Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent (DIABFIT)

University Hospital, Angers

Status and phase: Unknown; Phase 2

Conditions: Diabetes Insulin Dependent

Treatments: Other: Therapeutic education

Study type: Interventional

Funder types: Other

Identifiers

NCT01443741

PHRC 2009- 03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

FIT Therapy

Active Comparator group

Description:

Patient with functional insulin therapy

Treatment:

Other: Therapeutic education

Traditional way

Active Comparator group

Description:

Patient with traditional way

Treatment:

Other: Therapeutic education