Dexcom Pro Q User Manual page 47

Continuous glucose monitoring system
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Table 1-A. G6 Accuracy to YSI (n=324)
Patient
Number of
Population
subjects
Overall
Adults
(18+ YO)
Pediatrics
(6-17 YO)
Pediatrics
(2-5 YO)*
* No YSI measurements were taken for this age group; results presented are from
in-clinic CGM-SMBG matched paired measurements.
CGM readings are within 40-400 mg/dL, inclusive.
1
Table 1-B. G6 Accuracy to YSI within CGM Glucose Ranges (Adults; n=159)
CGM
Number
Glucose
of paired
Range
1
CGM-YSI
(mg/dL)
<54
383
54-69
1,537
70-180
9,453
181-250
4,093
>250
3,863
CGM readings are within 40-400 mg/dL, inclusive.
1
Dexcom Pro Q
System User Guide
Appendix E: Technical Information
Total number
of paired
CGM-YSI
324
25,101
159
19,329
165
5,772
8
82
Percent
Percent
Percent
within
within
within
15 mg/dL
20 mg/dL
40 mg/dL
YSI
YSI
YSI
84.3
90.6
89.6
95.1
Percent within
20/20%
YSI
% (95% LB)
91.7 (90.6)
91.6 (90.3)
92.0 (89.8)
92.7 (86.6)
Percent
Percent
within
within
15%
20%
YSI
YSI
98.4
99.5
74.1
86.8
80.2
92.1
91.1
97.7
Day 1
Percent
MARD
within
(%)
20/20%
YSI
87.8
9.8
87.1
9.9
90.2
9.6
NA
9.9
Percent
Mean
within
MARD
bias
40%
(%)
(mg/dL)
YSI
-6.9
13.8
-0.5
11.5
99.3
-2.8
10.9
99.9
-10.0
9.3
100.0
-3.8
7.1
45

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