Dexcom G5 Mobile - Page 328

Dexcom G5 Mobile System User Guide
326Technical Information
Table 12-B. System Difference to SMBG Within CGM Glucose Ranges
(Pediatric)
CGM
Glucose
Range
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 16318 2.2% 0.9% 15.3% 11.1%
Software 505 4264 -0.7% -1.1% 12.5% 9.5%
*40-60
Original 487 -22.1 -17.0 23.9 18.0
Software 505 240 -15.9 -14.0 16.9 14.0
*61-80
Original 1340 -11.8 -8.0 17.0 11.0
Software 505 399 -7.8 -6.0 13.7 10.0
81-180
Original 7084 1.1% -1.0% 15.4% 11.4%
Software 505 1650 -1.2% -2.6% 12.1% 9.5%
181-300
Original 5627 5.7% 3.4% 13.5% 9.5%
Software 505 1526 1.7% 0.9% 10.1% 7.7%
301-350
Original 1176 9.6% 7.2% 14.2% 10.4%
Software 505 319 6.7% 5.9% 11.8% 8.9%
351-400
Original 604 12.7% 10.2% 16.1% 11.9%
Software 505 130 12.0% 8.9% 15.7% 10.6%
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).
* 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 (Tables 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 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