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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1; Child

• Registration Number: NCT00462371
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-01
• Study Completion: 2004-02
• Status Verified: 2007-04
• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-18
• Last Update Submitted: 2007-04-18
• Study First Posted: 2007-04-19
• Last Update Posted: 2007-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
metabolic control
quality of life

Secondary Outcome Measures

Name	Time	Method
cost effectiveness
surrogate markers for late complications
adverse events
impact of disease

Trial Locations

Locations (1)

ErasmusMC/Sophia´s children´s Hospital; 🇳🇱 Rotterdam, Netherlands