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

NCT03980353 | Completed

• 2 other identifiers: 69HCL19_02182019-A01571-56
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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.

Children before entrance in primary school

Eligibility Criteria

• Age: 12 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'endocrinologie pédiatrique Hôpital Femme mère enfant

Bron, 69500, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nathalie BENDELAC, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: August 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

FR (1)