Dexcom G5 Mobile System User Guide
300Technical Information
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 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 system readings agreed
with laboratory standard BG results. The remainder of the study took place at home, and the system
performance was also paired with the comparative meter results, referred to as the “SMBG.”
Overview of Pediatric Studies
The system performance for children and adolescents was evaluated in two separate prospective
clinical studies: the Original Pediatric Study (SW10050) and the Software 505 Pediatric Study
(SW10505). Differences between the studies include the number of subjects enrolled, the number of
systems worn by each participant, the SMBG meter used, the length of time subjects were evaluated
in a controlled clinic environment and whether or not subjects ages 13-17 had their glucose levels
intentionally manipulated during the study. An overview of each study is provided here.
The Original Pediatric Study enrolled 176 subjects, with 16% of subjects younger than 6-years old,
and the Software 505 Pediatric Study enrolled 79 subjects, with 20% 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. In the Original Pediatric Study, about 99% of subjects had Type 1 diabetes
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