Freestyle Libre 2 Manual Del Usuario página 141

ART46983-001_rev-A 24-Aug-2022 2:30pm
Table A-5d: High Glucose Alarm Performance (Pediatric*; n=129)
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Sensor Accuracy Over Time
The Sensor can be worn for up to 14 days. The percentage of System readings within YSI values and the
Mean Absolute Relative Di!erence (MARD) is presented for the following di!erent wear periods in
Tables A-6a and A-6b: Beginning (Adult: 144 Subjects, Day 1, 2 or 3; Pediatric: 48 Subjects, Day 1 or 2)
Early Middle (Adult: 91 Subjects, Day 7 or 8; Pediatric: 50 Subjects, Day 7 or 8), Late Middle (Adult: 55
Subjects, Day 9 or 12; Pediatric: 51 Subjects, Day 9 or 12), and End (Adult: 76 Subjects, Day 13 or 14;
Pediatric: 51 Subjects, Day 13 or 14). 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 A-6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=144)
Table A-6b: Sensor Accuracy Relative to YSI over the wear duration (Pediatric*; n=129)
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Sensor Wear Duration
The Sensor can be worn for up to 14 days. To estimate how long a Sensor will work over the 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