- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01627184
Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus (LUCID)
February 10, 2015 updated by: DexCom, Inc.
The purpose of this study is to evaluate CGM glycemic control using the Dexcom G4 system as well as system performance during high levels of activity and home use by adult athletes with insulin-requiring diabetes mellitus, over an extended period of time.
Study Overview
Study Type
Observational
Enrollment (Actual)
13
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
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Georgia
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Atlanta, Georgia, United States, 30309
- Atlanta Diabetes Association
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult athletes with diabetes mellitus
Description
Inclusion Criteria:
- Age 18 years or older
- Diagnosis of diabetes mellitus
Exclusion Criteria:
- Extensive skin changes/diseases
- Known allergy to medical adhesives
- Pregnancy
- Dialysis
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Athletes with diabetes mellitus
Athletes who are insulin-requiring and insulin-dependent diabetics undergoing high levels of activity over extended period of time
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic Control during Exercise
Time Frame: multiple months, up to 6
|
The proportion of time spent in euglycemia zone as well as hypoglycemia zone will be determined from the system glucose readings, particularly during subject's high levels of activity.
Longitudinal data analysis methods will be used to assess the within-subject and between-subject effects of the glycemic control for the study population.
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multiple months, up to 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
System Utility and Usability
Time Frame: multiple months, up to 6
|
The objectives of the study are to evaluate the Dexcom G4 system utility and usability during high levels of activity and home use. The assessments may be evaluated by, but are not limited to, the following:
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multiple months, up to 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
June 21, 2012
First Submitted That Met QC Criteria
June 22, 2012
First Posted (Estimate)
June 25, 2012
Study Record Updates
Last Update Posted (Estimate)
February 12, 2015
Last Update Submitted That Met QC Criteria
February 10, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTL-900905
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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