.

Md, Phd

31/5/2015

Better glycemic control with sensor augmented

pump therapy (SAP) vs. MDI

Current situation

Average A1C reduction for SAP and MDI

The problem

Therapies

Clinical evidence

Sensor Augmented Pump (SAP) had greater A1C reduction vs. MDI
at 3 months and sustained it over 12 months.1,2

The VALUE of Insulin Pumps are supported numerous meta-analyses, and

20+ cost-effectiveness publications.
SAP reduces A1C up to 1.2%, without an increase in hypoglycaemia1,2
Significant reduction in glycaemic variability in children3
SAP enables more patients to reach target A1C levels4
SAP therapy has shown to be cost-effective vs pump alone and vs MDI5,6
1. Bergenstal RM et al. New England Journal 2010;363(4):311-20 2. Chase, H. Peter, et al. Diabetes Technology & Therapeutics 12.7 (2010): 507-515.
3. Kordonouri O et al. Diabetologia 2010;53(12):2487-95 4. JDFR. N Engl J. 2008 Oct;359(14):146476 5. Ly TT et al. Value Health. 2014;17(5):561-9
6. Roze, S. et al., 2014. Diabetic medicine , pp.19.

Reducing hypoglycemia is critical for better diabetes care

Hypoglycemia (low blood glucose) can cause confusion, disorientation, loss of consciousness, and in the worst
cases coma and even death. 1
Unmet need: CSII and SAP reduce A1C levels (vs. MDI) without increasing hypoglycemia, however effective
management of nocturnal and recurrent hypoglycemia calls for a therapy that detects and mitigates severe
hypoglycemia.2,3,4

Landscape of Options for Intensive Insulin Therapy

Current situation

The problem

Therapies

Clinical evidence

We know since the DCCT trial that when you try

Hypoglycaemia is one of the most important

to improve the metabolic control of type 1 diabetic

challenge currently. With the pump you can go

patients there is a price to pay, and the price is

lower with your blood sugars and prevent many

hypoglycaemia. And we all know that this is a

high blood sugars but the problem is now the low

huge burden for patients

side. You want to go low but you want to do it safely.

Dr Conget, Spain

- Dr Veeze, Netherlands, Current ISPAD President

1. Seaquist ER, et al. J Clin Endocrinol Metab. 2013;98(5):1845-59. 2. Pickup J et al. Diabet Med 2008;25:765-74 3. Misso ML et al. Cochrane Database Syst Rev. 2010;(1):CD005103. 4. Bergenstal
RM et al. N Engl J Med. 2013;369(3):224-32.

Economic burden of hypoglycemia

Current situation

DIRECT COSTS

Medical Costs:

The problem

Average severe episode 68 2

Hospitalizations for severe hypoglycemic episodes are the key cost

drivers in the management of diabetic patients without further
complications.1,3
Severe hypoglycemic episode (requiring hospitalization)
costs health care systems up to 4,830 in Europe.2
4.4 days of hospitalization per severe hypoglycemic episode (UK)3

Hospital Costs:
Hypoglycemic Episode
with Hospitalization
are up to 4,830 in DE2

Indirect Costs:
3.6 missed days of work
per severe event 6

INDIRECT COSTS
Patients with hypoglycemia have shown 77% more short-term disability
days annually and a 5-fold greater risk of short-term disability the week
following a hypoglycemic event.4
Absenteeism following a mild/moderate episode during work ranges
from 9.9 hours to 14.7 hours for a nocturnal episode.5
Severe episodes among T1DM patients result in 3.6 days off work on average.6

Curkendall S et al. Endocr Pract 2009 May 1;15(4):302-12. 2. DRG Browser (2013) 3. Leese GP et al. Diabetes Care 2003 Apr 1;26(4):1176-80.
4. Rhoads GG et al. J Occup Environ Med 2005;47(5):447-52. 5. Brod M et al. Value Health 2011;14(5):665-671. 6. Davis RE et al. Curr Med Res Opin 2005;21:1477-1483.

Therapies

Clinical evidence

Executive summary
The challenges of optimally managing T1DM faced by patients, physicians, and payers can be
effectively and economically addressed with MiniMed TM 640G and SmartGuardTM

Current situation

CURRENT SITUATION
The problem

Reducing and controlling A1C has significant clinical

and economic benefits1
Insulin Pump Therapy2 and Sensor Augmented Pump Therapy (SAP) 3
technologies have shown to reduce A1C more effectively compared to MDI
and are cost-effective4

Therapies

Clinical evidence

THE PROBLEM
Hypoglycemia has a significant clinical, economic
and human burden5
T1 patients have been shown to have 1 or more severe hypo
events per year leading to significant costs and impaired
quality of life. Hypo Prone and hypo-unaware patients will
have significantly higher rates6
Reducing hypoglycemia is CRITICAL for better diabetes care

ADVANCED PROTECTION FROM HYPOGLYCEMIA

MiniMedTM 640G with SmartGuardTM

THE CLINICAL EVIDENCE

2 large RCTs have shown reductions in hypoglycemia
1. Rose et al. Diabetes care. 2014 37(1), pp.449. 2. Pickup J et al. Diabet Med 2008;25:765-74 3. Bergenstal RM et al. New England Journal 2010;363(4):311-20 4. Roze, S. et
al. Diabet Med 2014; pp.19 5. Seaquist ER, et al. J Clin Endocrinol Metab. 2013;98(5):1845-59 6. Ly TT et al. Diabetes Care 2012;35(7):1462-1465. 8. Bergenstal RM, et al. N
Engl J Med. 2013;369(3):224-32. 9. Ly TT et al. JAMA. 2013;310(12):1240-7.

MiniMedTM 640G with SmartGuardTM

ADVANCED PROTECTION FROM
HYPOGLYCEMIA WITH SMARTGUARD1

Current situation

The problem

Continuous monitoring of sensor glucose levels.

Automatic suspension of insulin delivery when sensor
glucose is predicted to approach a low glycemic limit2
Resumption of insulin delivery when sensor glucose
levels recover3

Therapies

Clinical evidence

PERSONALIZED CONVENIENCE
Informative Bolus WizardTM
Programmable treatment reminders
Remote bolus from meter

INTUITIVE4, PATIENT-FRIENDLY DESIGN

Full-color, auto-brightness display for easy readability
even for patients with reduced eyesight
Waterproof,5 allowing uninterrupted wear
Louder,6 volume-adjustable alerts
1. Bergenstal RM et al. N Engl J Med. 2013;369(3):224-232. 2. Insulin is suspended when sensor glucose is at or within 3.9 mmol/L above the low limit and estimated to be within 1.1 mmol/L above the low limit in 30 minutes AND the pump must not be in
the refractory period. 3. Insulin resumes
when sensor glucose is at least 1.1 mmol/L above the low limit and estimated to be more than 2.2 mmol/L above in 30 minutes AND insulin must have been suspended for at least 30 minutes. 4. CCR Study, 2012 HFMD, Inc. Data on file at Medtronic
MiniMed, Inc. Northridge, CA. 5. The MiniMed 640G insulin pump has an IPX8 ratingis waterproof in up to 12 feet of water for 24 hours at a time; The Guardian 2 Link transmitter is waterproof in up to 8 feet of water for up to 30 minutes. See MiniMed

Home Screen
Statusbar: provides

Current time

a quick look at the

pumps status

BG reading: displays a BG
taken in the last 12 minutes

Bolus:
gives you access to the bolus delivery screen and
other bolus insulin options

Active insulin: displays any

insulin still active from
previous boluses

Basal: gives you access to basal insulin

options

Internal Use Only

Preset Temp Basal

Purpose
Can set a temp basal ahead of time for recurring, short term
situations

Benefit
A more convenient way to use a Temp Basal that is used repeatedly
without having to program it each time it is used

Details

Can set up to 8 Preset Temp basal rates

Temp 1- 4, High Activity, Moderate Activity, Low Activity, Sick
Once set up, Preset Temp appears as an option when Basal is
selected from the Home screen
Review or cancel by selecting Basal (T) on Home screen

Internal Use Only

Preset Bolus Setup

Purpose
Able to set up in advance bolus deliveries that you expect to use
frequently

Benefit
Allows common bolus amounts to be pre-programmed

Details:

Can set up to 8: Bolus 1- 4, Breakfast, Lunch, Dinner, Snack

Once set, Preset Bolus appears when Bolus is selected on the Home
screen
Can be delivered as Normal, Dual or Square Wave bolus

Internal Use Only

Using the Contour Next / Plus

Link
2.4
Meter
from
Bayer
Purpose
Allows blood glucose readings to be sent directly to the pump

Benefit
High accuracy
Wireless capability eliminates need to manually enter BG readings
into pump
Remote bolus capability
Communication device for CareLink
Compact, discreet design

Details

Menu and Power ButtonUSB Connector

Test Strip Port

and Port Light

Protective USB Cap

Display Screen

Selection/Scrolling Buttons

Internal Use Only

Home Screen when Using

CGM
Additional Sensor Icons
High Limit
3 hr Sensor

Glucose (SG) Graph

Low Limit

Trend Arrows
Most recent Sensor
Glucose (SG) Reading
Suspend by Sensor Icon

Trend Arrows
or
or
or

- SG has been rising or falling about 1-2 mmol/L over the last 20 minutes

- SG has been rising or falling about 2-3 mmol/L over the last 20 minutes
- SG has been rising or falling greater than 3 mmol/L over the last 20 minutes

Internal Use Only

Home Screen when Using

CGM

Additional Sensor Icons

Trend Arrows

High Limit

Most recent Sensor

Glucose (SG) Reading

3 hr Sensor
Glucose (SG)
Graph
Low Limit

Suspend by Sensor Ico

Suspend before low or Suspend on low feature is on and

ready.
Suspend before low or Suspend on low is active. Insulin delivery is
stopped.
Suspend feature is on but is unavailable due to a recent
suspend or sensor glucose values not available.
Internal Use Only

Sensor Glucose Alerts

13.9 mmol/L

4.0 mmol/L

CGM Alert Settings

Sensor must first be turned on before alerts can be set.

Internal Use Only

Low Settings
Purpose:
Provides alerts or suspends insulin delivery when sensor glucose
values are
approaching or reach the pre-set low limit

Benefit:
Helps to minimize low glucose excursions by providing alerts and/or
suspending insulin delivery

Details:
Up to 8 time segments and low limits can be set per day
Options per time segment:

Suspend before low

Alert before low
Suspend on low
Alert on low

Internal Use Only

Suspend by Sensor: Suspend on Low

Sensor Glucose Value

Suspends basal insulin because

SG reaches the Low Limit

Low Limit

00:000

30 01:00

60

minutes

Internal Use Only

90
02:00

120

Sensor Glucose Value

Suspend by Sensor: Suspend on Low

Alert before low: option to be alerted

when SG estimated to reach low limit in
30 minutes

Low Limit

00:000

30 01:00

60

minutes

Internal Use Only

90
02:00

120

Sensor Glucose Value

Suspend by Sensor: Suspend on Low

Alert on low: will always alert

when Suspend on low occurs

Low Limit

00:000

30 01:00

60

minutes

Internal Use Only

90
02:00

120

Suspend by Sensor: Suspend before Low

Sensor Glucose Value

Suspends basal insulin because SG:

is within 3.9 mmol/L above the Low Limit

AND estimated to be within 1.1 mmol/L above the Low Limit with
in 30 min

3.9 above Low Limit

1.1 above Low Limit

Low Limit

00:000

30 01:00

60

minutes

Internal Use Only

90
02:00

120

Sensor Glucose Value

Suspend by Sensor: Suspend before Low

Alert before low: option to be alerted

when insulin is suspended
3.9 above Low Limit

1.1 above Low Limit

Low Limit

00:000

30 01:00

60

minutes

Internal Use Only

90
02:00

120

Sensor Glucose Value

Suspend by Sensor: Suspend before Low

Alert on low: alert will sound if

low limit is reached during the
suspend.
3.9 above Low Limit

1.1 above Low Limit

Low Limit

00:000

30 01:00

60

minutes

Internal Use Only

90
02:00

120

Suspend by Sensor: Auto-resume based on SG

Sensor Glucose Value

Resumes basal delivery because:

SG is at least 1.1 mmol/L above Low Limit

AND estimated to be more than 2.2 mmol/L above the Low Limit within
30 min
AND insulin has been suspended for at least 30 min

2.2 above Low Limit

1.1 above Low Limit
Low Limit

00:000

30 01:00

60

Minutes

Internal Use Only

90
02:00

120

Suspend by Sensor: Maximum 2 hour suspend

Resumes basal delivery because:
Sensor Glucose Value

user has not manually resumed insulin

auto resume based on SG criteria has not been
met
basal insulin has been suspended for 2 hours

2.2 above Low Limit

1.1 above Low Limit
Low Limit

00:000

30 01:00

60

minutes

Internal Use Only

90
02:00

120

Sensor Glucose Value

Suspend by Sensor: Maximum 2 hour suspend

Alert will always occur when SG is auto

resumed after 2 hour maximum suspend
2.2 above Low Limit
1.1 above Low Limit
Low Limit

00:000

30 01:00

60

minutes

Internal Use Only

90
02:00

120

Messaging guide
What are the key product messages?

HCP

PATIENT

Reduction of hypoglycemia with

SmartGuard

Predictive suspend

Predictive suspend

Predictive resume avoiding hyperglycemic

rebound

Automatic resume when glucose level

recover

Increased protection when needed with

multiple low limit setting

Protection from dangerous highs and lows

with SmartGuard

Multiple low limit setting

Increased patient safety & protection thanks

to intelligent pump features:

Increased safety & protection thanks to

intelligent pump features:

Predictive battery end of life

Predictive battery end of life

Self-test

Self-test

Bolus progress bar and Stop Bolus

Bolus progress bar and Stop Bolus

Messaging guide
What are the key product messages?

HCP

Correct insulin dosing & better patient

understanding with Bolus Wizard

PATIENT

Simplified insulin dosing with Bolus Wizard

Simplicity & discretion with linking glucose

meter allowing for remote bolusing and uploading
of data to CL

Discretion & ease of use with remote bolusing

Easy therapy customisation with:

Preset bolus options

Personalised basal patterns

Programmable treatment reminders

Easy tailoring to individual needs with:

Preset bolus options & personalised basal

patterns

Programmable treatment reminders

Adjustable audio options

Messaging guide
What are the key product messages?

HCP
Easy training thanks to the
intuitive screen navigation

PATIENT
Less button pushing, ease of
use thanks to the intuitive screen
navigation

Easy readability for all patients

with the full-color, auto-brightness
display

Uninterrupted wear thanks to

the IPX8 waterproof rating

Easy readability in all conditions

with the full-color, auto-brightness
display
Flexibility to enjoy water
activities thanks to the IPX8
waterproof rating

PILGRIM Study demonstrates advanced protection from

hypoglycemia with SmartGuardTM technology1

Current situation

The problem

80% of hypoglycemic events were avoided by

use of SmartGuard (defined as SG <70 mg/dL)

SmartGuard achieved 42% less time spent low

compared to Low Glucose Suspend
Therapies

Clinical evidence

Single-center observational study of 22 youths (14-20 years) where hypoglycemia was induced
by exercise while using SmartGuart technology.* The results show that SmartGuard may further
reduce the severity of hypoglycemia.
1. Danne T et al. Diabetes Technology & Therapeutics. 2014; 16(6):338:347.
*PLGM (predictive low glucose management) was suspend terminology used in the study and report. Actual brand name is SmartGuard technology.

Landmark ASPIRE trial1 shows

significantly less hypoglycemic events*

Current situation

The problem

Hypoglycemia events less frequent in the

Low Glucose Suspend Group.**

Fewer SG values in hypoglycemic ranges in the Low

Glucose Suspend Group (p<0.001).

Hypoglycemia events*** per patient-week

Therapies

Sensor glucose distribution <70 mg/dL

Clinical evidence

*Study Design: Randomized controlled trial of 247 patients lasting 3 months comparing the MiniMed
Veo with Low Glucose Suspend off vs. with Low Glucose Suspend on; A1C control was similar in both groups
**Low-glucose insulin-suspend pumps consist of a CSII insulin pump that is linked to CGM and this automatically suspends the basal infusion rate for up to 2 h in the event of CGMdetected hypoglycaemia.
*** A nocturnal hypoglycemic event was defined as sensor glucose values of 65 mg per deciliter (3.6 mmol per liter) or less between 10 p.m. and 8 a.m. for more than 20 consecutive
minutes in the absence of a pump interaction (i.e., meter blood glucose entries, carbohydrate entries, and insulin-delivery changes) within 20 minutes, as determined by reviews of data
uploaded with the use of Medtronic CareLink Therapy Management Software for Diabetes.

1. Bergenstal RM et al. N Engl J Med. 2013;369(3):224-32.

Landmark ASPIRE1 trial shows reduction

in severity and duration of hypoglycemia

Current situation

The problem

37.5% Reduction in severity and duration

(AUC) of NH Events in the Low Glucose Suspend Group
Reduction in Nocturnal Hypoglycemia

31.4% Reduction in severity and duration (AUC) of

ALL Events in the Low Glucose Suspend Group

The Therapies

Reduction in (Day + Night) Hypoglycemia

Clinical evidence

Study Design: Randomized controlled trial of 247 patients lasting 3 months comparing the MiniMed Veo with
Low Glucose Suspend* off vs. with Low Glucose Suspend on; A1C control was similar in both groups
*Low-glucose insulin-suspend pumps consist of a CSII insulin pump that is linked to CGM and this automatically suspends the basal infusion rate
for up to 2 h in the event of CGM-detected hypoglycaemia.

1. Bergenstal RM, et al. N Engl J Med. 2013;369(3):224-32.

Reduction in severe hypoglycemia events

and improved awareness
Study Design: Randomized Control Trial over 6 months, n = 95 (children & adults with impaired hypo
awareness); 2 groups: MiniMed VEO SAP with LGS ON vs CSII alone
0 Severe Hypo Events (coma or seizure)1

Current situation

The problem

Therapies

Clinical evidence

Significantly reduced rate of severe hypoglycemic events, defined as seizure or coma1

Significant Improvement in Quality of Life (EQ5D Utility: +0.073 favouring the SAP+LGS group after 6 months, p<0.05) 2
CGM resulted in a significantly improved epinephrine response implying improved awareness of hypoglycemia
(604% change in CGM group vs 114% change in the standard care group, p=0.048). 3
SAP with insulin suspension is considered a cost effective treatment option for hypo-prone patients.4

1. Ly TT et al. JAMA. 2013;310(12):1240-7. 2. McBride M et al. Presented ISPOR 16th. Dublin November 2013. 3. Ly TT et al. Diabetes Care 34: 50 52.2011 4. Ly TT et al. Value Health. 2014;17(5):561-9.

 31/5/2015