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Why do we Need an Artificial Pancreas?

Why do we Need an Artificial Pancreas? . Why do we Need an Artificial Pancreas?. Georgeanna J Klingensmith, MD Barbara Davis Center Keystone 2010. Georgeanna J Klingensmith, MD Barbara Davis Center Keystone 2010. Why do we need an artificial pancreas?. Current glycemic targets

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Why do we Need an Artificial Pancreas?

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  1. Why do we Need an Artificial Pancreas? Why do we Need an Artificial Pancreas? Georgeanna J Klingensmith, MD Barbara Davis Center Keystone 2010 Georgeanna J Klingensmith, MD Barbara Davis Center Keystone 2010

  2. Why do we need an artificial pancreas? • Current glycemic targets • Current glycemic outcomes fall short • What factors contribute to achieving target glycemia • Can current technology allow youth to reach target glycemia?

  3. ADA Glycemic Guidelines Targets Age A1c %** < 6yrs 7.5-8.5 6-12 yrs <8 13-18 yrs <7.5 adult <7 ** Goals should be individualized, a lower A1C goal is reasonable based on benefit:risk assessment and if it can be achieved without excessive hypoglycemia Silverstein, et al. Care of Children with type 1 DM. Diabetes Care, 28:186-212, 2005 ADA Standards of Care. Diabetes Care, Suppl 1, 2010

  4. ISPAD Glycemic Guidelines for all children and adolescents A1C = <7.5% for all children All targets should be individualized Higher targets are recommended in those with severe hypoglycemia and/or hypoglycemia unawareness Rewers M, Pihoker C, Donaghue K, Hanas R, Swift P, Klingensmith GJ. Assessment and Monitoring of Glycemic Control. ISPAD clinical consensus guidelines 2009. Ped Diab 2009

  5. Severe hypoglycemia Diabetic retinopathy Nephropathy Neuropathy Microalbuminuria 120 Rate of Severe Hypo. (per 100 patient-years) 100 80 60 40 20 0 Risk of Progression of Complications:Related to Glycemia, the DCCT Study 15 13 11 9 7 5 3 1 Relative Risk 7 8 9 10 11 12 6 HbA1c, % GJ Klingensmith DCCT Research Group. N Engl J Med. 1993;329:977-986.

  6. The DCCT: A1C can be modified and Technology Lowers A1C 1 2 3 4 5 6 7 8 9 DCCT Intervention DCCT EDIC Observation S t u d y Y e a r

  7. Where are we in the ‘real world’ of pediatric diabetes?

  8. The Hvidore Study Group on Childhood DiabetesA1C for participating centers 9.5 9.0 Mean +/- SE % A1c Tosoh method 8.5 8.0 Mean A1C 8.2 + 1.4%, 7.5 7.0 Diabetes Care, 30:2245-50, 9/2007

  9. SEARCH for Diabetes A1c Results6 clinical centers in US Mean duration 5 years Mean 8.33% 8.24% N=2999 N=369 “Good”: age specific ADA A1c target “Poor”: A1c ≥ 9.5%. “Intermediate”: 1c between “good” and “poor” Petitti D, et al, J Peds, Nov 2009

  10. Factors associated with A1C in Multifactorial Analysis • Age, DM duration < 0.001 • Insurance status < 0.001 • Household income < 0.001 • Parental education < 0.001 • Race/ ethnicity < 0.001 When the HbA1c is adjusted for all of these factors, mean A1C for T1D = 8.0% Petitti D, et al, J Peds, Nov 2009

  11. Insulin Regimen in SEARCH Type 1, N=2743, duration >1 year Difference remains significant when controlling for socio-economic factors Journal of Pediatrics Aug 2009

  12. Factors associated with HbA1c in Multifactorial Analysis • Age, DM duration < 0.001 • Insurance status < 0.001 • Household income < 0.001 • Parental education < 0.001 • Race/ ethnicity < 0.001 • Frequency of BG testing < 0.001 • Type of insulin/ insulin delivery <0.001

  13. Improvement in HbA1c levelsThe Joslin Clinic Cohort 2 used more intensive management with more frequent SBGM and more on MDI and CSII A1c significantly lower for Cohort 2 compared to Cohort 1 at baseline (p=0.03) and two-year follow-up (p=0.04) J Pediatr. 2007 Mar;150(3):279-85

  14. Does the latest technology help adolescents? • JDRF sensor study • Randomized controlled trial of sensor use vs standard care • 3 age groups • >25 • 15-25 • 8-14 N Engl J Med. 2008. 359(14):1464-76

  15. 30% 86% 50% Only the >25 group had an improvement in A1C Diabetes Care, 11/2009, 32 (11), p. 1952

  16. Age Differences in Sensor use at 6 months % sensor >25 yrs 15-25 yrs 8-14 yr >6d/wk 64% 19%* 25% *21% of 15-24 year olds were not wearing the sensor at 6 months Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the JDRF-CGM trialJuvenile Diabetes Research Foundation Continuous Glucose Monitoring Study GroupDiabetes Care. 2010 Jan;33(1):17-22

  17. Who successfully uses CGM • Those >25 years (p<0.001) • Those who test more frequently prior to initiation of CGM (p<0.001) • Those who wore the device >6 days a week in the initial month (p<0.001) • Those who achieved a greater percent of glucose values of 70-180mg/dl in month 1 (p<0.002) Diabetes Care 2009;32: 1947-1953

  18. Do we need an ‘artificial pancreas’, or is CGM enough? • Some pediatric patients can successfully achieve A1C values <7% without significant hypoglycemia for many years • Even within a clinical trail, many cannot achieve a significantly lower A1C with CGM, due to the inability to consistently wear the device

  19. Why do we need an ‘artificial pancreas’? • Current ‘usual’ therapy does not achieve goal A1C values in over 50% of children • Using more intensified management can lower A1C levels in many patients • The newest current technology - CGM- can also be important in achieving target glycemic levels for some patients

  20. Conclusion • An artificial pancreas may remove enough of the ‘human error’ and ‘hassle’ factor to allow more patients to achieve success • A cure for adolescence would also help

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