Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus (LUCID)
This study is currently recruiting participants.
Verified June 2012 by DexCom, Inc.
Sponsor:
DexCom, Inc.
Information provided by (Responsible Party):
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT01627184
First received: June 21, 2012
Last updated: June 22, 2012
Last verified: June 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 21, 2012 | ||||
| Last Updated Date | June 22, 2012 | ||||
| Start Date ICMJE | May 2012 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Glycemic Control during Exercise [ Designated as safety issue: No ] 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. |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01627184 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
System Utility and Usability [ Designated as safety issue: No ] 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:
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus | ||||
| Official Title ICMJE | Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult athletes with diabetes mellitus |
||||
| Condition ICMJE | Diabetes Mellitus | ||||
| Intervention ICMJE | Device: Dexcom G4 CGM System | ||||
| Study Group/Cohort (s) | Athletes with diabetes mellitus
Intervention: Device: Dexcom G4 CGM System |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 15 | ||||
| Estimated Completion Date | May 2013 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01627184 | ||||
| Other Study ID Numbers ICMJE | PTL-900905 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | DexCom, Inc. | ||||
| Study Sponsor ICMJE | DexCom, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | DexCom, Inc. | ||||
| Verification Date | June 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||