System Agreement To Smbg Within Cgm Glucose Ranges (Pediatric) - Dexcom G5 User Manual

Table 11-B. System Agreement to SMBG 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).
Dexcom G5 Mobile System User Guide
Technical Information
Number
of Paired
2
CGM-SMBG
16,318
4264
487
240
1340
399
7084
1650
5627
1526
1176
319
604
130
Percent Percent
Within Within
15/15% 20/20%
SMBG SMBG
64% 76%
73% 84%
44% 55%
54% 71%
59% 70%
64% 76%
62% 74%
72% 84%
69% 80%
79% 89%
65% 77%
72% 83%
58% 72%
69% 79%
Original
(SW10050) or
Percent
Percent
Greater
Within
Than
30/30%
40/40%
SMBG
SMBG
89% 5%
94% 2%
68% 19%
86% 7%
85% 7%
92% 2%
90% 5%
95% 2%
90% 5%
97% 2%
90% 4%
94% 2%
86% 6%
86% 8%
Software
334