PUMPMASTER AND

GLUCOMMANDER

THE FAR SIDE OF THE DIABETES WORLD

Presented byPaul Davidson MD

at theMiniMed Symposium

Atlanta, GADecember 13, 2003

AIM Formulae (Accurate Insulin Management) Background

CSII dosing is related to a patient’s size

It consists of four parameters:

– Total insulin dose per day (TDD)

– Basal Insulin as percent of TDD

– Bolus insulin for meals

• Based on CHO to insulin ratio (CIR)

– Correction boluses from the correction factor (CF)

A database of 1815 records was used to find the optimal parameters for the most ideally controlled pump patients.

The interaction of the AIM formulae is portrayed as a nomogram.

Materials and Methods

Two groups of patients:

– Target Group (TG)--183 patients with A1C <7%

– Not-to-Target Group (NTG) the remainder of the patients

– Individual's slopes determined:

• Basal versus TDD

• CF versus 1/TDD

– Median of all slopes in the TG was used as the slope for each formula

– Slignificant differences between TG and NTG

.

• TDD versus BW

• CIR versus BW/TDD

AIM Formulaefor adults

• Carbohydrate / Insulin Ratio (CIR)

CIR = 2.8 x BodyWeight(lbs) / TDD• Correction Factor (CF)

CF = 1700 / TDD• Basal Insulin

Basal = 0.48 x TDD

0

20

40

60

80

100

120

140

160

0 100 200 300Body Weight (lbs)

Sta

rtin

g T

DD

Starting Total Daily Insulin Dose

TDDstart = 0.24 * Wt(lb)

n = 199

File: AIM031208 199 points

0

10

20

30

40

50

60

70

80

0 50 100 150Total Daily Insulin Dose (TDD)

Basal

Insu

lin

Basal Insulin

Basal = 0.48 * TDD

n = 199

File: AIM031208 199 points

If HbA1c is Not to Goal i.e. 6.5%

SMBG

– frequency

– recording

– memory meter

Diet

– accurate CHO counting

– appropriate CHO/insulin bolusing

Infusion site areas Over-treatment of low BG Delayed or under-treatment

of high BG

If HbA1c Not to Goal i.e. 6.5%

SMBG

– frequency

– recording

– memory meter

Infusion site areas Over-treatment of low BG Delayed or under-treatment

of high BG

More than 4/day

2.8 x Wt / TDD

1700 Rule

(100-BG) x 0.2

Diet

–accurate CHO counting

–appropriate CHO/insulin bolusing

0

2

4

6

8

10

12

14

0 5 10 15 20

0

0. 5

1

1 . 5

2

2. 5

3

3. 5

0 5 1 0 1 5 20

Average2 BG’s/d

Average12 BG’s/d

24

Blo

od

Glu

co

se

Blo

od

Glu

co

se

HoursHours

Frequency of Blood Glucose MonitoringFrequency of Blood Glucose MonitoringEffect of Recurrent Adjustment for Increased BG’sEffect of Recurrent Adjustment for Increased BG’s

5

6

7

8

9

10

0 2 4 6 8 10 12SMBG tests per day (BGpd)

A1

c %

Improvement in HbA1c with Increased BG Testing

If HbA1c Not to Goal i.e. 6.5%

SMBG

– frequency

– recording

– memory meter

Infusion site areas Over-treatment of low BG Delayed or under-treatment

of high BG

More than 4/day

2.8 x Wt / TDD

1700 Rule

(100-BG) x 0.2Diet

–accurate CHO counting

–appropriate CHO/insulin bolusing

450 Rule vs 2.8 Rule

Purpose of rule: Estimate the ratio: carbs / insulin. Start with:CIR = CarbsPerDay / TDD

• 2.8 Rule : says CarbsPerDay proportional to Wt(lb): CIR = 2.8 * Wt(lb) / TDD

• 450 Rule : says CarbsPerDay is the same for all people: CIR = 450 / TDD The case for 450 rule:• Advocates say it works better for children.

The case for 2.8 Rule: • Wt(lb) for CarbsPerDay makes better sense than constant.• Consistent with 1700 Rule• 450 Rule’s scatter chart data look curved.

A future study is planned for children. They were under-represented in AIM study.

0

5

10

15

20

25

0 2 4 6 8BW# / TDD

CIR

Median slope = 2.79

Data: file: AIM031208.xls, 179 pts

CARBOHYDRATE TO INSULIN RATIOCIR = 2.8 * BW# / TDD for adults

0

5

10

15

20

25

30

0 0.02 0.04 0.061 / TDD

CIR

Median slope = 450

Data: file: AIM031208.xls, 179 pts

CARBOHYDRATE TO INSULIN RATIOCIR = 450 / TDD

If HbA1c Not to Goal i.e. 6.5%

SMBG

– frequency

– recording

– memory meter

Infusion site areas Over-treatment of low BG Delayed or under-treatment

of high BG

More than 4/day

2.8 x Wt / TDD

1700 Rule

(100-BG) x 0.2

Diet

–accurate CHO counting

–appropriate CHO/insulin bolusing

20

40

60

80

100

120

140

160

Glu

cose

Correction of Hypoglycemia with Glucose100-BG X 0.2 Grams

Before After

Richardson Diabetes 1999 50:A200

100-BG X 0.15 Grams

If HbA1c Not to Goal i.e. 6.5%

SMBG

– frequency

– recording

– memory meter

Infusion site areas Over-treatment of low BG Delayed or under-treatment

of high BG

More than 4/day

2.8 x Wt / TDD

1700 Rule

(100-BG) x 0.2

Diet

–accurate CHO counting

–appropriate CHO/insulin bolusing

0

20

40

60

80

100

120

0 0.02 0.04 0.06 0.081 / TotalDailyInsulin

Co

rrecti

on

Facto

rCorrection Factor

The 1700 Rule

CF = 1705 / TDD

n = 199

File: AIM031208 199 points

1700 RuleMathematical Model

Purpose of 1700 Rule: Estimate Correction Factor (CF)

• 1700 Rule: says glucose burned per day and body volume are both proportional to Wt(lb). These cancel as shown below:

CF = (glucose burned per day)/[(Body volume)*TDD] CF = K1 * Wt(lb) / [ Wt(lb) * TDD]

CF = K1 / TDD

Statistics give: CF = 1700 / TDD

0

50

100

150

200

250

300

0 50 100 150 200

Total Daily Dose of Insulin (TDD)

Bo

dy

We

igh

t in

lbs

125

100

75

50

25

Co

r rection

Facto

r

25 20 15 12 10 8 7 6 5

Carbohydrate to Insulin Ratio

CF Curve

AIM Nomogram

( CIR = 2.8 Wt / TDD )( C

F =

17

00

/ TD

D )

Initial Dosing: Plot BW and 25 CIR for BI Plot BW and 12 CIR for TDD

Plot BW and TDD for CIRPlot TDD and CF curve for CF

4

3

2

0

50

100

150

200

250

300

0 50 100 150 200

Total Daily Dose of Insulin (TDD)

Bo

dy

We

igh

t in

lbs

125

100

75

50

25

Co

r rection

Facto

r

25 20 15 12 10 8 7 6 5

Carbohydrate to Insulin Ratio

CF Curve

( CIR = 2.8 Wt / TDD )( C

F =

17

00

/ TD

D )

4

3

2

CIR

TDDBI

Weight

Example•210 lb.. Man Type 1 Diabetes•Starting CSII•Poorly controlled HgA1c 8.1%

•10 units lispro tid•28 units glargine hs

•Initial Dosing:•Plot BW and 25 CIR for BI•Plot BW and 12 CIR for TDD

0

50

100

150

200

250

300

0 50 100 150 200

Total Daily Dose of Insulin (TDD)

Bo

dy

We

igh

t in

lbs

125

100

75

50

25

Co

r rection

Facto

r

25 20 15 12 10 8 7 6 5

Carbohydrate to Insulin Ratio

CF Curve

( CIR = 2.8 Wt / TDD )( C

F =

17

00

/ TD

D )

4

3

2

CF

TDD

Plot TDD and CF curve for CF

0

50

100

150

200

250

300

0 50 100 150 200

Total Daily Dose of Insulin (TDD)

Bo

dy

We

igh

t in

lbs

125

100

75

50

25

Co

r rection

Facto

r

25 20 15 12 10 8 7 6 5

Carbohydrate to Insulin Ratio

CF Curve

( CIR = 2.8 Wt / TDD )( C

F =

17

00

/ TD

D )

4

3

2

New TDD

NewCIR

NewBI

Follow-up One Month Later•Weight 200#•4.5 BG’s per day•Average BG 172•Current basal 1.2 u/hr (28.8 u/d)•TDD from pump 64 units

NewCF

NewWeight

AIM “N” Nomogram

80

40

30

70

40

30

100

10

40

60140

160

90

60

90

180

240

25

3550

30

80

10

40

70

100

110

100

220

4

6

8

10

3025

20

15

12

80

200

50

20

20

20

60

60

50

20

120

Carbohydrate / Insulin Ratio (CIR)

TDD

Co

rre

cti

on

Fa

cto

r (

CF

)

Kilograms(Kg)

Pounds(lb)

  Total CIR Daily Wt Wt for adults Insulin CF (kg) (lb) (gm/unit) (unit) (mg/dL/unit) 149┼329 ┼47 20┼88 142┼313 ┼43 21┼84 135┼298 ┼39 22┼80 129┼284 ┼35 23┼76 123┼270 ┼32 24┼72 117┼258 ┼29 25┼69 111┼245 ┼26 26┼65 106┼234 ┼24 28┼62 101┼222 ┼22 29┼59 96┼212 ┼20 30┼57 92┼202 ┼18 32┼54 87┼192 ┼16 33┼51 83┼183 ┼15 35┼49 79┼174 ┼13 37┼47 75┼166 ┼12 39┼44 72┼158 ┼11 41┼42 68┼151 ┼10 43┼40 65┼143 ┼9 45┼38 62┼137 ┼8 47┼36 59┼130 ┼7 49┼35 56┼124 ┼7 52┼33 54┼118 ┼6 55┼31 51┼112 ┼5 57┼30 49┼107 ┼5 60┼29 46┼102 ┼5 63┼27 44┼97 ┼4 66┼26 42┼92 ┼4 70┼25 40┼88 ┼3 73┼23 38┼84 ┼3 77┼22 36┼80 ┼3 81┼21 35┼76 ┼3 85┼20 33┼72 ┼2 89┼19 31┼69 ┼2 93┼18 30┼66 ┼2 98┼18 28┼63 ┼2 103┼17 27┼60 ┼2 108┼16 26┼57 ┼1 113┼15 25┼54 ┼1 119┼14 23┼51 ┼1 125┼14

Accurate Insulin Management

(AIM) Nomogram

1. Connect the columns with a

straight line between weight and

total daily dose of insulin (TDD).

2. Read correction factor (CF) and

carbohydrate/insulin ratio (CIR).

3. Basal insulin is one-half total daily

dose of insulin.

AIM Study(uncontrolled)

21 Patients

HbA1c>8

Competent Self-Monitoring

Pump Veterans

Bi-Weekly Fax and Phone Follow-Up

Three Month Study

6

6.5

7

7.5

8

8.5

9

HbA1c Mean BG

Davidson et al Diabetes Technology & Therapeutics 2003

180

160

140

120

P<0.0001 P<0.0001

PumpMaster

A Combined Database Collector

and

Patient-Treatment Advisor

for

Interactive Use by Practitioners

Pumpmaster

Day divided into five periods

– Sleep, dawn, am, pm, evening

BG monitored initially for each period

– Mean and SD

Variation of mean from target

– Correction formula used to quantify average insulin need for each period

– Summed for day

Program suggests change in insulin for each period balancing change in basal against CIR

– Simulates best controlled patients in database

Input Form, Screen 1

Input Form, Screen 2

• In development (Patent Pending)

• Has shown that it lowers A1c

• Will advise the pump therapist

• Will advise the pump-wearing diabetic

• Will encourage more pump prescribing

• Will facilitate progress to target control

• Can be programmed into PDA or pump

Overview of PumpMaster

Future of Diabetes Management Improvements in Insulin & Delivery

Insulin analogs and inhaled insulin

Smart external pumps

Internal pumps

Real-time sensors

Closed-loop systems

Unconceived-of solutions

QUESTIONS? For a copy or viewing of these slides

– Contact• www.adaendo.com

How can I get use of Glucommander? (Computer-directed IV insulin program)

– Available for review on internet,

• www.glucommander.com

How can I get use of Pumpmaster?

– Contact us expressing interest:

• Pumpmaster@adaendo.com