Dexcom G4 Platinum User Manual page 177

Agreement and Accuracy Relative to SMBG
During the study, agreement between the System and blood glucose
values is also characterized using paired System and SMBG results
(Tables 11-12). The System and SMBG values were compared by
pairing the comparative SMBG value to a System glucose reading that
occurred immediately after the SMBG was collected. These results
characterize the performance patients expect during real-time use of the
system in their daily diabetes management when comparing the system
readings to their home blood glucose meter results.
Table 11. System Agreement to SMBG Within CGM
Glucose Ranges (Pediatric Study)
CGM Glucose Number
Ranges of paired
mg/dL
(mmol/L)
Overall
40-60 (2.2-3.3)
61-80 (3.4-4.4)
81-180
(4.5-10.0)
181-300
(10.1-16.7)
301-350
(16.7-19.4)
351-400
(19.4-22.2)
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Percent
within
CGM- 15/15%
SMBG SMBG
16318 64%
487 44%
1340 59%
7084 62%
5627 69%
1176 65%
604 58%
Dexcom G4 PLATINUM (Pediatric) System User's Guide
Percent Percent
within within
20/20% 30/30%
SMBG SMBG
76% 89%
55% 68%
70% 85%
74% 90%
80% 90%
77% 90%
72% 86%
Percent
Percent
greater
within
than
40/40%
40/40%
SMBG
SMBG
95% 5%
81% 19%
93% 7%
95% 5%
95% 5%
96% 4%
94% 6%
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