Freestyle Libre User Manual page 65

Table 12: Detection of Hypoglycemic and Hyperglycemic Events
Type of Notification
Notification of Hypoglycemic Events
Detection Rate (%)
(Low Glucose message)
Missed Detection Rate (%)
False Notification Rate (%)
Notification of Hyperglycemic Events
Detection Rate (%)
(High Glucose message)
Missed Detection Rate (%)
False Notification Rate (%)
Impending Notification of Hypoglycemic
Detection Rate (%)
Events (Glucose Going Low message)
Missed Detection Rate (%)
False Notification Rate (%)
Impending Notification of Hyperglycemic
Detection Rate (%)
Events (Glucose Going High message)
Missed Detection Rate (%)
False Notification Rate (%)
121
ART38553-101_rev-A_manual.indd 121-122
15 Minute
Notification Status
Interval
85.4
14.6
39.9
95.1
4.9
22.1
95.0
5.0
46.8
97.2
2.8
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
Median CV Mean CV
(mg/dL)
175.3 4.6 6.0
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
final 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 fifth 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.
Number of Number of
Subjects Paired Readings
47 7319
122
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