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

NCT ID: NCT03980353

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 146 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2019-11-01

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Questionnaires

Intervention Type: OTHER

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.

Interventions

Questionnaires

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.

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie BENDELAC, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Service d'endocrinologie pédiatrique Hôpital Femme mère enfant

Bron, , France

Countries

France

Other Identifiers

2019-A01571-56

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL19_0218

Identifier Type: -

Identifier Source: org_study_id