Therapeutic Education in Very Young Children With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— DIAB-EDUC  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354288
• Other study ID #: P081254
• Status: Completed
• Phase: N/A
• Start date: December 7, 2011
• Est. completion date: December 1, 2014

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 1, 2014
• Est. primary completion date: December 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
France	Bicêtre Hospital	Le Kremlin Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c 12 months after therapeutic education		12 months
Secondary	HbA1C 24 months after therapeutic education		24 months
Secondary	Acute events number (hypoglycemia and ketosis) over a 12 and 24 months period		12 and 24 months
Secondary	Evolution of the parental knowledge about the disease 12 and 24 months after therapeutic education (evaluated by questionnaire)		12 and 24 months
Secondary	Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire)		12 and 24 months
Secondary	Evolution of the parental and child quality of life 12 and 24 months after therapeutic education (evaluated by questionnaire)		12 and 24 months