Comparison Between Insulin Pump Treatment and Multiple Daily Insulin Injections in Diabetic Type 1 Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00462371|
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : April 19, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1 Child||Device: Insulin pump (CSII)||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||38 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||January 2002|
|Actual Study Completion Date :||February 2004|
- metabolic control
- quality of life
- cost effectiveness
- surrogate markers for late complications
- adverse events
- impact of disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462371
|ErasmusMC/Sophia´s children´s Hospital|
|Rotterdam, Netherlands, 3015 GJ|
|Principal Investigator:||roos Nuboer, MD||Erasmus Medical Center|
|Principal Investigator:||Jan Bruining, MD||Erasmus Medical Center|