Precision
Precision of the System was evaluated by comparing the results from two separate sensors worn on
the same subject at the same time. Data from two sensors worn at the same time for 72 subjects
provided 49,806 pairs of GM measurements. The mean PARD during the study was 8.6% with a
coefficient of variation of 6.1%.
Sensor Wear Duration
Sensors may be worn for up to 14 days (≥324 hours). To estimate how long a sensor will work over
14 days, 34 sensors were evaluated to determine how many days of readings each sensor provided.
Results show that 85.3% of sensors lasted for the intended 14-day wear duration.
Adverse Events
No device-related serious adverse events occurred during the study. Mild skin irritation, such as
erythema, edema, rash, bleeding, itching, bruising, scaling skin, and induration were reported
around the insertion site and adhesive area by a moderate frequency of subjects (26 out of 72 or
36%). Pain was mostly reported as none with only one reported instance of mild pain.
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