Abbott FreeStyle Libre 2 - Glucose Rate of Change Accuracy

Glucose Rate of Change Accuracy
The System’s glucose rate of change accuracy, as assessed by concurrence analysis, is presented in
Tables 4a and 4b. For example, in the Adult study, when the Sensor glucose trend arrow indicated
that glucose was changing slowly downward (-1 to 0 mg/dL/min (
g)), 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. Digitally connected systems which do not utilize the
System’s trend arrow calculations may see dierent 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 (i)
34.4 44.9 18.3 2.2 0.3 . 323
-2 to -1 (m)
6.8 46.5 41.2 4.0 0.9 0.6 1090
-1 to 0 (g)
1.2 8.3 67.1 19.7 2.6 1.2 9389
0 to 1 (g)
0.9 3.4 26.0 46.9 15.5 7.3 5420
1 to 2 (k)
0.1 1.7 7.7 31.6 38.4 20.5 1151
>2 (h)
0.1 0.2 3.1 14.6 32.9 49.0 881
199