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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00462371

Enrollment

Registered

2007-04-19

Start date

2002-01-31

Completion date

2004-02-29

Last updated

2007-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Diabetes Mellitus, Type 1

Keywords

quality of life, child diabetes mellitus type 1, Continuous subcutaneous insulin infusion(CSII), metabolic control

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 cost effectiveness. We hypothesised that insulin pump treatment would give a better metabolic control and quality of life.

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.

Interventions

DEVICEInsulin pump (CSII)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
metabolic control	—
quality of life	—

Secondary

Measure	Time frame
cost effectiveness	—
surrogate markers for late complications	—
adverse events	—
impact of disease	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026