Dexcom SEVEN - 10.1 Device Performance Characteristics

Seven
™
System User’s Guide | 105
10.1 DEVICE PERFORMANCE CHARACTERISTICS
NOTE
We recommend that you have the information in this chapter reviewed by your
healthcare provider. We also suggest that you review this information with them in
order to understand how well the Seven System performs.
e Seven System uses a glucose Sensor Probe to continuously monitor your glucose
levels. e Sensor is “calibrated” using your OneTouch Ultra blood glucose meter (Auto
Upload) or a FDA cleared meter (Manual Entry). Once calibrated, the Seven System
reports glucose readings every 5 minutes. In a clinical study, Seven System readings were
compared to blood glucose measurements in order to assess its performance. Clinical
Study findings are presented below.
Although presentations to characterize performance of the Seven System are given
below, there is no commonly accepted statistical approach for capturing performance
of continuous glucose monitors such as the Seven System. Performance may be best
understood by viewing graphs called time-elapsed plots. In these plots, the readings from
the Seven System were recorded over time and were overlaid with readings taken at the
same time with a reliable laboratory method. ree representative time-elapsed plots
are presented in this section. ey are examples of good, average and poor Seven System
performance.