Text Size

Therapeutic Education in Very Young Children With Diabetes Mellitus (DIAB-EDUC)

This study is currently recruiting participants.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01354288
First received: May 12, 2011
Last updated: July 25, 2012
Last verified: July 2012
History of Changes

May 12, 2011
July 25, 2012
October 2011
October 2014   (final data collection date for primary outcome measure)
HbA1c 12 months after therapeutic education [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01354288 on ClinicalTrials.gov Archive Site
  • HbA1C 24 months after therapeutic education [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Acute events number (hypoglycemia and ketosis) over a 12 and 24 months period [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Evolution of the parental knowledge about the disease 12 and 24 months after therapeutic education (evaluated by questionnaire) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Therapeutic Education in Very Young Children With Diabetes Mellitus
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)

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Type 1 Diabetes
  • Diabetes Mellitus
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
Other Name: Experimental
  • Experimental: Therapeutic education
    Intervention: Other: Educational tool
  • No Intervention: Classical management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
12 Months to 6 Years
No
Contact: Pierre BOUGNERES, MD, PhD +33 1 40 48 80 82 sophie.le-fur@inserm.fr
Contact: Raphaël SERREAU, MD, PhD ++33 1 58 41 11 80 raphael.serreau@cch.aphp.fr
France
 
NCT01354288
P081254
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Pierre BOUGNERES, MD, PhD Bicêtre Hospital
Assistance Publique - Hôpitaux de Paris
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP