Dexcom G6 User Manual page 298

Agreement When CGM Reads "LOW" or "HIGH"
The G6 reports glucose readings between 40 and 400 mg/dL. When the G6 determines
the glucose reading is below 40 mg/dL, it displays "LOW" in the Receiver or Mobile
Application Status Box. When the G6 determines that the glucose level is above 400
mg/dL, it displays "HIGH" in the Receiver or Mobile Application Status Box. Because
the System does not display glucose values below 40 mg/dL or above 400 mg/dL, the
comparisons to the actual blood glucose levels (as determined by the YSI analyzer)
when CGM is classified as "LOW" or "HIGH" are included separately in Table 2 (data
is combined from Study 1 and Study 2). The tables include the numbers and the
cumulative percentages when YSI values were less than certain glucose levels (for
"LOW"), and when YSI values were greater than certain glucose levels (for "HIGH").
For example, when the G6 displayed "LOW" (139 occasions), 84% (117 out of 139)
of the YSI values were less than 80 mg/dL. When the G6 displayed "HIGH" (54
occasions), 100% (54 out of 54) of the YSI values were greater than 280 mg/dL.
Table 2. Distribution of YSI Values When CGM Readings are "LOW" or "HIGH"
CGM Readings
"LOW"
CGM Readings
"HIGH"
Dexcom G6 ® System User Guide
Appendix F: Technical Information
CGM-YSI
Pairs
< 55
n 65
Cumulative
47%
Percent
CGM-YSI
Pairs
> 340
n 53
Cumulative
98%
Percent
YSI (mg/dL)
< 60 < 70 < 80
80 95
58% 68% 84%
YSI (mg/dL)
> 320 > 280 > 250
53 54
98% 100% 100%
Total
≥ 80
117 22 139
16%
Total
≤ 250
54 0 54
0%
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