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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01354288
First received: May 12, 2011
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Diabetes Mellitus
Other: Educational tool

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • HbA1c 12 months after therapeutic education [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Experimental
No Intervention: Classical management

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

Ages Eligible for Study:   12 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354288

Locations
France
Bicêtre Hospital
Le Kremlin Bicêtre, France, 94275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Pierre BOUGNERES, MD, PhD Bicêtre Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01354288     History of Changes
Other Study ID Numbers: P081254
Study First Received: May 12, 2011
Last Updated: August 1, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diabetes
Children
Disease management
Ketosis
Hypoglycemia
Parents
Education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 30, 2014