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Table H-28. Trend Accuracy; Calibration every 12 hours, Buttock
Percent of Matched Pairs-in Each YSI (or BGM) Rate Range for Each SG Rate Range
SG Rate Ranges
(mg/dL/min)
Number of
Paired SG-YSI
or BGM
YSI (or BGM) (mg/dL/min)
<-2 [-2, -1] [-1, 0] [0, 1] [1, 2] >2
<-2 3 66.7% (2/3) 33.3% (1/3) 0.0% (0/3) 0.0% (0/3) 0.0% (0/3) 0.0% (0/3)
[-2, -1] 8 0.0% (0/8) 62.5% (5/8) 12.5% (1/8) 12.5% (1/8) 12.5% (1/8) 0.0% (0/8)
[-1, 0] 13 0.0% (0/13) 7.7% (1/13) 30.8% (4/13) 30.8% (4/13) 23.1% (3/13) 7.7% (1/13)
[0, 1] 6 0.0% (0/6) 16.7% (1/6) 16.7% (1/6) 16.7% (1/6) 50.0% (3/6) 0.0% (0/6)
[1, 2] 7 0.0% (0/7) 0.0% (0/7) 0.0% (0/7) 42.9% (3/7) 57.1% (4/7) 0.0% (0/7)
>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)
Table H-29. Trend Accuracy; Calibration 3 or 4 times a day, Buttock
Percent of Matched Pairs-in Each YSI (or BGM) Rate Range for Each SG Rate Range
SG Rate Ranges
(mg/dL/min)
Number of
Paired SG-YSI
or BGM
YSI (or BGM) (mg/dL/min)
<-2 [-2, -1] [-1, 0] [0, 1] [1, 2] >2
<-2 3 66.7% (2/3) 33.3% (1/3) 0.0% (0/3) 0.0% (0/3) 0.0% (0/3) 0.0% (0/3)
[-2, -1) 8 0.0% (0/8) 62.5% (5/8) 12.5% (1/8) 12.5% (1/8) 12.5% (1/8) 0.0% (0/8)
[-1, 0) 13 0.0% (0/13) 7.7% (1/13) 38.5% (5/13) 30.8% (4/13) 15.4% (2/13) 7.7% (1/13)
[0, 1] 6 0.0% (0/6) 16.7% (1/6) 0.0% (0/6) 16.7% (1/6) 66.7% (4/6) 0.0% (0/6)
(1, 2] 7 0.0% (0/7) 0.0% (0/7) 0.0% (0/7) 42.9% (3/7) 57.1% (4/7) 0.0% (0/7)
>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, both inserted in the
abdomen, 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, one inserted in the
abdomen and one in the buttock, provided 108 pairs of CGM Measurements, with
a mean Percent Absolute Relative Difference (PARD) during the study of 6.98% and
a coefficient of variation (%CV) of 4.7%.
Data from two sensors worn at the same time for 11 subjects, both inserted in the
buttock, 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
MiniMed 770G System Performance Data and Technical Information
MiniMed 770G System Performance Data and Technical Information 395
413


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