Diabetes MellitusNCT03291834
Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Aug 2017to 6 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital
Who may be able to join
- Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus
- Keywords
- type 1 diabetes mellitus, sports, child, adolescent
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation at sports
Detailed description of participation at daily sports in school and outside school
Measured: August 2017
Occurence of hypoglycemia or hyperglycemia
Measured: 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.
Measured: August 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start15 Aug 2017
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy G Massa, MD, PhD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291834
- Sponsor's protocol ID
- JessaH_PedEndo002
- Status last verified
- Aug 2017
- First submitted
- 1 Sep 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03291834
- Acronym / sponsor ID
- JessaH_PedEndo002
- Conditions
- Diabetes Mellitus
- Keywords
- type 1 diabetes mellitus, sports, child, adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital
Key inclusion criteria (1 listed)
- Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participation at sports
Time frame: August 2017
Detailed description of participation at daily sports in school and outside school
Occurence of hypoglycemia or hyperglycemia
Time frame: August 2017
1 secondary outcome
Measures taken to prevent hypoglycemia or hyperglycemia
Time frame: August 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy G Massa, MD, PhD principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation at sports (time frame: August 2017). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.