Freestyle Libre 2 Manual Del Usuario página 136

ART46983-001_rev-A 24-Aug-2022 2:30pm
Table A-1c: Accuracy to YSI within CGM Glucose Ranges (Pediatric*; n=129)
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
† System range is 40-400 mg/dL.
Table A-1d: Accuracy to YSI within YSI Glucose Ranges (Adult; n=144)
Table A-1e: Accuracy to YSI within YSI Glucose Ranges (Pediatric*; n=129)
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Agreement with 'LO' and 'HI' CGM Reading against YSI Reference
The System reports glucose concentrations between 40 and 400 mg/dL. When the System determines
that glucose level is below 40 mg/dL, it will report as 'LO'. When the System determines that glucose
level is above 400 mg/dL, it will report as 'HI'. Tables A-2a and A-2b display the concurrence between
the CGM and YSI reference glucose when CGM reads 'LO'. For example, in the Adult study, when CGM
reading was 'LO', YSI glucose values were less than 50 mg/dL 20.0% of the time, less than 60 mg/dL
40.0% of the time, less than 70 mg/dL 40.0% of the time, less than 80 mg/dL 80.0% of the time, and
equal to or above 80 mg/dL 20.0 % of the time.
Table A-2a: Concurrence Analysis with 'LO' CGM Reading (Adult; n=144)
Table A-2b: Concurrence Analysis with 'LO' CGM Reading (Pediatric*; n=129)
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Tables A-2c and A-2d display the concurrence between the CGM and YSI reference glucose when CGM
reads 'HI'. In the Adult study, when CGM reading was 'HI', YSI glucose values were above 350 mg/dL