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Experiences from the Hvidøre Study Group on Childhood Diabetes.

Experiences from the Hvidøre Study Group on Childhood Diabetes. Henrik B. Mortensen, Department of Paediatrics, Glostrup University Hospital. The Hvidøre Study Group on Childhood Diabetes.

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Experiences from the Hvidøre Study Group on Childhood Diabetes.

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  1. Experiences from the Hvidøre Study Group on Childhood Diabetes. Henrik B. Mortensen, Department of Paediatrics, Glostrup University Hospital

  2. The Hvidøre Study Group on Childhood Diabetes The purpose of the group to improve the management of children and adolescents with type 1 diabetes on a worldwide scale by: • Stimulating research • Improve the quality of care • Disseminate knowledge of childhood diabetes

  3. The Hvidøre Study Group on Childhood Diabetes • The task for the group is to establish a research network to carry out multicenter investigations to share and compare data on childhood diabetes. • The Study Group consist of medical doctors all specialized in paediatrics from 22 centres from 18 countries in Europe, North America and Japan

  4. Members of the Hvidøre Study Group on Childhood Diabetes H.B. Mortensen, Denmark S. Greene, U.K. H.-J. Aanstoot, Netherlands H.M.C.V. Hoey, Ireland J. Aman, Sweden E.A. Kaprio, Finland J.A. Atchison, USA M. Kocova, Macedonia F. Chiarelli, Italy P. Martul, Spain D. Daneman, Canada N. Matsuura, Japan T. Danne, Germany O. Søvik, Norway H. Dorchy, Belgium K.J. Robertson, U.K B. Dinesen, Denmark E.J. Schoenle, Switzerland P. Garandeau, France P.G.F. Swift, U.K R.W. Holl, Germany R.M. Tsou, Portugal P. Hougaard, Denmark M. Vanelli, Italy

  5. Publications • Comparison of metabolic control in a cross-sectional study of 2.873 children and adolescents with IDDM from 18 countries. Diabetes Care 1997;20:714-720. • Insulin management and metabolic control of Type 1 diabetes in childhood and adolescence in 18 countries. Diabetic Medicine 1998; 15:752-759. • Persistent center differences over 3 years in glycemic control and hypoglycemia in a study of 3,805 children and adolescents with type 1 diabetes.Accepted for publication: Diabetes Care • Good Metabolic Control is Associated with Better Quality of Life in 2,101 Adolescents with Type 1 Diabetes. Submitted

  6. The Hvidøre Study Group on Childhood Diabetes • Metabolic control and insulin management in the real world • The relation between HbA1c and insulin regimens over a three year period • Metabolic control and quality of life

  7. Study design Multicenter cross-sectional investigation with 22 participating paediatric departments from 18 countries in Europe, Japan and North America. The HbA1c concentration was determined once and analyzed both locally and centrally at The Steno Diabetes Center, Denmark. Age, sex, duration of diabetes, height, body weight, insulin regimen and number of severe hypoglycaemic events were recorded.

  8. HbA1c analysis Samples were collected locally using the Biorad- HbA1c Sample Preparation Kit and mailed to the central Laboratory Automatic high pressure liquid chromatography (Bio- Rad- VariantTM) Normal range is 4.4 – 6.3 (mean 5.4)% The interassay SD is 0.15% HbA1c results were found to be 0.3% higher than the DCCT level by direct sample exchange

  9. Summary • In 3000 children and adolescents only one third had HbA1c values < 8% • HbA1c increased during maturation of both genders irrespective of insulin regimen • HbA1c differed significantly across 22 centres irrespective of insulin regimen • Adolescent females on 4 or more insulin injections had significantly higher insulin dose and BMI. • The rate of severe hypoglycaemia was related to younger age and lower HbA1c level.

  10. The Hvidøre Study Group on Childhood Diabetes • Metabolic control and insulin management in the real world • The relation between HbA1c and insulin regimens over a three year period • Metabolic control and quality of life

  11. Objectives • To investigate if blood glucose control changes from 1995 to 1998 in an international cohort of children with type 1 diabetes aged 11-18 years in 1998 • To analyse differences in blood glucose control among centres in the 3 year period and relate possible changes to insulin regimen and daily insulin dosage • To assess centre differences in incidence of severe hypoglycaemic events

  12. Flow diagram for patients participating in the international cohort investigation 1,767 patients age 8-15 years in ‘95 229 DM duration < 1 year in 1995 55 Insufficient data 55 Transferred to other Paed.Clinic 178 Transferred to Adult Clinic 223 Other (narrow window) 105Unknown 30 Declined 1 Dead This study group consisted of 891 patients

  13. Distribution of HbA1c 40 Year 1995 1998 HbA1c in 1995 (grand mean): 8.7% (1.6%) 35 30 HbA1c in 1998 (grand mean): 8.9% (1.6%) 25 % of patients 20 15 10 5 0 < 5 5-6 6-7 7-8 8-9 9-10 10-11 11-12 12-13 > 13 HbA1c (%)

  14. Injection frequency 70 60 Number of injections 2 50 3+ 40 % of patients HbA1c in 1995 (grand mean): 8.7% (1.6%) 30 HbA1c in 1998 (grand mean): 8.9% (1.6%) 20 10 0 1995 1998 Year

  15. HbA1c by centre for ‘95 and ‘98 The 1995 baseline level, and the three year HbA change for HbA 1c 1c percent for the 21 centres. 12 11 * 10 * * * * * 9 8 7 6 Centers sorted by HbA in 1995 1c

  16. Centre changes in HbA1c adjusted for sex, age, duration of type 1 diabetes Number of injections HbA % 1c - o + + 2 6 3 o 0 9 1 - 0 0 0 Insulin dose HbA % 1c - o + 1 7 1 + o 1 8 3 - 0 0 0 +) significant increase, o) no significant change, -) significant decrease

  17. Rate of severe hypoglycaemic events according to the Poisson model Age (13 yr), duration (5 years) 20 Centres significantly: 15 above below Centres not significantly: Incidence per 100 patients years 10 different HbA1c (grand mean): 8.9% (1.6%) 5 0 5 6 7 8 9 10 11 12 13 14 15 Individual HbA1c (per cent)

  18. Summary • No significant change in HbA1c for the 3 year period despite the use of three or more daily insulin injection increased from 42 to 70%. • HbA1c varied significantly among centres. • Only 2 centres improved their metabolic control significantly in the 3 year period. • Fewer severe hypoglycaemic events in centres with a HbA1c significantly below the grand mean.

  19. Metabolic Control and Quality of Life • The DCCT study and the recent ISPAD guidelines recommend a treatment target for HbA1c of 7.5% in children and adolescents. • Will strict metabolic control influence the quality of life in adolescents with diabetes?

  20. COMPARISON WITH OTHER QOL STUDIES Author n age (yrs) Correlation with QOL Fonagy P, Arch Dis Child, 1987 Poor control = better QOL Ingersoll and Marrero, Diabetes Educ, 1991 74 10.8-20.8 None except health perception Guttman-Bauman, Diabetes Care, 1998 69 10-20 Good control=better QOL Grey, Diabetes Care, 1998 52 12-20 None

  21. Metabolic Control and Quality of Life • The study involved 20 centres in 17 countries in Europe, Japan and North America. • Adolescents aged 10-18 yrs at each study centre were invited to participate. • 2,101 adolescents were enrolled. • Samples and information from 79% of all patients registered at the centres were obtained.

  22. Demographic data and metabolic control on 2,101 adolescents with type 1 diabetes P-value 0.86* 0.06+ <0.0001# <0.01# 0.90# Age (yr) Diabetes duration (yr) BMI (kg/m2) HbA1C (%) Incidence of severe hypoglycemia (events per 100 patient-years) Boys(n=1085) 13.8 ± 2.1 5.1 ± 3.8 20.8 ± 3.2 8.6 ± 1.6 15.5 Girls(n=1016) 13.8 ± 2.1 5.4 ± 3.8 21.8 ± 3.6 8.9 ± 1.7 15.7 Results as means ± SD *Adjusted for Center, + Adjusted for center and age, # Adjusted for center, age and duration of diabetes.

  23. Patient characteristics on insulin management. Daily insulin regimen 1 injection 2 injections 3 injections 4 or more injections Premixed insulin, n (%) Insulin dose (U/kg/day) Boys(n=1085) 8 472 295 307 445 (41) 0.94 ± 0.32 Girls(n=1016) 10 380 287 339 407 (40) 1.01 ± 0.32 P-value <0.05 0.66 <0.0001# Results as means ± SD# Adjusted for center, age and duration of diabetes.

  24. Quality of Life Questionnaires • Adolescent - DQOL questionnaire - (Ingersoll and Marrero, 1991) • Parent - Family Burden questionnaire constructed • Health - - Family Burden questionnaire Professional constructed

  25. Questionnaire for Adolescent DQOL • 23 questions on impact of diabetes • 11 questions on worries • 17 questions on satisfaction • 1 question on health perception

  26. Questionnaire for Parents and for Health Professionals Burden relating to diabetes a) Medical treatment/nursing tasks b) Disruption in family routines c) Physical or psychological problems in the child d) Restriction in child's social and school activities e) Long term health concerns. We assessed family burden as one aspect of QOL in the family setting, which is of particular concern to health professionals.

  27. Translation and cross-cultural adaptation of the questionnaire to each of the 14 languages: • Forward translation from English to the national language of the country • Backward translation from the national language to English • Local lay panel testing • The consultant and the Originator discussed the report and prepared the final validation

  28. Completion of the questionnaires • Patients and parents completed questionnaires confidentially • Staff completed questionnaires independently. • All forms were forwarded to the coordinating center. • All questionnaires were received within 2-3 weeks of blood collection for glycated haemoglobin. • A middle score of 3 was used for missing questions when at least 70% questions on the relevant subscale was answered.If <70% answered forms discarded.

  29. Internal validity and consistency of the multiple item instrument • Questionnaire completion rates for adolescents, parents and health professionals (93 percent, 89 percent and 94 percent, respectively) • Item completion rates for all three groups (98.6–99.8 percent). • Cronbach’s a coefficient values for the questionnaires were: • Adolescent DQOL- impact 0.79, worries 0.84, satisfaction 0.92; • Parents 0.80 and health professionals 0.86,

  30. Quality of life scores with age perceived by adolescents, parent and health professionals • Age, gender, high and low HbA1c selected as 10th (6.8%) and 90th percentiles (10.8%) • Illustrate the variation in QOL score due to metabolic control. All QOL scores were linearly transformed: • Best possible score 0 • Worst possible score 100

  31. Impact of diabetes in adolescents by age, gender and HbA1C

  32. Worries about diabetes in adolescents by age, gender and HbA1C

  33. Satisfaction with life in adolescents by age, gender and HbA1C

  34. Health perception in adolescents by age, gender and HbA1C

  35. Metabolic Control and Quality of Life Key messages First large international multi-language study evaluating the relationship between metabolic control and QOL in 2,101 adolescents with diabetes. Lower HbA1c is associated with better QOL of adolescents and lesser perceived family burden by parents and health professionals. No relation between QOL and the actual insulin regimen.

  36. Speculation Young people with excellent QOL: Good physical and psychological balance Facilitate better metabolic control through improved self-care Bad metabolic control = poor QOL

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