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The Bigfoot Unity
™
Diabetes Management System User Guide | Appendix C
Glucose Rate of Change Accuracy
The Libre 2 Sensor’s glucose rate of change (ROC) accuracy, as
assessed by concurrence analysis, is presented in
Tables 4a and
4b
. For example, in the Adult study, when the Sensor glucose
ROC indicated that glucose was changing slowly downward
(-1 to 0 mg/dL/min ( )), actual glucose levels in the body were falling
quickly (< -2 mg/dL/min) 1.2% of the time, falling
(-2 to -1 mg/dL/min) 8.3% of the time, changing slowly downward
(-1 to 0 mg/dL/min) 67.1% of the time, changing slowly upward
(0 to 1 mg/dL/min) 19.7% of the time, rising (1 to 2 mg/dL/min)
2.6% of the time, and were rising quickly (> 2 mg/dL/min) 1.2% of the
time. The Bigfoot Unity System uses the FreeStyle Libre 2 Sensor’s
Trend Arrow calculation; however, third party digitally connected
systems that do not utilize these calculations may see different glucose
rate of change accuracy.
Table 4a: Concurrence Analysis by Glucose Rate of Change (Adult; n=144)
CGM
(mg/dL/min)
YSI (mg/dL/min)
N
< -2
[-2, -1)
[-1, 0)
[0, 1]
(1, 2]
> 2
< -2 ( )
34.4
44.9
18.3
2.2
0.3
.
323
-2 to -1 ( )
6.8
46.5
41.2
4.0
0.9
0.6
1090
-1 to 0 (
)
1.2
8.3
67.1
19.7
2.6
1.2
9389
0 to 1 (
)
0.9
3.4
26.0
46.9
15.5
7.3
5420
1 to 2 ( )
0.1
1.7
7.7
31.6
38.4
20.5
1151
> 2 ( )
0.1
0.2
3.1
14.6
32.9
49.0
881
Table 4b: Concurrence Analysis by Glucose Rate of Change (Pediatric; n=86)
CGM
(mg/dL/min)
YSI (mg/dL/min)
N
< -2
[-2, -1)
[-1, 0)
[0, 1]
(1, 2]
> 2
< -2 ( )
46.3
43.8
8.3
1.7
.
.
121
-2 to -1 ( )
12.7
51.2
30.8
4.4
0.3
0.6
338
-1 to 0 (
)
1.9
10.7
60.5
20.9
4.0
2.1
2084
0 to 1 (
)
0.9
5.0
25.8
43.0
15.3
9.9
1606
1 to 2 ( )
0.3
2.6
8.9
28.2
36.3
23.8
383
> 2 ( )
.
0.6
3.7
16.1
30.0
49.6
347
