Abbott FreeStyle Libre 2 User Manual page 81

Table 6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=144)
Number of
Wear
CGM-reference MARD (%)
Period
pairs
Beginning 6955 9.9
Early Middle 4522 8.5
Late Middle 3503 8.8
End 3755 9.1
Table 6b: Sensor Accuracy Relative to YSI over the wear duration (Pediatric*; n=129)
Number of
Wear
CGM-reference MARD (%)
Period
pairs
Beginning 1828 10.7
Early Middle 1642 8.0
Late Middle 1534 9.7
End 1542 10.2
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
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Within ±15% / Within ±20% / Within ±40% /
±15 mg/dL ±20 mg/dL ±40 mg/dL
83.4 90.4 99.3
87.7 94.5 99.8
86.8 93.4 99.7
86.4 92.9 100.0
Within ±15% / Within ±20% / Within ±40% /
±15 mg/dL ±20 mg/dL ±40 mg/dL
79.6 88.5 98.6
89.5 94.2 98.5
83.6 92.9 99.5
82.6 91.1 99.3
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 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-off" 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-off" where the Sensor algorithm detected that the Sensors did not function as intended and
presented the user with a Replace Sensor message. Tables 7a and 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.
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