Dexcom G5 User Manual page 265

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
and the Software 505 Pediatric
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
younger than 6-years old, and the
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
had Type 1 diabetes and 1% had Type 2 diabetes. In the
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
Pediatric Study, all subjects wore 2 sensors; in the
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
meter; the Software 505 Pediatric
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
subjects ages 6-17 also provided venous blood for comparison to a laboratory
method, the Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer.
This instrument is referred to as the "YSI." In the
Dexcom G5 Mobile System User Guide
Technical Information
Study (SW10505). Differences between the
Study enrolled 176 subjects, with 16% of subjects
Software 505 Pediatric
Original Pediatric
Study used the LifeScan
Study used Bayer's CONTOUR
Original Pediatric
Study, about 99% of subjects
Software 505 Pediatric
®
Original Pediatric
Study (SW10050)
Study enrolled 79
Software 505
Original
®
OneTouch Verio
®
NEXT
Study,
®
IQ
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