User`s guide
Dexcom G4 PLATINUM User’s Guide | 151
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CHAPTER 14: TECHNICAL INFORMATION
14.1 DEVICE PERFORMANCE
CHARACTERISTICS
NOTE: We recommend that you review the information in this chapter
with your healthcare provider to understand how well the Dexcom G4
PLATINUM System performs.
The Dexcom G4 PLATINUM 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; and once calibrated the System reports glucose readings up to
every 5 minutes. The System was evaluated in a clinical study 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 G4 PLATINUM System.
Clinical Study Overview
The System performance was evaluated in two separate prospective
clinical studies: the Original Receiver Software Study (SW10050) and
the Software 505 Receiver Software Study (SW10505). Differences
between the studies include the number of subjects enrolled, the
number of Systems worn by each participant, the SMBG meter used,
and the number of clinic days each subject participated in during the
study. An overview of each study is provided below. Both sets of study
data are presented in the tables that follow and are labeled as Original
Study or Software 505 Study from this point forward.
The Original Study enrolled 72 subjects, and the Software 505 Study
enrolled 51 subjects. All subjects had Type 1 or Type 2 diabetes mellitus,