Freestyle Libre - Page 65

Table 12: Detection of Hypoglycemic and Hyperglycemic Events
Type of Notication Notication Status
15 Minute
Interval
Notication of Hypoglycemic Events
(Low Glucose message)
Detection Rate (%) 85.4
Missed Detection Rate (%) 14.6
False Notication Rate (%) 39.9
Notication of Hyperglycemic Events
(High Glucose message)
Detection Rate (%) 95.1
Missed Detection Rate (%) 4.9
False Notication Rate (%) 22.1
Impending Notication of Hypoglycemic
Events (Glucose Going Low message)
Detection Rate (%) 95.0
Missed Detection Rate (%) 5.0
False Notication Rate (%) 46.8
Impending Notication of Hyperglycemic
Events (Glucose Going High message)
Detection Rate (%) 97.2
Missed Detection Rate (%) 2.8
False Notication Rate (%) 28.4
Precision
Precision of the System was evaluated by comparing the results from two separate sensors worn on
the same subject at the same time. Table 13 provides data from two separate sensors worn on 47
subjects at the same time, providing 7,319 real-time pairs of CGM measurements, with a mean CV
of 6.0%.
Table 13: Overall between Sensor Precision
Mean Glucose
(mg/dL)
Median CV Mean CV
Number of
Subjects
Number of
Paired Readings
175.3
4.6 6.0 47 7319
Sensor Wear Duration
After the 12 hour start-up period, the Sensor can be worn for up to 10 days. To estimate how long a
Sensor will work over the wear duration, 97 Sensors were evaluated in the clinical study to determine
how many days of readings each Sensor provided. Of these 97 sensors, 75 (77.3%) lasted until the
nal day of use. 84 sensors (86.6%) lasted more than 5 days. There were 22 (22.7%) sensors that
failed early, of which 11 (11.3%) failed on or before the fth day of wear.
Adverse Events
No device related serious adverse events occurred during the study. Mild skin irritations, such as
erythema, edema, rash, bleeding, itching, induration, and infection were reported around the
insertion site and adhesive area by a moderate frequency of subjects (5 out of 48 or 10.4%). Pain
was mostly reported as none with only one instance of mild pain.
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