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

Table 1-B. System Agreement 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 40-400 mg/dL, inclusive.
1
Both sets of study data are presented and are labeled as
2
505
(SW10505).

Agreement Relative to YSI

Agreement between the system and BG values is characterized using paired system and YSI values.
The system and YSI results were compared by pairing the YSI BG value to a system glucose reading
that occurred immediately after the YSI was collected.
The agreement of the system to BG value was assessed by calculating the percentage of system
readings that were within 15%, 20%, 30% and greater than 40% of the YSI values. For readings less
than or equal to 80 mg/dL the absolute difference in mg/dL between the two glucose results was
calculated. For values greater than 80 mg/dL the absolute percent difference (%) from the YSI values
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
Percent Percent
Within Within
15/15% 20/20%
YSI YSI
55% 68%
81% 91%
63% 74%
54% 74%
61% 82%
77% 82%
56% 69%
78% 88%
55% 68%
89% 96%
48% 62%
81% 91%
48% 61%
64% 81%
Original
Percent
Within
30/30%
YSI
85%
96%
79%
91%
92%
90%
84%
97%
85%
99%
80%
94%
79%
83%
Software
(SW10050) or
Percent
Greater
Than
40/40%
YSI
7%
2%
21%
3%
4%
3%
6%
1%
7%
1%
11%
5%
12%
8%
303