NCT00462371

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (planned)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Child

Interventions

Type	Name	Description
DEVICE	Insulin pump (CSII)

Timeline

• Start date: 2002-01-01
• Completion: 2004-02-01
• First posted: 2007-04-19
• Last updated: 2007-04-19

Locations

1 site across 1 country: Netherlands