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

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.

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Service d'endocrinologie pédiatrique Hôpital Femme mère enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Nathalie BENDELAC, MD, Hospices Civils De Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 69HCL19_0218; 2019-A01571-56 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No