Comparison Between Insulin Pump Treatment and Multiple Daily Insulin Injections in Diabetic Type 1 Children - Full Text View

Sponsors and Collaborators:	Erasmus Medical Center Netherlands: Ministry of Health, Welfare and Sports
Information provided by:	Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00462371

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 IV

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
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.

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:

Fox LA, Buckloh LM, Smith SD, Wysocki T, Mauras N. A randomized controlled trial of insulin pump therapy in young children with type 1 diabetes. Diabetes Care. 2005 Jun;28(6):1277-81.

Wilson DM, Buckingham BA, Kunselman EL, Sullivan MM, Paguntalan HU, Gitelman SE. A two-center randomized controlled feasibility trial of insulin pump therapy in young children with diabetes. Diabetes Care. 2005 Jan;28(1):15-9.

Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV. A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care. 2004 Jul;27(7):1554-8.

Weintrob N, Benzaquen H, Galatzer A, Shalitin S, Lazar L, Fayman G, Lilos P, Dickerman Z, Phillip M. Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens in children with type 1 diabetes: a randomized open crossover trial. Pediatrics. 2003 Sep;112(3 Pt 1):559-64.

DiMeglio LA, Pottorff TM, Boyd SR, France L, Fineberg N, Eugster EA. A randomized, controlled study of insulin pump therapy in diabetic preschoolers. J Pediatr. 2004 Sep;145(3):380-4.

Study ID Numbers:	ASB21004821
Study First Received:	April 18, 2007
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00462371
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

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Quality of Life

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009