Therapeutic Education in Very Young Children With Diabetes Mellitus

Therapeutic Education in Very Young Children With Diabetes Mellitus. Evaluation of the Impact of a Specific Tool for Parents on Glycemic Control and Prevention of Acute Events (Hypoglycemia and Ketosis)

DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management, over a period of 2 years. The investigators plan to include 300 type 1 diabetic children in 10 french hospitals.

General frame : 1 inclusion / randomization visit and delivery of the educational tool for patients of the "Therapeutic Education" arm, then follow-up visits every 6 months during 24 months.

V0 - Inclusion / randomization visit - Verification of eligibility - Clinical examination and data report - Blood samples for lab tests (HbA1c assay)- Collection of signed consent form- DIAB-EDUC questionnaire (diabetes knowledge, treatment, quality of life, hypoglycaemia and emergency situations, parental stress)- Randomization - Education tool explanation and delivery by the physicians to parents randomized in " Experimental " arm

M6 - Visit at 6 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)

M12 - Visit at 12 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)- DIAB-EDUC questionnaire

M18 - Visit at 18 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)

M24 - Visit at 24 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)- DIAB-EDUC questionnaire

Inclusion Criteria:

• Children with type 1 diabetes aged 1 to 6 years
• Disease evolution more than 1 year
• HbA1c > 8% or at least one acute accident (hypoglycemia or ketosis) during the last year
• Specific information given to parents from the physicians and consent form signed by the parents
• Physical examination of the children at enrolment- patient affiliated with or receiving health insurance

Exclusion Criteria:

• Non-insulin dependent diabetes
• Monogenic diabetes (MODY)
• Severe co-morbidities- cognitive disabilities or psychosocial disadvantage compromising the therapeutic education
• Children whose parents have a disorder of comprehension or expression of the French Language
• Patients included in another interventional trial