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Freestyle Libre 2 Manual Del Usuario página 150

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ART46983-001_rev-A 24-Aug-2022 2:30pm
Definition: Percentage of time the alarm issued, and blood glucose was above the alarm level within 15
minutes before or after the alarm.
False Alarm Rate
Tells you: Did you get a high glucose alarm that you shouldn't have?
Definition: Percentage of time the alarm issued, and blood glucose was not above the alarm level within
15 minutes before or after the alarm.
Detection Rate
Tells you: When you were high, did you get a high glucose alarm?
Definition: Percentage of time blood glucose was above the alarm level and the alarm issued within 15
minutes before or after the glucose event.
Missed Detection Rate
Tells you: When you were high, did you miss a high glucose alarm?
Definition: Amount of time blood glucose was above 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 High Glucose alarm level set to 200 mg/dL:
99.2% of the time a high glucose alarm was received when blood glucose was indeed above the alarm
level but 0.8% of the time a high glucose alarm was received when blood glucose wasn't actually above
the alarm level.
97.0% of the time blood glucose was above the alarm level and a high glucose alarm was appropriately
issued but 3.0% of the time the glucose event was missed, and no alarm was issued.
Table B-5c: High Glucose Alarm Performance (Adult; n=144)
Table B-5d: High Glucose Alarm Performance (Pediatric*; n=106)
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Sensor Accuracy Over Time
The percentage of System readings within YSI values and the Mean Absolute Relative Di!erence (MARD)

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46983-001