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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.

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Presentation on theme: "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."— Presentation transcript:

1 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

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

3 Question What are the glycemic targets for young children?

4 Glycemic Targets Glucose values are plasma (mg/mL) Age Pre-Meal BG HS/Night BG HbA1c Toddler (0-5 yrs) 100-180110-200 7.5 & 8.5% School-age (6-11 yrs) 90-180100-180<8% Adolescent (12-19 yrs) 90-13090-150<7.5% 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) 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 your child can grow and thrive, learn and explore Where blood sugars are corrected, not interrogated Where blood sugars are corrected, not interrogated Where the family is in balance – like a mobile Where the family is in balance – like a mobile And where the long haul is what is important 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 Year19951996199719981999200020012002200320042005N35741446874788799110721285137516641635 Mean A1c 8.48.68.58.28.38.58.58.28.38.28.07 % <7 1820 % 7- 7.99 4637445147424250482934 %8-103745423840444439404235 % >10 1718141113141411121111

8 HbA1c Statistics for CHLA 2003 Type 1: Diabetes > 1 year, followed > 1 year Enrolled in Long-term study – total n 1375 n Average ± SD All patients 1375 8.2 ± 1.6 Males673 Females702 < 5 61 7.8 ± 1.3 5-10 5-10450 7.9 ± 1.3 11-16 11-16579 8.4 ± 1.8 17-19>20157127 8.3 ± 1.5 7.4 + 1.3

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

10 <8.0 >8.0 P Age5.775.670.7 Duration2.562.880.2 HbA1c 7.0+.76 8.7+.74 <0.001 Regimen2.93.00.29 U/kg0.570.620.15 n8958

11 Hypoglycemia5.63.4NS DKA1.13.4NS Competency4.03.60.019 % within 40.329.2<0.0001 % above 37.151.7<0.0001 % below 22.719.10.23

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14 Question What are the principles of management?

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

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

17 4:0016:0020:0024:004:00 BreakfastLunchDinner 8:00 12:008:00 Time Glargine or Detemir Plasma insulin Basal/Bolus Treatment Program with Rapid-acting and Long-acting Analogs LisproLisproLispro Glulysene Glulysine Glulysine AspartAspartAspart

18 Type 1 Diabetes: Serum Insulin Concentrations Following Subcutaneous Injection of Insulin Lispro or Human Regular Time (minutes) Serum Insulin Conc. (ng/mL) 0.0 0.5 1.0 1.5 2.0 2.5 3.0 Insulin Lispro (n=10) Human Regular (n=10) 0.2 mU/min/kg insulin infusion -600 Meal 60120180240300360420480 Heinemann et al. Diabetic Medicine,13:625-629, 1996 Injection Mean + SE

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

20 0 0 1 2 3 4 5 6 24681012141618202224262830 NPH Glargine Placebo 0.4 U/kg Hours Glucose Infusion Rates (mg/kg/min) Linkeschowa R, et al. Diabetes.1999;48(Suppl 1):A97. Insulin Glargine - Pharmacokinetics by Glucose Clamp

21 21 Brunner et al. Exp Clin Endocrinol Diabetes. 2000;108. Insulin Detemir – Pharmacokinetics by Glucose Clamp Elapsed Time (min) 0.0 0.5 1.0 1.5 2.0 100 30050070090011001300 1500 Detemir­High Detemir­Low Placebo Glucose Infusion Rate (mg/kg/min)

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

23 4:0016:0020:0024:004:00 BreakfastLunchDinner 8:00 12:008:00 Time Basal infusion Bolus Plasma insulin Variable Basal Rate: CSII Program

24 A1c by Treatment type at CHLA: Year200020012002200320042005 3 Injections 8.5 ± 1.5 8.4 Basal- Bolus 9.2 ± 1.7 8.8 ± 1.5 8.4 8.4 ± 1.4 8.2 CSII8.1 ± 1.2 8.1 7.9 7.9 ± 1.1 7.8 ± 1.0 7.6 ± 1.2

25 Outcomes of Pump Therapy Kaufman, et al, Diabetes Metabolism and Reviews,2000 6 month data 130 subjects PREPOST P value HbA1c % 8.4 + 1.8 7.8 + 1.2 0.01 BMI 22.8 + 4 23.2 + 5 NS Hypo- glycemia events/pt/y 0.060.030.05 DKAevents/pt/y0.150.090.05

26 Results of Insulin Pump Therapy In Young Children Kaufman, et al, Diabetes Spectrum, 2001 PrePost P Value HbA1c 8.5+1.8 7.4+1.1 0.01 Mean BG 157+ 64 92 + 31 0.03 Hypo- glycemia 0.180.09ND Quality of Life Family Cohesion 82 + 6 90 + 5 0.009

27 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 for 6 months, age 46.3 ± 3.2 months 26 children randomly assigned to current therapy or CSII for 6 months, age 46.3 ± 3.2 months RESULTS RESULTS Mean HbA 1c and BG did not change Mean HbA 1c and BG did not change Frequency of severe hypoglycemia, ketoacidosis, or hospitalization was similar between groups Frequency of severe hypoglycemia, ketoacidosis, or hospitalization was similar between groups Subjects on CSII had more fasting and predinner mild/moderate hypoglycemia Subjects on CSII had more fasting and predinner mild/moderate hypoglycemia All subjects continued CSII after study completion All subjects continued CSII after study completion

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29 CSII in Young Children CONCLUSIONS CSII is safe and well tolerated in young children with diabetes and may have positive effects on QOL CSII is safe and well tolerated in young children with diabetes and may have positive effects on QOL CSII did not improve diabetes control when compared with injections CSII did not improve diabetes control when compared with injections The benefits and realistic expectations of CSII should be thoroughly examined before starting this therapy in very young children The benefits and realistic expectations of CSII should be thoroughly examined before starting this therapy in very young children

30 CGMS Tracing

31 Use of CGMS to Improve Clinical Care Use of CGMS to Improve Clinical Care 47 Patients 18 boys, 29 girls Age11.8 ± 4.6 years Duration5.5 ± 3.5 years A1c start8.61 + 1.51 A1c end8.36 + 1.28 p=0.01 Kaufman, et al: Diabetes Care 24:2030, 2001.

32 Mean Data for All Pts by Sensor

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

34 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

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36 Question Why About the Risk of Hypoglycemia From Intensive Regimens?

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

38 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

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

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

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

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

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

44 Question What are the Developmental Issues of Young Children?

45 Babies and Toddlers 0-3 Physical Physical Rapid growth Rapid growth Erratic eating and sleeping Erratic eating and sleepingCognitive Differentiates self Differentiates self Learns language to represent objects/people Learns language to represent objects/people Moral Development Judgments based on personal preference 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 Preschool 4-6

46 Emotional and Sense of Self Begins to recognize that others' feelings are different from own Begins to recognize that others' feelings are different from own Begins to have sense of self Begins to have sense of selfSocial Parallel play Parallel playResponsibility Total care by parents/ caretakers 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 Babies and Toddlers 0-3 Preschool4-6

47 School At home/daycare Beginning to learn routines At home/daycare Beginning to learn routines Adjusting to different caretakers Adjusting to different caretakers Extra-Curricular Activities Babysitters BabysittersIncentives Immediate and concrete 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) Babies and Toddlers 0-3 Preschool4-6

48 Management Issues Babies and Toddlers 0-3Preschool4-6 Medication Regimen Choosing a regime to fit eating patterns and lifestyle Getting child to accept injections Requiring supervision in all settings Needing insulin coverage at preschool Pumps Picking the right catheter Finding the right catheter placement based on fat Using very small basal Choosing a person to be responsible for pump Child wanting to push buttons Testing Choosing sites for testing Checking overnight Selecting the right meter Having a small sample size Needing to include child in care Progressing to do own checks Avoiding labeling blood glucose "good" or "bad

49 CGMS Reducing anxiety about overnight hypoglycemia Evaluating basal bolus balance Checking overnight basal rates or long-acting insulin Hypo/Hyperglycemia Unable to tell caregiver when high or low May not cooperate with treatment Learning meaning of high/low BG Needing help in identifying symptoms Fearing hypoglycemia Insulin Administration and Adjustment Using very small doses Needing quarter units Requiring diluted insulin Minimizing pain and fear Having needle phobia Health & Sick Day Having more frequent vomiting and diarrhea Becoming dehydrated rapidly Needing immunizations Having more outside exposures Increasing number of sick days Contracting childhood illnesses

50 Nutrition Breastfeeding makes measuring intake difficult Introducing solid foods Eating habits often erratic Using food as power struggle Grazing eating patterns Using artificial sweeteners may be controversial Needing to involve child in meal plan Exercise/Activity Growing very rapidly Becoming mobile Continuously in motion Energy level is high

51 Case Study 1 Ana is a two-year old recently diagnosed Ana is a two-year old recently diagnosed Very spirited toddler Very spirited toddler Fights blood glucose testing by screaming, hiding and clenching her fists. Fights blood glucose testing by screaming, hiding and clenching her fists. What should this family do with this challenge? What should this family do with this challenge?

52 Issues by Developmental Status Challenges of Diabetes Management: Testing Challenges of Diabetes Management: Testing Factors Contributing to the Challenge: Factors Contributing to the Challenge: Normal Growth and Development Family Dynamics Developmental Tasks: Developmental Tasks: Moral Development Emotional Development Incentives

53 Solution Anas judgment about glucose testing based on personal preference – she did NOT like fingersticks Anas judgment about glucose testing based on personal preference – she did NOT like fingersticks Not possible to convince Ana she needs to test her blood Not possible to convince Ana she needs to test her blood Parents worked together and developed matter-of-fact attitude Parents worked together and developed matter-of-fact attitude Committed to routine, no bargaining, stalling, chasing Committed to routine, no bargaining, stalling, chasing Parents provided immediate and concrete incentives - a hug, a good job, let her pick finger, read book as reward Parents provided immediate and concrete incentives - a hug, a good job, let her pick finger, read book as reward Picked meter capable of alternate site testing, very small sample and results in five seconds Picked meter capable of alternate site testing, very small sample and results in five seconds Within a very short time, Ana willingly participated Within a very short time, Ana willingly participated

54 Case 2 Terrel, 4-year old, type 1 for ten months and celiac disease Terrel, 4-year old, type 1 for ten months and celiac disease BG testing 8-10 times per day, MDI, on gluten-free diet with few management problems at home BG testing 8-10 times per day, MDI, on gluten-free diet with few management problems at home Problems occurred in pre-school Problems occurred in pre-school In school, regular episodes of hypoglycemia In school, regular episodes of hypoglycemia Continuous activity Continuous activity Not as much blood testing Not as much blood testing Skipped snacks related to less supervision Skipped snacks related to less supervision What does family do? What does family do?

55 DEVELOPMENTAL ISSUES Challenges of Diabetes Management: Testing, Hypoglycemia, Nutrition Challenges of Diabetes Management: Testing, Hypoglycemia, Nutrition Factors Contributing to the Challenge: Normal Growth and Development, School Factors Contributing to the Challenge: Normal Growth and Development, School Developmental Tasks: Developmental Tasks: Physical; Moral Development; Emotional Development; Responsibility; Incentives

56 Solution At age four, Terrel likes to help, wants to do things by himself and adapts well to routines At age four, Terrel likes to help, wants to do things by himself and adapts well to routines He is able to understand the meaning of low blood glucose and the importance of eating his carbohydrates He is able to understand the meaning of low blood glucose and the importance of eating his carbohydrates In the school setting, he needs supervision while at the same time he needs to learn to take some responsibility for participating in testing and eating In the school setting, he needs supervision while at the same time he needs to learn to take some responsibility for participating in testing and eating Incentives he likes - praise, stickers and providing choices Incentives he likes - praise, stickers and providing choices

57 Solution Every day before snack and recess Every day before snack and recess BG test BG test Choose a gluten-free snack provided by mother Choose a gluten-free snack provided by mother After the snack After the snack Pick a small prize from a treasure chest Pick a small prize from a treasure chest Terrel liked being involved Terrel liked being involved He was more inclined to eat and check He was more inclined to eat and check Getting a prize an extra incentive Getting a prize an extra incentive In a short time, this routine became the norm and hypoglycemia resolved In a short time, this routine became the norm and hypoglycemia resolved

58 Conclusion Ultimate Goals Of Diabetes Treatment Sustained Normal Blood Glucose Control Lowest Possible Incidence of Hypoglycemia No Long-Term Diabetes Complications No Acute Diabetes Complications = = Best Quality of Life with Diabetes For the child and your family


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