Abbott FreeStyle Libre 2 User Manual page 64

97.0% of the time blood glucose was above the alarm level and a high glucose alarm was appropriately
issued but 3.0% of the time the glucose event was missed and no alarm was issued.
Table 5c: High Glucose Alarm Performance (Adult; n=144) Table 5c: High Glucose Alarm Performance (Adult; n=144)
Table 5d: High Glucose Alarm Performance (Paediatric*; n=129) Table 5d: High Glucose Alarm Performance (Paediatric*; 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 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 Difference (MARD) is presented for the following different wear periods in
Tables 6a and 6b Tables 6a and 6b: Beginning (Adult: 144 Subjects, Day 1, 2 or 3; Paediatric: 48 Subjects, Day 1 or 2)
Early Middle (Adult: 91 Subjects, Day 7 or 8; Paediatric: 50 Subjects, Day 7 or 8), Late Middle (Adult: 55
Subjects, Day 9 or 12; Paediatric: 51 Subjects, Day 9 or 12), and End (Adult: 76 Subjects, Day 13 or 14;
Paediatric: 51 Subjects, Day 13 or 14). For values ≥ 3.9 mmol/L, the percentage of readings within 15%,
20%, and 40% of the YSI value was calculated. For values < 3.9 mmol/L, the percentage of readings
within 0.83 mmol/L, 1.11 mmol/L, and 2.2 mmol/L of the YSI value was calculated. The percentage of
System readings within YSI values for the first 12 hours of a Sensor wear is presented in Table 6c
Table 6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=144) Table 6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=144)
Table 6b: Sensor Accuracy Relative to YSI over the wear duration (Paediatric*; Table 6b: Sensor Accuracy Relative to YSI over the wear duration (Paediatric*; n=129)
* Includes children 6–17 years of age. No YSI measurements were obtained for children 4–5 years of age.
Table 6c: Sensor Accuracy Relative to YSI over the First 12 Hours of Sensor Wear Table 6c: Sensor Accuracy Relative to YSI over the First 12 Hours of Sensor Wear
ART41753-100_rev-A 5:36pm 18-JAN-2021
Table 6c.
n=129)