Precision
Precision of the System was evaluated by comparing the results from two separate Sensors worn on
the same subject at the same time. Table 14 provides data from two separate Sensors worn on 95
subjects at the same time, providing 15,283 real-time pairs of CGM measurements, with a mean CV
of 5.6%.
Table 14: Overall between Sensor Precision
Mean Glucose
(mg/dL)
Median CV Mean CV
Number of
Subjects
Number of
Paired Readings
164.2
4.2 5.6 95 15283
Sensor Wear Duration
The Sensor can be worn for up to 14 days. To estimate how long a Sensor will work over the wear
duration, 190 Sensors were evaluated in the clinical study to determine how many days of readings
each Sensor provided. Of these 190 Sensors, 136 (71.6%) lasted until the nal day of use. 168 Sensors
(88.4%) lasted at least 7 days. There were 54 (28.4%) Sensors that failed early, of which 22 (11.6%)
failed on or before the seventh day of wear.
Adverse Events
No device related serious adverse events occurred during the study. Mild skin irritations, such as
erythema, bruising, bleeding, infection and papule were reported around the insertion site and
adhesive area by a small number of subjects (8 out of 95 or 8.4%).
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