User's Manual

Dexcom G5x System User Guide
Technical Information
280
Chapter 17
Everything Else G5x:
Technical Information
17.1 Device Performance Characteristics
NOTE: We recommend that you review the information in this chapter with
your healthcare professional to understand how well the G5 Mobile performs.
The G5 Mobile (the System) uses a glucose sensor to continuously measure
and monitor your glucose levels. The sensor is “calibrated” using a
commercially available BG meter. Once calibrated, the System reports
glucose readings up to every 5 minutes. The System was evaluated in clinical
studies in which System readings were compared to BG values to assess its
performance and how well the System readings compared to a laboratory test
method that measures BG values. Additionally, subjects performed self-
monitoring BG meter tests at home to assess the System performance in a
real use environment.
Although the performance characteristics of the System are presented in the
following, there is no commonly accepted statistical approach for capturing
performance of continuous glucose monitors (CGMs), such as the G5 Mobile.
Clinical Study Overview
The System performance was evaluated in four separate prospective clinical
studies. Two studies included adults, and two studies included pediatrics. In
the following sections and tables, the studies will be identified as follows:
Adult Studies (18 years and older)
Original Adult Study: the receiver included software version SW10050
Software 505 Adult Study: the receiver included software version
SW10505
Pediatric Studies (2 to 17 years)
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