Dexcom G4 User Manual page 24

Table 12. CGM System Difference to SMBG within CGM Glucose Ranges
CGM Glucose Ranges
1
(mg/dL)
Overall
*40-60
*61-80
81-180
181-300
301-350
351-400
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as
* For CGM ≤ 80 mg/dL, the differences in mg/dL are included instead of percent differences (%).
Table 12 is categorized within CGM glucose ranges. Overall, the System in the
average, 0.4% lower (Mean Percent Difference) than SMBG values and 14.0% absolute different (Mean
Absolute Percent Difference) than the SMBG values. The Median Percent Difference shows that half of the
time the System reads -1.4% or less than the SMBG values and the Median Absolute Percent Difference
shows that half of the time the System reads about 11.0% or less different than SMBG values.
Overall, the System in the
than SMBG values and 11.3% absolute different (Mean Absolute Percent Difference) than the SMBG
values. The Median Percent Difference shows that half of the time the System reads lower in 2.7% or less
Number of Paired
Study
2
CGM-SMBG
Original 7508
Software 505 2992
Original 731
Software 505 221
Original 968
Software 505 336
Original 3141
Software 505
1362
Original
1960
Software 505
826
Original
450
Software 505
161
Original
258
Software 505 86
Software 505 Study reads, on average, 2.6% lower (Mean Percent Difference)
Median
Mean Percent
Percent
Difference
Difference
-0.4% -1.4%
-2.6% -2.7%
-9.3 -8.0
-10.3 -6.0
-1.0 1.0
-4.0 -2.0
1.4% 0.0%
-2.6% -3.1%
-0.7% -2.8%
-1.4% -2.0%
-0.7% -2.6%
-0.0% 0.0%
5.0% 3.0%
3.9% 3.2%
Original (SW10050) or
Mean Absolute
Percent
Difference
Difference
14.0%
11.3%
11.7
13.0
10.7
10.1
14.2%
11.4%
13.0%
9.5%
10.5%
8.3%
11.9%
8.1%
Software 505 (SW10505).
Original Study reads, on
Median
Absolute
Percent
11.0%
8.6%
8.0
8.0
8.0
7.0
11.0%
8.9%
10.3%
7.4%
8.6%
6.0%
8.6%
6.7%