Diabetes Mellitus, Type IPROGETENCT02970357
Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes
A study testing DIAPASON Questionnaire and WHO-5 in people with Diabetes Mellitus, Type I and Program Evaluation, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial summary
The needs of children and teens with type 1 diabetes are very specific and different from the adults with type 1 diabetes. Many organizations such as the World Health Organization or the International Society for Pediatric and Adolescent Diabetes, recommend a patient therapeutic education when it comes to children… Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Diabetes Mellitus, Type I, Program Evaluation, Therapeutic Education
- What is being tested?
- DIAPASON Questionnaire and WHO-5
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2016to 20 Mar 2017
- 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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrollment between January 15 to March 15, 2016
- Insulin-dependent type 1 Diabetes
- Treatment received at the Hospital of Mulhouse, France
Who cannot join
- Opposition to study participation
- Behavioral issues
- Uncontrolled psychological issue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes. A French Monocentric Prospective Study. Pilot Study
The needs of children and teens with type 1 diabetes are very specific and different from the adults with type 1 diabetes. Many organizations such as the World Health Organization or the International Society for Pediatric and Adolescent Diabetes, recommend a patient therapeutic education when it comes to children with type 1 diabetes.
This study aims to evaluate the impact of a therapeutic education program on theoretical knowledge of the disease and also on quality of life, on biological and clinical indicators.
Read the detailed description
Structuring a therapeutic education program for patients with a chronic disease was the initiative of the French High Health Authority in June 2007.
The Prevention and Care of Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse is a partner of the Mulhouse Hospital. Besides the usual care given at the hospital of Mulhouse for patients with a type 1 diabetes, both organizations also provide therapeutic education to these patients.
Each therapeutic education program is organized according to the patient's age. They can also be organized in a group or individually.
The aim of the therapeutic education is to help the young patients to cope with diabetes in their daily activities. Therapeutic education is known to bring good results for patients with diabetes, but there is no studies in France for children and teens with a type 1 diabetes.
- Being tested
- DIAPASON Questionnaire, WHO-5
- Keywords
- Evaluation, Therapeutic education, Type 1 Diabetes, Children
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAPASON QuestionnaireOther
50 item questionnaire of the French Youth Diabetes Association to evaluate one's theoretical knowledge about the diabetes disease. 6 main themes are evaluated :
- what is diabetes
- Monitoring
- Hypoglycemia and Hyperglycemia
- Nutrition
- Insuline
WHO-5Behavioural
Also called Quality of Life Questionnaire
5 item questionnaire of the World Health Organization about quality of life
| Study group | Role | What they receive |
|---|---|---|
| Enrolled patient | Other | Every patient of the Mulhouse Hospital with a type 1 diabetes who joins the study will be followed for 10 months. They will fill in the DIAPASON questionnaire and the quality of life WHO-5 questionnaire on the day of enrollment and 10 months after enrollment, at the end of the study. Young patients followed for a type 1 diabetes at the Mulhouse Hospital usually come every two months to see the pediatric endocrinologist, so the data collected for a regular visit will also be collected for the study every two months between the enrollment and the end of study participation. Receives: Other: DIAPASON Questionnaire; Behavioral: WHO-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The DIAPASON questionnaire
50 item questionnaire that evaluates the patient's theoretical knowledge of the type 1 diabetes disease. Questionnaire submitted to patients and a parent.
Measured: The outcome will be the change of the answers to the questionnaire from enrollment to the end of the study, ten months later.
Secondary outcomes (6)
Evolution of glycated hemoglobin
Measured: Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation
Occurrence of severe hypoglycemic events
Measured: Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation
Occurrence of ketoacidosis events
Measured: Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation
Need for care indicators
Visits to the emergency room of a hospital, consultation with general practitioner
Measured: Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation
Behavioral indicators
Evaluation of diabètes self-management, participation to therapeutic programs
Measured: Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation
Psychological indicators
quality of life questionnaire for patient and parent
Measured: On day 1, at enrollment, and 10months later, at the end of the study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start26 Jan 2016
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatiha GUEMAZI-KHEFFI, MD, Principal investigator, Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970357
- Sponsor's protocol ID
- GHRMSA 805
- Other IDs
- 2015-A017101-48
- Acronym
- PROGETE
- Status last verified
- Jul 2017
- First submitted
- 7 Oct 2016
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes. A French Monocentric Prospective Study. Pilot Study
- ClinicalTrials.gov ID
- NCT02970357
- Acronym / sponsor ID
- PROGETE / GHRMSA 805
- Keywords
- Evaluation, Therapeutic education, Type 1 Diabetes, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 26 Jan 2016 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 22 Nov 2016 (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.
The needs of children and teens with type 1 diabetes are very specific and different from the adults with type 1 diabetes. Many organizations such as the World Health Organization or the International Society for Pediatric and Adolescent Diabetes, recommend a patient therapeutic education when it comes to children with type 1 diabetes.
This study aims to evaluate the impact of a therapeutic education program on theoretical knowledge of the disease and also on quality of life, on biological and clinical indicators.
Detailed description
Structuring a therapeutic education program for patients with a chronic disease was the initiative of the French High Health Authority in June 2007.
The Prevention and Care of Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse is a partner of the Mulhouse Hospital. Besides the usual care given at the hospital of Mulhouse for patients with a type 1 diabetes, both organizations also provide therapeutic education to these patients.
Each therapeutic education program is organized according to the patient's age. They can also be organized in a group or individually.
The aim of the therapeutic education is to help the young patients to cope with diabetes in their daily activities. Therapeutic education is known to bring good results for patients with diabetes, but there is no studies in France for children and teens with a type 1 diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled patient | Other | Other: DIAPASON Questionnaire, Behavioral: WHO-5Every patient of the Mulhouse Hospital with a type 1 diabetes who joins the study will be followed for 10 months. They will fill in the DIAPASON questionnaire and the quality of life WHO-5 questionnaire on the day of enrollment and 10 months after enrollment, at the end of the study. Young patients followed for a type 1 diabetes at the Mulhouse Hospital usually come every two months to see the pediatric endocrinologist, so the data collected for a regular visit will also be collected for the study every two months between the enrollment and the end of study participation. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Enrollment between January 15 to March 15, 2016
- Insulin-dependent type 1 Diabetes
- Treatment received at the Hospital of Mulhouse, France
Key exclusion criteria (3 listed)
- Opposition to study participation
- Behavioral issues
- Uncontrolled psychological issue
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 |
|---|---|---|
| DIAPASON Questionnaire50 item questionnaire of the French Youth Diabetes Association to evaluate one's theoretical knowledge about the diabetes disease. 6 main themes are evaluated : * what is diabetes * Monitoring * Hypoglycemia and Hyperglycemia * Nutrition * Insuline | Other | Enrolled patient |
| WHO-5Also: Quality of Life Questionnaire5 item questionnaire of the World Health Organization about quality of life | Behavioural | Enrolled patient |
Primary outcome
The DIAPASON questionnaire
Time frame: The outcome will be the change of the answers to the questionnaire from enrollment to the end of the study, ten months later.
50 item questionnaire that evaluates the patient's theoretical knowledge of the type 1 diabetes disease. Questionnaire submitted to patients and a parent.
6 secondary outcomes
Evolution of glycated hemoglobin
Time frame: Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation
Occurrence of severe hypoglycemic events
Time frame: Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation
Occurrence of ketoacidosis events
Time frame: Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation
Need for care indicators
Time frame: Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation
Behavioral indicators
Time frame: Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation
Psychological indicators
Time frame: On day 1, at enrollment, and 10months later, at the end of the study participation
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 20 Nov 2025.
- Individual participant dataSharing planned: Yes
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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.
Fatiha GUEMAZI-KHEFFI, MD principal investigator
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIAPASON Questionnaire and WHO-5 in people with Diabetes Mellitus, Type I and Program Evaluation, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace 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 3 inclusion and 3 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 20 Nov 2025. 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?
The DIAPASON questionnaire (time frame: The outcome will be the change of the answers to the questionnaire from enrollment to the end of the study, ten months later.). 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 20 Nov 2025.