Type 1 DiabetesDIAB-EDUCNCT01354288
Therapeutic Education in Very Young Children With Diabetes Mellitus
A study testing Educational tool in people with Type 1 Diabetes and Diabetes Mellitus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 6 years
- Conditions the study is for
- Type 1 Diabetes, Diabetes Mellitus
- What is being tested?
- Educational tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2011to 1 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Conditions
- Type 1 Diabetes, Diabetes Mellitus
- Being tested
- Educational tool
- Keywords
- Diabetes, Children, Disease management, Ketosis, Hypoglycemia, Parents, Education
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Ketosis, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational toolOther
Also called Experimental
Specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic education | Experimental | Not described Receives: Other: Educational tool |
| Classical management | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c 12 months after therapeutic education
Measured: 12 months
Secondary outcomes (5)
HbA1C 24 months after therapeutic education
Measured: 24 months
Acute events number (hypoglycemia and ketosis) over a 12 and 24 months period
Measured: 12 and 24 months
Evolution of the parental knowledge about the disease 12 and 24 months after therapeutic education (evaluated by questionnaire)
Measured: 12 and 24 months
Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire)
Measured: 12 and 24 months
Evolution of the parental and child quality of life 12 and 24 months after therapeutic education (evaluated by questionnaire)
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study start7 Dec 2011
- Primary completion1 Dec 2014
- Study completion1 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Pierre BOUGNERES, MD, PhD, Principal investigator, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354288
- Sponsor's protocol ID
- P081254
- Acronym
- DIAB-EDUC
- Status last verified
- Mar 2026
- First submitted
- 12 May 2011
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01354288
- Acronym / sponsor ID
- DIAB-EDUC / P081254
- Conditions
- Type 1 Diabetes, Diabetes Mellitus
- Keywords
- Diabetes, Children, Disease management, Ketosis, Hypoglycemia, Parents, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 7 Dec 2011 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 1 Dec 2014 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic education | Experimental | Other: Educational tool |
| Classical management | No intervention | – |
Who may qualify
- Ages
- 12 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational toolAlso: ExperimentalSpecific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management | Other | Therapeutic education |
Primary outcome
HbA1c 12 months after therapeutic education
Time frame: 12 months
5 secondary outcomes
HbA1C 24 months after therapeutic education
Time frame: 24 months
Acute events number (hypoglycemia and ketosis) over a 12 and 24 months period
Time frame: 12 and 24 months
Evolution of the parental knowledge about the disease 12 and 24 months after therapeutic education (evaluated by questionnaire)
Time frame: 12 and 24 months
Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire)
Time frame: 12 and 24 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre BOUGNERES, MD, PhD principal investigator
Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational tool in people with Type 1 Diabetes and Diabetes Mellitus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c 12 months after therapeutic education (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.