NCT01354288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

December 7, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

May 12, 2011

Last Update Submit

March 26, 2026

Conditions

Diabetes MellitusType 1 Diabetes

Keywords

DiabetesChildrenDisease managementKetosisHypoglycemiaParentsEducation

Outcome Measures

Primary Outcomes (1)

  • HbA1c 12 months after therapeutic education

    12 months

Secondary Outcomes (5)

  • 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)

    12 and 24 months

  • Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire)

    12 and 24 months

  • Evolution of the parental and child quality of life 12 and 24 months after therapeutic education (evaluated by questionnaire)

    12 and 24 months

Study Arms (2)

Therapeutic education

EXPERIMENTAL
Other: Educational tool

Classical management

NO INTERVENTION

Interventions

Educational toolOTHER

Specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management

Also known as: Experimental
Therapeutic education

Eligibility Criteria

Age12 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusKetosisHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesAcidosisAcid-Base Imbalance

Study Officials

  • Pierre BOUGNERES, MD, PhD

    Bicêtre Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 16, 2011

Study Start

December 7, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)