Expanding The Indications Expanding The Indications For CSII and CGMSFor CSII and CGMS

Bruce W. Bode, MD, FACEAtlanta Diabetes Associates

Atlanta, Georgia

U.S. Diabetes PrevalenceU.S. Diabetes Prevalence

— Diabetes kills 1 American every 3 minutes

— New case diagnosed every 40 seconds

— More deaths than AIDS and breast cancer combined

— Average life expectancy: 15 years less than non-diabetes population

— Afflicts over 120 million people worldwide

— 300 million afflicted by 2025

18 Million

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

Centers for Disease Control. Available at: http://www.cdc.gov/diabetes/pubs/estimates.htm; Harris MI. In: National Diabetes Data Group. Diabetes in America. 2nd ed. Bethesda, Md: NIDDK; 1995:15-36; U.S. Census Bureau Statistical Abstract of the U.S.; 2001

US Population: 275 Million in 2000

3

World View

• 4th leading cause of death by disease• India 33 million people with diabetes• China 23 million people with diabetes• Population of diabetes will double to triple

by 2025 • One out of every three Americans born

today will develop diabetes

Time magazine December 2003; CDC

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

RELA

TIV

E

RIS

K

Mean HbA1c

• 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.

DCCTDCCT

• 10% reduction in A1C

• 43% reduced risk of retinopathy progression

• 18% increased risk of severe hypoglycemia with coma and/or seizure

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

*Percent risk reduction per 0.9% decrease in HbA1C; UKPDS. Lancet. 1998;352:837-853.

Lowering A1C Reduces Risk Lowering A1C Reduces Risk of Complicationsof Complications

Red

ucti

on

in

ris

k (

%)*

p=0.029

p=0.0099

p=0.052

p=0.015

p=0.000054

0

-10

-20

-30

-40

-50

-12

-25

-16

-34

-21

Any diabetes-related endpoint

Microvascular endpoint

MI

Retinopathy

Albuminuria at 12 years

United Kingdom Prospective Diabetes Study United Kingdom Prospective Diabetes Study (UKPDS)(UKPDS)

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 (%)

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.

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

Specific Goals in Management of DiabetesSpecific Goals in Management of Diabetes

• Fasting or premeal BG 70 to 140 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

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

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

0600 0600

Time of day

20

40

60

80

100 B L D

Multiple Daily InjectionsMultiple Daily InjectionsHuman InsulinsHuman Insulins

B=breakfast; L=lunch; D=dinner

0600 0800 18001200 2400 0600

Regular NPHNPHRegular

Normal pattern

U/mL

Regular

Barriers to Intensive Insulin TherapyBarriers to Intensive Insulin TherapySevere HypoglycemiaSevere Hypoglycemia

•DCCT. Diabetes 1997;46:271-86 UKPDS. Lancet 1998;352:837-853

Type 1 Diabetes in the DCCT

Conventional insulin 35% of pts 19 events/100pt-yrA1c ~9%, 6 yr

Intensive insulin 65% of pts 61 events/100 pt-yrA1c 7.2%, 6 yr

Type 2 Diabetes in the UKPDS

Intensive policy insulin 2.3%/yr A1c 7.0%, 10 yr

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

CSII Reduces HypoglycemiaCSII Reduces Hypoglycemia

Chantelau, E et al., Diabetologia 1989, 32:421-6.Bode, BW et al., Diabetes Care 1996, 19:324-7.Boland, EA et al., Diabetes Care 1999, 22:1779-84.Maniatis AK, et al., Pediatrics 2001, 107:351-6.

0

20

40

60

80

100

120

140Pre-Pump

Post-Pump

n=55Mean age 42

n=107Mean age 36

n=116Mean age 29

n=25Mean age 14

n=56Mean age 17

Even

ts p

er

hun

dr e

d p

ati

ent

years

Bode Rudolph Chanteleau Boland Maniatis

CSII Reduces A1CCSII Reduces A1C

Chantelau, E et al., Diabetologia 1989, 32:421-6.Bode, BW et al., Diabetes Care 1996, 19:324-7.Boland, EA et al., Diabetes Care 1999, 22:1779-84.Bell, DSH et al., Endocrine Practice 2000, 6:357-60.Maniatis AK, et al., Pediatrics 2001, 107:351-6.

5

5.5

6

6.5

7

7.5

8

8.5

9

9.5

10MDI CSII

n= 58 n=107 n=116 n=50 n=25 n=56

Adolescents AdultsMean Dur.=36 Mean Dur.=36 Mean Dur.=54 Mean Dur.=42 Mean Dur.=12 Mean Dur.=12

Bell Rudolph Chanteleau Bode Boland Maniatis

DCCT: Diabetes Care 1995; 18:361-376.

Pump 42%

MDI 56%

Unknown 2%

Insulin Delivery Therapy at end of DCCT

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

Intrasubject Variability (GIR) With Lantus® (insulin glargine)

Scholtz et al. Diabetologia. 1999;42(suppl 1):A235.

Glu

cose

infu

sio

n r

ate

(mg

/kg

/min

)

Subject 14Subject 14 Subject 16Subject 16 Subject 19Subject 19 Subject 22Subject 22

Subject 27Subject 27 Subject 28Subject 28 Subject 34Subject 34 Subject 36Subject 36

-1-1 44 99 1414 1919 2424 -1-1 44 99 1414 1919 2424 -1-1 44 99 1414 1919 2424 -1-1 44 99 1414 1919 2424

11.011.08.88.86.66.64.44.4

2.22.20.00.0

11.011.0

8.88.86.66.64.44.42.22.20.00.0

11.011.08.88.86.66.64.44.42.22.2

0.00.0

Visit 2 Visit 3Time (h)

Subject 2Subject 2 Subject 3Subject 3 Subject 7Subject 7 Subject 9Subject 9

• 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

Evolution of Pump IndicationsEvolution of Pump Indications

• Severe Hypoglycemia• Hypoglycemia unawareness• Dawn phenomenon• Pregnancy• Pre-conception• Shift workers• Gastroparesis• Athletes• Pediatrics

1980s

2000

1990s

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

Pump Therapy-Getting StartedPump Therapy-Getting Started

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

glargine insulin

Meal boluses• Insulin needed premeal

— Premeal BG— Carbohydrates in meal— Activity level

• Correction bolus for high BG

Meal bolus

1

2

3

4

5

6

12 AM 12 PM 12 AM

Time of day

Basal rate

Un

its

• 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.

• 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

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

Alternative Method:

500 Rule: 500 divided by TDD

Example: 500 / 50 = 10

Insulin to carb ratio = 1u for 10g

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

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

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

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

ParadigmParadigm®® 512 Pump 512 PumpCustomizableCustomizable

• Basal and Bolus Options—Dual Wave—Basal Patterns

• BG Testing Reminders• High or Low Blood Glucose Alerts• Vibrate or Beep Mode• Wireless Remote (optional)• Safety Block

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

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

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

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

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