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

Phase 2

• Conditions: Diabetes Insulin Dependent
• Interventions: Other: Therapeutic education

• Registration Number: NCT01443741
• Lead Sponsor: University Hospital, Angers

Brief 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.

Study Timeline

• Status Verified: 2011-09
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-28
• Last Update Submitted: 2011-09-28
• Study First Posted: 2011-09-30
• Last Update Posted: 2011-09-30
• Study Start: 2012-01
• Primary Completion: 2015-01
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FIT Therapy	Therapeutic education	Patient with functional insulin therapy
Traditional way	Therapeutic education	Patient with traditional way

Primary Outcome Measures

Name	Time	Method
Variation in HbA1c	One year	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.

Secondary Outcome Measures

Name	Time	Method
Severe hypoglycemia over 6 months and quality of life	One year and six months	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).

Trial Locations

Locations (6)

University Hospital of Tours; 🇫🇷 Tours, Région Centre, France

University Hospital of Toulouse; 🇫🇷 Toulouse, Midi-Pyrénées, France

University Hospital of Angers Service of Pediatric Diabetology and Endocrinology; 🇫🇷 Angers, Pays de Loire, France

University Hospital of Nantes; 🇫🇷 Nantes, Pays de Loire, France

University Hospital of Brest; 🇫🇷 Brest, Bretagne, France

University Hospital of Lyon; 🇫🇷 Lyon, Rhône Alpes, France