System Difference To Ysi Within Cgm Glucose Ranges (Pediatric); Accuracy Relative To Ysi - Dexcom G5 User Manual

Table 4-B. System Difference to YSI Within CGM Glucose Ranges
(Pediatric)
CGM
Glucose
Study
Range
1
(mg/dL)
Original
Overall
Software 505
Original
*40-60
Software 505
Original
*61-80
Software 505
Original
81-180
Software 505
Original
181-300
Software 505
Original
301-350
Software 505
Original
351-400
Software 505
CGM readings are within 40 to 400 mg/dL, inclusive.
1
Both sets of study data are presented and are labeled as
2
505
(SW10505).
* For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included instead of percent
differences (%).

Accuracy Relative to YSI

Accuracy between matched pairs was also estimated by calculating the percent difference between
the system reading and the YSI value. For example, if the YSI value is 100 mg/dL and the system
reading is 90 mg/dL, a 10% difference between the system and the YSI is reported. The system and
YSI values were compared by pairing the system reading that fell immediately after the YSI value
was collected.
Dexcom G5 Mobile System User Guide
Technical Information
Number
of Paired
2
CGM-YSI
2922
2262
19
86
76
142
1155
805
1380
957
206
209
86
63
Mean Median
Percent Percent
Difference Difference
13.5% 11.6%
1.8% 1.2%
-18.1 -9.1
-15.3 -13.2
-3.7 -2.3
-4.8 -1.0
11.9% 9.7%
1.9% 0.7%
14.8% 12.4%
2.2% 1.0%
19.2% 15.9%
7.8% 6.5%
18.5% 15.5%
14.9% 11.6%
Original
Mean
Absolute
Percent
Difference
17.4%
10.4%
19.2
16.1
13.4
11.8
17.0%
10.6%
17.4%
8.1%
19.4%
11.0%
19.1%
15.2%
Software
(SW10050) or
Median
Absolute
Percent
Difference
13.5%
7.9%
9.1
13.2
10.6
7.7
13.0%
8.1%
13.3%
6.5%
15.9%
7.9%
15.5%
11.6%
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