User`s guide
174 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System
14
Table 12. CGM System Difference to SMBG within CGM
Glucose Ranges
CGM
Glucose
Ranges
1
(mg/dL)
Study
2
Number of
Paired
CGM-SMBG
Mean
Percent
Difference
(%)
Median
Percent
Difference
(%)
Mean
Absolute
Percent
Difference
(%)
Median
Absolute
Percent
Difference
(%)
Overall
Original
7508 -0.4% -1.4% 14.0% 11.0%
Software 505
2992 -2.6% -2.7% 11.3% 8.6%
*40-60
Original
731 -9.3 -8.0 11.7 8.0
Software 505
221 -10.3 -6.0 13.0 8.0
*61-80
Original
968 -1.0 1.0 10.7 8.0
Software 505
336 -4.0 -2.0 10.1 7.0
81-180
Original
3141 1.4% 0.0% 14.2% 11.0%
Software 505
1362 -2.6% -3.1% 11.4% 8.9%
181-300
Original
1960 -0.7% -2.8% 13.0% 10.3%
Software 505
826 -1.4% -2.0% 9.5% 7.4%
301-350
Original
450 -0.7% -2.6% 10.5% 8.6%
Software 505
161 -0.0% 0.0% 8.3% 6.0%
351-400
Original
258 5.0% 3.0% 11.9% 8.6%
Software 505
86 3.9% 3.2% 8.1% 6.7%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original
(SW10050) or Software 505 (SW10505).
*ForCGM≤80mg/dL,thedifferencesinmg/dLareincludedinsteadof
percent differences (%).