Dexcom G4 Professional User Manual page 201

14
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
CGM
Glucose Number
Ranges of paired
mg/dL CGM-SMBG
(mmol/L)
Overall 7508
40-60
(2.2-3.3)
61-80
(3.4-4.4)
81-180
(4.5-10.0)
181-300
1960
(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.
Table 11 is categorized within CGM glucose ranges. For readings less
than or equal to 80 mg/dL (4.4 mmol/L) the absolute difference in mg/dL
(mmol/L) between the two glucose results was calculated. For values
greater than 80 mg/dL (4.4 mmol/L) the absolute percent difference
(%) from the SMBG values was calculated. The percentages of total
readings within 15 mg/dL (0.8 mmol/L) or 15%, 20 mg/dL (1.1 mmol/L)
or 20%, 30 mg/dL (1.7 mmol/L) or 30%, 40 mg/dL (2.2 mmol/L) or 40%
200 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Percent
within
15/15%
SMBG
69%
731 75%
968 78%
3141 65%
68%
450 77%
258 75%
Percent Percent
within within
20/20% 30/30%
SMBG SMBG
81% 94%
84% 92%
86% 95%
78% 93%
81% 94%
88% 98%
85% 95%
Percent
Percent
greater
within
than
40/40%
40/40%
SMBG
SMBG
98% 2%
96% 4%
99% 1%
98% 2%
97% 3%
99% 1%
98% 2%