Therapeutic Education in Very Young Children With Diabetes Mellitus

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Diabetes Mellitus
• Interventions: Other: Educational tool

• Registration Number: NCT01354288
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Study Start: 2011-12-07
• Primary Completion: 2014-12-01
• Study Completion: 2014-12-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic education	Educational tool	-

Primary Outcome Measures

Name	Time	Method
HbA1c 12 months after therapeutic education	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bicêtre Hospital; 🇫🇷 Le Kremlin Bicêtre, France