<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03291834</url>
  </required_header>
  <id_info>
    <org_study_id>JessaH_PedEndo002</org_study_id>
    <nct_id>NCT03291834</nct_id>
  </id_info>
  <brief_title>Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus</brief_title>
  <official_title>A Study on Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jessa Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      On the basis of a questionnaire the participation at sports activities of children and&#xD;
      adolescents with type 1 diabetes mellitus will be studied. The occurrence of hypoglycemia and&#xD;
      hyperglycemia will be evaluated, as well as the measures to prevent these complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">July 6, 2018</completion_date>
  <primary_completion_date type="Actual">July 6, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Participation at sports</measure>
    <time_frame>August 2017</time_frame>
    <description>Detailed description of participation at daily sports in school and outside school</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurence of hypoglycemia or hyperglycemia</measure>
    <time_frame>August 2017</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measures taken to prevent hypoglycemia or hyperglycemia</measure>
    <time_frame>August 2017</time_frame>
    <description>The ingestion of extra carbohydrates to prevent hypoglycemia and/or the administration of extra insulin to prevent hyperglycemia.</description>
  </secondary_outcome>
  <enrollment type="Actual">70</enrollment>
  <condition>Diabetes Mellitus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes&#xD;
        clinic of the Jessa Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and adolescents with type 1 diabetes mellitus followed at the pediatric&#xD;
             diabetes clinic of the Jessa Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guy G Massa, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jessa Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jessa Hospital</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>B3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>July 10, 2018</last_update_submitted>
  <last_update_submitted_qc>July 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 1 diabetes mellitus</keyword>
  <keyword>sports</keyword>
  <keyword>child</keyword>
  <keyword>adolescent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03291834
org study id: JessaH_PedEndo002
nct id: NCT03291834
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Retrospective
measure: Participation at sports
time frame: August 2017
description: Detailed description of participation at daily sports in school and outside school
measure: Occurence of hypoglycemia or hyperglycemia
time frame: August 2017
measure: Measures taken to prevent hypoglycemia or hyperglycemia
time frame: August 2017
description: The ingestion of extra carbohydrates to prevent hypoglycemia and/or the administration of extra insulin to prevent hyperglycemia.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: No
last name: Guy G Massa, MD, PhD
role: Principal Investigator
affiliation: Jessa Hospital
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No