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Diabetes Technology and Insulin Therapy

Diabetes Technology and Insulin Therapy. Bruce W. Bode, MD, FACE Atlanta Diabetes Associates Atlanta, Georgia. Case 1: New Onset Diabetes. 45-year-old male lawyer presents with “polys” and weight loss

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Diabetes Technology and Insulin Therapy

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  1. Diabetes Technology and Insulin Therapy Bruce W. Bode, MD, FACE Atlanta Diabetes AssociatesAtlanta, Georgia

  2. Case 1: New Onset Diabetes • 45-year-old male lawyer presents with “polys” and weight loss • Sees internist who recommends metformin (blood glucose 500, urine ketones small, BMI 26) • The lawyer does some internet reading and seeks a second opinion from diabetes specialist who was a high school classmate he has not seen for 27 years

  3. Case 1: New Onset Diabetes • What type of diabetes does he have? • Type 1 • Type 1.5 • LADA • Type 2 • a, b or c

  4. Case 1: New Onset Diabetes (cont’d) • What is your best diagnostic tests to determine the type of diabetes? • Islet cell antibody panel (ICA, anti-GAD) • Serum C-peptide • Genetic Typing • Other tests?

  5. LADA: Detection and Impact of GAD Antibodies • GAD: Glutamic acid decarboxylase • Other antibodies • ICA, IA2, insulin autoantibodies • 7% of the patients screened in the Treat to Target Study had GAD antibodies • 95% of patients in the UKPDS who were anti-GAD or anti-ICA required insulin within 6 years UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1997;350:1288-1293. Shimada A et al. Ann N Y Acad Sci. 2003;1005:378-386.

  6. Progression of Type 1 Diabetes Precipitating Event Genetic predisposition Antibody Progressive loss of insulin release Normal insulin release Overt diabetes Glucose normal Beta cell mass C-peptide present No C-peptide present Age (y) Adapted from: Atkinson. Lancet. 2002;358:221-229.

  7. Diabetes: New Cases Diagnosed Annually in the US Number Age Group 1999 – 2001 National Health Survey Estimates Projected to 2002, Centers for Disease Control and Prevention, National Diabetes Fact Sheet.

  8. Case 1: New Onset Diabetes • Sees me the following AM (BG 514, urine ketones small) • I concur with him that he has type 1 diabetes and metformin is not the treatment, insulin is • What is your initial treatment? • IV insulin • Basal/bolus therapy with MDI • Premixed • Insulin pump therapy

  9. Options in Insulin Therapy for Type 1 Diabetes • Current • Multiple injections • Insulin pump (CSII)

  10. Case 1: New Onset Diabetes (cont’d) • He asks about insulin pump therapy instead of multiple injections • I hospitalize him and tell him I will get back to him the following AM

  11. DCCT Absolute Risk of Retinopathy:Conventional vs Intensive Insulin Therapy • At the same A1C level, intensive insulin therapy provides a greater risk reduction of the development of retinopathy Development of Retinopathy Conventional Therapy Intensive Therapy 24 24 11% 10% Mean A1C 9% 20 20 16 16 Rate per 100 patient- years 12 12 Mean A1C 8% 9% 8 8 8% 7% 4 4 7% 6% 0 0 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 Time during study (y) DCCT Research Group. Diabetes. 1995;44:968–983.

  12. Does Intensive Diabetes Therapy Preserve Beta Cell Function? 1.0 0.9 0.8 0.7 Patient probability of maintaining C-peptide > 2.0 0.6 0.5 0.4 0.3 Intensive therapy 0.2 Conventional 0.1 therapy 0.0 0 0 1 2 3 4 5 6 Years Post Enrollment Number of evaluated patients in each treatment group Intensive 108 131 80 53 32 8 2 Conventional 165 150 63 32 22 3 0 Adapted from: DCCT Study Group: Ann Intern Med. 1998;128:517-523.

  13. The Physiological Insulin Profile Short-lived, rapidly generatedprandial insulin peaks 70 Normal free insulin levelsfrom genuine data (mean) 60 50 Insulin (mU/L) 40 Low, steady, basalinsulin profile 30 20 10 0 0600 0900 1200 1500 1800 2100 2400 0300 0600 Breakfast Lunch Dinner Adapted from Polonsky, et al. 1988.

  14. Basal/Bolus Treatment Program with Rapid-acting and Long-acting Analogs Breakfast Lunch Dinner Aspart,LisproorGlulisine Aspart,LisproorGlulisine Aspart,LisproorGlulisine Plasma insulin Glargine or Detemir 4:00 8:00 12:00 16:00 20:00 24:00 4:00 8:00 Time

  15. Insulin Predictability of Basal Insulin Pumps Detemir Gold Standard Glargine 27% NPH 46% Intrasubject Variability 59% Lepore M, et al. Diabetes. 2000;49:2142-2148. Heise TC, et al. Diabetes. 2003;52(suppl 1):A121.

  16. Duration of Effectiveness N=20 T1DM Mean ± SEM sc insulin 220 200 NPH 180 Ultralente Glucose mg/dl 160 Glargine 140 CSII 120 0 4 8 12 16 20 24 Time (hours) Lepore M, et al. Diabetes. 2000;49:2142-2148.

  17. Insulin Treatment in Type 2 Diabetes • Basal Treatment (NPH, Glargine, or Detemir) Start 10U and titrate; will need ~0.5U/kg; will lower A1C 1.5 to 2 points • Bolus Treatment Premeal Start at 3-5U premeal and titrate; will lower A1C 2 plus points • Premixed Therapy Start at 5U BID and titrate; will need ~0.8U/kg; will lower A1C 2 plus points • Basal Bolus Therapy

  18. Case 1: New Onset Diabetes • If you decided on MDI, how do you determine his starting doses of insulin? • Based on trial and error • Based on BMI • Based on weight • Let the CDE decide

  19. Starting Basal/Bolus Therapy • Starting insulin dose is based on weight • 0.2 x wgt. in lbs. or 0.5 x wgt. in kg • Bolus dose (aspart/lispro) = 20% of starting dose at each meal • Basal dose (glargine/NPH) = 40% of starting dose at bedtime

  20. Starting MDI in 180-lb Person • Starting dose = 0.2 x 180 lb • 0.2 x 180 = 36 units • Bolus dose = 20% of starting dose at each meal • 20% of 36 units = 7 units ac (tid) • Basal dose = 40% of starting dose at bedtime • 40% of 36 units = 14 units at HS

  21. Correction Bolus (Supplement) • 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 units, then CF = 1700/36 = ~50 • Meaning 1 unit will lower the BG ~50 mg/dl

  22. 220 – 10050 =2.4u Correction Bolus Formula Current BG - Ideal BG Glucose Correction Factor • Example: • Current BG: 220 mg/dl • Ideal BG: 100 mg/dl • Glucose Correction Factor: 50 mg/dl

  23. Insulin Pens The first insulin pen was developed by NovoNordisk in 1926 but not launched until 1985. Since then, numerous pens, both disposable and reusable, have been developed adding to accuracy in dosing and convenience to insulin injection therapy. Disposable Lilly Pen Aventis Reusable Pen with disposable cartridge Novo Reusable Pen with disposable cartridge Disposable NovoNordisk Pen

  24. Options to MDI • A Simpler Regimen • Insulin Pump • Premixed BID (DM 2 only)

  25. Variable Basal Rate: CSII Program Breakfast Lunch Dinner Bolus Bolus Bolus Plasma insulin Basal infusion 4:00 8:00 12:00 16:00 20:00 24:00 4:00 8:00 Time

  26. Summary: The Benefits of CSII in Mimicking Normal Physiology • Nocturnal variability • Covering the dawn phenomenon • Exercise-related changes • Reducing basal insulin to normalize glucose • Normal eating patterns • Multiple boluses; dual bolus • Complex carbohydrates and dietary fat • Covering delayed carbohydrate absorption

  27. Metabolic Advantages with CSII • Improved glycemic control • Better pharmacokinetic delivery of insulin • Less hypoglycemia than NPH based therapy • Less insulin required • Improved quality of life

  28. Insulin Delivery Therapy at End of DCCT Pump 42% Unknown 2% MDI 56% DCCT. Diabetes Care. 1995;18:361-376.

  29. CSII vs MDI with Glargine in Adults • Insulin aspart (CSII) vs insulin aspart / glargine (MDI) IAsp + Glarg MDI IAsp CSII IAsp + Glarg MDI IAsp CSII Run-in (1 week) Period 1 (5 weeks) Period 2 (5 weeks) • 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 Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

  30. CSII vs MDI in 100 DM 1 Patients 200 CSII (n=93) MDI (n=91) 180 Self-monitored BG (mg/dL) 160 140 120 100 BL 3 AM BB AB AL BD AD Midnight Mean ± 2 SEM Bode BW, et al. Diabetes. 2003;52(suppl 1). Abstract 438.

  31. CSII (aspart) n=16 MDI (aspart/glargine) n=16 Injectiontherapy 16 Week treatment period CSII vs MDI with Glargine in Children Randomized, Parallel-group, 16 week study Subjects at baselineAge: 8-19 yr (mean 12.7 ± 2.7) Type 1 DM > 1 yr duration Standard insulin therapy (2-3 injections/day) Doyle EA, et al. Diabetes Care 2004; 27: 1554

  32. P < 0.05 MDI CSII 16 Week Comparison of MDI using Glargine versus CSII: Children P < .001 Doyle EA, et al. Diabetes Care 2004; 27: 1554

  33. CSII versus MDI in Type 2 Diabetes14 Center Randomized Parallel Group Study Insulin aspart in CSII (n = 66) Screen: DM 2 >2 years On insulin >6 months A1C > 7.5%; Stop OHA Target FBG 80-120 Insulin aspart/NPH in MDI (n = 61) Maintenance period Dose adjustment Week 8 Week 0 Week 24 Raskin et al. Diabetes Care 26(9): 2598-2603, 2003

  34. CSII versus MDI in Type 2 Diabetes14 Center Randomized Parallel Group Study • A1C Raskin et al. Diabetes Care 26(9): 2598-2603, 2003

  35. CSII vs MDI in DM 2 Patients CSII MDI Less pain Fewer 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 Testa et al. Diabetes. 2001;50(suppl 2):1781.

  36. CSII vs MDI in Older Adults with Type 2 DM 2 Center Randomized Parallel Group Study Insulin lispro in CSII (n = 48) Screen: DM 2 On insulin Age > 60yo Stop OHA Insulin lispro/glargine in MDI (n = 50) Dose adjustment Week 0 Week 52 Herman W et al, Poster 504-P, ADA 2005

  37. CSII vs MDI in Older Adults with Type 2 DM 2 Center Randomized Parallel Group Study A1C Herman W et al, Poster 504-P, ADA 2005

  38. Case 1: New Onset Diabetes • I see patient in the AM and tell him that 8 out of 10 patients polled yesterday would have started CSII at onset if offered the choice • Dr. Pozzilli, an expert in DM 1 prevention, also recommended CSII at onset if it was him or a close relative • Patient opted for CSII

  39. Case 1: New Onset Diabetes on CSII: A1C Results A1C

  40. Case 1: New Onset Diabetes on CSII • Patient extremely satisfied with his care • C-peptide 0.9 to 0.8 at 1 year, 0.5 to 0.7 at 3 years • Does not understand why everyone is not on CSII with optimal control

  41. Current Pump Therapy Indications • Need to normalize blood glucose (BG) • A1C > 6.5% • Glycemic excursions • Hypoglycemia or hypoglycemia unawareness • Need for a flexible insulin regimen

  42. US Pump Usage: Total Patients Using Insulin Pumps Industry estimates

  43. Current Continuation Rate: Continuous Subcutaneous Insulin Infusion (CSII) Continued 97% Discontinued 3% N = 165 Average duration = 3.6 years Average discontinuation <1%/y Bode BW, et al. Diabetes. 1998;47(suppl 1):392.

  44. Smart Insulin Pumps Photograph reproduced with permission of manufacturer.

  45. Smart PumpsBolus Calculator: Meter-Entered • Monitor sends BG value to pump or patient dials in BG value • Enter carbohydrate intake into pump • “Bolus Calculator” calculates suggested dose ) ) ) ) ) ) ) ) ) ) ) ) ) Paradigm 512™ Paradigm Link™

  46. Calculator: OnCarb Units: GramsCarb Ratios: 10BG Units: mg/dlSensitivity: 40BG Target: 80-100Active Insulin Time: 5 hours Bolus Calculator Set Up Screen

  47. Pump Infusion Sets: Perpendicular vs Oblique • Perpendicular (Sof-set™, Quick-set™, Ultraflex™) • Easier insertion • Prone to kink • Oblique (Silhouette™, Tender™, Comfort™) • More difficult insertion • Less kinking

  48. Disposable Patch Pumps

  49. CSII:Factors Affecting A1C • Monitoring • A1C = 8.3 - (0.21 x BG per day) Bode BW, et al. Diabetes. 1999;48(suppl 1):264. Bode BW, et al. Diabetes Care. 2002;25:439.

  50. Increased SMBG Testing Frequency Lowers A1C Atlanta Diabetes Associates study: 378 patients sorted from a database of 591 Pumps=MM 511 or earlier BG Target=100 C peptide <0.1

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