NCT00462371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

April 18, 2007

Last Update Submit

April 18, 2007

Conditions

Diabetes Mellitus, Type 1Child

Keywords

quality of lifechild diabetes mellitus type 1Continuous subcutaneous insulin infusion(CSII)metabolic control

Outcome Measures

Primary Outcomes (2)

  • metabolic control

  • quality of life

Secondary Outcomes (4)

  • cost effectiveness

  • surrogate markers for late complications

  • adverse events

  • impact of disease

Interventions

Insulin pump (CSII)DEVICE

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ErasmusMC/Sophia´s children´s Hospital

Rotterdam, 3015 GJ, Netherlands

Location

Related Publications (5)

  • 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. doi: 10.2337/diacare.28.6.1277.

    PMID: 15920039BACKGROUND

  • 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. doi: 10.2337/diacare.28.1.15.

    PMID: 15616227BACKGROUND

  • 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. doi: 10.2337/diacare.27.7.1554.

    PMID: 15220227BACKGROUND

  • 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. doi: 10.1542/peds.112.3.559.

    PMID: 12949284BACKGROUND

  • 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. doi: 10.1016/j.jpeds.2004.06.022.

    PMID: 15343195BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • roos Nuboer, MD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • Jan Bruining, MD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 19, 2007

Study Start

January 1, 2002

Study Completion

February 1, 2004

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations

NL(1)