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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Athletes with diabetes mellitus | Athletes who are insulin-requiring and insulin-dependent diabetics undergoing high levels of activity over extended period of time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G4 CGM System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| System Utility and Usability | 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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Inclusion Criteria:
Exclusion Criteria:
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Adult athletes with diabetes mellitus
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Diabetes Association | Atlanta | Georgia | 30309 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| multiple months, up to 6 |