Tandem T:Slim X2 User Manual page 294

Chapter 30 – Technical Specifications
Study, all subjects wore 1 sensor only.
Throughout the 7-day wear period, the
sensors were calibrated with an aver-
age of 2 fingersticks per day (approx-
imately once every 12 hours), using
self-monitoring blood glucose (SMBG)
meter values. The Original Pediatric
Study used the LifeScan OneTouch
®
Verio IQ meter; the Software 505
®
Pediatric Study used Bayer's CON-
TOUR 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 CGM 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
TM
Analyzer. This instrument is referred to
as the "YSI." In the Original Pedi-
atric 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 CGM were reported
294
every 5 minutes and paired with YSI
values collected every 15 minutes 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."
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