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NCT Number: NCT02970357

Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type I Autoimmune Diseases Children Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Program Evaluation Therapeutic Education

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHRMSA

Mulhouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DIAPASON Questionnaire

Other

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-5

Behavioral

5 item questionnaire of the World Health Organization about quality of life

Other names: Quality of Life Questionnaire

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

    Visits to the emergency room of a hospital, consultation with general practitioner

  5. 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

    Evaluation of diabètes self-management, participation to therapeutic programs

  6. Psychological indicators

    Time frame: On day 1, at enrollment, and 10months later, at the end of the study participation

    quality of life questionnaire for patient and parent

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Registry information

Official study title

Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes. A French Monocentric Prospective Study. Pilot Study

Acronym: PROGETE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2016
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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