Product Info

The SG data collected by the blinded GSRs were retrospectively processed through
the real-time CGM algorithm. This is the same algorithm used in the Guardian
Connect and pump CGM systems. Thus all data is representative of real-time
sensor usage.
The CONTOUR NEXT LINK 2.4 Wireless Meter was the study meter used for all
calibrations in this study, and was the only meter evaluated with the Guardian
Sensor (3) CGM systems. The sensor has not been tested with other meters.
Therefore, the performance with other BG meters may differ from the performance
with the CONTOUR NEXT LINK 2.4 Wireless Meter described below.
FST was performed on days 1, 3, and 7 over the life of the sensor. Reference blood
(plasma) glucose values were obtained with a Yellow Springs Instrument (YSI)
Glucose Analyzer every 5 to 15 minutes. During the FSTs, the subjects were
instructed to calibrate the sensors once every 12 hours, or as requested by the
display device. During home use (outside the clinic), subjects were instructed to
calibrate both sensors 3 or 4 times spread throughout the day.
A total of 93 subjects previously diagnosed with type 1 or 2 diabetes were enrolled
in the study, and 88 subjects participated in at least one day of FST. The overall
number of subjects that participated in FST procedures on days 1, 3, and 7 were
88, 87, and 79, respectively. During each FST period, subjects with an established
insulin sensitivity ratio and insulin carbohydrate ratio underwent a hypoglycemic
challenge and a hyperglycemic challenge to evaluate performance at high and low
glycemic ranges.
During the study, subjects were instructed to continue with their current diabetes
regimen (including glucose monitoring with their own meter when appropriate)
independent of their use of the study devices. The insulin pumps were not used to
infuse insulin, and neither of the two real-time CGM systems nor the blinded GSR
system was used to manage diabetes during this study. The study meter was used
for confirmation of alerts, treatment decisions, and sensor calibrations.
Results
Sensor accuracy
The following information highlights the Guardian Sensor (3) performance from
88 subjects only during FST.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 329