Freestyle Libre User Manual page 64

System Glucose Availability
The System is designed to produce a glucose reading after each user initiated scan that is performed
after the start-up time, through the wear period. Table 11 shows the number of available glucose
readings reported by all sensors and the expected number based on the total number of scan
attempts. Results are shown for sensors which produced at least one CGM reading during the
clinical study over the total wear period. The percentage of available CGM readings is presented in
comparison to the number of expected CGM readings. Overall, 99.5% of CGM readings (9,228 CGM
readings out of an expected 9,272) were available.
Table 11: CGM Availability
No. CGM No. Scan
9228 9272
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Detection of Hypoglycemic and Hyperglycemic Events
Table 12 shows the accuracy of the System's Glucose Messages in informing the user of low or
high glucose events within 15 minutes before or after the true low or high blood glucose value.
Percentages are displayed for three different parameters:
• Detection Rate – amount of time the System displays a Glucose Message correctly.
• Missed Detection Rate – amount of time the System did not display a Glucose Message when it
should have.
• False Notification Rate – amount of time the System displays a Glucose Message when it shouldn't
have.
For example, in the clinical study, the System was able to detect 85.4% of actual low glucose
%
events (detection rate), but 39.9% of the time a Low Glucose message was displayed in error (false
notification rate) and 14.6% of the time a Low Glucose message was not displayed when it should
99.5
have been (missed detection rate).
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