Chapter 14: Technical Information; Device Performance Characteristics - Dexcom G4 PLATINUM User Manual

CHAPTER 14: TECHNICAL INFORMATION

[Section 14.1 will be updated to reflect the labeling changes approved for P120005/S018]

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
Receiver Software Study (SW10050) and the
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
The Study enrolled 72 subjects, and the
Original
Type 1 or Type 2 diabetes mellitus, and required insulin or oral medication to manage their diabetes. In
the Study, 83% of subjects had Type 1 diabetes, and 17% of subjects had Type 2 diabetes. In
Original
the Study, 86% of subjects had Type 1 diabetes, and 14% of subjects had Type 2 diabetes.
Advanced
Both studies included subjects greater than 18 years of age.
Receiver Software Study (SW10505).
Advanced
Study or
Original Advanced
Advanced
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Study from this point forward.
Study enrolled 51 subjects. All subjects had
Original