENT ALTERNATIVE TO INTRAVENOUS
INSULIN INFUSION (IVII) THERAPY IN PATIENTS
REQUIRING HOSPITALIZATION OR ICU STAY
K. Singh1
1
Fortis Hospital Mohali, Endocrinology, Chandigarh,
India
319 CONTINUOUS SUBCUTANEOUS INSULIN
INFUSION(CSII) PATCH PUMP IMPROVES QUALITY
OF LIFE (QOL) IN TYPE 1 PATIENTS USING FOOD
LIBRARY AND ACTIVITY TO CALCULATE
INSULIN CARBOHYDRATE RATIO
P. Kelly1, S. Read1, P. English1
1
Plymouth Hospitals NHS Trust, Diabetes Centre, Plymouth,
United Kingdom
320 GLP-1 AGONIST IN COMBINATION WITH
CAN IMPROVE GLUCOSE CONTROL:
M. Zivkovic1, G. Petrovski1, B. Todorova1
1
University Clinic of Endocrinology, National Center
for Insulin Pump, Skopje, FYR Macedonia
321 CAN WIRELESS CARDIOVASCULAR FAST
TRACKING MONITORING SYSTEMS BE PREDICTIVE
OF INPATIENT INTENSITY OF CARE IN DIABETES
SUBJECTS?
A. Scorsone1, D. Brancato1, F. Gargano2, M. Fleres1,
L. Spano1, G. Picone2, V. Provenzano1
1
ASP 6 Palermo- Partinico Civic Hospital, Referral Centre for
Diabetes and Insulin Pumps Implantation, Palermo, Italy
ASP 6 Palermo- Partinico Civic Hospital, Medicine Unit,
Palermo, Italy
ON THE GLYCEMIC CONTROL AT THE INSULIN
B. Caric1, B. Vukovic1
1
Bosnia-Herzegovina
323 CLASSIFICATION, MODELING AND PREDICTION
OF GLYCEMIA IN DIABETES PATIENTS BY
EVOLUTIONARY AND HEURISTIC COMPUTATION
FROM CONTINUOUS GLUCOSE MONITORING,
CARBOHYDRATES AND INSULIN RECORDS
J.M. Colmenar1, S.M. Winkler2, G. Kronberger2, E. Maqueda3,
M. Botella-Serrano4, A. Sanchez5, J.M. Velasco5, S. Contador5,
O. Garnica5, J. Lanchares5, J.I. Hidalgo5
1
Universidad Rey Juan Carlos, Ciencias de la Computacion,
Mostoles, Spain
2
University of Applied Sciences Upper Austria, Heuristic and
ATTD 2017 READ BY TITLE A-129

Evolutionary Algorithm Laboratory, Hagenberg, Austria
3
Hospital Virgen de la Salud de Toledo, Servicio de En-
docrinologa y Nutricion, Toledo, Spain
4 1
Hospital Universitario Prncipe de Asturias, Servicio de En-
docrinologa y Nutricion, Alcala de Henares, Spain Spain
5
Universidad Complutense de Madrid, Adaptive and Bioin-
spired Systems Group, Madrid, Spain
324 PREDICTIVE FACTORS OF THE ADHERENCE
TO THE REAL-TIME CGM SENSORS:
A PROSPECTIVE OBSERVATIONAL STUDY
(PARCS STUDY): STUDY DESIGN
T. Murata1, M. Matsuhisa2, A. Kuroda2, M. Toyoda3,
Y. Hirota4, K. Kato5, H. Sawaki6, A. Tone7, S. Kawashima8,
A. Okada9, N. Sakane10
1
NHO Kyoto Medical Center, Diabetes Center, Kyoto, Japan
2
Tokushima University, Diabetes Therapeutics and Research
Center, Institute of Advanced Medical Sciences, Tokushima,
Japan
3
Tokai University School of Medicine, Division of Nephrology-
Endocrinology and Metabolism, Department of Internal Medi-
cine, Isehara, Japan
4
Kobe University Hospital, Division of Diabetes and
Endocrinology, Department of Internal Medicine, Kobe,
Japan
5
NHO Osaka National Hospital, Diabetes Center, Osaka,
Japan
6
Arisawa General Hospital, Diabetes Center, Hirakata,
Japan
7
Okayama University Hospital, Diabetes Center, Okayama,
Japan
8
Kanda Naika Clinic, Department of Internal Medicine, Osaka,
Japan
9
Okada Clinic, Department of Internal Medicine, Fukuoka,
Japan
10
NHO Kyoto Medical Center, Division of Preventive Medicine,
Clinical Research Institute, Kyoto, Japan
325 GLYCEMIC CONTROL WITH V-GO INSULIN
DELIVERY DEVICE COMPARED TO INSULIN PEN
DEVICES IN PATIENTS REQUIRING BASAL-
PRANDIAL THERAPY
R. Lajara1, J. Davidson2, C. Nikkel3, T. Morris4
1 Unit, Torino, Italy
Diabetes America, Endocrinology, Plano, USA
2 4
University of Texas Southwestern Medical Center/Touchstone
Diabetes Center, Endocrinology, Dallas, USA
3 5
Valeritas, Medical Affairs, Edmond, USA
4 and Metabolic Diseases, Alessandria, Italy
University of Central Oklahoma, Mathematics and Statistics,
Edmond, USA
326 EXAMINING THE EFFECTS OF INSULIN
PEN COMPLIANCE DEVICE ON HBA1C
AND LIFESTYLE ON INDIVIDUALS LIVING
WITH TYPE 1 DIABETES MELLITUS
D. Minnock1, S. ODonnell2, G. Doyle2, R. Canavan3,
D. OShea3
1
Health Sciences, School of Physiotherapy- Public Health and
Sports science, Dublin 4, Ireland
2
University College Dublin, UCD College Of Business, Dublin
4, Ireland
3
St Vincents University Hospital, Endocrinology, Dublin, Ire-
land
327 SWITCHING TO INSULIN DEGLUDEC IN TYPE 1
DIABETES MELLITUS IN A REAL-LIFE SETTING
V. Bellido1, B. Gonzalez1, I. Goicolea1, F.J. Santamara1
Hospital Universitario Cruces, Endocrinologia, Barakaldo,
328 MULTI CENTRE OPEN-LABEL CLINICAL STUDY
OF THE SUGARBEAT NON-INVASIVE CONTINUOUS
GLUCOSE MONITORING PATCH
T. Rahman1
1
Nemaura Medical, Diagnostics, Loughborough, United King-
dom
329 DIABETES (D) APPEARANCE IN ANOMALOUS
MAGNETIC FIELD (AMF)
N. Trifunovic1
1
Belgrade, Serbia
330 BIOMETRIC DATA FROM HEALTH PATCH FOR
GLYCEMIC MODELING
D. Mul1, P. Funke2, R. Focia2, R. Vandenberg2, H.J. Aanstoot1,
R. Bruinsma3, H.J. Veeze1
1
Diabeter - Center for Pediatric and Adolescent Diabetes Care
and Research, Pediatrics, Rotterdam, The Netherlands
2
Aspire Ventures, Technology and services, Lancaster PA, USA
3
Tempo Health, LLC, Rotterdam, The Netherlands
331 PROPOSAL FOR AN ITALIAN CONSENSUS FOR
USE OF CSII IN TYPE 2 DIABETES:
IS IT FEASIBLE?
G. Grassi1, G. Cristina2, C. Gauna2, P. Massucco3, L. Gentile4,
E. Ansaldi5, A. Girelli6, L. Sciangula7, A. Ciucci8, C. Tubili9,
C. Vitale10, L. De Candia11, A. Piccinni12, G. Tonolo13,
E. Guastamacchia14
1
Citta della salute e della Scienza, Endocrinology, Torino, Italy
2
ASL TO2, Endocrinology and Metabolic Disease, Torino, Italy
3
San Luigi Gonzaga Faculty of Medicine of Turin University,
San Luigi Gonzaga Hospital, Medicine and Metabolic Disease
Cardinal Massaja Hospital, Endocrinology and Diabetes Unit,
Asti, Italy
Santi Antonio e Biagio Hospital, Department of Endocrinology
6
Spedali Civili of Brescia, Diabetologic Unit, Brescia, Italy
7
ASST Lariana- Presidio Polispecialistico, Diabetology Centre,
Como, Italy
8
A. O. SantAnna di Como Ospedale di Mariano Comense,
Diabetology Endocrinology, Como, Italy
9
S. Camillo-Forlanini, Diabetic Unit, Roma, Italy
10
ASREM Termoli/Larino, Italy, Diabetology Center, Termoli/
Larino, Italy
11
Ospedale M. Sarcone Terlizzi BA, Diabetology Center, Ter-
lizzi Bari, Italy
12
A. O. Card. G. Panico Tricase LE, UO Internal Medicine,
Lecce, Italy
13
Struttura sanitaria San Giovanni di Dio, Diabetology, Olbia,
Italy
14
Policlinico di Bari, Internal Medicine Department, Bari, Italy
A-130
332 A SMART BASAL-BOLUS CALCULATOR FOR
PEOPLE WITH DIABETES
D. Boiroux1, T.B. Aradottir1, N.K. Poulsen1, H. Madsen1,
J.B. Jorgensen1
1 1
Technical University of Denmark, Department of Applied
Mathematics and Computer Science, Kgs. Lyngby, Denmark
333 TELEMEDICINE CONSULTATION IN PATIENTS
WITH TYPE 1 DIABETES MELLITUS TREATED WITH
CONTINUOUS SUBCUTANEOUS INSULIN INFUSION
(CSII): ANALISYS OF EFFICIENCY AND EFFICACY
AFTER TWO YEARS
V.M. Andia1, M. Picallo1, A. Lopez Guerra1, M. Moyano1,
M.J. Rodrguez Calero1, M.L. Ramrez Rodrguez1,
M. Requena1, Y. Olmedilla1, M. Arnoriaga1, J. Agreda1,
M.A. Velez1, J. Atencia1, B. Weber1, C. Gonzalez Antiguedad1,
M. Sambo1, S. Monereo1
1 UNN - University Hospital of North-Norway, Norwegian
Hospital General Universitario Gregorio Maranon, En-
docrinology, Madrid, Spain
334 SELF-REPORTED HYPOGLYCEMIA REDUCTION
IN TANDEM PUMP USE COMPARED TO PREVIOUS
METHODS OF DIABETES THERAPY
G. Marin1
1
Tandem Diabetes, Marketing, San Diego, USA
335 TELEMEDICINE IN GESTATIONAL DIABETES
(GDM): FEASIBILITY, DIABETOLOGICAL AND
OBSTETRICS-NEONATAL OUTCOMES, COSTS
AND PATIENTS SATISFACTION ANALYSIS
E. Gamarra1, V. Rovei2, C. Monzeglio2, D. Ciochetto2,
F. Leone3, S. Rizzo2, A. Valla3, G. Maletto4, A. Bisio5,
F. Broglio1, E. Ghigo1, G. Grassi1
1
AO Citta della Salute e della Scienza di Torino,
S.C.D.U. Endocrinologia, Diabetologia e Metabolismo,
Torino, Italy
2
AO Citta della Salute e della Scienza di Torino,
P.O. SantAnna - S.C.D.U. Ginecologia e Ostetricia,
Torino, Italy
3
AO Citta della Salute e della Scienza di Torino, P.O.
SantAnna - Servizio di Dietetica, Torino, Italy
4
AO Citta della Salute e della Scienza di Torino,
Dipartimento di Scienze Mediche, Torino, Italy
5
Universita degli Studi di Torino, Facolta di Medicina e
Chirurgia, Torino, Italy
336 THE BURDEN OF SEVERE HYPOGLICAEMIAS
AND DIABETES KETOACIDOSIS IN T1DM PATIENTS
R. Ciampichini1, P. Cozzolino2, P. Cortesi1, C. Fornari1,
F. Madotto1, V. Chiodini1, L. Mantovani1, G. Cesana1
1
University of Milano-Bicocca, Research Centre on Public
Health, Monza, Italy
2
CHARTA Foundation, Public Health, Monza, Italy
337 MORTALITY OF HYPO DM PATIENTS: A COM-
PARISON WITH AMI AND PAD FOR FURTHER
DISCUSSION
R. Ciampichini1, P. Cozzolino2, P. Cortesi1, C. Fornari1,
F. Madotto1, V. Chiodini1, L. Mantovani1, G. Cesana1
1
University of Milano-Bicocca, Research Centre on Public
Health, Monza, Italy
2
CHARTA Foundation, Public Health, Monza, Italy
ATTD 2017 READ BY TITLE
338 COMPARISON THE DATA OF SMBG WITH CGMS
IN PREGNANT WOMEN WITH PRECONCEPTION
DIABETES MELLITUS
T. Shestakova1, A. Dreval1, O. Dreval1, O. Medvedev2
Moscow Regional Research and Clinical Institute MONIKI,
Endocrinology, Moscow, Russia
2
Lomonosov Moscow state university, Department of Basic
Medicine, Moscow, Russia
339 EVALUATING THE ROLE OF MHEALTH
INTERVENTIONS IN PATIENT EMPOWERMENT
FOR CHRONIC DISEASE MANAGEMENT SUCH
AS DIABETES
O. Saadatfard1, D. Wiljer2, A.G. Ekeland3, M. Bradway1,
E. Arsand3
1
Centre for eHealth Research, Troms, Norway
2
University Hospital Network, Education Technology Innova-
tion, Toronto, Canada
3
UNN - University Hospital of North-Norway, Norwegian
Centre for E-health Research, Troms, Norway
340 AN INTEGRATED MOBILE DIABETES
APPLICATION CAN BENEFIT GLUCOSE MANAGE-
MENT AND DECREASE DISEASE BURDEN IN TYPE 1
DIABETES: A MIXED METHOD STUDY
T.H. van de Belt1, J. Lancee1, B.C. Heeren1, L.J. Engelen1,
M.M. Van Gelder2, C.J. Tack3
1
Radboud University Medical Center, Radboudumc REshape
Innovation Center, Nijmegen, The Netherlands
2
Radboud University Medical Center, Department for Health
Evidence- Radboud Institute for Health Sciences, Nijmegen,
The Netherlands
3
Radboud University Medical Center, Department of Internal
Medicine, Nijmegen, The Netherlands
341 ASSESSMENT OF INSULIN DISTRIBUTION
IN SUBCUTANEOUS ADIPOSE TISSUE WHEN
USING NOVEL INSULIN INFUSION CATHETERS
T. Altendorfer-Kroath1, P.K. Schondorff2, R. Juliussen2,
M. Heschel2, F. Sinner1, T. Birngruber1
1
JOANNEUM RESEARCH Forschungsgesellschaft mbH,
HEALTH, Graz, Austria
2
Unomedical a/s, A ConvaTec Company, Lejre, Denmark
342 NOVELTY IN TREATMENT OF DIABETIC
ULCER WITH ABU-KHALSA (ARNEBIA EUCHROMA)
OINTMENT
M. Amiri1, Z. Abdi2, R. Alipour3, M. Alipour4
1
Faculty of Medicine, Islamic Azad University, Kazerun
Branch, Milad Medical Center, Shiraz, Iran
2
Shiraz High School of Medical Sciences, Milad Medical
Center, Shiraz, Iran
3
Faculty of Nursing, Islamic Azad University, Tehran Branch,
Milad Medical Center, Shiraz, Iran
4
Islamic Azad University, Kazerun Branch, Milad Medical
Center, Shiraz, Iran
ATTD 2017 READ BY TITLE A-131

343 AUTOMATIC PROCESSING OF THE SELF- 349 WHAT MEDICINES ARE USED FOR DIABETES
MONITORING OF BLOOD GLUCOSE (SMBG) DATA IN BRAZIL: DATA FROM AN NATIONAL SURVEY
WITH GLUCOPRINT DEVICE: SMBG FREQUENCY M.M. Milward de Azevedo Meiners1, N. Urruth Leao Tavares1,
AND HBA1C TRENDS S. Serrate Mengue2, P.F. Couto Vieira1, A. Turmina Fonta-
A. Mayorov1, E. Surkova1, G. Galstyan1 nella2, E. Merchan-Hamann1
1 1
Endocrinology Research Centre, Diabetes Institution, Moscow, Health Sciences Facultat, University of Braslia, Post Gradu-
Russia ation Program on Public Health, Brasilia, Brazil
2
University of Rio Grande do Sul, Post Graduation Program on
344 OPTIMISING EDIARY DESIGN FOR DIABETES Epidemiology, Porto Alegre, Brazil
CLINICAL TRIALS USING REAL WORLD USAGE
DATA
J. Thilaganathan1, A. Heikkila1, P. ODonohoe1, O. Kotiranta1 350 IMPROVING GLYCEMIC CONTROL WITH
1
CRF Health, Product & Services Management, London, INSULIN PUMP THERAPY: THE IMPACT
United Kingdom OF DIABETES DURATION
S. Pejakovic1
1
Clinical Center of Vojvodina, Clinic for Endocrinology,
345 ESTIMATION OF HBA1C BASED ON 30-DAY Diabetes and Metabolic Disorders, Novi Sad, Serbia
SELF-MONITORING OF BLOOD GLUCOSE
N. Hosszufalusi1, A.G. Tabak2, G. Jermendy3, G. Vandorfi4,
A. Fulcz5, G. Bibok6, L. Koranyi7
1 351 IMPACT OF INSULIN FORMULATIONS
Semmelweis University, 3rd Department of Internal Medicine,
ON SUCCESSFUL CONTINUOUS SUBCUTANEOUS
Budapest, Hungary
2 INSULIN INFUSION (CSII): ROLE OF DILUENTS
Semmelweis University, 1st Department of Internal Medicine,
ON CSII INDUCED TISSUE REACTIONS
Budapest, Hungary
3 U. Klueh1, Y. Qiao2, I. Ludzinska2, C. Czajkowski2,
Bajcsy-Zsilinszky Hospital, 3rd Department of Internal Medi-
D. Kreutzer2
cine, Budapest, Hungary 1
4 Wayne State University, Biomedical Engineering, Detroit,
Vanderlich, Health Center, Veszprem, Hungary
5 Michigan, USA
Csolnoky Ferenc Hospital, Endocrine and diabetes center, 2
University of Connecticut School of Medicine, Surgery,
Veszprem, Hungary
6 Farmington, USA
77 Elektronika, Medical Department, Budapest, Hungary
7
DRC, Research Center, Balatonfured, Hungary

352 CONTINUOUS GLUCOSE MONITORING

346 THE METHOD OF INSULIN ADMINISTRATION
AND PERINATAL OUTCOMES IN PREGNANT
WOMEN WITH TYPE 1 DIABETES
E. Deryabina1
1
Ural Research Institute of Maternity and Infancy Welfare,
Yekaterinburg, Russia
347 THE ROLE OF CONTINUOUS GLUCOSE
MONITORING SYSTEM ON THERAPY OF CYSTIC
FIBROSIS RELATED DIABETES IN YOUTH - PILOT
PROJECT
S. Todorovic1, T. Milenkovic1, K. Mitrovic1, R. Vukovic1,
L. Plavsic1
1 POPULATION IN AN ENVIRONMENT WITH THE
Mother and Chiled Health Care Institute, Endocrinology,
Belgrade, Serbia
348 HELPING ON DIABETES MANAGEMENT:
SHOWING PATTERNS ON RECORDS
AND PROVIDING ADVICES ON A SMARTPHONE APP
D. Machado1, T. Paiva1, I. Dutra2, P. Brandao1, C. Neves3,
S. Oliveira3, C. Esteves3, C. Arteiro4, D. Carvalho3
1
Faculdade de Ciencias da Univ. Porto/Inst. Telecomunicacoes,
Computer Science, Porto, Portugal
2
Faculdade de Ciencias da Univ. Porto/CRACS, Computer
Science, Porto, Portugal
3
Faculdade de Medicina, Universidade do Porto, Servico de
Endocrinologia, Porto, Portugal
4 2
Faculdade de Ciencias da Nutricao e Alimentacao, Uni-
versidade do Porto, Servico de Nutricao, Porto, Portugal
IN GLYCOGEN STORAGE DISEASE TYPE IA
A MAJOR IMPROVEMENT FOR PATIENTS
D. Martins1, D. Oliveira1, C. Baptista1, S. Paiva1, H. Esperto2,
S. Moreira2, H. Clemente2, N. Vicente1, L. Cardoso1, A. Lages1,
M. Ventura1, N. Cunha1, F. Carrilho1
1
Centro Hospitalar e Universitario de Coimbra, Servico de
Endocrinologia, Diabetes e Metabolismo, Coimbra, Portugal
2
Centro Hospitalar e Universitario de Coimbra, Servico de
Medicina Interna, Coimbra, Portugal
353 MODELING TREATMENT WITH METFORMIN,
WITH AND WITHOUT INSULIN IN A VIRTUAL T2DM
VARIABILITY OF COMMON SELF-MANAGEMENT
BEHAVIORS
Y.Y. Chang1, M. Weinheimer1, S. Riddle1, G. Kongable1
1
The Epsilon Group, Simulation and Modeling, Charlottesville,
USA
354 TIME SPIRALS: NEW APPROACH TO VISUALIZE
LARGE DATASETS OBTAINED FROM CGM
MEASUREMENTS OF PATIENTS WITH DIABETES
D. Akotia1, A. Holubova1,2, J. Muzik1,2
1
Charles University, Spin-off Company and Research Results
Commercialization Center of the First Faculty of Medicine,
Prague, Czech Republic
Czech Technical University in Prague, Faculty of Biomedical
Engineering, Prague, Czech Republic
A-132
355 AUTOMATIC DETECTION OF MEALTIME
SITUATIONS IN DAILY REGIMEN OF PATIENTS
WITH TYPE 1 DIABETES WHO USE MHEALTH
TECHNOLOGIES
A. Holubova 1,2, J. Muzk1,2, M. Polacek2, D. Fiala1,
E. Arsand3,4, M. Bradway3,4, J. Kaspar1,2, K. Hana2,
P. Smrcka2, M. Kvapil5, J. Broz5
1
Charles University, Spin-off Company and Research Results
Commercialization Center of the First Faculty of Medicine,
Prague, Czech Republic
2 3
Czech Technical University in Prague, Faculty of Biomedical
Engineering, Prague, Czech Republic
3
Norwegian Centre for E-Health Research, University Hospital
of North Norway, Troms, Norway
4
UiT The Arctic University of Norway, Department of Clinical
Medicine, Troms, Norway
5
Second Faculty of Medicine, Department of Internal Medicine,
Prague, Czech Republic
356 COMMON BARRIERS TO USING NEW SITES
FOR INSULIN INJECTION/INFUSION IN ADULTS
WITH TYPE 1 DIABETES (T1D)
E. Patrakeeva1, E. Mokhova1, T. Zagorovskaya2,
A. Mosikian1
1
Saint-Petersburg Medical University, Endocrinology, Saint-
Petersburg, Russia
2
Saint-Petersburg State University, Saint-Petersburg, Russia
357 CONNECTING DIABETES TELEMEDICINE
SYSTEM TO A NONSTOP EMERGENCY
HELPDESK
J. Muzik1, A. Holubova1, M. Vlasakova2, D. Fiala1,
M. Polacek1, K. Hana1, K. Jan1, M. Muzny2, J. Broz3
1
Czech Technical University in Prague, Faculty of Biomedical
Engineering, Prague 2, Czech Republic
2
Charles University, Spin-off Company and Research Results
Commercialization Center, First Faculty of Medicine, Prague,
Czech Republic
3
Charles University, Department of Internal Medicine- 2nd
Faculty of Medicine, Prague, Czech Republic
358 TREATMENT OF AUTOIMMUNE DIABETES
AND INSULITIS IN NOD MICE WITH A SYNTHETIC
PEPTIDE VACCINE BASED ON EPITOPE OF DPP4
AND P277
T. Li1, X. Wei1, Z. Li1, J. Fang1
1
China Pharmaceutical University, Life Science and Technology
College, Nanjing, China
359 INSULIN DEGLUDEC AND PREGNANCY:
CASES REPORT IN TYPE 1 DIABETIC WOMEN
E. Gamarra1, C. Monzeglio2, G. Grassi1
1
AO Citta della Salute e della Scienza
di Torino, S.C.D.U. Endocrinologia, Diabetologia e Metabo-
lismo, Torino, Italy
2 2
AO Citta della Salute e della Scienza di Torino, Ginecologia e
Ostetricia, Torino, Italy
ATTD 2017 READ BY TITLE
360 THE EFFICACY AND SAFETY OF INSULIN
DEGLUDEC AS BASAL-BOLUS INSULIN THERAPY
IN CHILDREN AND ADOLESCENTS WITH TYPE 1
DIABETES IN ROUTINE CLINICAL PRACTICE
A. Kiiaev1, O. Koksharova1, L. Chernikh2, O. Pollyak2,
A. Yusupova2, I. Korneva3, M. Slovak3
1
Ural State Medical University, Department of Outpatient Pe-
diatrics, Ekaterinburg, Russia
2
Regional Pediatrics University Hospital No 1, Department of
Endocrinology, Ekaterinburg, Russia
University Hospital No 40, Department of Endocrinology,
Ekaterinburg, Russia
361 FLASH GLUCOSE MONITORING IN CLINICAL
PRACTICE: COMPARISON BETWEEN BASIC
AND PROFESSIONAL APPROACH
A. Tumminia1, V. Rapisarda2, C. Egiziano2, L. Frittitta1,
L. Sciacca1, L. Tomaselli2
1
Garibaldi-Nesima Hospital, Endocrinology Section, Clinical
and Experimental Medicine, Catania, Italy
2
Garibaldi-Nesima Hospital, Endocrinology Unit,
Catania, Italy
362 COMPARATIVE PHARMACOECONOMIC
ASSESSMENT OF THE TYPE 2 DIABETES
TREATMENT WITH INSULIN DEGLUDEC
AND INSULIN GLARGINE IN BASAL-BOLUS
INSULIN THERAPY
M. Shestakova1, A. Kolbin2, G. Galstyan3, A. Kurilev2,
Z. Wenlong2, J. Balykina4, M. Proskurin4, Y. Alekseeva5,
E. Startseva6
1
Endocrinology Research Centre, Diabetes Institute, Moscow,
Russia
2
Pavlov First Saint Petersburg State Medical University, De-
partment of Clinical Pharmacology and Evidence-based Med-
icine, Saint Petersburg, Russia
3
Endocrinology Research Centre, Diabetic Foot Department,
Moscow, Russia
4
Saint Petersburg State University, Department of Mathema-
tical Modelling of Energy Systems, Saint Petersburg, Russia
5
Novo Nordisk, Medical Affairs, Moscow, Russia
6
Novo Nordisk, Clinical, Medical and Regulatory Department,
Moscow, Russia
363 USE OF MOBILE-BASED TECHNOLOGIES
TO IMPROVE DIABETES SELF-MANAGEMENT
BEHAVIOR AND POSTPRANDIAL GLUCOSE
CONTROL
E. Toschi- MD1,2, S. Edwards1, H. Wolpert- MD1,2
1
Joslin Diabetes Center, Clinical- Behavioral- and Outcomes
Research, Boston, USA
2
Harvard Medical School, Boston, USA
364 MENTAL HEALTH AND DIABETES: CAN TECH-
NOLOGY BE A GAME CHANGER AND TRANSFORM
CARE IN PATIENTS WITH BOTH DIABETES
AND MENTAL HEALTH PROBLEMS?
G. Mlawa1,2
1
Queens Hospital-London, Acute Medicine/Diabetes & Endo-
crinology, London, United Kingdom
King George Hospital, Acute Medicine/Diabetes & Endo-
crinology, London, United Kingdom
ATTD 2017 READ BY TITLE
365 GLYCEMIC CONTROL DURING PREGNANCY
IN WOMEN WITH TYPE 1 DIABETES MELLITUS
TREATED THE PREDICTIVE LOW-GLUCOSE
SUSPEND INSULIN PUMP (640G) A CASE
REPORT
K. Cyganek1, T. Klupa1,2, M. Malecki1,2
1
Hospital University, Department of Metabolic Diseases, Kra-
kow, Poland
2
Jagiellonian University, Medical College, Department
of Metabolic Diseases, Krakow, Poland
366 EFFECTIVENESS OF TRANSITION BETWEEN
MULTIPLE DAILY INJECTIONS TO CONTINUOUS
SUBCUTANEOUS INSULIN INFUSION IN PATIENTS
WITH TYPE 1 DIABETES
C. Neves1, S. Oliveira1, J.S. Neves1, M. Pereira1, C. Esteves1,
C. Arteiro1, C. Redondo1, A. Costa1, D. Carvalho1
1
Hospital de Sao Joao, Department of Endocrinology, Diabetes
and Metabolism, Porto, Portugal
A-133
367 THE COURSE OF DIABETES IN MONGOLOIDS
L. Kolesnikova1, S.I. Kolesnikov1, M.A. Darenskaya1,
L.A. Grebenkina1, S.V. Gnusina2
1
Scientific Centre for Family Health and Human Reproduction
Problems, Department of Pathophysiology, Irkutsk, Russia
2
Scientific Centre for Family Health and Human Reproduction
Problems, Department of Pathophysiology, Irkutsk, Russia
368 HEALING OF DIABETIC FOOT ULCER USING
AUTOLOGOUS PERIPHERAL BLOOD
MONONUCLEAR CELLS
B. Supartono1,2, P. Kusumaningsih3, M. Sakiinah4
1
University of Pembangunan Nasional Veteran Jakarta,
Stem Cell Research and Tissue Engineering Center, Jakarta,
Indonesia
2
National Sport Hospital, Orthopaedic Department, Jakarta,
Indonesia
3
RSU Al-Fauzan, Obstetrics and gynecology, Jakarta, In-
donesia
4
RSU Al-Fauzan, Emergency Room, Jakarta, Indonesia