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Eversense CGM User Guide
19. Device Performance
This section lists Device Performance Characteristics.
Clinical Study Performance
The safety and effectiveness of the Eversense CGM System has been evaluated in several feasibility and pivotal
studies. Two studies – PRECISE II (2016) and PRECISION (2018) – were conducted in the U.S. to evaluate the
Eversense CGM System performance in terms of safety and effectiveness. The data collected was analyzed using a
new algorithm, SW 602. Accuracy assessments were made at various points during the studies and subjects were
asked to report any adverse events throughout the studies.
PRECISE II Study
PRECISE II was a multi-site, non-randomized single-arm pivotal clinical study. Ninety (90) adults (18 years and older)
with type 1 or type 2 diabetes participated in the study across 8 sites in the U.S. Each had a sensor inserted in the
upper arm to collect glucose data but not be displayed to the subject. Some participants had a sensor inserted into
each arm for clinical data collection. Participants interacted with the system to calibrate and address notifications
not related to glucose data. Accuracy was measured during day-long clinic visits, with blood taken about every
15 minutes. These visits occurred on Days 1, 30, 60, and 90. At each visit, sensor accuracy was evaluated relative to
a standard laboratory analyzer known as the YSI. Glucose readings were compared at the same moment in time
between the reference analyzer and the continuous device. A safety follow-up visit occurred at Day 100, or ten days
after the sensor was removed.
PRECISION Study
PRECISION was a second non-randomized single-arm pivotal clinical study conducted in the U.S. in 3 sites.
Thirty-five (35) adults (18 years and older) with type 1 or type 2 diabetes participated in the study which was
similar in study design as PRECISE II, except glucose readings and high/low glucose alerts were not blinded to the
participants, and study visits on days 7 and 14 were added. The table below characterizes accuracy of the system by
assessing the sensor glucose values against the YSI reference values.
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