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Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03291834
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Jessa Hospital

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
Diabetes Mellitus

Study Type : Observational
Estimated Enrollment : 100 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 : August 15, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Participation at sports [ Time Frame: August 2017 ]
    Detailed description of participation at daily sports in school and outside school

  2. Occurence of hypoglycemia or hyperglycemia [ Time Frame: August 2017 ]

Secondary Outcome Measures :
  1. Measures taken to prevent hypoglycemia or hyperglycemia [ Time Frame: August 2017 ]
    The ingestion of extra carbohydrates to prevent hypoglycemia and/or the administration of extra insulin to prevent hyperglycemia.



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital
Criteria

Inclusion Criteria:

  • Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital

Exclusion Criteria:


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): NCT03291834


Contacts
Contact: Guy G Massa, MD, PhD +3211309866 guy.massa@jessazh.be
Contact: Renate Zeevaert, MD, PhD renate.zeevaert@jessazh.be

Locations
Belgium
Jessa Hospital Recruiting
Hasselt, Limburg, Belgium, B3500
Contact: Guy G Massa, MD, PhD    +3211309866    guy.massa@jessazh.be   
Contact: Renate Zeevaert, MD, PhD       renate.zeevaert@jessazh.be   
Sponsors and Collaborators
Jessa Hospital
Investigators
Principal Investigator: Guy G Massa, MD, PhD Jessa Hospital

Responsible Party: Jessa Hospital
ClinicalTrials.gov Identifier: NCT03291834     History of Changes
Other Study ID Numbers: JessaH_PedEndo002
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases