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

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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