User`s guide

200 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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
Ranges
mg/dL
(mmol/L)
Number
of paired
CGM-SMBG
Percent
within
15/15%
SMBG
Percent
within
20/20%
SMBG
Percent
within
30/30%
SMBG
Percent
within
40/40%
SMBG
Percent
greater
than
40/40%
SMBG
Overall 7508 69% 81% 94% 98% 2%
40-60
(2.2-3.3)
731 75% 84% 92% 96% 4%
61-80
(3.4-4.4)
968 78% 86% 95% 99% 1%
81-180
(4.5-10.0)
3141 65% 78% 93% 98% 2%
181-300
(10.1-16.7)
1960 68% 81% 94% 97% 3%
301-350
(16.7-19.4)
450 77% 88% 98% 99% 1%
351-400
(19.4-22.2)
258 75% 85% 95% 98% 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%