Freestyle Libre 2 Manual Del Usuario página 139

ART46983-001_rev-A 24-Aug-2022 2:30pm
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Alarm Performance
The tables in this section show the accuracy of the System's Low and High Glucose Alarms. The Alarm
Rate tells you how often the alarm is right or wrong. The Detection Rate tells you how often the System
is able to recognize and notify you about a low or high glucose event.
Low Glucose Alarm Performance
Tables A-5a and A-5b display the percentages for these parameters:
True Alarm Rate
Tells you: When you got a low glucose alarm, were you actually low?
Definition: Percentage of time the alarm issued and blood glucose was below the alarm level within 15
minutes before or after the alarm.
False Alarm Rate
Tells you: Did you get a low glucose alarm that you shouldn't have?
Definition: Percentage of time the alarm issued and blood glucose was not below the alarm level within
15 minutes before or after the alarm.
Detection Rate
Tells you: When you were low, did you get a low glucose alarm?
Definition: Percentage of time blood glucose was below the alarm level and the alarm issued within 15
minutes before or after the glucose event.
Missed Detection Rate
Tells you: When you were low, did you miss a low glucose alarm?
Definition: Percentage of time blood glucose was below the alarm level and the alarm didn't issue
within 15 minutes before or after the glucose event.
For example, the Adult study found that for a Low Glucose alarm level set to 70 mg/dL:
86.0% of the time a low glucose alarm was received when blood glucose was indeed below the alarm
level but 14.0% of the time a low glucose alarm was received when blood glucose wasn't actually below
the alarm level.
89.3% of the time blood glucose was below the alarm level and a low glucose alarm was appropriately
issued but 10.7% of the time the glucose event was missed and no alarm was issued.
Table A-5a: Low Glucose Alarm Performance (Adult; n=144)