System Difference To Smbg Within Cgm Glucose Ranges (Pediatric); Agreement And Accuracy Relative To Smbg - Dexcom G5 User Manual

Table 12-B. System Difference to SMBG Within CGM Glucose Ranges
(Pediatric)
CGM
Glucose
Study
Range
1
(mg/dL)
Original
Overall
Software 505
Original
*40-60
Software 505
Original
*61-80
Software 505
Original
81-180
Software 505
Original
181-300
Software 505
Original
301-350
Software 505
Original
351-400
Software 505
CGM readings are within 40 to 400 mg/dL, inclusive.
1
Both sets of study data are presented and are labeled as
2
505
(SW10505).
* For CGM ≤ 80 mg/dL, the differences in mg/dL are included instead of percent differences (%).

Agreement and Accuracy Relative to SMBG

Agreement between the system and BG values is also characterized using paired system and SMBG
results (Table 11-A/B to 12-A/B). The system and SMBG values were compared by pairing the
comparative SMBG value to a system glucose reading that occurred immediately after the SMBG was
collected. These results characterize the performance that subjects expect during real-time use of the
system in their daily diabetes management when comparing the system readings to their home BG
meter results. For readings less than or equal to 80 mg/dL, the absolute difference in mg/dL between
the two glucose results was calculated. For values greater than 80 mg/dL, the absolute percent
Dexcom G5 Mobile System User Guide
Technical Information
Number
2 of Paired
CGM-SMBG
16318
4264
487
240
1340
399
7084
1650
5627
1526
1176
319
604
130
Mean Median
Percent Percent
Difference Difference
2.2% 0.9%
-0.7% -1.1%
-22.1 -17.0
-15.9 -14.0
-11.8 -8.0
-7.8 -6.0
1.1% -1.0%
-1.2% -2.6%
5.7% 3.4%
1.7% 0.9%
9.6% 7.2%
6.7% 5.9%
12.7% 10.2%
12.0% 8.9%
Original
Mean
Absolute
Percent
Difference
15.3%
12.5%
23.9
16.9
17.0
13.7
15.4%
12.1%
13.5%
10.1%
14.2%
11.8%
16.1%
15.7%
(SW10050) or Software
Median
Absolute
Percent
Difference
11.1%
9.5%
18.0
14.0
11.0
10.0
11.4%
9.5%
9.5%
7.7%
10.4%
8.9%
11.9%
10.6%
336