Product Info

Table 29. Trend Accuracy; Calibration 3 or 4 times a day, Buttock
SG Rate
Ranges (mg/
dL/min)
Percent of Matched Pairs-in Each YSI Rate Range for Each SG Rate Range
YSI (mg/dL/min)
Number of
Paired SG-YSI
<-2 [-2, -1) [-1, 0) [0, 1] (1, 2] >2
>2 7 0.0% (0/7) 0.0% (0/7) 0.0% (0/7) 0.0% (0/7) 42.9% (3/7) 57.1% (4/7)
Precision
Precision of the System was evaluated by comparing the results from two separate
sensors worn on the same subject at the same time.
Data from two sensors worn at the same time for 2 subjects in the abdomen/
abdomen insertion locations provided 124 pairs of CGM Measurements, with a
mean Percent Absolute Relative Difference (PARD) during the study of 10.29% and
a coefficient of variation (%CV) of 7.6%.
Data from two sensors worn at the same time for 2 subjects in the abdomen/
abdomen insertion locations provided 124 pairs of CGM Measurements, with a
mean Percent Absolute Relative Difference (PARD) during the study of 10.29% and
a coefficient of variation (%CV) of 7.6%.
Data from two sensors worn at the same time for 11 subjects in the buttock/
buttock insertions location provided 754 pairs of CGM Measurements, with a mean
PARD during the study of 5.98% and a coefficient of variation (%CV) 4.2%.
Sensor life
After the first successful calibration, 50% of sensors worn in the abdomen operated
more than six days and up to the full seven days of wear (144 to 168 hours). The
mean functional sensor life for sensors worn in the abdomen insertion site over
the course of the study was 142.1 hours, with a median functional life of 163.2
hours.
After the first successful calibration, 72.2% of sensors worn in the buttock operated
more than six days and up to the full seven days of wear (144 to 168 hours). The
mean functional sensor life for sensors worn in the buttock insertion site over the
course of the study was 146.4 hours, with a median functional life of 166.8 hours.
Safety
There were no moderate or severe device-related or procedure-related adverse
events, device- related or procedure-related serious adverse events, or
unanticipated adverse device effects through seven days of use.
392 Chapter 17