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Eversense E3 CGM User Guide
19. Device Performance
This section lists Device Performance Characteristics.
Clinical Study Performance
The safety and eectiveness of the Eversense E3 CGM System has been evaluated in the PROMISE clinical study
conducted in the U.S. The data included in this Device Performance section is based on the data collected during the
PROMISE study with new algorithm (SW604) and minor design modification in the Sensor (E3 Sensor). Accuracy
assessments were made at various points during the study and subjects were asked to report any adverse events
throughout the study. The Safety section reflects all subjects (n=181) from the study.
PROMISE Study
The PROMISE study was a multi-site, prospective, non-randomised pivotal clinical study. One hundred and eighty-one
(181) adults (18 years and older) with type 1 or type 2 diabetes participated in the study across 8 sites in the U.S.
Ninety-six (96) subjects had two sensors inserted, one in each arm. Forty-three (43) of the secondary sensors were
SBA sensors. Participants interacted with the system to calibrate and address notifications not related to glucose data.
All diabetes care decisions were based on blood glucose values and clinical standard of care. Accuracy was measured
during day-long clinic visits. These visits occurred on Days 1, 7 or 14, 22, 30, 60, 90, 120, 150, and 180. At each visit,
sensor accuracy was evaluated relative to a standard laboratory analyser known as the YSI. Glucose readings were
compared at the same moment in time between the reference analyser and the continuous device. A safety follow-up
visit occurred ten days after the sensor was removed.
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