Chapter 18 - Technical Information; Device Performance Characteristics - Dexcom G5 MOBILE User Manual

Chapter 18
Everything Else G5:
Technical Information

18.1 Device Performance Characteristics

NOTE: We recommend that you review the information in this chapter with your healthcare provider to
understand how well the Dexcom G5 performs.
The Dexcom G5 (the System) uses a glucose sensor to continuously measure and monitor your glucose
levels. The sensor is "calibrated" using a commercially available blood glucose 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 blood glucose values to assess its performance
and how well the System readings compare to a laboratory test method that measures blood glucose
values. Additionally, subjects performed self-monitoring blood glucose meter tests at home to assess
the System performance in 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 Dexcom G5.
Clinical Study Overview
The System performance was evaluated in four separate prospective clinical studies. In all four
studies, subjects were required to confirm glucose readings with their SMBG meters before making
any treatment decisions. 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)
Original Pediatric
Study: the Receiver included software version SW10050
Software 505 Pediatric Study: the Receiver included software version SW10505
The Dexcom G5 Mobile CGM System incorporates the algorithm from software version SW10505 and
has a new software number.
Dexcom G5 Mobile System User Guide
Technical Information
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