The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing. Device performance will be primarily evaluated in terms of the proportion of glucose values within a pre-specified range compared to reference values. Safety data of the G4 System will also be collected vis-a-vis adverse event reporting characterized by the incidence and severity of Serious Adverse Device Events, and Adverse Device Events experienced by study participants.
Study Type
OBSERVATIONAL
Enrollment
21
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Absolute Relative Difference (%) to Reference Standard
The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI. The point accuracy is measured as the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels \>80 mg/dL and ±20 mg/dL at YSI glucose levels \<80 mg/dL.
Time frame: one time measure (day 1)
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