Dexcom G5 User Manual page 264

Software 505 Pediatric
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:
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 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
subjects had Type 2 diabetes. In the
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
Study, thirty-six subjects each wore 2 sensors; in the
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
used the LifeScan
Study, subjects used Bayer's CONTOUR
In the Original Adult
environment on all three clinic days: Day 1, Day 4, and Day 7 of the 7-day
wear period. In the
of the three clinic days so there are fewer data samples than in the
Adult Study. While using the system in the clinic, subjects had their BG
measured every 15 minutes with a reliable laboratory method, the Yellow
Springs Instrument 2300 STAT Plus™ Glucose Analyzer. This instrument is
referred to as the "YSI." Readings from the system were reported every 5
minutes and paired with YSI values in order to characterize how well the
Dexcom G5 Mobile System User Guide
Technical Information
Study: the receiver included software version
Original Adult Study (software SW10050) and the
Study enrolled 72 subjects, and the
Study, 83% of subjects had Type 1 diabetes, and 17% of
® ®
OneTouch
Study, all subjects were evaluated in a controlled clinic
Software 505 Adult
Software 505 Adult
Original Adult
®
Ultra 2 meter and in the
®
NEXT USB meter.
Study, subjects were evaluated in one
Software
Software 505 Adult
Study, 86% of
Original Adult
Software 505 Adult
Study, subjects
Software 505 Adult
Original
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