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CompletedNCT03291834Updated Jul 11, 2018

Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus

An observational study in Diabetes Mellitus, sponsored by Jessa Hospital. Completed at 1 site in Belgium. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-07-11.

Sponsored by Jessa Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
8 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus

Keywords

  • type 1 diabetes mellitus
  • sports
  • child
  • adolescent
03

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Participation at sports

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

    Time frame: August 2017

  2. Occurence of hypoglycemia or hyperglycemia

    Time frame: August 2017

Secondary outcomes

  1. Measures taken to prevent hypoglycemia or hyperglycemia

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

    Time frame: August 2017

06

Study locations

1 site
  • Jessa Hospital
    Hasselt, Limburg B3500, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03291834
Lead sponsor
Jessa Hospital
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Aug 15, 2017
Primary completion
Jul 6, 2018
Completion
Jul 6, 2018
Last update
Jul 11, 2018

Study contacts

Guy G Massa, MD, PhD
principal investigator · Jessa Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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