Therapeutic Education in Very Young Children With Diabetes Mellitus

Assistance Publique - Hôpitaux de Paris24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Type 1 Diabetes Diabetes Mellitus

Interventions

Educational toolOTHER

Specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Bicêtre Hospital

Le Kremlin-Bicêtre, France

Outcomes

Primary Outcomes

HbA1c 12 months after therapeutic education

Time frame: 12 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.