Sensor Stability
Sensors can be worn for up to 10 days. Performance was estimated by calculating
the percentage of G6 readings within 15 mg/dL or 15% (15/15%), 20 mg/dL or 20%
(20/20%), and 40 mg/dL or 40% (40/40%), of the YSI values at the beginning (Day
1, 2), middle (Day 4, 5) and end (Day 7, 10) of the G6 lifecycle. For blood glucose
values less than or equal to 70 mg/dL, the absolute difference in mg/dL between the
two glucose results was calculated. For values greater than 70 mg/dL, the absolute
difference (%) relative to the YSI values was calculated. In addition, the mean absolute
relative difference (MARD) shows the average amount the sensor readings differ from
the YSI glucose. The MARD values included in Table 6-A and 6-B show consistent
accuracy and sensor stability over the 10-day life of the sensor.
Table 6-A. Sensor Stability Relative to YSI (Accuracy over Time
Number
Wear
of paired
Period
CGM-YSI
Beginning
6,696
Middle
6,464
End
6,169
CGM readings are within 40-400 mg/dL, inclusive.
1
Dexcom G6
®
System User Guide
Appendix F: Technical Information
Percent
MARD
within
(%)
15/15% YSI
(%)
10.9
76.5
9.2
84.3
9.6
82.3
) (Adults; n=159)
1
Percent
Percent
within
within
20/20% YSI
40/40% YSI
(%)
88.0
99.6
94.6
99.8
92.4
99.8
(%)
310
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