Dexcom G4 Professional User's Guide download pdf (Page 143)

Dexcom G4 PLATINUM User’s Guide | 143

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, 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.

Participants used the System for seven days. Thirty-six participants

each wore 2 sensors. Sensors were calibrated approximately once

every 12 hours, using the self-monitoring blood glucose (SMBG)

meter values obtained from the LifeScan® OneTouch® Ultra®2 meter.

Throughout the 7-day wear period, the sensor was calibrated with an

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Dexcom G4 Professional User's Guide Page 143