Product Info

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 6, 7, and 8, 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 21
subjects (2 to 6 years old) wearing the Guardian Link (3) Transmitter that served as
a glucose sensor recorder (GSR, transmitter/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 H-1 shows the sensor accuracy measured by the mean absolute relative
difference (MARD). MARD represents the average relative difference (regardless if
positive or negative) between the sensor glucose (SG) values and the paired blood
glucose values measured by YSI (or BGM).
Table H-1: SG MARD Versus YSI or BGM (within YSI glucose ranges)
YSI Glucose
Ranges
(mg/dL)
Abdomen Insertion Site Buttock Insertion Site
Calibration every 12 hours Calibration 3 or 4 times a day Calibration every 12 hours Calibration 3 or 4 times a day
Number of
Paired SG-YSI
Mean
Absolute
Relative
Difference
(%)
Number of
Paired SG-YSI
Mean
Absolute
Relative
Difference
(%)
Number of
Paired SG-YSI
Mean
Absolute
Relative
Difference
(%)
Number of
Paired SG-YSI
Mean
Absolute
Relative
Difference
(%)
Overall62 10.7 6210.9619510.115910.05
40-60*----221.5223
61-80*17171214.761211.51
81-180 26 10.12 26 10.12 99 10.72 78 11.54
181-300 30 11.9 30 11.98 73 7.09 60 6.03
301-350 5 6.73 5 9.46 8 6.63 7 7.5
351-400----17.71--
378 Chapter 17