Device Performance Characteristics; Clinical Study Overview; Chapter 18 - Technical Information - Dexcom G5 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 HCP to
understand how well the Dexcom G5 Mobile performs.
The Dexcom 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 Dexcom G5 Mobile.

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 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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