User's Manual

Dexcom G5x System User Guide
Technical Information
281
Original Pediatric Study: the receiver included software version
SW10050
Software 505 Pediatric Study: the receiver included software version
SW10505
The G5 Mobile incorporates the algorithm from software version SW10505
and has a new software number.
Overview of Adult Studies
The System performance for adults was evaluated in two separate
prospective clinical studies: Original Adult Study (software SW10050) and
the Software 505 Adult Study (software 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 here.
The Original Adult Study enrolled 72 subjects, and the Software 505
Adult Study enrolled 51 subjects. All subjects had Type 1 or Type 2 diabetes
mellitus, and required insulin or oral medication to manage their diabetes. In
the Original Adult Study, 83% of subjects had Type 1 diabetes, and 17% of
subjects had Type 2 diabetes. In the Software 505 Adult Study, 86% of
subjects had Type 1 diabetes, and 14% of subjects had Type 2 diabetes. Both
studies included subjects greater than 18 years of age.
Subjects in both studies used the System for seven days. In the Original
Adult Study, thirty-six subjects each wore 2 sensors; in the Software 505
Adult Study, all subjects wore 1 sensor only. Throughout the 7-day wear
period, the sensor was calibrated with an average of 2 fingersticks per day
(approximately once every 12 hours). In the Original Adult Study, subjects
used the LifeScan
®
OneTouch
®
Ultra
®
2 meter and in the Software 505
Adult Study, subjects used Bayer’s CONTOUR
®
NEXT USB meter.
In the Original Adult Study, all subjects were evaluated in a controlled clinic
environment on all three clinic days: Day 1, Day 4, and Day 7 of the 7-day
wear period. In the Software 505 Adult Study, subjects were evaluated in
one of the three clinic days so there are fewer data samples than in the
Original Adult Study. While using the System in the clinic, subjects had their
BG measured every 15 minutes with a reliable laboratory method, the Yellow
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