Freestyle Libre 2 Manual Del Usuario página 146

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.
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 B-2a and B-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 B-2a: Concurrence Analysis with 'LO' CGM Reading (Adult; n=144)
Table B-2b: Concurrence Analysis with 'LO' CGM Reading (Pediatric*; n=106)
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Tables B-2c and B-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
97.3% of the time, above 300 mg/dL 100.0% of the time, above 250 mg/dL 100.0 % of the time, and less
than or equal to 250 mg/dL 0.0% of the time.
Table B-2c: Concurrence Analysis with 'HI' CGM Reading (Adult; n=144)
Table B-2d: Concurrence Analysis with 'HI' CGM Reading (Pediatric; n=106)
Concurrence of System and Reference (CGM vs. YSI)
The percentage of concurring glucose values (CGM vs. YSI) in each glucose reference range is presented
for each CGM range in Tables B-3a and B-3b and for each YSI range in Tables B-3c and B-3d. For
example, in the Adult study, when the System glucose readings were within the 81 to 120 mg/dL range,
actual blood glucose values were between 40 and 60 mg/dL 0.0% of the time, between 61 and 80 mg/dL
10.2% of the time, between 81 and 120 mg/dL 70.0% of the time, between 121 and 160 mg/dL 18.6% of