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

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ClinicalTrials.gov Identifier: NCT01354288
Recruitment Status : Unknown
Verified April 2015 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2011
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Diabetes Mellitus Other: Educational tool Not Applicable

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)
Study Start Date : October 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Experimental
No Intervention: Classical management



Primary Outcome Measures :
  1. HbA1c 12 months after therapeutic education [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. HbA1C 24 months after therapeutic education [ Time Frame: 24 months ]
  2. Acute events number (hypoglycemia and ketosis) over a 12 and 24 months period [ Time Frame: 12 and 24 months ]
  3. Evolution of the parental knowledge about the disease 12 and 24 months after therapeutic education (evaluated by questionnaire) [ Time Frame: 12 and 24 months ]
  4. Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire) [ Time Frame: 12 and 24 months ]
  5. 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 ]


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Ages Eligible for Study:   12 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01354288     History of Changes
Other Study ID Numbers: P081254
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases