Freestyle Libre 2 Manual Del Usuario página 148

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.
† Levels out of System dynamic range
Glucose Rate of Change Accuracy
The System's glucose rate of change accuracy, as assessed by concurrence analysis, is presented in
Tables B-4a and B-4b. For example, in the Adult study, when the Sensor glucose trend arrow indicated
that glucose was changing slowly downward (-1 to 0 mg/dL/min (->)), actual glucose levels in the body
were falling quickly (<-2 mg/dL/min) 1.2% of the time, falling (-2 to -1 mg/dL/min) 8.5% of the time,
changing slowly downward (-1 to 0 mg/dL/min) 66.8% of the time, changing slowly upward (0 to
1 mg/dL/min) 19.6% of the time, rising (1 to 2 mg/dL/min) 2.7% of the time, and were rising quickly
(>2 mg/dL/min) 1.2% of the time. Digitally connected systems which do not utilize the System's trend
arrow calculations may see di!erent glucose rate of change accuracy.
Table B-4a: Concurrence Analysis by Glucose Rate of Change (Adult; n=144)
Table B-4b: Concurrence Analysis by Glucose Rate of Change (Pediatric*; n=106)
* 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 B-5a and B-5b display the percentages for these parameters:
True Alarm Rate