Dexcom G5 - Page 303

Dexcom G5 Mobile System User Guide
301Technical Information
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 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 Original Pediatric Study, subjects’ glucose levels were not
intentionally manipulated during this study; in the Software 505 Pediatric Study, subjects ages 13-17
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.”