Chapter 17 - Technical Information; Device Performance Characteristics - Dexcom G5 mobile User Manual

Chapter 17
Everything Else G5:
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 Dexcom G5 Mobile CGM System performs.
The Dexcom G5 Mobile CGM System (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 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 Mobile CGM System.
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
Pediatric Studies (2 to 17 years)
Original Pediatric Study: the Receiver included software version SW10050
Software 505 Pediatric
The Dexcom G5 Mobile CGM System incorporates the algorithm from software version SW10505 and
has a new software number.
Overview of Adult Studies
The System performance for adults was evaluated in two separate prospective clinical studies:
Original Adult Study (software SW10050) and the
Dexcom G5 Mobile System User Guide
Technical Information
Study: the Receiver included software version SW10505
Study: the Receiver included software version SW10505
Software 505 Adult Study (software SW10505).
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