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Search / Trial NCT00462371

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

Launched by ERASMUS MEDICAL CENTER · Apr 18, 2007

Trial Information

Current as of July 06, 2025

Completed

Keywords

Quality Of Life Child Diabetes Mellitus Type 1 Continuous Subcutaneous Insulin Infusion(csii) Metabolic Control

ClinConnect Summary

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 safe...

Gender

ALL

Eligibility criteria

  • 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

About Erasmus Medical Center

Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.

Locations

Rotterdam, , Netherlands

Patients applied

0 patients applied

Trial Officials

roos Nuboer, MD

Principal Investigator

Erasmus Medical Center

Jan Bruining, MD

Principal Investigator

Erasmus Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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