Dexcom G5 mobile User Manual page 276

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
(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 blood glucose values is also characterized using paired System
and SMBG results (Table 11 to 12). 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 subjects expect during real-time use of the
System in their daily diabetes management when comparing the System readings to their home blood
glucose 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 difference (%) from the SMBG values was calculated. The percentages of total readings within
Dexcom G5 Mobile System User Guide
Technical Information
Number
of Paired
2
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%
Software 505
(SW10050) or
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%
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