Freestyle Libre 2 Manual Del Usuario página 138

ART46983-001_rev-A 24-Aug-2022 2:30pm
Table A-3c: Concurrence Analysis by YSI Glucose Level (Adult; n=144)
† Levels out of System dynamic range.
Table A-3d: Concurrence Analysis by YSI Glucose Level (Pediatric*; n=129)
* 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 A-4a and A-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) 8.3% of the time,
changing slowly downward (-1 to 0 mg/dL/min ) 67.1% of the time, changing slowly upward (0
to 1 mg/dL/min ) 19.7% of the time, rising (1 to 2 mg/dL/min ) 2.6% 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 A-4a: Concurrence Analysis by Glucose Rate of Change (Adult; n=144)
Table A-4b: Concurrence Analysis by Glucose Rate of Change (Pediatric*; n=129)