Freestyle Libre 2 Manuel D'utilisation page 63

* 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 Glucose Rate of Change Accuracy
The System's glucose rate of change (ROC) accuracy, as assessed by concurrence analysis, is presented
in Tables 4a and 4b Tables 4a and 4b. For example, in the Adult study, when the Sensor glucose rate of change
indicated that glucose was changing slowly (-0.06 to 0.06 mmol/L/min), actual glucose levels in the body
were falling quickly (<-0.1 mmol/L/min) 1.1% of the time, falling (-0.1 to -0.06 mmol/L/min) 6.5% of the
time, changing slowly (-0.06 to 0.06 mmol/L/min) 81.7% of the time, rising (0.06 to 0.1 mmol/L/min)
7.3% of the time, and were rising quickly (> 0.1 mmol/L/min) 3.5% of the time.
Table 4a: Concurrence Analysis by Glucose Rate of Change (Adult; Table 4a: Concurrence Analysis by Glucose Rate of Change (Adult; n=144)
Table 4b: Concurrence Analysis by Glucose Rate of Change (Paediatric*; n=129) Table 4b: Concurrence Analysis by Glucose Rate of Change (Paediatric*; n=129)
* Includes children 6–17 years of age. No YSI measurements were obtained for children 4–5 years of age.
Alarm Performance 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 recognise and notify you about a low or high glucose event.
Low Glucose Alarm Performance Low Glucose Alarm Performance
Tables 5a and 5b Tables 5a and 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
ART41758-100_rev-A 3:14pm 18-JAN-2021
n=144)