Concurrence Analysis by Glucose Trend Arrow
Trend Arrow accuracy of the System, as assessed by concurrence analysis, is presented in Table 7. For
example, in the clinical study, when the trend arrow indicated that glucose was changing slowly (-1 to
1 mg/dL/min (g) ), actual glucose levels in the body were falling quickly (i) 0.3% of the time, falling
(m) 3.7% of the time, changing slowly (g) 83.0% of the time, rising (k) 3.9% of the time, and rising
quickly (h) 0.5% of the time.
Table 7: Concurrence Analysis by Glucose Trend Arrow
CGM
(mg/dL/min)
YSI (mg/dL/min)
N
<-2 [-2, -1] [-1, 0] [0, 1] [1, 2] >2 NA*
<-2 (i)
26.3 45.5 10.3 1.3 0.0 0.0 16.7 156
-2 to -1 (m)
4.3 27.0 54.6 3.8 0.6 0.0 9.7 652
-1 to 1 (g)
0.3 3.7 49.4 33.6 3.9 0.5 8.6 4175
1 to 2 (k)
0.0 0.6 8.8 38.6 33.3 9.2 9.4 477
>2 (h)
0.0 0.0 2.8 14.6 34.9 40.6 7.1 212
NA† 2.5 9.1 33.1 20.7 14.0 9.1 11.6 121
* Glucose rate of change not available due to the time dierence between glucose readings exceeding 30 minutes.
† Glucose Trend Arrow not available.
Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference
The System reports glucose concentrations between 40 and 500 mg/dL. When the System
determines that glucose level is below 40 mg/dL, it will report as ‘LO’. When the System determines
that glucose level is above 500 mg/dL, it will report as ‘HI’. No measurements were obtained above
500 mg/dL in the clinical study. Table 8 displays the concurrence between the CGM and YSI reference
glucose when CGM reads ‘LO’. For example, in the clinical study, when CGM reading was ‘LO’ YSI
glucose values were less than 40 mg/dL 0.0% of the time, above 40 mg/dL 100.0% of the time,
above 50 mg/dL 95.2% of the time, above 60 mg/dL 80.9% of the time, above 70 mg/dL 42.8% of
the time, and above 80 mg/dL 19.0% of the time.
Table 8: Concurrence Analysis with ‘LO’ CGM Reading
YSI (mg/dL)
Total
<40 >40 >50 >60 >70 >80
% of CGM points in
YSI range
0.0 100.0 95.2 80.9 42.8 19.0
Number of CGM
points in YSI range
0 21 20 17 9 4 21
115 116
ART38553-101_rev-A_manual.indd 115-116 2/1/18 2:13 PM
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