User`s guide

Dexcom G4 PLATINUM User’s Guide | 175
Table 12 is categorized within CGM glucose ranges. Overall, the System
in the Original Study reads, on 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.
Overall, the System in the Software 505 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.
Adverse Events
No serious adverse events or device-related serious adverse events
occurred during either study. Mild or very slight skin irritation, such as
erythema or edema, occurred in low frequency around the adhesive
area. No infection, bruising, or bleeding occurred at the sensor needle
insertion area or the adhesive area.