Basal%20Bolus:%20The%20Strategy%20for%20Managing%20All%20Diabetes

1
Basal Bolus The Strategy for Managing All
Diabetes
Presented in San Antonio, May 3, 2003

• Paul Davidson, MD, FACE
• Atlanta Diabetes Associates
• Atlanta, Georgia

2
ACE/AACE Targets for Glycemic Control

• A1C lt6.5
• Fasting/preprandial glucose lt110 mg/dL
• Postprandial glucose lt140 mg/dL

ACE/AACE Consensus Conference August 2001
Washington, DC.
3
Type 2 Diabetes A Progressive Disease

• Over time, patients will need insulin
  to be controlled to target

all
most
4
MIMICKING NATURE WITH INSULIN THERAPY

• All persons need
• both basal and mealtime insulin
• to control glucose

(endogenous or exogenous)

6-19
5
Basal/Bolus Treatment Program with Rapid-acting
and Long-acting Analogs
75
Breakfast
Lunch
Dinner
Aspart or Lispro
Aspart or Lispro
Aspart or Lispro
50
Plasma insulin (?U/mL)
Glargine or Detemir
25
400
1600
2000
2400
400
800
1200
800
Time
6
Starting Multiple Dosage Insulin (MDI)

• Starting insulin dose is based on weight
• 0.25 x wt in lb
• Basal dose (glargine/detemir)
• 50 of starting dose at bedtime
• Bolus dose (aspart/lispro)
• 16 of starting dose at each meal
• CIR 12
• Correction bolus
• (BG-Target)/CF

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Correction Bolus

• An estimate of how much glucose will be lowered
  by 1 unit of rapid-acting insulin
• This value is the correction factor (CF)
• Use the 1700 rule to estimate the CF
• CF 1700 divided by the total daily dose (TDD)
• (Current BG - Target BG) / CF Bolus

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Alternatives to MDI

• Simpler regimen
• Premixed BID (DM 2 only)
• Insulin pump

9
Variable Basal Rate CSII Program
75
Breakfast
Lunch
Dinner
50
Bolus
Bolus
Bolus
Plasma insulin (?U/mL)
25
Basal infusion
400
1600
2000
2400
400
800
1200
800
Time
CSIIcontinuous subcutaneous insulin infusion.
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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
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Insulin for CSII Mean SBGM
NovoLog
Buffered Regular
Humalog

Blood Glucose (mg/dl)


Type 1 Diabetes
Bode, Diabetes 2001 50(S2)A106
12
Symptomatic or Confirmed Hypoglycemia
Plt0.05
Plt0.05
12
30 relative reduction
10
8

• Episodes/month/patient

6
4
2
0
Insulin aspart
Human insulin
Insulin lispro
Bode et al. Diabetes Care. March 2002.
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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)
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DM 1 CSII PatientLispro to Aspart
Lispro
Aspart
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DM 1 CSII Patient Lispro to Aspart
Lispro
Aspart
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CSII Usage in Type 2 PatientsAtlanta Diabetes
Experience
Davidson et al. Diabetologica. 199942(suppl
1)796.
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(No Transcript)
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Glycemic Control in Type 2 DM CSII vs MDI in
127 Patients

• A1C

Raskin et al. Diabetes. 200150(suppl 2)A128.
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CSII vs MDI in DM 2 Patients
Raskin et al. Diabetes 200150 Suppl 2A128
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US Pump Usage Total Patients Using Insulin Pumps
250,000
200,000
200,000
157,000
150,000
Total no. of patients
120,000
100,000
81,000
60,000
35,000
26,500
43,000
20,000
50,000
15,000
11,400
8700
6600
0
'90
'91
'92
'93
'94
'95
'96
'97
'98
'99
'00
'01
'02
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Current Pump Therapy Indications

• Need to normalize BG
• A1C ?6.5
• Glycemic excursions
• Hypoglycemia
• New onset type 1 DM
• Pregnancy and diabetes

Anyone with Diabetes
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How to Prime a Pump
STATISTICAL ESTIMATES FOR CSII PARAMETERS
CARBOHYDRATE-TO-INSULIN RATIO (CIR, 2.8 Rule)
CORRECTION FACTOR (CF,1700 Rule)
BASAL INSULIN
Paul C Davidson, Harry R Hebblewhite, Bruce W
Bode, R Dennis Steed, N Spencer Welch,
Patricia L Richardson, and Joseph A
Johnson Atlanta, GA, USA Diabetes Technology
Therapeutics 2003
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AIM INTRODUCTION

• Prescription for insulin therapy includes
• Basal Insulin (BI)
• Carbohydrate-to-Insulin Ratio (CIR)
• Correction Factor (CF)
• Data from well-controlled pump patients
• Analyzed for optimum parameters
• Resulting formulae
• The Accurate Insulin Management (AIM) formulae.
  

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Materials and Methods

• Target Group (TG) of 182 patients with A1C lt7
• Not-to-Target Group (NTG) of 214
• Determine individuals slopes of
• Basal versus total daily dose of insulin (TDD)
• Correction factor (CF) versus 1/TDD
• TDD versus body weight (BW)
• CIR versus BW/TDD
• Median of all slopes in the TG was used for each
  formula.

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Sampling Results
Plt.01
Plt.01
Plt.01
Plt.03
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AIM Starting Total Dose of Insulin TDDstart
0.24 BW
27
Basal Insulin 0.48 TDD
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CARBOHYDRATE TO INSULIN RATIO CIR 2.8 BW /
TDD
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Correction Factor The 1700 Rule
CF 1708 / TDD n 179
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RESULTS
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AIM FORMULAE and Slopes
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AIM Nomogram
Carbohydrate to Insulin Ratio
( CIR 2.8 Wt / TDD )
25 20 15 12 10 9 8 7 6
5
Intial Dosing Plot BW and 25 CIR for BI Plot
BW and 12 CIR for TDD
4
125 100 75 50 25

3
Plot BW and TDDfor CIR Plot TDD and CF curve for
CF Follow-up Dosing Change CF as above
Change CIR by 20 toward CIRAIM
Correction Factor
2

CF Curve
( CF 1700 / TDD )

Davidson et al Diab Tech Ther 2003 Vol 5 No 2
33
Initial Visit

• Type 1 Diabetes
• Starting CSII
• Poorly controlled on QID insulin
• 10 units lispro tid and 28 units glargine hs
• Mean BG 189, A1c 9
• Weight 210

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AIM Nomogram
Carbohydrate to Insulin Ratio
( CIR 2.8 Wt / TDD )
25 20 15 12 10 9 8 7 6
5
Intial Dosing Plot BW and 25 CIR for BI Plot
BW and 12 CIR for TDD
4
125 100 75 50 25

3
Plot BW and TDDfor CIR Plot TDD and CF curve for
CF Follow-up Dosing Change CF as above
Change CIR by 20 toward CIRAIM
Correction Factor
2

CF Curve
( CF 1700 / TDD )

BI 24 units
Davidson et al Diab Tech Ther 2003 Vol 5 No 2
35
AIM Nomogram
Carbohydrate to Insulin Ratio
( CIR 2.8 Wt / TDD )

CIR
25 20 15 12 10 9 8 7 6
5
Intial Dosing Plot BW and 25 CIR for BI Plot
BW and 12 CIR for TDD
4
125 100 75 50 25

3
Plot BW and TDDfor CIR Plot TDD and CF curve for
CF Follow-up Dosing Change CF as above
Change CIR by 20 toward CIRAIM
Correction Factor
2

CF 35
CF Curve
( CF 1700 / TDD )

TDD 50 units
BI 24 units
Davidson et al Diab Tech Ther 2003 Vol 5 No 2
36
Follow-up One Month Later

• Weight 210
• 4.5 BGs per day
• Average BG 158
• Current basal 1.2 u/hr (28.8 u/d)
• TDD from pump 64 units

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AIM Nomogram
Carbohydrate to Insulin Ratio
( CIR 2.8 Wt / TDD )
CIRNew
CIROld
25 20 15 12 10 9 8 7 6
5
Intial Dosing Plot BW and 25 CIR for BI Plot
BW and 12 CIR for TDD
4
125 100 75 50 25

3
Plot BW and TDDfor CIR Plot TDD and CF curve for
CF Follow-up Dosing Change CF as above
Change CIR by 20 toward CIRAIM
Correction Factor
2

CFOld 35
CF Curve
( CF 1700 / TDD )
CFNew 25

BasalAIM TDD/232
TDDCurrent
Davidson et al Diab Tech Ther 2003 Vol 5 No 2
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AIM Study

• 21 Patients
• HbA1cgt8
• Competent Self-Monitoring
• Pump Veterans
• Bi-Weekly Fax and Phone Follow-Up
• Three Month Study

180
160
140
120
Plt0.0001
Plt0.0001
Davidson et al Diabetes Technology Therapeutics
2003
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PumpMaster
A Combined Database Collector and
Patient-Treatment Advisor for Interactive Use
by Practitioners
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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

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Input Form, Screen 1
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Input Form, Screen 2
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Overview of PumpMaster

• In development (Patent Pending)
• Has shown that it lowers HbA1c
• 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

44
AIM Nomogram for MDI Background

• Because of the similar bolus-basal nature of
  glargine/detemir plus rapid acting insulin to
  pump therapy the AIM program is also
  applicable to MDI programs.
• The AIM formulae are designed to
• Recommend an estimated initial TDD which can be
  used in the other formulae.
• Promote treatment of follow up patients to
  target by balanced incremental adjustments.
• Basal insulin may be given as glargine or
  detemir.
• Bolus insulin is given as rapid acting insulin.

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If HbA1c Not to Goal i.e. 6.5

• SMBG
• frequency
• recording
• memory meter
• Diet
• accurate CHO counting
• appropriate CHO/insulin bolusing

• Infusion site areas
• Overtreatment of low BG
• Delayed or undertreatment of high BG

(100-BG) x 0.2
More than 4/day
1700 Rule
2.8 x Wt / TDD
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If HbA1c Not to Goal i.e. 6.5

• SMBG
• frequency
• recording
• memory meter
• Diet
• accurate CHO counting
• appropriate CHO/insulin bolusing

• Infusion site areas
• Overtreatment of low BG
• Delayed or undertreatment of high BG

(100-BG) x 0.2
More than 4/day
1700 Rule
2.8 x Wt / TDD
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Improvement in HbA1c with Increased BG Testing
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If HbA1c Not to Goal i.e. 6.5

• SMBG
• frequency
• recording
• memory meter
• Diet
• accurate CHO counting
• appropriate CHO/insulin bolusing

• Infusion site areas
• Overtreatment of low BG
• Delayed or undertreatment of high BG

(100-BG) x 0.2
More than 4/day
1700 Rule
2.8 x Wt / TDD
49
Correction of Hypoglycemia with Glucose100-BG X
0.2 Grams
100-BG X 0.15 Grams
Richardson Diabetes 1999 50A200
Before
After
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If A1c Not at Goal and No Reason Identified

• Place on a continuous glucose monitoring system
• CGMS
• GlucoWatch
• TheraSense

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Summary

• Insulin is the only powerful agent we have to
  control diabetes
• When used in a basal/bolus format,
  near-normoglycemia can be achieved
• Newer insulins, new insulin delivery devices, and
  developing glucose sensors with better algorithms
  for linking them are revolutionizing the care of
  diabetes

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Conclusion

• For the Responsible, Informed Physician
• Like Yourself
• Intensive Therapy is the ONLY Way to Treat
  Patients with Diabetes

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Questions

• For a copy or viewing of these
• slides, contact
• www.adaendo.com
• Address correspondence to
• Paul C. Davidson, M.D.
• Atlanta Diabetes Associates
• 77 Collier Road, Suite 2080
• Atlanta, GA 30309
• email paul_c_davidson_at_msn.com