Tandem T:Slim X2 User Manual page 293

subjects had Type 1 or Type 2 diabetes
mellitus, and required insulin or oral
medication to manage their diabetes.
In the Original Adult Study, 83% of
subjects had Type 1 diabetes, and
17% of subjects had Type 2 diabetes.
In the Software 505 Adult 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
CGM for seven days. In the Original
Adult Study, thirty-six subjects each
wore 2 sensors; in the Software 505
Adult Study, all subjects wore 1 sen-
sor only. 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 Original Adult Study, subjects
used the LifeScan OneTouch
®
meter and in the Software 505 Adult
Study, subjects used Bayer's CON-
TOUR NEXT USB meter.
®
In the Original Adult Study, all sub-
jects were evaluated in a controlled
clinic environment on all three clinic
days: Day 1, Day 4, and Day 7 of the
Customer Technical Support: (877) 801-6901
7-day wear period. In the Software
505 Adult Study, subjects were evalu-
ated in one of the three clinic days so
there are fewer data samples than in
the Original Adult Study. While using
the CGM in the clinic, subjects had
their blood glucose measured every
15 minutes with a reliable laboratory
method, the Yellow Springs Instrument
2300 STAT Plus
This instrument is referred to as the
"YSI." Readings from the CGM were
reported every 5 minutes and paired
with YSI values in order to characterize
how well the CGM readings agreed
with laboratory standard blood glucose
results. The remainder of the study
took place at home, and the CGM
performance was also paired with the
comparative meter results, referred to
as the "SMBG."
Overview of Pediatric Studies
Ultra 2
® ®
The CGM performance for children and
adolescents was evaluated in two sep-
arate prospective clinical studies: the
Original Pediatric Study (SW10050)
and the Software 505 Pediatric Study
(SW10505). Differences between the
studies include the number of subjects
Chapter 30 – Technical Specifications
enrolled, the number of sensors worn
by each participant, the SMBG meter
used, the length of time subjects were
evaluated in a controlled clinic envi-
ronment 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.
Glucose Analyzer.
TM
The Original Pediatric Study enrolled
176 subjects, with 16% of subjects
younger than 6-years old, and the
Software 505 Pediatric Study enrolled
79 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 Orig-
inal Pediatric Study, about 99% of
subjects had Type 1 diabetes 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 but-
tocks.
Subjects in all studies used the CGM
for seven days. In the Original Pediat-
ric Study, all subjects wore 2 sen-
sors; in the Software 505 Pediatric
293