Freestyle Libre 2 Manual Del Usuario página 142

ART46983-001_rev-A 24-Aug-2022 2:30pm
the insertion site with soap and water before applying the Sensors and wore two Sensors
simultaneously. Of the 146 Sensors in the Adult study, 71.1% lasted until the final day of use. 6 Sensors
(4.1%) had "early sensor shut-o!" where the Sensor algorithm detected that the Sensors did not
function as intended and presented the user with a Replace Sensor message. In the Pediatric study,
78.1% of the Sensors lasted until the final day of use. 3 Sensors (2.2%) had "early sensor shut-o!" where
the Sensor algorithm detected that the Sensors did not function as intended and presented the user
with a Replace Sensor message. Tables A-7a and A-7b display the data for each day in the wear
duration for the Adult & Pediatric studies.
A third clinical study was also conducted to further evaluate wear duration in subjects who first washed
the insertion site with a plain soap and water, according to the full instructions in the labeling and wore
only a single Sensor. Of the 39 Sensors evaluated in this study, 97% lasted until the final day of use.
Table A-7a: Sensor Survival Rate Over Wear Duration (Adult; n=146)
Table A-7b: Sensor Survival Rate Over Wear Duration (Pediatric; n=139)
Glucose Reading Availability
The System is designed to show a Sensor glucose reading after each scan that is performed throughout
the wear period after the start-up time. Tables A-8a and A-8b show the glucose reading capture rate
for each day of the wear duration.
Table A-8a: Glucose Reading Capture Rate Over Wear Duration (Adult; n=146)