User's Manual

Dexcom G5x System User Guide
Technical Information
282
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 and 1% had Type 2 diabetes. In the Software
505 Pediatric Study, all subjects had Type 1 diabetes. Sensors were
inserted in either the abdomen or upper buttocks.
Subjects in all studies used the System for seven days. In the Original
Pediatric Study, all subjects wore 2 sensors; in the Software 505
Pediatric Study, all subjects wore 1 sensor only. Throughout the 7-day wear
period, the sensors were calibrated with an average of 2 fingersticks per day
(approximately once every 12 hours), using self-monitoring BG (SMBG) meter
values. The Original Pediatric Study used the LifeScan
®
OneTouch
®
Verio
®
IQ meter; the Software 505 Pediatric Study used Bayer’s
CONTOUR
®
NEXT USB meter.
All subjects were evaluated in a controlled clinic environment on Day 1, Day 4,
or Day 7 of the 7-day wear period. While using the System in the clinic,
subjects provided at least two fingerstick measurements per hour, and
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