Therapeutic Education in Very Young Children With Diabetes Mellitus (DIAB-EDUC)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Type 1 Diabetes

Diabetes Mellitus

Treatments

Other: Educational tool

Study type

Interventional

Funder types

Other

Identifiers

NCT01354288

P081254

Details and patient eligibility

About

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.

Full description

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

Enrollment

24 patients

Sex

All

Ages

12 months to 6 years old

Volunteers

No Healthy Volunteers

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