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 day 1, 3, or 7 for 6 hours each, over the life of the sensor.
Reference blood (plasma) glucose values were obtained with a 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 three to four times spread throughout the day.
The overall number of subjects that participated in FST procedures on day 1, 3, or
7 were 21, 13, and 10 respectively.
During the study, the meter was used for confirmation of alarms, treatment
decisions, and sensor calibrations.
Results
Sensor accuracy
The following information highlights the Guardian Sensor (3) performance from 50
subjects (7 to 13 years old) wearing the Guardian Link (3) Transmitter that served
as a glucose sensor recorder (GSR, transmitter and recorder for sensor-integrated
pump systems and the Guardian Connect Transmitter, which transmitted to the
Guardian Connect app, a standalone CGM display device) during FST.
Mean absolute relative difference, by number of daily calibrations
Table E-1 shows the sensor accuracy measured by the MARD. MARD represents the
average relative difference (regardless if positive or negative) between the SG
values and the paired BG values measured by YSI.
354 Chapter 17