Freestyle Libre 2 Manual Del Usuario página 151

ART46983-001_rev-A 24-Aug-2022 2:30pm
is presented for the following di!erent wear periods in Tables B-6a and B-6b: Beginning (Adult: 144
Subjects, Day 1, 2 or 3; Pediatric: 48 Subjects, Day 1 or 2), Middle (Adult: 91 Subjects, Day 7 or 8;
Pediatric: 50 Subjects, Day 7 or 8), and End (Adult: 36 Subjects, Day 9; Pediatric: 25 Subjects, Day 9). For
values 70 mg/dL and above, the percentage of readings within 15%, 20%, and 40% of the YSI value was
calculated. For values below 70 mg/dL, the percentage of readings within 15 mg/dL, 20 mg/dL, and
40 mg/dL of the YSI value was calculated.
Table B-6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=144)
Table B-6b: Sensor Accuracy Relative to YSI over the wear duration (Pediatric*; n=106)
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Sensor Wear Duration
To estimate how long a Sensor will work for the 10 day wear duration, 146 Sensors were evaluated in
the Adult study and 139 Sensors were evaluated in the Pediatric study to determine how many days of
readings each Sensor provided. Subjects did not wash the insertion site with soap and water before
applying the Sensors and wore two Sensors simultaneously. Of the 146 Sensors in the Adult study,
82.2% lasted 10 days. In the Pediatric study, 89.9% of the Sensors lasted 10 days. Tables B-7a and B-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. A total of 39 Sensors were evaluated in this study, all the Sensors (100%) lasted 10
days.
Table B-7a: Sensor Survival Rate Over Wear Duration (Adult; n=146)
Table B-7b: Sensor Survival Rate Over Wear Duration (Pediatric; n=139)