Dexcom G5 MOBILE User Manual page 298

Continuous glucose monitoring system
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Table 2-B. Number and Percentage of YSI Values When CGM Readings are
"LOW" or "HIGH" (Pediatric)
CGM
Study
Readings
Original
"LOW"
Software
505
CGM
Study
Readings
Original
"HIGH"
Software
505
Both sets of study data are presented and are labeled as
1
(SW10505).
Agreement When CGM Reads "LOW" or "HIGH"
The System reports glucose readings between 40 and 400 mg/dL. When the System determines the
glucose reading is below 40 mg/dL, it displays "LOW" in the Receiver Status Box. When the Dexcom
G5 determines that the glucose level is above 400 mg/dL, it displays "HIGH" in the Receiver 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 Tables 2-A and 2-B. 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").
Dexcom G5 Mobile System User Guide
Technical Information
CGM-YSI
1
Pairs
n
Cumulative
Percent
n
Cumulative
Percent
CGM-YSI
> 340
1
Pairs
n
Cumulative
Percent
n
Cumulative
Percent
YSI mg/dL
< 55
< 60
0
0
0%
0%
3
5
19%
31%
YSI mg/dL
> 320
> 280
38
51
54%
73%
14
19
58%
79%
Original
< 70
< 80
0
0
0%
0%
10
15
63%
94%
> 240
≤ 240
68
69
97%
99%
22
23
92%
96%
Software 505
(SW10050) or
Total
≥ 80
13
13
100%
1
16
6%
Total
1
70
1%
1
24
4%
296

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