NCT01443741

Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent

Evaluation of Interests of the Functional Insulin Therapy (FIT Therapy) on Metabolic Control, Hypoglycemia Prevention and Life Quality of Diabetics Children Insulin-dependent Treated With Insulin Pump.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of interests of the functional insulin therapy (FIT Therapy) on metabolic control, hypoglycemia prevention and life quality of diabetics children insulin-dependent treated with insulin pump.

Detailed description

Open multicenter randomized study of one year, evaluating two groups of 44 children with diabetes mellitus (diabetes over 1 year) treated with insulin pump, one group by traditional way (fixed doses of insulin and meals providing stable quantities complex carbohydrates) and the other group by FIT Therapy.

Conditions

• Diabetes Insulin Dependent

Interventions

Type	Name	Description
OTHER	Therapeutic education	Specific program for FIT Therapy and specific program for traditional way

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-01-01
• Completion: 2015-07-01
• First posted: 2011-09-30
• Last updated: 2011-09-30

Locations

6 sites across 1 country: France