Diabetes Mellitus
Conditions
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.
Interventions
DEVICEDexcom G4 CGM System
Sponsors
DexCom, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Diagnosis of diabetes mellitus
Exclusion criteria
1. Extensive skin changes/diseases 2. Known allergy to medical adhesives 3. Pregnancy 4. Dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control during Exercise | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Utility and Usability | 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: * Number and duration of sensors used by subject * Percentage of CGM system communication during wear * Percentage of CGM system glucose reading during wear * Incidence of System prompts and error messages recorded in the receiver |
Countries
United States
Outcome results
None listed