Basal Bolus The Strategy for Managing All Diabetes
Basal Bolus: The Strategy for Managing All Diabetes Presented in San Antonio, May 3, 2003 Paul Davidson, MD, FACE Atlanta Diabetes Associates Atlanta, Georgia
ACE/AACE Targets for Glycemic Control A 1 C <6. 5 % Fasting/preprandial glucose <110 mg/d. L Postprandial glucose <140 mg/d. L ACE/AACE Consensus Conference; August 2001; Washington, DC.
Type 2 Diabetes: A Progressive Disease Over time, most patients will need insulin to be controlled to target
MIMICKING NATURE WITH INSULIN THERAPY All persons need both basal and mealtime insulin to control glucose (endogenous or exogenous) 6 -
Basal/Bolus Treatment Program with Rapid-acting and Long-acting Analogs 75 Plasma insulin ( U/m. L) Breakfast Lunch Aspart or Lispro 50 Dinner Aspart or Lispro Glargine or Detemir 25 4: 00 8: 00 12: 00 16: 00 Time 20: 00 24: 00 8: 00
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
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
Alternatives to MDI • Simpler regimen • Premixed BID (DM 2 only) • Insulin pump
Variable Basal Rate: CSII Program 75 Plasma insulin ( U/m. L) Breakfast 50 Lunch Bolus Dinner Bolus 25 Basal infusion 4: 00 8: 00 12: 00 16: 00 Time CSII=continuous subcutaneous insulin infusion. 20: 00 24: 00 8: 00
Insulin for CSII Mean SBGM Blood Glucose (mg/dl) 220 Novo. Log® Buffered Regular Humalog® 200 180 160 * * 140 120 Type 1 Diabetes 100 80 * Before and 90 min. after breakfast Before and 90 min. after lunch Before and 90 min. after dinner Bedtime 2 AM Bode, Diabetes 2001 ; 50(S 2): A 106
Symptomatic or Confirmed Hypoglycemia P<0. 05 Episodes/month/patient 12 30% relative reduction 10 8 6 4 2 0 Insulin aspart Human insulin Bode et al. Diabetes Care. March 2002. Insulin lispro
DM 1 CSII Patient: Lispro to Aspart Glucose (mg/d. L) Lispro Average = 140 SD = 118 Lispro Aspart Average = 118 SD = 73 Aspart
CSII Usage in Type 2 Patients: Atlanta Diabetes Experience 10. 00 9. 2 9. 00 8. 00 7. 57 7. 19 7. 00 6. 00 5. 00 Baseline N=11 6 months P=0. 026 Mean A 1 C (%) Davidson et al. Diabetologica. 1999; 42(suppl 1): 796. 18 months P=0. 040
Glycemic Control in Type 2 DM: CSII vs MDI in 127 Patients A 1 C Baseline End of study (24 wk) 8. 4 8. 2 8. 0 7. 8 7. 6 7. 4 7. 2 7. 0 CSII Raskin et al. Diabetes. 2001; 50(suppl 2): A 128. MDI
CSII vs MDI in DM 2 Patients CSII MDI Less Pain Less Social Limitations Preference * ** Advocacy Less Hassle * * Less Life Interference *** General Satisfaction Flexibility *** Convenience Less Burden *** -5 0 5 10 15 20 25 30 35 Change in Scores (Raw Units) From Baseline to Endpoint Raskin et al. Diabetes 2001; 50 Suppl 2: A 128
US Pump Usage: Total Patients Using Insulin Pumps 250, 000 Total no. of patients 200, 000 157, 000 150, 000 120, 000 100, 000 81, 000 50, 000 6600 15, 000 11, 400 8700 '91 35, 000 26, 500 43, 000 20, 000 60, 000 0 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02
Current Pump Therapy Indications • Need to normalize BG — A 1 C 6. 5% — Glycemic excursions • Hypoglycemia • New onset type 1 DM • Pregnancy and diabetes
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
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.
Materials and Methods • Target Group (TG) of 182 patients with A 1 C <7% • 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.
Sampling Results P<. 01 P<. 03
AIM Starting Total Dose of Insulin TDDstart = 0. 24 * BW#
Basal Insulin = 0. 48 * TDD
CARBOHYDRATE TO INSULIN RATIO CIR = 2. 8 * BW# / TDD
Correction Factor The 1700 Rule CF = 1708 / TDD n = 179
RESULTS
AIM FORMULAE and Slopes
AIM Nomogram Carbohydrate to Insulin Ratio 25 20 15 12 10 9 8 7 ( CIR = 2. 8 Wt / TDD ) 6 5 Intial Dosing: Plot BW and 25 CIR for BI Plot BW and 12 CIR for TDD 4 3 2 100 75 CF Curve 25 Davidson et al Diab Tech Ther 2003 Vol 5 No 2 ( CF = 1700 / TDD ) 50 Correction Factor 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 125
Initial Visit • Type 1 Diabetes • Starting CSII • Poorly controlled on QID insulin — 10 units lispro tid and 28 units glargine hs — Mean BG 189, A 1 c 9 • Weight 210 #
AIM Nomogram Carbohydrate to Insulin Ratio 25 20 15 12 10 9 8 7 ( CIR = 2. 8 Wt / TDD ) 6 5 Intial Dosing: Plot BW and 25 CIR for BI Plot BW and 12 CIR for TDD 4 3 2 100 75 CF Curve 25 BI 24 units Davidson et al Diab Tech Ther 2003 Vol 5 No 2 ( CF = 1700 / TDD ) 50 Correction Factor 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 125
AIM Nomogram Carbohydrate to Insulin Ratio CIR 25 20 15 12 10 9 8 7 ( CIR = 2. 8 Wt / TDD ) 6 5 Intial Dosing: Plot BW and 25 CIR for BI Plot BW and 12 CIR for TDD 4 3 2 100 75 CF Curve CF 35 25 BI 24 units TDD 50 units Davidson et al Diab Tech Ther 2003 Vol 5 No 2 ( CF = 1700 / TDD ) 50 Correction Factor 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 125
Follow-up One Month Later • • • Weight 210# 4. 5 BG’s per day Average BG 158 Current basal 1. 2 u/hr (28. 8 u/d) TDD from pump 64 units
AIM Nomogram Carbohydrate to Insulin Ratio CIROld CIRNew 25 20 15 12 10 9 8 7 ( CIR = 2. 8 Wt / TDD ) 6 5 Intial Dosing: Plot BW and 25 CIR for BI Plot BW and 12 CIR for TDD 4 3 2 100 75 Correction Factor 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 125 CF Curve Basal. AIM TDD/2=32 CFOld 35 CFNew 2525 TDDCurrent Davidson et al Diab Tech Ther 2003 Vol 5 No 2 ( CF = 1700 / TDD ) 50
AIM Study • 21 Patients • Hb. A 1 c>8 • Competent Self. Monitoring • Pump Veterans • Bi-Weekly Fax and Phone Follow-Up • Three Month Study 180 160 140 120 P<0. 0001 Davidson et al Diabetes Technology & Therapeutics 2003 P<0. 0001
Pump. Master 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
Overview of Pump. Master • In development (Patent Pending) • Has shown that it lowers Hb. A 1 c • 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
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.
If Hb. A 1 c Not to Goal i. e. 6. 5% • SMBG —frequency —recording —memory meter • Diet • Infusion site areas • Overtreatment of low BG • Delayed or (100 -BG) x 0. 2 undertreatment of high BG —accurate CHO counting More than 4/day —appropriate CHO/insulin bolusing 2. 8 x Wt / TDD 1700 Rule
If Hb. A 1 c Not to Goal i. e. 6. 5% • SMBG —frequency —recording —memory meter • Diet • Infusion site areas • Overtreatment of low BG • Delayed or (100 -BG) x 0. 2 undertreatment of high BG —accurate CHO counting More than 4/day —appropriate CHO/insulin bolusing 2. 8 x Wt / TDD 1700 Rule
Improvement in Hb. A 1 c with Increased BG Testing
If Hb. A 1 c Not to Goal i. e. 6. 5% • SMBG —frequency —recording —memory meter • Diet • Infusion site areas • Overtreatment of low BG • Delayed or (100 -BG) x 0. 2 undertreatment of high BG —accurate CHO counting More than 4/day —appropriate CHO/insulin bolusing 2. 8 x Wt / TDD 1700 Rule
Correction of Hypoglycemia with Glucose 100 -BG X 0. 2 Grams 100 -BG X 0. 15 Grams Richardson Diabetes 1999 50: A 200 Before After
If A 1 c Not at Goal and No Reason Identified • Place on a continuous glucose monitoring system — CGMS — Gluco. Watch — Thera. Sense
Summary • Insulin is the only powerful agent we have to control diabetes • When used in a basal/bolus format, nearnormoglycemia 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
Conclusion • For the Responsible, Informed Physician • Like Yourself • Intensive Therapy is the ONLY Way to Treat Patients with Diabetes
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@msn. com
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