Therapeutic Education in Very Young Children With Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Type 1 Diabetes, Diabetes Mellitus

Intervention / Treatment
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* Other: Educational tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic education<br> | Other: Educational tool<br>* Specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management<br>* Other names: Experimental;|
| No Intervention: Classical management<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c 12 months after therapeutic education |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Children, Disease management, Ketosis, Hypoglycemia, Parents, Education