Device Performance Characteristics - Dexcom G4 Professional User Manual

CHAPTER 14: TECHNICAL INFORMATION
14.1 DEVICE PERFORMANCE
CHARACTERISTICS
NOTE: We recommend that you review the information in this chapter to
understand how well the Dexcom G4 PLATINUM Professional System
performs. The Dexcom G4 PLATINUM Professional System is the same
as the Dexcom G4 PLATINUM System with the addition of the receiver
shield. Therefore, the Dexcom G4 PLATINUM System clinical study
is applicable to this system. The Dexcom G4 PLATINUM Professional
System uses a real-time algorithm and does not retrospectively process
sensor glucose data.
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 sensor 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,
patients 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 a prospective clinical study;
72 participants were enrolled. All participants had Type 1 or Type 2
diabetes mellitus, and required insulin or oral medication to manage
their diabetes. About 83% of participants had Type 1 diabetes and about
17% of participants had Type 2 diabetes. The study included subjects
greater than 18 years of age.
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