Freestyle Libre 2 Manual Del Usuario página 137

ART46983-001_rev-A 24-Aug-2022 2:30pm
97.5% 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 A-2c: Concurrence Analysis with 'HI' CGM Reading (Adult; n=144)
Table A-2d: Concurrence Analysis with 'HI' CGM Reading (Pediatric; n=129)
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 A-3a and A-3b and for each YSI range in Tables A-3c and A-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 0.2% of the time, between 61 and 80 mg/dL
11.0% of the time, between 81 and 120 mg/dL 70.1% of the time, between 121 and 160 mg/dL 17.8% of
the time, between 161 and 200 mg/dL 0.8% of the time, and between 201 and 250 mg/dL 0.1% of the
time.
Table A-3a: Concurrence Analysis by CGM Glucose Level (Adult; n=144)
† Levels out of System dynamic range.
Table A-3b: Concurrence Analysis by CGM 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.