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

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ClinicalTrials.gov Identifier: NCT03980353
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Other: Questionnaires

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Study Type : Observational
Estimated Enrollment : 146 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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.
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   12 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980353


Contacts
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Contact: Nathalie BENDELAC, MD : 04.72.12.95.29 ext 33 nathalie.bendelac@chu-lyon.fr
Contact: Aurélie PORTEFAIX 04.72.35.79.99 ext 33 aurelie.portefaix@chu-lyon.fr

Locations
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France
Service d'endocrinologie pédiatrique Hôpital Femme mère enfant Recruiting
Bron, France, 69500
Contact: Nathalie BENDELAC         
Principal Investigator: Nathalie BENDELAC         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Nathalie BENDELAC, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03980353     History of Changes
Other Study ID Numbers: 69HCL19_0218
2019-A01571-56 ( Other Identifier: ID-RCB )
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases