User`s guide

152 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System
14
and required insulin or oral medication to manage their diabetes. In
the Original Study, 83% of subjects had Type 1 diabetes, and 17%
of subjects had Type 2 diabetes. In the Software 505 Study, 86% of
subjects had Type 1 diabetes, 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
Original Study, thirty-six subjects each wore 2 sensors; in the Software
505 Study, all subjects wore 1 sensor only. Throughout the 7-day wear
period,thesensorwascalibratedwithanaverageof2ngersticksper
day (approximately once every 12 hours). In the Original Study, subjects
used the LifeScan
®
OneTouch
®
Ultra
®
2 meter and in the Software 505
Study, subjects used Bayers CONTOUR
®
NEXT USB meter.
In the Original Study, all subjects were evaluated in a controlled clinic
environment on all three clinic days: Day 1, Day 4, and Day 7 of the
7-day wear period. In the Software 505 Study, subjects were evaluated
in one of the three clinic days so there are fewer data samples than
in the Original 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.”