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Diabetes in Young Children The Lollipop Brigade

Diabetes in Young Children The Lollipop Brigade. Francine R. Kaufman, M.D. Professor of Pediatrics The Keck School of Medicine of USC Head, Center for Diabetes and Endocrinology Childrens Hospital Los Angeles. What Will Be Discussed . What are the Targets for Young Children?

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Diabetes in Young Children The Lollipop Brigade

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  1. Diabetes in Young ChildrenThe Lollipop Brigade Francine R. Kaufman, M.D. Professor of Pediatrics The Keck School of Medicine of USC Head, Center for Diabetes and Endocrinology Childrens Hospital Los Angeles

  2. What Will Be Discussed • What are the Targets for Young Children? • What are the Diabetes Regimens? • Is There a Greater Risk of Hypoglycemia? • What are the Developmental Issues ?

  3. Question What are the glycemic targets for young children?

  4. Glycemic TargetsGlucose values are plasma (mg/mL) Diabetes Care 28:186-212, 2005

  5. But What are the Goals? • To give your child a loving, supportive environment where each day is taken at a time (not each blood sugar) • Where your child can grow and thrive, learn and explore • Where blood sugars are corrected, not interrogated • Where the family is in balance – like a mobile • And where the long haul is what is important

  6. Question Can Intensive Management Be Done Safely in Young Children?

  7. CHLA Type 1 DM

  8. HbA1c Statistics for CHLA 2003 Type 1: Diabetes > 1 year, followed > 1 yearEnrolled in Long-term study – total n 1375

  9. Evaluation of Young Children at CHLAKaufman, et al, Pediatr Diabetes, 3:179-183, 2002. • Retrospective analysis of data • 147 children < 8 years of age • 2 year data from July 99 – July 2001 • Study Question : Is HbA1c < 8.0 associated with more severe or assymptomatic hypoglycemia?

  10. Question What are the principles of management?

  11. Diabetes Management Principles • An effective insulin regimen • Monitoring of glucose • As flexible with food and activity as possible • Must remember • Young children need routine and rules • Young children need to develop autonomy • Young children need to explore and experience • Young children need to begin to make decisions

  12. Insulin management • Fixed dose regimens: • requires scheduled meals and snacks and is not flexible enough for most young children • Basal: bolus regimens: • MDI • useful only if child is willing to take frequent injections • Insulin pumps • child must be willing to wear the pump

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

  14. 3.0 2.5 2.0 1.5 1.0 0.5 0.0 -60 0 Meal 60 120 180 240 300 360 420 480 Type 1 Diabetes: Serum Insulin Concentrations Following Subcutaneous Injection of Insulin Lisproor Human Regular Injection Insulin Lispro (n=10) Human Regular (n=10) Serum Insulin Conc. (ng/mL) Mean + SE 0.2 mU/min/kg insulin infusion Time (minutes) Heinemann et al. Diabetic Medicine,13:625-629, 1996

  15. Effectiveness of Postprandial Humalog in Toddlers Rutledge, Chase, Klingensmith et al Pediatrics 100:968,97 • Determine if postprandial rapid-acting insulin effective • Subjects < 5 years old • Results: 2-hour glucose excursions lower with postprandial Humalog compared to preprandial regular • Similar to preprandial Humalog

  16. 6 NPH 5 4 Glargine Glucose Infusion Rates(mg/kg/min) 0.4 U/kg 3 2 Placebo 1 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 Hours Insulin Glargine - Pharmacokinetics by Glucose Clamp Linkeschowa R, et al. Diabetes.1999;48(Suppl 1):A97.

  17. 2.0 1.5 1.0 Detemir­High Detemir­Low 0.5 Placebo 0.0 1500 100 100 300 500 700 900 1100 1300 Insulin Detemir – Pharmacokinetics by Glucose Clamp Glucose Infusion Rate(mg/kg/min) Elapsed Time (min) Brunner et al. Exp Clin Endocrinol Diabetes. 2000;108.

  18. GHb, FBG, and Nocturnal Hypoglycemia in Children With T1DM(Plus Regular Insulin) (N=349) Glargine NPH 8 6 18 4 % of Patients Change in GHB (%) and FBG (mmol/L) 2 6 p<0.05 0 -2 -6 Nocturnal GHb FBG Hypoglycemia* *Nocturnal hypoglycemia with FBG <36 mg/dL, month 2 to study end Schoenle et al. EASD 1999; Abst 883. Study 3003

  19. 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

  20. A1c by Treatment type at CHLA:

  21. Outcomes of Pump TherapyKaufman, et al, Diabetes Metabolism and Reviews,2000 6 month data 130 subjects

  22. Results of Insulin Pump Therapy In Young ChildrenKaufman, et al, Diabetes Spectrum, 2001

  23. A Randomized Controlled Trial of Insulin Pump Therapy in Young Children With Type 1 Diabetes Larry A. Fox, et al Diabetes Care 28:1277-1281, 2005 • 26 children randomly assigned to current therapy or CSII for6 months, age 46.3 ± 3.2 months • RESULTS— • Mean HbA1c and BG did not change • Frequency of severe hypoglycemia, ketoacidosis,or hospitalization was similar between groups • Subjects on CSII had more fasting and predinner mild/moderatehypoglycemia • All subjects continued CSII after study completion

  24. CSII in Young ChildrenCONCLUSIONS • CSII is safe and well tolerated in young childrenwith diabetes and may have positive effects on QOL • CSII didnot improve diabetes control when compared with injections • The benefits and realisticexpectations of CSII should be thoroughly examined before startingthis therapy in very young children

  25. CGMS Tracing

  26. Use of CGMS to Improve Clinical Care 47 Patients 18 boys, 29 girls Age 11.8 ± 4.6 years Duration 5.5 ± 3.5 years A1c start 8.61 + 1.51 A1c end 8.36 + 1.28 p=0.01 Kaufman, et al:Diabetes Care24:2030, 2001.

  27. Mean Data for All Pts by Sensor

  28. Result Summary: Treatment Changes Basal (57%) Bolus (43%)

  29. Result Summary: Glucose Changes • HbA1c reduced from 8.1 to 7.8% after only 30 days • Average glucose decreased from 167 to 156 mg/dl

  30. Question Why About the Risk of Hypoglycemia From Intensive Regimens?

  31. Intensive Management and HypoglycemiaHbA1c Association Is There Greater Risk of Hypoglycemia at Lower HbA1c Levels? Or with Intensive Regimens?

  32. Lack of Association Between HbA1c and Hypoglycemia Cox – no association in 78 pts with mean level of 10.25% Bhatia, Wolfsdorf – incidence of 0.12/pt/yr in 196 pts with HbA1 11.4% (nl 5.4-7.4) Daneman - 16% of 311 pts with HbA1 of 8.7% Nordfelt, Ludvigsson – 146 pts intensive therapy, no increase in severe hypoglycemia Levine- highest HbA1c tertile, 36/pt/yr Kaufman et al Endocrinologist 9:342,99

  33. Analysis of data to determine bedtime BG level • 167 nights • Analyze the number of glucose values <40 and < 50 mg/dl through the night Kaufman FR, et al, J Pediatr. 141:625-630, 2002.

  34. Results • 45 nights (27%) – at least one reading < 40 mg/dl • 59 nights (35%) – at least one reading < 50 mg/dl • For nights < 100 at HS – 86.4 minutes • No relation to A1c or regimen Kaufman FR, et al, J Pediatr. 141:625-630, 2002.

  35. Adverse Events in Intensively Treated Children and Adolescents with Type 1Nordfeldt, Ludvigsson Acta Pediatr 88:1184,99 • 139 Subjects, ages 1-18 yrs on MDI • Mean HbA1c 6.9% • Severe Hypoglycemia - 0.17 events/pt/yr • Decreased from 1-2 injections • Correlated with previous severe hypoglycemia r=.38,p<0.0001 • DKA rate 0.015 events/pt/yr • MDI effective and safe

  36. How Well Are We Doing? Metabolic Control in Patients with DiabetesThomsett, Shield, Batch, Cotterill J Pediatr & Child Health 35:479,99 Brisbane • 268 < 19 yrs mean 11.2 yrs • Duration 4.4 0-16 yrs • Mean HbA1c 8.6+1.4%, range 5.2-14% • Puberty 8.7+1.5%, Prepubertal 8.5+1.2% • 33% < 8.0% • HbA1c correlated • insulin dose, duration • Not correlated • severe hypoglycemia, DKA, age, # of injections, # clinic visits

  37. Good Predictors Weighted assessment of low BG for 2-3 wks Nighttime BG < 100-108 mg/dl Age < 5-7 yrs > 2 previous episodes Daily dose > 0.85 U/kg Duration > 2 yrs > 2 consecutive low BG in 2 wks > 4 BG < 50 mg/dl in 2 wks Poor Predictors Glycated hemoglobin level Number of insulin injections Intensive vs conventional treatment Prediction of Hypoglycemia Kaufman et al Endocrinologist 9:342,99

  38. Question What are the Developmental Issues of Young Children?

  39. Physical Rapid growth Erratic eating and sleeping Cognitive Differentiates self Learns language to represent objects/people Moral Development Judgments based on personal preference Physical Greater mastery of gross and fine motor skills Cognitive Egocentric/Classifies objects by a single feature Magical thinking/Simple Moral Development Judgment of good/bad based on punishment/ reward Preschool4-6 Babies and Toddlers0-3

  40. Emotional and Sense of Self Begins to recognize that others' feelings are different from own Begins to have sense of self Social Parallel play Responsibility Total care by parents/ caretakers Emotional and Sense of Self Sex role differentiation Likes to help Wants to do things by self Deference to authority Social Cooperative play Responsibility Child begins to have some responsibility with adult assistance Preschool 4-6 Babies and Toddlers0-3

  41. School At home/daycare Beginning to learn routines Adjusting to different caretakers Extra-Curricular Activities Babysitters Incentives Immediate and concrete School Entering school /Separation from parents Learning routines, rules outside of home School readiness skills Extra-Curricular Activities School aftercare Playdates Incentives Immediate and can be symbolic (stickers, stars, etc) Preschool 4-6 Babies and Toddlers0-3

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