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 9 provides data from
100 subjects in Study 3. For adults, the paired absolute relative difference (PARD)
between the two Sensors was 5.9% with coefficient of variation (CV) of 4.2%. For
children ages 4-5, PARD was 4.7% with CV of 3.3%. For children ages 6-17, PARD
was 8.1% with CV of 5.7%. Paired absolute difference (PAD) is a measurement of
absolute difference (in mg/dL) between paired CGM readings, while PARD is the
absolute relative difference (in %) between paired CGM readings.
Table 9: Overall between Sensor Precision (n=100)
Adverse Events
No device related serious adverse events occurred during the studies. In Study 1,
mild skin irritations, such as erythema, bruising, bleeding, and scabbing were
reported around the insertion site and adhesive area by a small number of
subjects (10 out of 146 or 6.8%). Pain was mostly reported as none with only one
DOC44383_rev-C 1:14pm 22-SEP-2021