User's Manual

96
Table 7. Percentage of System Readings
1
within YSI Values with Data Stratified in
2-Hour Increments after Calibration
Time from
Calibration
Study
2
Number of
paired
CGM-YSI
Percent
within
15/15%
YSI
Percent
within
20/20%
YSI
Percent
within
30/30%
YSI
Percent
greater
than
40/40%
YSI
0-2 hours
Original 1929 78% 88% 96% 2%
Advanced 469 93% 97% 99% 0%
2-4 hours
Original 1516 69% 81% 91% 4%
Advanced 389 90% 97% 99% 0%
4-6 hours
Original 1547 69% 79% 91% 5%
Advanced 383 85% 91% 97% 2%
6-8 hours
Original 1520 68% 79% 92% 3%
Advanced 380 79% 90% 97% 2%
8-10 hours
Original 1555 71% 82% 92% 4%
Advanced 347 83% 92% 98% 0%
10-12 hours
Original 1068 65% 77% 91% 4%
Advanced 295 80% 90% 98% 0%
12-14 hours
Original 17 65% 76% 82% 12%
Advanced 0 -- -- -- --
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as
Original
(SW10050) or
Advanced
(SW10505).
Calibration Stability
The System must be calibrated every 12 hours. To demonstrate performance of the System over a 12-hour
calibration period, Systems were evaluated to verify that performance remains consistent over the 12-hour
calibration period. Systems were evaluated in 2-hour increments after calibration. Performance was
estimated at each 2-hour interval and stratified by glucose values by calculating the percentage of System
readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30 mg/dL or 30%, 40 mg/dL or 40% and greater than
40 mg/dL or 40% of the YSI values in Table 7.