Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus
LUCID
1 other identifier
observational
13
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 12, 2015
February 1, 2015
8 months
June 21, 2012
February 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Glycemic Control during Exercise
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.
multiple months, up to 6
Secondary Outcomes (1)
System Utility and Usability
multiple months, up to 6
Study Arms (1)
Athletes with diabetes mellitus
Athletes who are insulin-requiring and insulin-dependent diabetics undergoing high levels of activity over extended period of time
Interventions
Eligibility Criteria
Adult athletes with diabetes mellitus
You may qualify if:
- Age 18 years or older
- Diagnosis of diabetes mellitus
You may not qualify if:
- Extensive skin changes/diseases
- Known allergy to medical adhesives
- Pregnancy
- Dialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DexCom, Inc.lead
Study Sites (1)
Atlanta Diabetes Association
Atlanta, Georgia, 30309, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 25, 2012
Study Start
May 1, 2012
Primary Completion
January 1, 2013
Study Completion
June 1, 2013
Last Updated
February 12, 2015
Record last verified: 2015-02