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

Diabetes Mellitus, Type 1 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462371
• Other study ID #: ASB21004821
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2007
• Last updated: April 18, 2007
• Start date: January 2002
• Est. completion date: February 2004

Study information

• Verified date: April 2007
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Insulin pump (CSII)

Locations

Country	Name	City	State
Netherlands	ErasmusMC/Sophia´s children´s Hospital	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metabolic control
Primary	quality of life
Secondary	cost effectiveness
Secondary	surrogate markers for late complications
Secondary	adverse events
Secondary	impact of disease