Dexcom G4 Platinum User Manual page 158

14
study (72 patients, age 18 and older).
Subjects used the System for seven days. All subjects wore 2 sensors.
Sensors were calibrated approximately once every 12 hours, using the
self-monitoring blood glucose (SMBG) meter values obtained from a
LifeScan OneTouch
®
LifeScan OneTouch
®
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, all subjects provided at least two fingerstick measurements
per hour, and subjects ages 6-17 also provided venous blood for
comparison to 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 collected every 15 minutes
in order to characterize how well the System readings agreed with
laboratory standard blood glucose results. The System performance
was also paired with the comparative LifeScan OneTouch Verio IQ
meter results, referred to as the "SMBG." The remainder of the study
took place at home where subjects took a minimum of 7 fingersticks
per day.
Agreement Relative to YSI
Agreement between the System and blood glucose values is
characterized using paired System and YSI values. The System and
YSI results were compared by pairing the YSI blood glucose value to
a System glucose reading that occurred immediately after the YSI was
collected.
The agreement of the System to blood glucose value was assessed by
calculating the percentage of System readings that were within 15%,
20%, 30%, 40% and greater than 40% of the YSI values. For readings
less than or equal to 80 mg/dL (4.4 mmol/L) the absolute difference
in mg/dL (mmol/L) between the two glucose results was calculated.
For values greater than 80 mg/dL (4.4 mmol/L) the absolute percent
difference (%) from the YSI values was calculated. The percentages
of total readings within 15 mg/dL (0.8 mmol/L) or 15%, 20 mg/dL (1.1
156 | Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System
Verio IQ meter. The adult clinical study used the
® ®
Ultra 2 meter.
® ®