User's Manual

Dexcom G5x System User Guide
Technical Information
324
Agreement and Accuracy Relative to SMBG
Agreement between the System and BG 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 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 difference (%) from the SMBG values was calculated. The
percentages of total readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30
mg/dL or 30%, 40 mg/dL or 40% or greater than 40 mg/dL or 40% were then
calculated.
For example, if the System reads 100 mg/dL, it is between 81-180 mg/dL
range and you can expect the System readings to be within 20% of the SMBG
values 85% of the time for the Software 505 Adult Study, as seen in Table
11-A.
Overall, the System in the Software 505 Adult Study reads, on average,
2.6% lower (Mean Percent Difference) 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 than the SMBG values and the Median Absolute Percent
Difference shows that half of the time the System reads about 8.6% or less
different than SMBG values, as seen in Table 12-A.
Adverse Events
No serious adverse events or device-related serious adverse events occurred
during the studies. Mild to moderate skin irritation, such as erythema or
edema, occurred at the sensor needle insertion area or around the adhesive
area. No infection, bruising, or bleeding occurred at the sensor needle
insertion area or the adhesive area.
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