Diabetes Mellitus, Type 1 Diabetes
Conditions
Keywords
Diabetes, Children, Disease management, Ketosis, Hypoglycemia, Parents, Education
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
Interventions
OTHEREducational tool
Specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Months to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c 12 months after therapeutic education | 12 months |
Secondary
| Measure | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPierre BOUGNERES, MD, PhD
Bicêtre Hospital
Outcome results
None listed