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

April 18, 2007 updated by: Erasmus Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands, 3015 GJ
        • ErasmusMC/Sophia´s children´s Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
metabolic control
quality of life

Secondary Outcome Measures

Outcome Measure
cost effectiveness
surrogate markers for late complications
adverse events
impact of disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Ministry of Health

Investigators

  • Principal Investigator: roos Nuboer, MD, Erasmus Medical Center
  • Principal Investigator: Jan Bruining, MD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion

December 6, 2022

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

April 18, 2007

First Submitted That Met QC Criteria

April 18, 2007

First Posted (Estimate)

April 19, 2007

Study Record Updates

Last Update Posted (Estimate)

April 19, 2007

Last Update Submitted That Met QC Criteria

April 18, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASB21004821

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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