Dexcom G4 PLATINUM User Manual page 100

range and you can expect the CGM readings to be within 20% of the SMBG values 78% of the time for the
System and 85% time for the
Original
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.
Advanced
Number of Paired
Study
2
CGM-SMBG
Original 7508
Advanced 2992
Original 731
Advanced 221
Original 968
Advanced 336
Original 3141
Advanced 1362
Original 1960
Advanced 826
Original 450
Advanced 161
Original 258
Advanced 86
System.
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%
(SW10050) or
Original
100
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%
(SW10505).
Advanced
Study reads, on
Original
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%