Therapeutic Education in Very Young Children With Diabete... | NCT01354288

Studies
Therapeutic Education in Very Young Children With Diabetes Mellitus

NCT01354288

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Mar 31, 2026Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes
Diabetes Mellitus

Interventions

Educational tool

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 7, 2011Actual

Primary Completion Date

Dec 1, 2014Actual

Completion Date

Dec 1, 2014Actual

First Submitted Date

May 12, 2011

First Submission Date that Met QC Criteria

May 13, 2011

First Posted Date

May 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2026

Last Update Posted Date

Mar 31, 2026Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Therapeutic education	Experimental		Other: Educational tool
Classical management	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Educational tool	Other	Specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management	Therapeutic education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c 12 months after therapeutic education		12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre BOUGNERES, MD, PhD	Bicêtre Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bicêtre Hospital		Le Kremlin-Bicêtre		94275	France

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus
D007662	Ketosis
D007003	Hypoglycemia

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided