Difficulties and Obstacles to the Integration in Community of Children With Type 1 Diabetes Before Primary School. (DIABECO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03980353|
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : August 5, 2019
The incidence of type 1 diabetes is increasing worldwide and in France, including among young children.
Type 1 diabetes has consequences for integration in community, especially on the management of hypoglycemia and hyperglycemia, mealtimes, participation in sporting activities and school trips.
This works' purpose is to describe obstacles and difficulties to the integration in community before primary school (day care center, childminder, and nursery school) of a complete sample of children with type 1 diabetes followed in the Diabetology Department of Lyon Pediatric Hospital, at the start of the school year 2018-2019. The investigating team will carry out a descriptive study, using different questionnaires addressed to the professionals (nursery school directors, day care nursery directors, childminders, school doctors, pediatricians and doctors of child and maternal protection centers) and to the parents of children with type 1 diabetes. These different questionnaires will help to take into account different points of view, in order to identify all the obstacles to integration of children with type 1 diabetes in community.
Through this work, secondary information actions through training and/or information leaflets will be carried out in order to facilitate the reception of these children in the community.
|Condition or disease||Intervention/treatment|
|Type 1 Diabetes Mellitus||Other: Questionnaires|
|Study Type :||Observational|
|Estimated Enrollment :||146 participants|
|Official Title:||Evaluation of Difficulties and Obstacles to the Integration in Community of Children With Type 1 Diabetes Before Primary School, Followed by the Diabetology Department of Lyon Pediatric Hospital.|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
Children before entrance in primary school
Children with type 1 diabetes, who are too young to go to primary school at the start of the school year 2018-2019, followed in the Diabetology Department of Lyon Pediatric Hospital.
The questionnaires have two parts: a general part and a second part focused on the integration in community of the type 1 diabetes children with specific questions about blood glucose, mealtimes, sporting activities and school trips.
- Identification of community integration obstacles for children with type 1 diabetes [ Time Frame: 15 minutes ]Participants will respond to a multi-question interview by telephone or a paper questionnaire. The questions will focus on the child's lifestyle (such as meal times, activities, blood glucose levels...) in order to identify integration obstacles
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980353
|Contact: Nathalie BENDELAC, MD||: 04.72.12.95.29 ext email@example.com|
|Contact: Aurélie PORTEFAIX||04.72.35.79.99 ext firstname.lastname@example.org|
|Service d'endocrinologie pédiatrique Hôpital Femme mère enfant||Recruiting|
|Bron, France, 69500|
|Contact: Nathalie BENDELAC|
|Principal Investigator: Nathalie BENDELAC|
|Principal Investigator:||Nathalie BENDELAC, MD||Hospices Civils de Lyon|