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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Diabetes Insulin Dependent

Intervention / Treatment
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* Other: Therapeutic education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Ages <1 year or> 17 years Duration of diabetes <1 year HbA1c <7.6% or HbA1c> 10% Treatment-by multiple injections Mental disability Refusal to adhere to the constraints of the study Language barrier, preventing any understanding or cooperation Eating behavior-type anorexia or bulimia Pregnancy 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FIT Therapy<br>Patient with functional insulin therapy | Other: Therapeutic education<br>* Specific program for FIT Therapy and specific program for traditional way<br>* Other names: Traditional way (fixed doses of insulin);|
| Active Comparator: Traditional way<br>Patient with traditional way | Other: Therapeutic education<br>* Specific program for FIT Therapy and specific program for traditional way<br>* Other names: Traditional way (fixed doses of insulin);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | One year and six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FIT Therapy, Diabetes mellitus, Insulin pump, Pediatric