Clinical trial NCT03980353: Difficulties and Obstacles to the Integration in Community of Children With Type 1 Diabetes Before Primary School.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 146
Sex: ALL
Minimum age (years): 12
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 1 year to 8 years old with Type 1 diabetes followed by the Diabetology Department of Lyon Pediatric Hospital.

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.


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

Primary outcomes:
measure: Identification of community integration obstacles for children with type 1 diabetes
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service d'endocrinologie pédiatrique Hôpital Femme mère enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Nathalie BENDELAC, MD
role: PRINCIPAL_INVESTIGATOR
References: