Therapeutic Education in Very Young Children With Diabetes Mellitus
NCT ID: NCT01354288
Last Updated: 2021-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2011-12-07
2014-12-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Therapeutic education
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
Classical management
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Months
6 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Pierre BOUGNERES, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Bicêtre Hospital
Locations
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Bicêtre Hospital
Le Kremlin-Bicêtre, , France
Countries
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Other Identifiers
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P081254
Identifier Type: -
Identifier Source: org_study_id
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