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

Type 1 Diabetes Mellitus Clinical Trial

— DIABECO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980353
• Other study ID #: 69HCL19_0218
• Secondary ID: 2019-A01571-56
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: February 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Service d'endocrinologie pédiatrique Hôpital Femme mère enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of community integration obstacles for children with type 1 diabetes	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	15 minutes