Expanding The Indications Expanding The Indications For CSII and SensingFor CSII and Sensing

Bruce W. Bode, MD, FACEAtlanta Diabetes Associates

Atlanta, Georgia

Undiagnosed diabetes

~5.2 million

Prevalence of Glycemic Abnormalities Prevalence of Glycemic Abnormalities in the United Statesin the United States

Additional 25 - 35 million

with IGT

Diagnosed type 2 diabetes

~12 million

Diagnosed type 1 diabetes

~1.0 million

US Population: 275 Million in 2000

3

Relative Risk of Progression of Relative Risk of Progression of Diabetic ComplicationsDiabetic Complications

DCCT Research Group, N Engl J Med 1993, 329:977-986.

1

3

5

7

9

11

13

15

6 7 8 9 10 11 12

Retinop

Neph

Neurop

RELATIVE RISK

Mean A1C

• Gain of 15.3 years of complication free living compared to conventional therapy

• Gain of 5.1 years of life compared to conventional therapy

Lifetime Benefits ofLifetime Benefits ofIntensive Therapy (DCCT)Intensive Therapy (DCCT)

DCCT Study Group, JAMA 1996, 276:1409-1415.

1-90 5

Stratton IM et al. BMJ 2000;321:405

Effect of A1C on Myocardial Infarction and Microvascular Complications in the UKPDS Study

0

10

20

30

40

50

60

MI Microvasc Dz

5.5%

6.5%

7.5%

8.5%

9.5%

10.5%

A1C

Lessons from the DCCT and UKPDS:Lessons from the DCCT and UKPDS:Sustained Intensification of Therapy is DifficultSustained Intensification of Therapy is Difficult

DCCT EDIC(Type 1)

UKPDS (Type 2),Insulin Group

DCCT/EDIC Research Group. New Engl J Med 2000; 342:381-389Steffes M et al. Diabetes 2001; 50 (suppl 2):A63UK Prospective Diabetes Study Group (UKPDS) 33Lancet 1998; 352:837-853

4

6

8

10

9.0

8.1

7.3

7.9

0 6.5 + 4 + 6 yrs

DCCT EDIC

0

6

7

8

0 2 4 6 8 10 yrs

A1C (%)

Normal

Baseline

A1C (%)

Specific Goals in Management of DiabetesSpecific Goals in Management of Diabetes

• Fasting < 110 mg/dL

• Post-meal < 140 mg/dL

• A1C < 6.5%

• Blood Pressure < 130/80

• LDL < 100 mg/dL; HDL > 45 mg/dL

• Triglycerides < 150 mg/dL

Primary Objectives of Effective Primary Objectives of Effective ManagementManagement

A1C%

SBPmm Hg

LDLmg/dL

45 50 55 60 65 70 75 80 85 90

9

Diagnosis

8

7

130

100

145

140

Patient Age

Reduction of both

micro- and macro-

vascular event rates

…by 75%!

lGæde P, Vedel P, Larsen N, Jensen GVH, Parving H-H, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with

type 2 diabetes. N Engl J Med. 2003;348:383-393.

InsulinInsulin

The most powerful agent we have

to control glucose

Patient J.L., December 15, 1922

February 15, 1923

The Miracle of InsulinThe Miracle of Insulin

Progression of Type 1 DiabetesProgression of Type 1 Diabetes

Adapted from: Atkinson. Lancet. 2002;358:221-229.

Age (y)

Precipitating Event

Be

ta-c

ell

ma

ss

Genetic predisposition

Normal insulin release

Glucose normal

Overt diabetes

No C-peptidepresent

Progressive loss of insulin release

C-peptidepresent

AntibodyAntibody

Options in Insulin Therapy Options in Insulin Therapy for Type 1 Diabetesfor Type 1 Diabetes

• Current—Multiple injections

—Insulin pump (CSII)

• Future—Implant (artificial pancreas)

—Transplant (pancreas; islet cells)

Type 2 Diabetes … Type 2 Diabetes … A Progressive DiseaseA Progressive Disease

Over time, most patients will need insulin

to control glucose

Multiple factors may drive progressive Multiple factors may drive progressive decline of decline of -cell function-cell function

-cell(genetic background)

Hyperglycaemia(glucose toxicity)

Proteinglycation

Amyloiddeposition

Insulin resistance

“lipotoxicity”elevated FFA,TG

Goals of Targeted Insulin Therapy Goals of Targeted Insulin Therapy (Intensive/Physiologic/Flexible) (Intensive/Physiologic/Flexible)

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

0 12 24

Hours

4:004:00

2525

5050

7575

8:008:00 12:0012:00 16:0016:00 20:00 20:00 24:0024:00 4:004:00

BreakfastBreakfast LunchLunch DinnerDinner

Pla

sma

insu

lin

(P

lasm

a in

suli

n (µ U

/ml)

U

/ml)

TimeTime

8:008:00

Physiological Serum Insulin Physiological Serum Insulin Secretion ProfileSecretion Profile

4:00 16:00 20:00 24:00 4:00

Breakfast Lunch Dinner

8:0012:008:00

Time

Glargine

Pla

sma

insu

lin

Basal/Bolus Treatment Program with Basal/Bolus Treatment Program with Rapid-acting and Long-acting AnalogsRapid-acting and Long-acting Analogs

Lispro Lispro Lispro

Aspart Aspart Aspartor oror

4:004:00 16:0016:00 20:00 20:00 24:0024:00 4:004:00

BreakfastBreakfast LunchLunch DinnerDinner

8:008:0012:0012:008:008:00

TimeTime

Basal infusion

Bolus Bolus Bolus

Pla

sma

insu

lin

Pla

sma

insu

lin

Variable Basal Rate: Variable Basal Rate: CSII ProgramCSII Program

• Insulin aspart (CSII) vs insulin aspart / glargine (MDI)

Run-in (1 week) Period 1 (5 weeks) Period 2 (5 weeks)

IAsp CSII

IAsp CSII

IAsp + Gar MDI

IAsp + Gar MDI

CSII vs MDI with Glargine in CSII vs MDI with Glargine in AdultsAdults

Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

• 100 patients with type 1 on CSII at entry

• A1C <9%

• Efficacy: A1C, fructosamine, 8-point BG profile, glucose exposure (CGMS)

• Safety: frequency of hypoglycemia, AEs

Pumps vs MDI:Pumps vs MDI:Characteristics of Enrolled PopulationCharacteristics of Enrolled Population

Data of file, Novo Nordisk. ANA-2155

Treatment Sequencea

CSII to MDI MDI to CSII All Subjects

Subjects Treated 50 50 100

Age (years) 41.7 11.1 44.2 11.0 43.0 11.1

BMI (kg/m2) 27.1 4.1 26.7 4.0 26.9 4.0

A1C at screening (%) 7.5 0.8 7.4 0.8 7.5 0.8

Duration of diabetes (years)

19.7 11.3 23.9 12.3 21.8 11.9

Daily insulin dose 42.3 17.9(n = 45)

41.6 16.1(n = 50)

41.9 16.9(n = 95)

Basal 21.1 8.1 22.6 10.7 21.9 9.2

Bolus 22.7 13.8 19.3 8.7 20.9 11.4

CSII vs MDI: Better BG Control CSII vs MDI: Better BG Control

Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

Mean ± 2 SEM

200

160

140

120

100

180

Se

lf-m

on

ito

red B

G (

mg

/dL

)

BB AB BL AL BD AD Midnight 3 AM

CSII (n=93)

MDI (n=91)

n=63 in each treatment

0

500

1000

1500

2000

2500

3000

CSII MDI

P=0.0027

*Measurement of AUC(glu) ≥80 mg/dL during the 48-hour continuous glucose monitoring period.

AU

Cg

lu

(mg

•h/d

L)

Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

CSII vs MDI: Less Glucose Exposure CSII vs MDI: Less Glucose Exposure

CSII vs MDI: Rate of HypoglycemiaCSII vs MDI: Rate of HypoglycemiaE

pis

od

es/s

ub

ject

/5 w

eeks

12

10

8

6

4

2

0Total Daytime Nocturnal

P=0.0039

P<0.0001

P=0.0006

CSIIMDI

Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

CSII vs MDI with Glargine in Children – CSII vs MDI with Glargine in Children – Preliminary DataPreliminary Data

Boland et al., Diabetes 2003, 52:S1, A45, 192-OR

Subjects at baselineAge: 8-19 yr (mean 12.7 ± 2.7)Type 1 DM > 1 yr duration Standard insulin therapy (2-3 injections/day)

CSII (aspart) n=12

MDI (aspart/glargine) n=14

16 Week treatment period

Injectiontherapy

Randomized, Parallel-group, 16 week study

6

6.5

7

7.5

8

8.5

9

Baseline 4 weeks 8 weeks 12 weeks 16 weeks

Glargine (n=16)

CSII (n=14)

CSII vs. MDI with Glargine in Children CSII vs. MDI with Glargine in Children (Preliminary Data)(Preliminary Data)

Boland, E. Diabetes 52,(Suppl 1), 2003 Abstract 192.

A1c

CSII vs MDI in Children – Preliminary DataCSII vs MDI in Children – Preliminary Data Safety and PreferenceSafety and Preference

SafetySevere hypoglycemic episodes

MDI: 4CSII: 2

No cases of DKA

Preference (at 16 weeks)All 12 CSII subjects remained on CSII12 of 14 MDI subjects switched to CSII

Boland et al., Diabetes 2003, 52:S1, A45, 192-OR

CSII Reduced HbA1c CSII Reduced HbA1c in Type 2 Patientsin Type 2 Patients

7.0

7.2

7.4

7.6

7.8

8.0

8.2

8.4

CSII MDI

Baseline

End of study (24 weeks)

Raskin et al. Diabetes. 2001;50(suppl 2):A128.

A1C

(%

) N=127

Change in scores (raw units) from baseline to endpoint

-5 0 5 10 15 20 25 30 35

Convenience

Less burden

Less hassle

Advocacy

Preference

General satisfaction

Flexibility

Less life interference

Less pain

Fewer social limitations

MDICSII

Patient Satisfaction in Type 2 DMPatient Satisfaction in Type 2 DM

Testa et al. Diabetes. 2001;50(suppl 2):1781

Metabolic Advantages with CSIIMetabolic Advantages with CSII

• Improved glycemic control

• Better pharmacokinetic delivery of insulin

— Less hypoglycemia

— Less insulin required

• Improved quality of life

N=165.Average duration=3.6 years.Average discontinuation <1%/y.

Continued 97%

Discontinued 3%

Current Continuation Rate: Continuous Current Continuation Rate: Continuous Subcutaneous Insulin Infusion (CSII)Subcutaneous Insulin Infusion (CSII)

Bode BW, et al. Diabetes. 1998;47(suppl 1):392.

195,000

157,000

120,000

43,00035,000

26,50020,000

15,00011,40087006600

60,000

81,000

0

50,000

100,000

150,000

200,000

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002

US Pump Usage: Total Patients US Pump Usage: Total Patients Using Insulin PumpsUsing Insulin Pumps

Industry estimates

Photograph reproduced with permission of manufacturer.

Pump Infusion SetsPump Infusion Sets

Current Pump Therapy Current Pump Therapy IndicationsIndications

• Diagnosed with diabetes

(even new-onset type 1 diabetes)

• Need to normalize blood glucose

— A1C > 6.5%

— Glycemic excursions

— Hypoglycemia

• Need for flexible insulin program

• 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)

CSIICSIIFactors Affecting A1CFactors Affecting A1C

Bode et al. Diabetes 1999;48 Suppl 1:264

Bode et al. Diabetes Care 2002;25 439

Initial Adult Dosage: CalculationsInitial Adult Dosage: Calculations

Starting doses

• Based on pre-pump total daily dose (TDD)

reduce TDD by 25% to 30% for pump TDD

• Calculated based on weight

0.24 x weight in lb (0.53 x weight in kg)

Bode BW, et al. Diabetes. 1999;48(suppl 1):84.Bell D, Ovalle F. Endocr Pract. 2000;6:357-360.Crawford LM. Endocr Pract. 2000;6:239-243.

• Normal—Preprandial: 70 - 140 mg/dl—1 hr postprandial: <160 mg/dl

• Hypoglycemic unawareness—Preprandial: 100 - 160 mg/dl

• Pregnant—Preprandial: 60 - 90 mg/dl—1 hr postprandial: <120 mg/dl

Individually set for each patient

Target BG Ranges for CSIITarget BG Ranges for CSII

Fanelli CG et al., Diabetologia 1994, 37:1265-76.

Jovanovich L, AMJObGynec 1991, 164:103-11.

Initial Adult Dosage: CalculationsInitial Adult Dosage: Calculations

Basal rate

• 45% to 50% of pump TDD

• Divide total basal by 24 hours to decide on hourly basal

• Start with only 1 basal rate

• See how it goes before adding basals

Basal Dose Adjustment OvernightBasal Dose Adjustment Overnight

Rule of 30:Check BG

Bedtime 12 AM3 AM6AM

Adjust overnight basal if readings vary > 30 mg/dl

• Adults often need an increase in basal rate in the “Dawn” hours (4 am to 9 am)

• Children often need an increase in basal rate earlier starting at 10 pm to 2 am

Basal Dose Adjustment OvernightBasal Dose Adjustment Overnight

4:004:00 16:0016:00 20:00 20:00 24:0024:00 4:004:00

BreakfastBreakfast LunchLunch DinnerDinner

8:008:0012:0012:008:008:00

TimeTime

Basal infusion

Bolus Bolus Bolus

Pla

sma

insu

lin

Pla

sma

insu

lin

Variable Basal Rate: CSII ProgramVariable Basal Rate: CSII Program

Basal Dose Adjustment DaytimeBasal Dose Adjustment Daytime

Rule of 30:

Check BG Before usual meal timeSkip mealEvery 2 hrs (for 6 hrs)

Adjust daytime basal if readings vary > 30 mg/dl

Bolus Dose CalculationsBolus Dose Calculations

Meal (food) Bolus Method 1

• Test BG before meal• Give pre-determined insulin dose for

pre-determined CHO content

• Test BG after meal• Goal < 60 mg/dl rise post meal or < 160 mg/dl

Individually determined

• CIR = (2.8 x wgt in lbs) / TDD

• Anywhere from 5 to 25 g CHO is covered by 1 unit of insulin

Estimating the Estimating the Carbohydrate to Insulin Ratio (CIR)Carbohydrate to Insulin Ratio (CIR)

Davidson et al: Diabetes Tech & Therap. April 2003

What Type of Bolus to Use?What Type of Bolus to Use?

• 9 DM 1 patients on CSII ate pizza, tiramisu, and coke on four consecutive Saturdays

• Single bolus

• Double bolus at -10 and 90 min

• Square wave bolus over 2 hours

• Dual wave bolus (70% at meal, 30% as 2-h square)

Chase HP et al: Diabetic Medicine 2002;19:317-321

-40

-20

0

20

40

60

80

100

BG

Cha

nge

from

Bas

elin

e in

mg/

dl

1 bolus

2 bolus

Square

Dual

Comparison of Pump Boluses with High Comparison of Pump Boluses with High Carbohydrate & High Fat MealCarbohydrate & High Fat Meal

0.5 1.0 1.5 2.0 4.0 5.0

Hours from Baseline

Chase HP et al: Diabetic Medicine 2002;19:317-321

Correction Bolus Correction Bolus

• Must determine how much glucose is lowered by 1 U of rapid-acting insulin

• This number is known as the correction factor (CF)

• Use the 1700 rule to estimate the CF• CF=1700 divided by TDD example: if TDD=36 U, then

CF=1700/36=50, meaning 1 U will lower the BG 50 mg/dL

Correction Bolus FormulaCorrection Bolus Formula

Example:—Current BG: 220 mg/dL—Ideal BG: 100 mg/dL—Glucose CF: 50

mg/dL

Current BG - Ideal BGGlucose Correction Factor

220 - 100

50= 2.4 U

If A1C is Not to GoalIf A1C is Not to Goal

• 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

Must look at:

If A1C Is Not at Goal and If A1C Is Not at Goal and No Reason IdentifiedNo Reason Identified

• Place on a continuous glucose monitoring system

• CGMS by Medtronic MiniMed or GlucoWatch by Cygnus to determine the cause

GlucoWatchGlucoWatch®® Biographer Biographer

CGMS

CGMS Sensor

Monitor and Com-StationMonitor and Com-Station

Case Study # 1Case Study # 1

• GL, male, age 39

• Type 1 X 8 years

• A1C= 7%; recent increase from 6%

• CSII basal rates: 12 am 1.0 u/h;

4:30 am 1.6 u/h; 11:30 am 1.0 u/h

• Insulin: carbohydrate ratio =1u : 10 grams

• Correction Factor: BG - 100 divided by 40

• CGMS done to assist with improving overall glycemic control

Modal Day ViewModal Day View

Cheese / Crackers 20 g; 3units

30 gm CHO; Heavy Exercise 80 CHO; 7u 2u; 57 g CHO

Milk choc 15g; 8u

Juice box; no insulin

Ice Cream; 3 u

6u

Most common bolusing errorsMost common bolusing errors

• Under-estimation of carbohydrates consumed (CHO bolus)

• Over-correction of post-prandial elevations (CF bolus)— Remaining unused, active insulin— Stacking of boluses

Bolus: Source of ErrorsBolus: Source of Errors

• “Inability” to count carbs correctly— Lack of knowledge, skill— Lack of time— Too much work

• Incorrect use of SMBG number• Incorrect math in calculation• “WAG” estimations

The Major ProblemsThe Major Problems

♦ Up until now we have not taken the active insulin issue into consideration

♦ The math involved with this has become too complicated, and it would be impossible to accurately calculate the active insulin without assistance

Dosing Tools: The FUTUREDosing Tools: The FUTURE

• Monitor sends BG value to pump via radio waves : No transcribing error

• Enter carbohydrate intake into pump• “Bolus Wizard” calculates suggested dose

Paradigm Link™

Paradigm 512™) ) ) ) ) ) ) ) ) )

) ) )

Bolus Wizard Calculator :Bolus Wizard Calculator : meter-meter-entered entered

The Bolus WizardThe Bolus Wizard™™ CalculatorCalculator

• Can be customized with up to 8 different setting per day for:—Blood glucose targets—Carbohydrate ratios—Insulin-sensitivity factors

• Simplifies Diabetes Management—Reduces math errors—Decreases the number of correction boluses required*

—Lowers the entry error rate when using the Paradigm LinkTM Blood Glucose Monitor, powered by BD LogicTM Technology

Bolus WizardBolus WizardTMTM

CalculatorCalculatorUses an Active Insulin FormulaUses an Active Insulin Formula

• Based on insulin pharmacodynamic data

• Helps prevent insulin stacking

Insulin Activity Over TimeInsulin Activity Over Time

0

100

200

300

400

500

600

700

0 1 2 3 4 5 6 7 8

Rapid ActingRegular

Insu

lin A

ctiv

ity

(GIR

)

Time (hrs)

Insulin Pharmacodynamic Data

Adapted from Henry R: Diabetes Care 1999

0

20

40

60

80

100

0 1 2 3 4 5 6 7 8

Rapid ActingRegular

Time (hrs)

Per

cen

t R

emai

nin

gAdjusting for Active Insulin:Adjusting for Active Insulin:

How smart pumps do itHow smart pumps do it

Wizard: OnCarb Units: gramsCarb Ratios: 10BG Units: mg/dlSensitivity: 50BG Target: 100

Wizard: OnCarb Units: gramsCarb Ratios: 10BG Units: mg/dlSensitivity: 50BG Target: 100

Bolus Wizard Set Up ScreenBolus Wizard Set Up Screen

Breakfast - Step 1. Check BGBreakfast - Step 1. Check BG

• Use the Paradigm Link™,

powered by BD Logic™

Technology

or their currrent meter

• Robin accepts the transferred blood glucose value—Requires confirmation—Can change glucose value if necessary

Breakfast - Step 2. Accept BGBreakfast - Step 2. Accept BG

• Enters CHO grams—53 grams of carbohydrate

• The Paradigm® presents the dose—5.3 U for 53 grams carb (CIR = 10)—No correction dose—Shows total 5.3 U

• Accept suggested dose • Pump delivers dose

Breakfast - Step 3. Accept DoseBreakfast - Step 3. Accept Dose

• Robin has a late lunch at 2:10 PM— Blood glucose 160— Accepts the transferred BG value

Late Lunch - Step 1,2Late Lunch - Step 1,2

• Enters CHO grams— 50 grams of carbohydrate

50

• The Paradigm® presents the dose—5.0 U for 50 grams carb (CIR = 10)—Correction dose = 1.2 U

(160-100) / 50 = 60/50 = 1.2 —Shows total 6.2 U

• Accept suggested dose • Pump delivers dose

Late Lunch - Step 3. Accept DoseLate Lunch - Step 3. Accept Dose

• Enters CHO grams—50 grams of carbohydrate

50

• Robin plans to have appetizers at 5:30 PM— This is only 3.5 hours after lunch. — There is still an active insulin depot— Blood glucose is 157— Accepts the transferred BG value

Early Supper - Step 1,2Early Supper - Step 1,2

• The Paradigm® presents the dose— 5.0 U for 50 grams carb (CIR = 10)— Correction dose = 1.1 U (157 -100)/50— Remaining active insulin = 2.6 U— Remaining active insulin > correction

dose— No correction dose is recommended— Total shows 5.0 U

Early Supper - Step 3. Accept DoseEarly Supper - Step 3. Accept Dose

• Accept dose

• Pump delivers dose

For This System To WorkFor This System To Work

♦ It is critical the target, basal doses, the correction doses, and the carbohydrate ratios are accurate

♦ Understanding how to match carbohydrate amounts with insulin is critical

♦ Even though the active insulin and complicated math is calculated by the system, the patient needs to understand the basic principles of how the insulin doses are calculated.

Do Smart Pumps Enable Others To Do Smart Pumps Enable Others To Go To CSII? Go To CSII?

• YES• All patients with diabetes not at goal

are candidates for Insulin Pump Therapy

- Type 1 any age - Type 2 - Diabetes in Pregnancy

ParadigmParadigm®® Pathway to Pathway to Future Diabetes ManagementFuture Diabetes Management

• As technology advances, so does the Paradigm pump

• New tools and applications will be available— Wireless communication— More memory and brain power

GLUCOSE MONITORING SYSTEMS - GLUCOSE MONITORING SYSTEMS - TelemetryTelemetry

Wireless communication from sensor to monitor

High and low glucose alarms (Guardian 1 or 715)

“Real time” glucose readings

(Guardian 2 or 722)Not FDA approved

Consumer Product

FreeStyle NavigatorFreeStyle NavigatorTheraSense Continuous Glucose MonitorTheraSense Continuous Glucose Monitor

• Patient Inserted Sensor

• “On demand” glucose and trend arrow

• User-configurable Low Glucose and High Glucose Alarms

• Projected alarms give advance warning of glucose excursions

• Integrated FreeStyle blood glucose meter

• (3) BG calibrations for each 3-day sensor

• Wireless sensor-to-Meter path (10 foot operating range)

FreeStyle NavigatorFreeStyle NavigatorTheraSense Continuous Glucose MonitorTheraSense Continuous Glucose Monitor

–Designed to monitor interstitial fluid and provide continuous glucose readings–Patient-attached adhesive section includes sensor, and wireless transmitter–Designed to be self-inserted every three days and provide patients with glucose for use in managing therapy

The DexCom Continuous Glucose The DexCom Continuous Glucose Sensor SystemSensor System

• Sensor—7 x 1 cm —Cylindrical —7 cc —Battery—Microprocessor—Antenna

• Receiver—Pager-Like Receiver with

Graphical Display

The DexCom Continuous Glucose The DexCom Continuous Glucose Sensor System Technology DescriptionSensor 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

Implanted Closed-Loop External Closed-Loop

Vision towards the Artificial Vision towards the Artificial PancreasPancreas

* This product concept not yet submitted to the FDA for commercialization.

Predicted TimesPredicted Times

• Glucose Sensors

- Alarm sensor (72 hr) early 2004

- Replace fingersticks mid late 2005

• Semi-Closed loop 2006 – 2007

• Implantable 2007-2008

SummarySummary

• 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

QuestionsQuestions

• For a copy or viewing of these slides, contact

• WWW.adaendo.com