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
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
Child
Device: Insulin pump (CSII)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • metabolic control
  • quality of life

Secondary Outcome Measures:
  • cost effectiveness
  • surrogate markers for late complications
  • adverse events
  • impact of disease

Estimated Enrollment: 38
Study Start Date: January 2002
Study Completion Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462371

Locations
Netherlands
ErasmusMC/Sophia´s children´s Hospital
Rotterdam, Netherlands, 3015 GJ
Sponsors and Collaborators
Erasmus Medical Center
Netherlands: Ministry of Health, Welfare and Sports
Investigators
Principal Investigator: roos Nuboer, MD Erasmus Medical Center
Principal Investigator: Jan Bruining, MD Erasmus Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00462371     History of Changes
Other Study ID Numbers: ASB21004821
Study First Received: April 18, 2007
Last Updated: April 18, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
quality of life
child diabetes mellitus type 1
Continuous subcutaneous insulin infusion(CSII)
metabolic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014