Device Performance Characteristics - Dexcom G4 Platinum User Manual

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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 professional to understand how well the Dexcom
G4 PLATINUM (Pediatric) System performs.
The Dexcom G4 PLATINUM (Pediatric) 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, patients performed self-monitoring blood glucose
meter tests at home to assess the System performance in a real
use environment.
Although the performance characteristics of the System are presented
here, there is no commonly accepted statistical approach for capturing
performance of continuous glucose monitors (CGMs), such as the
Dexcom G4 PLATINUM (Pediatric) System.
Clinical Study Overview
The System performance for children and adolescents was evaluated
in an observational prospective clinical study; 176 subjects age 2 to
17 were enrolled, with 16% of subjects younger than 6-years old. All
subjects had Type 1 or Type 2 diabetes mellitus and required insulin
or oral medication to manage their diabetes. About 99% of subjects
had Type 1 diabetes and 1% had Type 2 diabetes. Sensors were
inserted in either the abdomen or upper buttocks. Performance was
similar between the two insertion sites. Subject's glucose levels were
not intentionally manipulated during this study, so there are fewer data
samples in the low and high glucose ranges than in the adult clinical
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