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

April 16, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Kremlin Bicêtre, France, 94275
        • Bicetre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic education
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 Names:
  • Experimental
No Intervention: Classical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c 12 months after therapeutic education
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1C 24 months after therapeutic education
Time Frame: 24 months
24 months
Acute events number (hypoglycemia and ketosis) over a 12 and 24 months period
Time Frame: 12 and 24 months
12 and 24 months
Evolution of the parental knowledge about the disease 12 and 24 months after therapeutic education (evaluated by questionnaire)
Time Frame: 12 and 24 months
12 and 24 months
Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire)
Time Frame: 12 and 24 months
12 and 24 months
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
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Pierre BOUGNERES, MD, PhD, Bicetre Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 12, 2011

First Submitted That Met QC Criteria

May 13, 2011

First Posted (Estimate)

May 16, 2011

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P081254

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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