Dexcom G5 MOBILE User Manual page 292

Overview of Adult Studies
The System performance for adults was evaluated in two separate prospective clinical studies:
Original Adult
Study (software SW10050) and the
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 below.
Original Adult
The
subjects. All subjects had Type 1 or Type 2 diabetes mellitus, and required insulin or oral medication to
manage their diabetes. In the
subjects had Type 2 diabetes. In the
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
subjects each wore 2 sensors; in the
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
OneTouch Ultra 2 meter and in the
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NEXT USB meter.
Original Adult
In the
clinic days: Day 1, Day 4, and Day 7 of the 7-day wear period. In the
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 blood glucose 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 blood glucose 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
(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 below.
The Original Pediatric
and the Software 505 Pediatric
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
Dexcom G5 Mobile System User Guide
Technical Information
Study enrolled 72 subjects, and the
Original Adult
Software 505 Adult
Software 505 Adult
Software 505 Adult
Study, all subjects were evaluated in a controlled clinic environment on all three
Original Pediatric
Study (SW10050) and the
Study enrolled 176 subjects, with 16% of subjects younger than 6-years old,
Study enrolled 79 subjects, with 20% of subjects younger than
Original Pediatric
Software 505 Adult
Software 505 Adult
Study, 83% of subjects had Type 1 diabetes, and 17% of
Study, 86% of subjects had Type 1 diabetes,
Original Adult
Study, all subjects wore 1 sensor only.
Original Adult
Study, subjects used the LifeScan
Study, subjects used Bayer's CONTOUR
Study, about 99% of subjects had Type 1 diabetes
Study (software SW10505).
Study enrolled 51
Study, thirty-six
Software 505 Adult
Software 505 Pediatric
®
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Study,
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Study
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