NCT03291834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2018

Completed
Last Updated

July 11, 2018

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

September 1, 2017

Last Update Submit

July 10, 2018

Conditions

Diabetes Mellitus

Keywords

type 1 diabetes mellitussportschildadolescent

Outcome Measures

Primary Outcomes (2)

  • Participation at sports

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

    August 2017

  • Occurence of hypoglycemia or hyperglycemia

    August 2017

Secondary Outcomes (1)

  • Measures taken to prevent hypoglycemia or hyperglycemia

    August 2017

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, B3500, Belgium

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Guy G Massa, MD, PhD

    Jessa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 25, 2017

Study Start

August 15, 2017

Primary Completion

July 6, 2018

Study Completion

July 6, 2018

Last Updated

July 11, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)