Clinical trial NCT01354288: Therapeutic Education in Very Young Children With Diabetes Mellitus
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Diabetes Mellitus
Keywords: Diabetes
Children
Disease management
Ketosis
Hypoglycemia
Parents
Education
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c 12 months after therapeutic education
timeFrame: 12 months
Secondary outcomes:
measure: HbA1C 24 months after therapeutic education
timeFrame: 24 months
measure: Acute events number (hypoglycemia and ketosis) over a 12 and 24 months period
timeFrame: 12 and 24 months
measure: Evolution of the parental knowledge about the disease 12 and 24 months after therapeutic education (evaluated by questionnaire)
timeFrame: 12 and 24 months
measure: Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire)
timeFrame: 12 and 24 months
measure: Evolution of the parental and child quality of life 12 and 24 months after therapeutic education (evaluated by questionnaire)
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: Bicêtre Hospital
Study officials:
affiliation: Bicêtre Hospital
name: Pierre BOUGNERES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: