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

Diabetes Mellitus Clinical Trial

Official title:
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)

Clinical Trial Summary

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01354288
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase N/A
Start date December 7, 2011
Completion date December 1, 2014
View Details
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