An interventional study of DIAPASON Questionnaire and WHO-5 in Diabetes Mellitus, Type I, Program Evaluation and Therapeutic Education, sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace. Completed at 1 site in France. Open to participants aged 10 Years to 20 Years. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Not applicable, Interventional, and Supportive care
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 68 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Groupe Hospitalier de la Region de Mulhouse et Sud Alsace is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: DIAPASON Questionnaire · Behavioral: WHO-5
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
5 item questionnaire of the World Health Organization about quality of life
Also known as: Quality of Life Questionnaire
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.
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.
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
Visits to the emergency room of a hospital, consultation with general practitioner
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
Evaluation of diabètes self-management, participation to therapeutic programs
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
quality of life questionnaire for patient and parent
Time frame: On day 1, at enrollment, and 10months later, at the end of the study participation
Plan to share: Yes
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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier de la Region de Mulhouse et Sud Alsace