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Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus

Sponsor
Jessa Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03291834
Collaborator
(none)
70
Enrollment
1
Location
10.7
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

On the basis of a questionnaire the participation at sports activities of children and adolescents with type 1 diabetes mellitus will be studied. The occurrence of hypoglycemia and hyperglycemia will be evaluated, as well as the measures to prevent these complications.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    70 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Study on Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus
    Actual Study Start Date :
    Aug 15, 2017
    Actual Primary Completion Date :
    Jul 6, 2018
    Actual Study Completion Date :
    Jul 6, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Participation at sports [August 2017]

      Detailed description of participation at daily sports in school and outside school

    2. Occurence of hypoglycemia or hyperglycemia [August 2017]

    Secondary Outcome Measures

    1. Measures taken to prevent hypoglycemia or hyperglycemia [August 2017]

      The ingestion of extra carbohydrates to prevent hypoglycemia and/or the administration of extra insulin to prevent hyperglycemia.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jessa Hospital Hasselt Limburg Belgium B3500

    Sponsors and Collaborators

    • Jessa Hospital

    Investigators

    • Principal Investigator: Guy G Massa, MD, PhD, Jessa Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jessa Hospital
    ClinicalTrials.gov Identifier:
    NCT03291834
    Other Study ID Numbers:
    • JessaH_PedEndo002
    First Posted:
    Sep 25, 2017
    Last Update Posted:
    Jul 11, 2018
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jessa Hospital
    type 1 diabetes mellitus
    sports
    child
    adolescent
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Jul 11, 2018