master template

1
Insulin and Sensors Where are we now and where
are we heading?
Bruce W. Bode, MD, FACE Atlanta Diabetes
Associates Atlanta, Georgia
2
Goals of Intensive Diabetes Therapy

• Maintain near normal glycemia
• Avoid short-term crisis
• Minimize long-term complications
• Improve the quality of life

3
Goals in Management of Diabetes

• Pre-meal BG 4 to 8 mmol/l
• Post-meal BG lt 8 to 9 mmol/l
• A1C lt 6.5
• Blood Pressure lt 130/80
• LDL lt 100 mg/dL HDL gt 45 mg/dL
• Triglycerides lt 150 mg/dL

4
Insulin

• The most powerful agent we haveto control glucose

5
The Miracle of Insulin
February 15, 1923
Patient J.L., December 15, 1922
6
Options in Insulin Therapy for Type 1 Diabetes

• Current
• Multiple injections
• Insulin pump (CSII)
• Future
• Implant (artificial pancreas)
• Transplant (pancreas islet cells)

7
Progression of Type 1 Diabetes
Precipitating Event
Antibody
Progressive loss of insulin release
Normal insulin release
Overt diabetes
Glucose normal
Beta-cell mass
C-peptide present
No C-peptide present
Age (y)
Adapted from Atkinson. Lancet. 2002358221-229.
8
Type 2 Diabetes A Progressive Disease

• Over time, most patients will need insulin to
  control glucose

9
Type 2 Diabetes Two Principal Defects
Reaven GM. Physiol Rev. 199575473-486 Reaven
GM. Diabetes/Metabol Rev. 19939(Suppl
1)5S-12S Polonsky KS. Exp Clin Endocrinol
Diabetes. 1999107 Suppl 4S124-S127.
10
A1C in the UKPDS
11
UKPDS b-Cell Function for the Patients
Remaining on Diet for 6 Years
b-Cell Function ( b)
N376
Years After Diagnosis
Adapted from UKPDS Group. Diabetes. 1995
441249-1258.
12
Multiple factors may drive progressive decline of
b-cell function
Hyperglycaemia (glucose toxicity)
Insulin resistance
b-cell (genetic background)
Protein glycation
lipotoxicity elevated FFA,TG
Amyloid deposition
13
Approach to Combination Oral Therapy
14
Comparison of Human Insulins / Analogues

• Insulin Onset of Duration ofpreparations
  action Peak action

Regular 3060 min 24 h 610 h
NPH/Lente 12 h 48 h 1020 h
Ultralente 24 h Unpredictable 1620 h
Aspart/Lispro 515 min 12 h 46 h
Glargine 12 h Flat 24 h
15
Dissociation Absorption of Aspart
16
Short-Acting Insulin AnalogsLispro and Aspart
Plasma Insulin Profiles
400
500
Regular Lispro
Regular Aspart
450
350
400
300
350
250
300
Plasma insulin (pmol/L)
200
250
Plasma insulin (pmol/L)
200
150
150
100
100
50
50
0
0
0
30
60
90
120
180
210
150
240
0
50
100
150
200
300
250
Time (min)
Time (min)
Meal SC injection
Meal SC injection
Heinemann, et al. Diabet Med. 199613625629
Mudaliar, et al. Diabetes Care. 19992215011506.
17
Glucose Infusion Rate
n 20 T1DM Mean SEM
SC insulin
24 20 16 12 8 4 0
4.0 3.0 2.0 1.0 0
µmol/kg/min
mg/kg/min
0 4 8 12 16 20 24
Time (hours)
Lepore M, et al. Diabetes. 20004921422148.
18
Plasma Glucose
220 200 180 160 140 120
12 11 10 9 8 7
n 20 T1DM Mean SEM
SC insulin
mmol/L
mg/dL
CSII
0 4 8 12 16 20 24
Time (hours)
Lepore M, et al. Diabetes. 20004921422148.
19
Overall Summary Glargine

• Insulin glargine has the following clinical
  benefits
• Once-daily dosing because of its prolonged
  duration of action and smooth, peakless
  time-action profile (mean 23.5 hours)
• Comparable or better glycemic control (FBG)
• Lower risk of nocturnal hypoglycemic events
• Safety profile similar to that of human insulin

20
ANA-2155Insulin aspart CSII vs. insulin
aspart/glargine MDI

• Open-label, randomized, crossover, two-arm study
  of 10-week duration
• Comparison of insulin aspart CSII vs. insulin
  aspart/glargine MDI
• Subjects n100, type 1 patients on CSII at
  entry, HbA1c lt 9
• Assessments
• Efficacy HbA1c, fructosamine, 8-pt BG profile,
  glucose exposure ( CGMS)
• Safety Freq. of hypoglycaemia, AEs

21
Aspart (CSII) vs Aspart/Insulin glargine (MDI)
8-Point Blood Glucose Profiles
200
CSII (n93)
MDI (n91)
180
160
Self-Monitored BG (mg/dL)
140
120
100
Mean 2 sem
Novo Nordisk, data on file (Study 2155/US)
22
Aspart (CSII) vs Aspart/Insulin glargine (MDI)
Glucose Exposure During CGMS

p 0.0027

3000
Measurement of AUC(glu) 80 mg/dL during the
48-hour continuous glucose monitoring period
2500
AUCglu (mghr/dL)
2000
n63 in each treatment
1500
1000
500
0
CSII
MDI
Novo Nordisk, data on file (Study 2155/US)
23
Aspart (CSII) vs Aspart/Insulin glargine (MDI)
Serum Fructosamine
Fructosamine (µmol/L)
p 0.0001
400
n97
300
means 2 sem
200
100
0
CSII
MDI
Novo Nordisk, data on file (Study 2155/US)
24
Aspart (CSII) vs Aspart/Insulin Glargine (MDI)
Rate of Minor Hypoglycemia
7
p0.21
plt0.01
6
5
4
plt0.01
Episodes / subject / 5 weeks
3
2
1
0
Total
Daytime
Nocturnal
Novo Nordisk, data on file (Study 2155/US)
25
Primary Structure of Lys(B29)-N-?-Tetradecanoyl,
Des(B30)-Insulin
26
Insulin Detemir in Nondiabetic SubjectsPharmacoki
netics by Glucose Clamp
2.0
1.5
Glucose infusion rate(mg/kg/min)
1.0
Detemir-high
Detemir-low
0.5
Placebo
0.0
-100
100
300
500
700
900
1100
1300
1500
Elapsed time (min)
Brunner GA, et al. Exp Clin Endocrinol Diabetes.
2000108100-105.
27
ConclusionsFrom Phase 2 and 3 Studies
Insulin detemir in comparison to NPH

• Lowers A1C as effectively
• Lowers FPG significantly more
• Provides significantly lower intra-subject
  variation of fasting blood glucose (more
  predictable)
• Produces a smoother nocturnal glucose profile
• Causes a lower incidence of hypoglycaemia
• Associated with some weight loss
• Causes no safety concerns

28
Physiological Serum Insulin Secretion Profile
75
Breakfast
Lunch
Dinner
50
Plasma insulin (µU/ml)
25
400
800
1200
1600
2000
2400
400
800
Time
29
Basal/Bolus Treatment Program withRapid-acting
and Long-acting Analogs
Breakfast
Lunch
Dinner
Aspart Aspart Aspart
or
or
or
Lispro Lispro Lispro
Plasma insulin
Glargine or Detemir
400
1600
2000
2400
400
800
1200
800
Time
30
The Basal/Bolus Insulin Concept

• Basal insulin
• Suppresses glucose production between meals and
  overnight
• 40 to 50 of daily needs
• Bolus insulin (mealtime)
• Limits hyperglycemia after meals
• Immediate rise and sharp peak at 1 hour
• 10 to 20 of total daily insulin requirement at
  each meal

31
Treatment to Target Study NPH vs Glargine in DM2
patients on OHA

• Add 10 units Basal insulin at bedtime
  (NPH or Glargine)
• Continue current oral agents
• Titrate insulin weekly to fasting BG lt 5.5 mmol/l
• - if 5.5-6.6 mmol/l, increase 0 to 2 units
• - if 6.7-7.7 mmol/l, increase 4 units
• - if 7.8-8.8 mmol/l, increase 6 units
• - if 8.9-10.0 mmol/l, increase 8 units

32
Treatment to Target Study A1C
Decrease
33
Treat to Target Study Glargine vs NPH Added to
Oral Therapy of Type 2 Diabetes

• Nocturnal Hypoglycemia reduced by 40 in
  the Glargine group (532 events)
  vs NPH group (886 events)

Riddle et al, Diabetes June 2002, Abstract 457-p
34
Advancing Basal/Bolus Insulin

• Indicated when FBG acceptable but
• A1C gt 7 or gt 6.5
• and/or
• SMBG before dinner gt 7.8 mmol/l
• Insulin options
• To glargine or NPH, add mealtime aspart / lispro
• To suppertime 70/30, add morning 70/30
• Consider insulin pump therapy

35
Novo Nordisk devices in diabetes care

• First pen (NovoPen 1) launched in 1985
• Committed to developing one new insulin
  administration system per year.

36
Insulin Pens
37
Prefilled Syringe with Flexible Dosing
38
Pen Preference Study

• 82 of DNEs Preferred FlexPen

Source Diabetes Nurse Educators In-Depth
StudyReactions to FlexPen.
39
Novo Innolet
Large push button with low resistance
Maximum dose 50 units
Large-scale numbers
Clear uncomplicated dial, dials forward and
back
Audible clicks
1 unit increments
Contains 300 units Novolin 70/30, NPH, or R
Needle storage compartment
Support shoulder
NovoFine disposable needle
40
InDuo - Integration

• Feature
• Combined insulin doser and blood glucose monitor

41
InDuo - Doser Remembers

• Feature
• Remembers amount of insulin delivered and time
  since last dose

• Benefit
• Helps people inject the right amount of insulin
  at the right time

42
Device Preference InDuo vs Vial/Syringe/Meter
Multicenter, Randomized, Cross-over Study of 125
DM 1 patients
Bode et al, Diabetes June, 2003
43
Starting MDI

• Starting insulin dose is based on weight
• 0.2 x wgt. in lbs. or 0.45 x wgt. in kg
• Bolus dose (aspart/lispro) 20 of starting
  dose at each meal
• Basal dose (glargine/NPH) 40 of starting dose
  at bedtime

44
Starting MDI in 80 kg person

• Starting dose 0.45 x 80 kg
• 0.45 x 80 36 units
• Bolus dose 20 of starting dose at each meal
• 20 of 36 units 7 units ac (tid)
• Basal dose 40 of starting dose at bedtime
• 40 of 36 units 14 units at HS

45
Correction Bolus

• Must determine how much glucose is lowered by 1
  unit of short- or rapid-acting insulin
• This number is known as the correction factor
  (CF)
• Use the 90 rule to estimate the CF
• CF 90 divided by the total daily dose (TDD)
• ex if TDD 36 units, then CF 90/36 2.5
• meaning 1 unit will lower the BG 2.5 mmol/l

46
Correction Bolus Formula
Current BG - Ideal BG Glucose Correction factor

• Example
• Current BG 12 mmol/l
• Ideal BG 5.5 mmol/l
• Glucose Correction Factor 2.5

12 5.5 2.5
2.6 units
47
Options to MDI

• A Simpler Regimen
• Insulin Pump
• Premixed BID (DM 2 only)

48
Human Insulin Time-action Patterns
Normal insulin secretion at mealtime
Change in serum insulin
Baseline level
Time (h)
SC injection
49
A More Physiologic Insulin
Normal insulin secretion at mealtime
NovoLog?
NPH insulin
NovoLog? Mix 70/30
Change in serum insulin
Baseline Level
Time (h)
50
Analog Mix 70/30 Serum Insulin Levels in Type 2
Diabetes


100
Cmax
80
60
Serum insulin (mU/L)
40
20
0
600 PM
1000 PM
800 AM
600 PM
100 PM
Breakfast
Lunch
Dinner
Time
Plt0.05.
McSorley. Clin Ther. 200224(4)530-539.
51
Aspart Mix 70/30Serum Glucose Levels in Type 2
Diabetes
Glucose excursions 0-4 h, Plt0.05. McSorley. Clin
Ther. 200224(4)530-539.
52
Analog Mix 70/30 vs 75/25 vs 70/30 Premix Serum
Insulin Levels in Type 2 Diabetes
80
Aspart Mix 70/30
Lispro Mix 75/25
60
70/30 Premix
Serum insulin (mU/L)
40
20
0
Time (h)
Hermansen. Diabetes Care. 200225(5)883-888.
53
Variable Basal Rate CSII Program
Breakfast
Lunch
Dinner
Bolus
Bolus
Bolus
Plasma insulin
Basal infusion
400
1600
2000
2400
400
800
1200
800
Time
54
History of Pumps
55
(No Transcript)
56
Pump Infusion Sets
57
Metabolic Advantages with CSII

• Improved glycemic control
• Better pharmacokinetic delivery of insulin
• Less hypoglycemia
• Less insulin required
• Improved quality of life

58
CSII Reduces HbA1c
10.0
Pre-pump Post-pump
9.5
.09
8.5
8.0
HbA1c
7.5
7.0
6.5
6.0
5.5
5.0
Bell Rudolph Chanteleau Bode Boland Chase
n 58 n 107 n 116 n 50 n 25 n 56
Mean dur. 36
Mean dur. 36
Mean dur. 54
Mean dur. 42
Mean dur. 12
Mean dur. 12
Adolescents
Adults
Chantelau E, et al. Diabetologia.
198932421426 Bode BW, et al. Diabetes Care.
199619324327 Boland EA, et al. Diabetes Care.
19992217791784 Bell DSH, et al. Endocrine
Practice. 20006357360 Chase HP, et al.
Pediatrics. 2001107351356.
59
CSII Reduces Hypoglycemia
160
Pre-pump Post-pump
140
120
100
Events per hundred patient years
80
60
40
20
0
Bode Rudolph Chanteleau Boland Chase
n 55 Mean age 42
n 107 Mean age 36
n 116 Mean age 29
n 25 Mean age 14
n 56 Mean age 17
Chantelau E, et al. Diabetologia.
198932421426 Bode BW, et al. Diabetes Care.
199619324327 Boland EA, et al. Diabetes Care.
19992217791784 Chase HP, et al. Pediatrics.
2001107351356.
60
CSIIFactors Affecting A1C

• Monitoring
• A1C 8.3 - (0.21 x BG per day)
• Recording 7.4 vs 7.8
• Diet practiced
• CHO 7.2
• Fixed 7.5
• WAG 8.0
• Insulin type (Aspart)

Bode et al. Diabetes 199948 Suppl 1264
Bode et al. Diabetes Care 200225 439
61
Insulin aspart versus buffered R versus insulin
lispro in CSII study
Insulin aspart
Screening
Buffered regular human insulin (Velosulin)
Insulin lispro

• 146 patients in the USA 225 years with Type 1
  diabetes
• 7 ? HbA1c ? 9 previously treated with CSII
  for 3 months

Bode et al Diabetes Care, March 2002
62
Glycemic Control with CSII
Type 1 Diabetes
8.0
7.8
7.6
HbA1c ()
7.4
7.2
7.0
0
Baseline
Week 8
Week 12
Week 16
Bode, Diabetes 2001 50(S2)A106
63
Self-Monitored Blood Glucose in CSII
NovoLog
Buffered Regular
Humalog

Blood Glucose (mg/dl)


Type 1 Diabetes
Bode, Diabetes 2001 50(S2)A106
64
Pharmacokinetic Comparison Aspart vs Lispro
350
Aspart
300
Lispro
250
200
Free Insulin (pmol/L)
150
100
50
0
Time (hours)
Hedman, Diabetes Care 2001 24(6)1120-21
65
Symptomatic or Confirmed Hypoglycaemia
p lt 0.05
p lt 0.05
12
10
8

• Episodes/month/patient

6
4
2
0
insulin aspart
human insulin
insulin lispro
Bode et al Diabetes Care, March 2002
66
Insulin aspart versus buffered R versus insulin
lispro in CSII study pump compatibility
Insulin aspart
Buffered human insulin
50
Insulin lispro
40
30
Patients with trouble-free use ()
20
10
0
Data on file (study ANA 2024)
67
DM 1 CSII Patient Lispro to Aspart
Aspart Average 6.6 SD 4.0
Lispro Average 7.8 SD 6.6
68
Long-term Heat Stability of Insulin Aspart in
Infusion Pumps
In-vitro 6-day stability study under conditions
of simulated CSII pump use (37C with constant
shaking)

• Antimicrobial Effectiveness and Particulate
  Matter were within USP requirements after 6 days.
  
• Stable pH during the 6 days
• Physico-chemical integrity of insulin aspart was
  retained.

69
Glycemic Control in Type 2 DM CSII vs MDI in
127 patients

• A1C

Baseline
End of Study (24 wks)
8.4
8.2
8.0
7.8
7.6
7.4
7.2
7.0
CSII
MDI
Raskin et al. Diabetes 200150 Suppl 2A128
70
CSII vs MDI in DM 2 Patients
Raskin et al. Diabetes 200150 Suppl 2A128
71
DM 2 Study CSII vs MDI

• 93 in the CSII group preferred the pump to their
  prior regiment (insulin /- OHA)
• Overall treatment satisfaction improved in the
  CSII group 59 pre to 79 at 24 weeks
• CSII group had less hyperglycemic episodes (3
  subjects, 6 episodes in CSII group vs.
  11 subjects, 26 episodes in
  the MDI group)

Raskin et al. Diabetes 200150 Suppl 2A128
72
Normalization of Lifestyle

• Liberalization of diet timing amount
• Increased control with exercise
• Able to work shifts through lunch
• Less hassle with travel time zones
• Weight control
• Less anxiety in trying to keep on schedule

73
Current Continuation RateContinuous Subcutaneous
Insulin Infusion (CSII)
Continued 97
Discontinued 3
N 165 Average Duration 3.6 years Average
Discontinuation lt1/yr
Bode BW, et al. Diabetes. 199847(suppl 1)392.
74
U.S. Pump Usage Total Patients Using Insulin Pumps
75
Current Pump Therapy Indications

• Diagnosed with diabetes (even new onset DM 1)
• Need to normalize blood glucose (BG)
• A1C ?? 7.0
• Glycemic excursions
• Hypoglycemia

76
Poor Candidates for CSII

• Unwilling to comply with medical
• follow-up
• Unwilling to perform self blood glucose
  monitoring 4 times daily
• Unwilling to quantitate food intake

77
Pump Therapy

• Meal boluses
• Insulin needed pre-meal
• Pre-meal BG
• Carbohydrates in meal
• Activity level
• Correction bolus for high BG

• Basal rate
• Continuous flow of insulin
• Takes the place of NPH or glargine insulin

6
5
Meal bolus
4
Units
3
2
1
Basal rate
12 am
12 pm
12 am
Time of day
78
Target BG Ranges for MDI or CSII

• Average Joe adult target ranges
• Preprandial 4 8 mmol/l
• 2 hr postprandial lt 9 mmol/l
• Bedtime 5 8 mmol/l
• 3 am gt 4.5 mmol/l
• Individually set for each patient

DCCT, N Engl J Med 1993, 329977-986. ADA
Clinical Practice Recommendations, 2001.
79
Target BG Ranges for MDI or CSII

• Hypoglycemic unawareness
• Preprandial 4.5 9.0 mmol/l
• Pregnant
• Preprandial 3.3 5.0 mmol/l
• 1 hr postprandial lt 6.7 mmol/l
• 2 hr postprandial lt 6.7 mmol/l
• Individually set for each patient

Fanelli CG et al., Diabetologia 1994,
371265-76. Jovanovich L, AMJObGynec 1991,
164103-11.
80
Initial Adult Dosage Calculations

• Starting Doses
• Based on pre-pump Total Daily Dose (TDD) Reduce
  TDD by 25-30 for Pump TDD
• Calculated based on weight
• 0.53 x weight in kg

Bode BW, et al., Diabetes 1999,(Suppl 1)84. Bell
D and Ovalle F, Endocrine Practice 2000,
6357-360. Crawford, LM, Endocrine Practice 2000,
6239-43.
81
Initial Adult Dosage Calculations

• Basal Rate
• 50 of pump Total Daily Dose
• Divide total basal by 24 hours to decide on
  hourly basal
• Start with only one basal rate
• See how it goes before adding additional basals

82
Initial Dosage Calculations

• Meal (food) Bolus
• Usually 50 of Pump Total Daily Dose
• Marjorie C.
• Total Daily Dose 40 Units
• Basal Rate 20 Units
• Meal Bolus (total) 20 Units

83
Initial Dosage Calculations

• Meal (food) Bolus Method
• - Divide total bolus dose by 3
• - Test BG before meal
• - Give correction bolus
• - Give pre-determined insulin dose for
  pre-determined CHO content
• - Test BG after meal

84
Estimating the Carbohydrate to Insulin Ratio
(CIR)

• Individually determined
• 1st option
• CIR (1.3 x Wgt in kg) / TDD
• 2nd option
• 500 divided by TDD
• Anywhere from 5 to 25 g CHO is covered by 1 unit
  of insulin

85
What Type of Bolus Should You Give?Immediate vs
Square vs Dual Wave

• 9 DM 1 patients on CSII ate pizza and coke on
  four consecutive Saturdays
• Dual wave bolus (70 at meal, 30 as 2-h square)
• 0.5 mmol/l glucose rise
• Single bolus 1.8 mmol/l rise
• Double bolus at -10 and 90 min 3.7 mmol/l rise
• Square wave bolus over 2 hours 4.4 mmol/l rise

Chase et al, Diabetes June 2001 365
86
Basal Dose Adjustment

• Rule of 1.7
• Basal Rate(s) Adjustments Overnight
• Check BG
• Bedtime
• 12 AM
• 3 AM
• 7AM
• Adjust overnight basal if readings vary gt 1.7
  mmol/l

87
Insulin Dose Adjustment

• Rule of 1.7
• Basal Rate(s) Adjustments Daytime
• Check BG
• Before usual meal time
• Skip meal
• Every 2 hrs (for 6 hrs)
• Adjust daytime basal if readings vary gt 1.7
  mmol/l

88
Prevention of Hypoglycemia

• Monitor BG
• 4-6 times a day
• Set appropriate BG target range
• Set minimum BG level before sleep
• Never lt 4.5 mmol/l, unless pregnant

89
Treatment of Hyperglycemia

• If blood glucose is above 15 mmol/l
• Take a correction bolus by pump
• Check BG again in 1 hr
• If still above 15 mmol/ll
• Take correction bolus by syringe
• Change infusion set and reservoir
• Check BG again in 1 hr
• If BG has not decreased
• Increase correction bolus by syringe
• CALL PHYSICIAN

90
If A1C is Not to Goal
Must look at

• SMBG frequency and recording
• Diet practiced
• Do they know what they are eating?
• Do they bolus for all food and snacks?

• Infusion site areas
• Are they in areas of lipohypertrophy?
• Other factors
• Fear of low BG
• Overtreatment of low BG

91
If A1C Not to Goal and No Reason Identified

• Place on a continuous glucose monitoring system
  (CGMS by Medtronic Minimed, Glucowatch by Cygnus)
  to determine the cause

92
Medtronic MiniMed Continuous Glucose Monitoring
System (CGMS)
93
CGMS
94
CGMS Sensor
95
Performance of the CGMS

• Glucose reading every 10 seconds, average every 5
  minutes (288 per day)
• Correlation to finger stick r 0.91
• Lag time avg lt 5 minutes, max lt13 minutes
• Not affected by age, race, gender, illness, type
  of DM

Gross TM, et al Diabetes Technology and
Therapeutics, Vol 2, No. 1, 2000
96
GLUCOSE MONITORING SYSTEMS - Telemetry
97
GlucoWatch Biographer
98
Therasense Continuous Glucose Monitoring System

• Features
• Easy to use, 3 day, disposable
• sensor
• Hyperglycemia/hypoglycemia
• alarms
• Interstitial fluid glucose values
• trends
• Memory
• FreeStyle calibration built in

99
The DexCom Continuous Glucose Sensor System
Technology Description

• Sensor
• Multi-layer membrane
• Modifies foreign body response
• Promotes local vascularization
• Glucose oxidase
• Measures glucose every 30 seconds
• Wireless transmission to receiver

• Receiver
• Receives and processes data from sensor
• Updates value every 5 minutes
• Displays glucose value
• Displays 1, 3, and 9 hour graphic trends
• High and low Alerts

100
Implantable Insulin Pump

• Average HbA1c 7.1
• Hypoglycemic events reduce to 4 episodes per 100
  pt-years

101
The Long-Term Sensor System a prototype of
implantable artificial pancreas
Sensor Tip
Inlet to Pump
Abdominal Lead Assembly (ALA)
Catheter Header with Inlet Port
Sensor Connection to the Pump
Catheter Tip for Insulin Delivery
102
Medtronic-Minimed Long-term IV Glucose Sensor
(LTSS)

• Results to date
• 18 patients
• Sensor life gt14 months
• Calibration check once per week
• Learning about insertion / positioning
• Four closed-loop experiments

103
Medtronic Minimed Long-Term Sensor System (LTSS)
Human Clinical Trial
Source Medical Research Group, Inc.
104
IV Sensor Performance in a Diabetic Patient over
11 Months
E. Renard et al, Lapeyronie Hospital,
Montpellier, France
Month 2
Month 4
Month 8
Month 11
105
Medtronic Minimed Artificial Pancreas
106
Blood Glucose Profile, Before, During and After
Closed Loop using LTSS
closed loop
107
Distribution of Blood Glucose One Week Before and
During 48H-Closed-Loop
E. Renard et al, Lapeyronie Hospital,
Montpellier, France
Average Glucose (mmol/l) 6.4
5.8 Daily Insulin Use (IU) 35 45
108
Closed-loop control using an external insulin
pump and a subcutaneous glucose sensor

subcutaneous glucose sensor
Insulin infusion pump (currently MiniMed 511)
109
Summary

• Insulin remains the most powerful agent we have
  to control diabetes
• When used appropriately in a basal/bolus format,
  near-normal glycemia can be achieved
• Newer insulins and insulin delivery devices along
  with glucose sensors will revolutionize our care
  of diabetes

110
Conclusion

• Intensive therapy is
• the best way to treat
• patients with diabetes

111
Questions

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