120 | SEVEN
™
CONTINUOUS GLUCOSE MONITORING SYSTEM
SENSOR STABILITY
Sensors may be worn for up to 7 days. To verify that sensors perform consistently over the 7
days period, 94 Sensors were evaluated at Day 1, Day 4, and Day 7 of the lifecycle. Performance
was estimated by calculating the percentage of Seven System readings within 20%, 30% and
>40% of the YSI readings at the beginning (Day 1), middle (Day 4) and end (Day 7) of Seven
System lifecycle. Results are shown in the table below.
Table 10. Seven System Sensor Stability (Accuracy Over Time)
Day of Wear and
YSI Glucose Range
(mg/dL)
Number of Paired
Readings
% of Readings within
20% of YSI
% of Readings within
30% of YSI
% of Readings
greater than 40%
of YSI
Day 1
40-75* 36 69% 89% 11%
76-180 416 52% 77% 9%
181-350 401 75% 93% 1%
350-400 29 69% 100% 0%
Day 4
40-75* 33 82% 91% 3%
76-180 346 69% 81% 7%
181-350 325 62% 89% 3%
350-400 16 75% 94% 0%
Day 7
40-75* 76 68% 93% 0%
76-180 389 85% 95% 2%
181-350 251 86% 94% 3%
350-400 28 54% 89% 0%
*For the low glucose range (40-75 mg/dL), the reading shown is the percent within 20 mg/dL, 30 mg/dL or greater than 40 mg/dL).
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