Comparison Between Insulin Pump Treatment and Multiple Daily Insulin Injections in Diabetic Type 1 Children

Study Overview
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Brief Summary
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Comparison between insulin pump treatment and multiple daily insulin injections in 38 children with type 1 diabetes4-16 years old. Outcome metabolic control, quality of life, impact of disease and cost effectiveness. We hypothesised that insulin pump treatment would give a better metabolic control and quality of life.

Detailed Description
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The current standard of insulin treatment in type 1 diabetes is multiple daily insulin injection therapy (MDII). In the seventies, continuous subcutaneous insulin infusion (CSII) was introduced. CSII has been gaining popularity, perhaps because of technical advances resulting in improved patient comfort. In children five randomised studies(1-5) were completed to compare MDII and CSII. No data were gained about quality of life and impact of disease. In our trial we focussed on quality of life next to metabolic control. The trial was an open-labelled,randomised trial. Both efficacy and safety data were collected. The trial started with a 14 weeks run in phase, during all patients started MDII.In the following randomisation phase patients were randomised to continue MDII or to CSII.This phase lasted 14 weeks.In the phase thereafter all patients used CSII for 14 weeks. The trial was concluded by a 14 weeks allocated patient preference phase. Patients were type 1 diabetic children 4-16 years old with poor metabolic control.hypothesis: better metabolic control in CSII, better quality of life in CSII.

Official Title
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Open-Label, Randomised Trial Comparing Efficacy of Continuous Subcutaneous Insulin Infusion(CSII) and Multiple Daily Insulin Injections (MDII) in Improving Glycemic Control and Quality of Life in Poorly Regulated Type 1 Diabetic Children.

Conditions
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Diabetes Mellitus, Type 1, Child

Intervention / Treatment
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* Device: Insulin pump (CSII)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes, Diagnosed by the presence of IA-2, GAD-65 or islet cell cytoplasmatic auto antibodies, Daily insulin adminstration or 1 year of longer, Random C-peptide <200 pMol, Hba1c>8.0% and/or a history of repeated symptomatic hypoglycaemias, Attending regular school Exclusion Criteria: Clinical manifest chronic complications, Pregnancy, Co-morbidity, Mental retardation, Psychiatric treatment or symptoms in child or parent, Insufficient Dutch language capabilities and absence of telephone at home

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Insulin pump (CSII)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic control |  |  | 
| quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost effectiveness |  |  | 
| surrogate markers for late complications |  |  | 
| adverse events |  |  | 
| impact of disease |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, child diabetes mellitus type 1, Continuous subcutaneous insulin infusion(CSII), metabolic control