Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes (PROGETE)
November 17, 2025 updated by: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mulhouse, France
- GHRMSA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Enrollment between January 15 to March 15, 2016
- Insulin-dependent type 1 Diabetes
- Treatment received at the Hospital of Mulhouse, France
Exclusion Criteria:
- Opposition to study participation
- Behavioral issues
- Uncontrolled psychological issue
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Enrolled patient
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.
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50 item questionnaire of the French Youth Diabetes Association to evaluate one's theoretical knowledge about the diabetes disease. 6 main themes are evaluated :
5 item questionnaire of the World Health Organization about quality of life
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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50 item questionnaire that evaluates the patient's theoretical knowledge of the type 1 diabetes disease.
Questionnaire submitted to patients and a parent.
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The outcome will be the change of the answers to the questionnaire from enrollment to the end of the study, ten months later.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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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
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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
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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
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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
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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
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Visits to the emergency room of a hospital, consultation with general practitioner
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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
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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
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Evaluation of diabètes self-management, participation to therapeutic programs
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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
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Psychological indicators
Time Frame: On day 1, at enrollment, and 10months later, at the end of the study participation
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quality of life questionnaire for patient and parent
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On day 1, at enrollment, and 10months later, at the end of the study participation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fatiha GUEMAZI-KHEFFI, MD, Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- White NH, Cleary PA, Dahms W, Goldstein D, Malone J, Tamborlane WV; Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Beneficial effects of intensive therapy of diabetes during adolescence: outcomes after the conclusion of the Diabetes Control and Complications Trial (DCCT). J Pediatr. 2001 Dec;139(6):804-12. doi: 10.1067/mpd.2001.118887.
- Likitmaskul S, Wekawanich J, Wongarn R, Chaichanwatanakul K, Kiattisakthavee P, Nimkarn S, Prayongklin S, Weerakulwattana L, Markmaitree D, Ritjarean Y, Pookpun W, Punnakanta L, Angsusingha K, Tuchinda C. Intensive diabetes education program and multidisciplinary team approach in management of newly diagnosed type 1 diabetes mellitus: a greater patient benefit, experience at Siriraj Hospital. J Med Assoc Thai. 2002 Aug;85 Suppl 2:S488-95.
- Renders CM, Valk GD, Griffin S, Wagner EH, Eijk JT, Assendelft WJ. Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings. Cochrane Database Syst Rev. 2001;2000(1):CD001481. doi: 10.1002/14651858.CD001481.
- Kelo M, Martikainen M, Eriksson E. Self-care of school-age children with diabetes: an integrative review. J Adv Nurs. 2011 Oct;67(10):2096-108. doi: 10.1111/j.1365-2648.2011.05682.x. Epub 2011 Jun 2.
- Ivernois JF d', Gagnayre R. Apprendre à éduquer le patient : Approche pédagogique. 4ème édition. Maloine:2011. 160p.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2016
Primary Completion (Actual)
March 20, 2017
Study Completion (Actual)
March 20, 2017
Study Registration Dates
First Submitted
October 7, 2016
First Submitted That Met QC Criteria
November 17, 2016
First Posted (Estimated)
November 22, 2016
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GHRMSA 805
- 2015-A017101-48 (Other Identifier: France: Agence Nationale de Sécurité du Médicament et des produits de santé)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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