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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Specific program for FIT Therapy and specific program for traditional way
University Hospital of Lyon
Lyon, Auvergne-Rhône-Alpes, France
University Hospital of Brest
Brest, Brittany Region, France
University Hospital of Tours
Tours, Centre-Val de Loire, France
University Hospital of Toulouse
Toulouse, Midi-Pyrénées, France
Variation in HbA1c
Variation in HbA1c from baseline in the study (M0) and 1 year later the beginning of the program (M12) for assess the importance of the FIT Therapy to improve metabolic control of children with diabetes mellitus treated with subcutaneous insulin pump.
Time frame: One year
Severe hypoglycemia over 6 months and quality of life
Number of severe hypoglycemia over 6 months (M6 to M12 and evolution of quality of life assessed by validated questionnaries in children with diabetes (WHO questionnary items 5, 27 KIDSCREEN questionnary, DISABKID questionnary).
Time frame: One year and six months
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University Hospital of Angers Service of Pediatric Diabetology and Endocrinology
Angers, Pays de Loire, France
University Hospital of Nantes
Nantes, Pays de Loire, France