Status:
COMPLETED
Comparison Between Insulin Pump Treatment and Multiple Daily Insulin Injections in Diabetic Type 1 Children
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Ministry of Health
Conditions:
Diabetes Mellitus, Type 1
Child
Eligibility:
All Genders
4-16 years
Phase:
PHASE4
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 cos...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
February 1 2004
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00462371
Start Date
January 1 2002
End Date
February 1 2004
Last Update
April 19 2007
Active Locations (1)
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1
ErasmusMC/Sophia´s children´s Hospital
Rotterdam, Netherlands, 3015 GJ