Device Performance Characteristics - Dexcom SEVEN PLUS User Manual

10.1

DEVICE PERFORMANCE CHARACTERISTICS

NOTE: The Performance Characteristics section of this User's Guide has changed
to reflect the recent study done. The overall results of the trial showed that this next-
generation SEVEN System will provide you more continuous glucose readings, and you
should expect more of your Sensors to provide data for the entire 7-day use period. Note
that the data described in the Performance Section also showed a difference from this
generation SEVEN device to the original SEVEN device in performance in the low glucose
region (40-80 mg/dL).
Our study showed that at 50 mg/dL blood glucose, the device reported glucose to be as
high as 64 mg/dL and at 80 mg/dL blood glucose; the device reported glucose to be as
high as 90 mg/dL. Because the performance of the Next-Generation SEVEN System
varies from the original, it is important that you assess how the new generation device
performs for you, especially in the low range. You should review the performance of this
device with your healthcare provider to understand how well the Next-Generation SEVEN
System performs.
The SEVEN PLUS uses a glucose Sensor to continuously measure and monitor your glucose
levels. The Sensor is "calibrated" using your OneTouch
Upload) or a FDA-cleared blood glucose meter (using the OpenChoice
calibrated, the SEVEN PLUS reports glucose readings up to every 5 minutes. In a clinical
study, SEVEN PLUS readings were compared to blood glucose measurements in order to
assess its performance or how well the SEVEN PLUS measurements compare to a laboratory
method that measures blood glucose levels. Clinical Study findings are presented below.
Although presentations to characterize performance of the SEVEN PLUS
are given below, there is no commonly accepted statistical approach for capturing performance
of continuous glucose monitors such as the SEVEN PLUS. Performance may be best
understood by viewing graphs called
"time-elapsed plots". In these plots, the readings from the SEVEN PLUS were recorded over
time and were overlaid with readings taken at the same time with a reference laboratory
method. Three representative time-elapsed plots are presented in this section (see Figures
2-3). They are examples of excellent, average and poor SEVEN PLUS performance.
Ultra blood glucose meter (Auto
® ®
feature). Once
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