Comparison Between Insulin Pump Treatment and Multiple Daily Insulin Injections in Diabetic Type 1 Children
NCT ID: NCT00462371
Last Updated: 2007-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
38 participants
INTERVENTIONAL
2002-01-31
2004-02-29
Brief Summary
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We hypothesised that insulin pump treatment would give a better metabolic control and quality of life.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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Insulin pump (CSII)
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy,
* Co-morbidity,
* Mental retardation,
* Psychiatric treatment or symptoms in child or parent,
* Insufficient Dutch language capabilities and absence of telephone at home
4 Years
16 Years
ALL
No
Sponsors
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Ministry of Health
AMBIG
Erasmus Medical Center
OTHER
Principal Investigators
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roos Nuboer, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Jan Bruining, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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ErasmusMC/Sophia´s children´s Hospital
Rotterdam, , Netherlands
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ASB21004821
Identifier Type: -
Identifier Source: org_study_id