Dexcom G5 User Manual page 303

and 1% had Type 2 diabetes. In the
Sensors were inserted in either the abdomen or upper buttocks.
Subjects in all studies used the system for seven days. In the
wore 2 sensors; in the
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
Pediatric
Study used the LifeScan
used Bayer's CONTOUR
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
is referred to as the "YSI." In the
intentionally manipulated during this study; in the
had their glucose levels intentionally manipulated during the clinic session. Readings from the system
were reported every 5 minutes and paired with YSI values collected every 15 minutes 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."
Dexcom G5 Mobile System User Guide
Technical Information
Software 505 Pediatric
Software 505 Pediatric
OneTouch
®
NEXT USB meter.
®
Original Pediatric
Study, all subjects had Type 1 diabetes.
Original Pediatric
Study, all subjects wore 1 sensor only. Throughout
Verio IQ meter; the
® ®
™
Study, subjects' glucose levels were not
Software 505 Pediatric
Study, all subjects
Software 505 Pediatric
Glucose Analyzer. This instrument
Study, subjects ages 13-17
Original
Study
301