Overview

This trial is active, not recruiting.

Conditions type 1 diabetes, diabetes mellitus
Treatment educational tool
Sponsor Assistance Publique - Hôpitaux de Paris
Start date October 2011
End date December 2015
Trial size 24 participants
Trial identifier NCT01354288, P081254

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
educational tool Experimental
Specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management
(No Intervention)

Primary Outcomes

Measure
HbA1c 12 months after therapeutic education
time frame: 12 months

Secondary Outcomes

Measure
HbA1C 24 months after therapeutic education
time frame: 24 months
Acute events number (hypoglycemia and ketosis) over a 12 and 24 months period
time frame: 12 and 24 months
Evolution of the parental knowledge about the disease 12 and 24 months after therapeutic education (evaluated by questionnaire)
time frame: 12 and 24 months
Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire)
time frame: 12 and 24 months
Evolution of the parental and child quality of life 12 and 24 months after therapeutic education (evaluated by questionnaire)
time frame: 12 and 24 months

Eligibility Criteria

Male or female participants from 12 months up to 6 years old.

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

Additional Information

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)
Principal investigator Pierre BOUGNERES, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.