Therapeutic Education in Very Young Children With Diabetes Mellitus (DIAB-EDUC)
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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) |
- HbA1c 12 months after therapeutic education [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| Bicêtre Hospital | Recruiting |
| Le Kremlin Bicêtre, France, 94275 | |
| Principal Investigator: Pierre BOUGNERES, MD, PhD | |
| 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: | July 25, 2012 |
| 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 Hypoglycemia Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013