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Management of Type 2 Diabetes with Basal Bolus Treatment Strategies. Bruce W. Bode, MD, FACE Atlanta Diabetes Associates Atlanta, Georgia. 0. 12. 24. Hours. Goals of Intensive Insulin Therapy. Maintain near-normal glycemia Avoid short-term crisis Minimize long-term complications
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Management of Type 2 Diabetes with Basal Bolus Treatment Strategies Bruce W. Bode, MD, FACE Atlanta Diabetes Associates Atlanta, Georgia
0 12 24 Hours Goals of Intensive Insulin Therapy • Maintain near-normal glycemia • Avoid short-term crisis • Minimize long-term complications • Improve quality of life
ACE/AACE Targets for Glycemic Control Fasting/preprandial glucose <110 mg/dL Postprandial glucose <140 mg/dL A1C <6.5 % ACE/AACE Consensus Conference; August 2001; Washington, DC.
Over time, most patients will need insulin to control glucose Type 2 Diabetes:A Progressive Disease
Over time, most patients will need both basal and mealtime insulin to control glucose Mimicking Nature with Insulin Therapy
The Basal/Bolus Insulin Concept • Basal insulin • Suppresses glucose production between meals and overnight • 40% to 50% of daily needs • Bolus insulin (mealtime) • Limits hyperglycemia after meals • Immediate rise and sharp peak at 1 hour • 10% to 20% of total daily insulin requirement at each meal
75 Breakfast Lunch Dinner 50 Plasma insulin (U/mL) 25 4:00 8:00 12:00 16:00 20:00 24:00 4:00 8:00 Time Physiological Serum Insulin Secretion Profile
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) 25 Glargine or Detemir 4:00 8:00 12:00 16:00 20:00 24:00 4:00 8:00 Time
Novo Nordisk Devices in Diabetes Care • First pen (NovoPen® 1) launched in 1985 • Committed to developing 1 new insulin administration system per year
Novo FlexPen® • 3-mL prefilled disposable pen offers precise dosing
NovoLog® FlexPen® 82% of DNEs Preferred FlexPen® ® Source: Diabetes Nurse Educators In-Depth Study—Reactions to FlexPen.
InDuo™—Integration Feature: • Combined insulin doser and blood glucose monitor
InDuo™—Doser Memory Feature: • Remembers amount of insulin delivered and time since last dose Benefit: • Helps people inject the right amount of insulin at the right time
Starting MDI • Starting insulin dose is based on weight • 0.2 x wt in lb or 0.45 x wt in kg • Bolus dose (aspart/lispro) • 20% of starting dose at each meal • Basal dose (glargine/NPH) • 40% of starting dose at bedtime MDI=multiple dosage insulin.
Starting MDI in 180-lb Person • Starting dose = 0.2 x wt in lb • 0.2 x 180 lb = 36 U • Bolus dose = 20% of starting dose at each meal • 20% of 36 U = 7 U ac (TID) • Basal dose = 40% of starting dose at bedtime • 40% of 36 U = 14 U HS
Correction Bolus • Must determine how much glucose is lowered by 1 unit of short- or rapid-acting insulin • This number is known as the correction factor (CF) • Use the 1700 rule to estimate the CF • CF = 1700 divided by the total daily dose (TDD) • Ex: if TDD = 36 U, then CF = 1700/36 = 50, meaning 1 U will lower the blood glucose (BG) 50 mg/dL
Example: Current BG: 220 mg/dL Ideal BG: 100 mg/dL Glucose CF: 50 mg/dL Correction Bolus Formula Current BG - Ideal BG Glucose CF 220 - 100 50 = 2.4 U
Case 1: DM 2 on SU with Infection • 49-year-old white man • DM 2 onset age 43, ht 70", wt 173 lb • On glimepiride (Amaryl®) 4 mg/d, A1C 7.3% (intolerant to metformin) • Infection in colostomy pouch (ulcerative colitis) glucose up to 300 mg/dL plus • SBGM 3 times per day SU=sulfonylurea; DM=diabetes mellitus; SBGM=self blood-glucose monitoring.
Case 1: DM 2 on SU with Infection (cont’d) • Started on MDI • Did well, average BG 138 mg/dL at 1 month and 117 mg/dL at 2 months post episode with A1C 6.1%
Case 2: DM 2 on 70/30 • 60-year-old African American man • DM 2 age 56, ht 69", wt 180 lb • Failed oral agents • On 70/30 BID: 10 U AM and PM • A1C 8.4%, • SMBG 144 on 0.8 tests/d • Increased 70/30, tried 3x/d, still not at goal
Case 2: DM 2 on 70/30 (cont’d) • Finally agrees to MDI • Starting dose: 0.2 x wt in lb (36 U) • Bolus: 20% pre-meal (7 U ac TID) • Basal: 40% bedtime or anytime (14 U HS) • CF: 1700 divided by TDD (50 mg/dL) • Does great—A1C 6.4% • Current dose: • 4 U AM, 4 U noon, 10 U PM, 16 U Lantus® HS
Options to MDI • Simpler regimen • Insulin pump • Premixed BID (DM 2 only)
Variable Basal Rate: CSII Program 75 Breakfast Lunch Dinner 50 Bolus Bolus Bolus Plasma insulin(U/mL) 25 Basal infusion 4:00 8:00 12:00 16:00 20:00 24:00 4:00 8:00 Time CSII=continuous subcutaneous insulin infusion.
Metabolic Advantages with CSII • Improved glycemic control • Better pharmacokinetic delivery of insulin • Less hypoglycemia • Less insulin required • Improved quality of life
CSII: Factors Affecting A1C • Monitoring • A1C = 8.3 - (0.21 x BG/d) • Recording 7.4 vs 7.8 • Diet practiced • CHO: 7.2 • Fixed: 7.5 • WAG: 8.0 • Insulin type (Aspart) Bode et al. Diabetes. 1999;48(suppl 1):264. Bode et al. Diabetes Care. 2002;25:439.
220 200 180 160 140 120 100 80 Before and90 min. after lunch Before and90 min. after breakfast Before and90 min. after dinner Bedtime 2 AM Self-Monitored Blood Glucose in CSII NovoLog® Buffered Regular Humalog® * Blood Glucose (mg/dl) * * Type 1 Diabetes Bode, Diabetes 2001 ; 50(S2):A106
Episodes/month/patient Symptomatic or Confirmed Hypoglycemia P<0.05 P<0.05 12 30% relative reduction 10 8 6 4 2 0 Insulin aspart Human insulin Insulin lispro Bode et al. Diabetes Care. March 2002.
DM 1 CSII Patient:Lispro to Aspart Aspart Average = 118 SD = 73 Lispro Average = 140 SD = 118 Glucose (mg/dL)
A1C Baseline End of study (24 wk) 8.4 8.2 8.0 7.8 7.6 7.4 7.2 7.0 CSII MDI Glycemic Control in Type 2 DM: CSII vs MDI in 127 Patients Raskin et al. Diabetes. 2001;50(suppl 2):A128.
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 CSII vs MDI in DM 2 Patients Raskin et al. Diabetes 2001;50 Suppl 2:A128
DM 2 Study: CSII vs MDI • 93% in the CSII group preferred the pump to their prior regimen (insulin ± OHA) • CSII group had fewer hyperglycemic episodes (3 subjects, 6 episodes vs 11 subjects, 26 episodes in the MDI group) Raskin et al. Diabetes. 2001;50(suppl 2):A128.
Case 3: DM 2 Poorly Controlled • 58-year-old woman presented with a 12-year history of poorly controlled, insulin treated diabetes • Ht 66", wt 174 lb, BMI 28, C-peptide 2.1 • A1C 10.4% on 165 U/d (70/30 BID) • Added troglitazone, metformin, glimepiride to MDI insulin • A1C range 7.7% to 12.6% over 3 years
Case 3: DM 2 Poorly Controlled (cont’d) • Admitted twice for IV insulin and fasting with short-lived success (A1C to 7.6% but back up to 12.6%) • Tried WeightWatchers® and appetite suppressants—no help • Decided to try CSII
14 13 A1C 12 11 10 9 8 7 6 5 4 Jul 00 Jul 01 Jan 00 Jan 01 Jan 02 Sep 00 Sep 01 Nov 00 Nov 01 Mar 00 Mar 01 Mar 02 May 00 May 01 Case 3: DM 2 on CSII—A1C Results %
Case 3: DM 2 Poorly Controlled • Patient loves the pump • A1C remains normal as of 3/03 on 110 U/d consuming 2 meals/d (1.4 U/kg or 0.6 U/lb) • Also on rosiglitazone 4 mg/d
Normalization of Lifestyle • Liberalization of diet—timing and amount • Increased control with exercise • Able to work shifts and through lunch • Less hassle with travel—time zones • Weight control • Less anxiety in trying to keep on schedule
Current Continuation Rate: CSII Continued 97% Discontinued 3% N=165. Average duration=3.6 y. Average discontinuation <1%/y. Bode BW, et al. Diabetes. 1998;47(suppl 1):392.
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 50,000 20,000 15,000 11,400 8700 6600 0 '90 '91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02
Current Pump Therapy Indications • Diagnosed with diabetes (even new onset DM 1) • Need to normalize BG • A1C > 6.5% • Glycemic excursions • Hypoglycemia
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 6 5 Meal bolus 4 Units 3 2 1 Basal rate 12 AM 12 PM 12 AM Time of day Pump Therapy
Must look at: 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 If A1C Is Not at Goal
If A1C Not at Goal and No Reason Identified • Place on a continuous glucose monitoring system (CGMS by Medtronic MiniMed, GlucoWatch® by Cygnus) to determine the cause
Summary • 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
Conclusion • Intensive therapy is the best way to treat patients with diabetes
Billing • Get paid for what you do • Use your codes and negotiate for coverage • Detailed visit: 99214 • Prolonged visit with contact plus above: 99354 or 99355 (insulin start or pump start) • Prolonged visit w/o contact plus above: 99358 or 99359 (faxes, phone calls, e-mails)
Billing (cont’d) • Bill faxes as prolonged visits without contact or negotiate a separate charge • Bill meter download: 99091 • Bill CGMS: 95250 • Bill immediate A1C: 83036