Difficulties and Obstacles to the Integration in Community of Children With Type 1 Diabetes Before Primary School.

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Questionnaires

• Registration Number: NCT03980353
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-10
• Study Start: 2019-08-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Children:

• Type 1 Diabetes
• Followed in the diabetology department of Lyon pediatric hospital
• Who are too young to go to primary school in 2018-2019
• Residing in the Rhône-Alpes region of France
• No parental opposition to the completion of the questionnaire (reflection period of 15 days after receipt the leaflet information)

For school directors, school doctors, pediatricians, child and maternal protection center doctors

• Questionnaire responses will be considered as evidence of no opposition.

Directors of nurseries and childminders who will agree to answer the telephone questionnaire after parents allow the study team to contact them

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Exclusion Criteria

Children:

• Child requiring another facilities for school (food allergies, celiac disease...)
• Language barrier not permitting a response to the questionnaires

For childminders and nursery directors

• refusal of parents to contact them
• refusal to participate declared during the telephone interview

For school directors, doctors and school doctors

• No prior involvement in the reception in community of a type 1 diabetes child

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children before entrance in primary school	Questionnaires	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.

Primary Outcome Measures

Name	Time	Method
Identification of community integration obstacles for children with type 1 diabetes	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

Trial Locations

Locations (1)

Service d'endocrinologie pédiatrique Hôpital Femme mère enfant; 🇫🇷 Bron, France