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
Other: Therapeutic education
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Locations near you
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Full eligibility criteria for NCT01443741
Ages eligible for Study
1 Years to 17 Years
Genders eligible for Study
Accepts Healthy Volunteers
aged 1-17 years
diabetic for at least 1 year
whose HbA1c is between 7.6 and 10% (7.6% <HbA1C <10%)
treated with insulin pump
agreeing to perform at least three blood glucose/day
willing to follow the treatment with functional insulin therapy if necessary
Ages <1 year or> 17 years
Duration of diabetes <1 year
HbA1c <7.6% or HbA1c> 10%
Treatment-by multiple injections
Refusal to adhere to the constraints of the study
Language barrier, preventing any understanding or cooperation
Eating behavior-type anorexia or bulimia
Use of alcohol or drugs
Severe chronic or genetic pathology other than diabetes
Participation in another clinical study or refusal to participate in the study
All locations for NCT01443741
University Hospital of Brest
Brest, Bretagne, France, 29200
University Hospital of Toulouse
Toulouse, Midi-Pyrénées, France, 31059
University Hospital of Angers Service of Pediatric Diabetology and Endocrinology
Angers, Pays de Loire, France, 49933
University Hospital of Nantes
Nantes, Pays de Loire, France, 44093
University Hospital of Lyon
Lyon, Rhône Alpes, France, 69000
University Hospital of Tours
Tours, Région Centre, France, 37000
View full eligibility
Tris trial is registered with FDA with number: NCT01443741. The sponsor of the trial is University Hospital, Angers and it is looking for 88 volunteers for the current phase.
Official trial title: 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.
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