Type 1 DiabetesNCT01398826
Glycemic Response to Road Cycling in Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Team Type 1, Inc..
Trial summary
The purpose of this study is to assess the glycemic response to cycling road races (using continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic controls. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Aug 2011
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Professional cyclists on TeamType 1 cycling teams
Who may be able to join
- ≥18 years of age
- A1C ≤8.0% if diagnosed with type 1 DM
Who cannot join
- If diagnosed with type 1 diabetes, has had recurrent severe hypoglycemia (greater than 2 episodes in previous 6 months requiring assistance by a third party)
- Has any medical condition or medical history that may affect successful completion of the study and/or personal well-being (as assessed by the PI)
About this study
Official title: A Pilot Study Assessing the Glycemic Response and Its Relationship to Performance During Road Cycling in Elite Athletes With Type 1 Diabetes and Non-Diabetic Controls
The purpose of this study is to assess the glycemic response to cycling road races (using continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic controls. The investigators will also assess the relationship between power/work during cycling (using a power meter) and the subject's glucose profile.
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Exercise, Continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Team Type 1, Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Juan P Frias, MD, Principal investigator, Team Type 1, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398826
- Sponsor's protocol ID
- TT1-001
- Status last verified
- Jul 2011
- First submitted
- 19 Jul 2011
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing the Glycemic Response and Its Relationship to Performance During Road Cycling in Elite Athletes With Type 1 Diabetes and Non-Diabetic Controls
- ClinicalTrials.gov ID
- NCT01398826
- Acronym / sponsor ID
- TT1-001
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Exercise, Continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Team Type 1, Inc.University, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 21 Jul 2011 (estimated)
- 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.
The purpose of this study is to assess the glycemic response to cycling road races (using continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic controls. The investigators will also assess the relationship between power/work during cycling (using a power meter) and the subject's glucose profile.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Professional cyclists on TeamType 1 cycling teams
Key inclusion criteria (2 listed)
- ≥18 years of age
- A1C ≤8.0% if diagnosed with type 1 DM
Key exclusion criteria (2 listed)
- If diagnosed with type 1 diabetes, has had recurrent severe hypoglycemia (greater than 2 episodes in previous 6 months requiring assistance by a third party)
- Has any medical condition or medical history that may affect successful completion of the study and/or personal well-being (as assessed by the PI)
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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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.
Juan P Frias, MD principal investigator
Team Type 1, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Team Type 1, Inc..
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 21 Jul 2011.