- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03291834
Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus
July 10, 2018 updated by: Jessa Hospital
A Study on Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Hasselt, Limburg, Belgium, B3500
- Jessa hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participation at sports
Time Frame: August 2017
|
Detailed description of participation at daily sports in school and outside school
|
August 2017
|
Occurence of hypoglycemia or hyperglycemia
Time Frame: August 2017
|
August 2017
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
August 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guy G Massa, MD, PhD, Jessa hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2017
Primary Completion (Actual)
July 6, 2018
Study Completion (Actual)
July 6, 2018
Study Registration Dates
First Submitted
September 1, 2017
First Submitted That Met QC Criteria
September 21, 2017
First Posted (Actual)
September 25, 2017
Study Record Updates
Last Update Posted (Actual)
July 11, 2018
Last Update Submitted That Met QC Criteria
July 10, 2018
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JessaH_PedEndo002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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