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

This study has been completed.
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00462371
First received: April 18, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

April 18, 2007
April 18, 2007
January 2002
Not Provided
  • metabolic control
  • quality of life
Same as current
No Changes Posted
  • cost effectiveness
  • surrogate markers for late complications
  • adverse events
  • impact of disease
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 1
  • Child
Device: Insulin pump (CSII)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
February 2004
Not Provided

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
Both
4 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00462371
ASB21004821
Yes
Not Provided
Erasmus Medical Center
Netherlands: Ministry of Health, Welfare and Sports
Principal Investigator: roos Nuboer, MD Erasmus Medical Center
Principal Investigator: Jan Bruining, MD Erasmus Medical Center
Erasmus Medical Center
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP