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Completed

NCT Number: NCT03980353

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

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.

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Key information

Age range

12 month–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'endocrinologie pédiatrique Hôpital Femme mère enfant

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

questionnaires

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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.

Acronym: DIABECO

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 10, 2019
Registry last updated
Feb 13, 2020

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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