Dexcom stelo - Page 97

16 • Technical Information | Stelo Glucose Biosensor User Guide 91
Table 1-B. Accuracy to comparator method within Biosensor glucose ranges
(adults; n=130)
Biosensor
glucose
range
1
(mg/dL)
Number of
paired
Biosensor
1
-
YSI
Percent
within 15
mg/dL YSI
Percent
within 20
mg/dL YSI
Percent
within 40
mg/dL YSI
Percent
within
15% YSI
Percent
within
20% YSI
Percent
within
40% YSI
Mean
bias
(mg/dL)
MARD
(%)
<70 1,807 89.0
94.6
99.5 --- --- --- -3.5 10.5
70–180 10,902 --- --- --- 84.8
93.3 99.6
-1.1 8.5
180–250 3,301 --- --- ---
84.3
91.5 100.0 -11.3 8.3
>250 4,320 --- --- ---
91.6 96.8
100.0 -9.2 6.8
1
Biosensor readings are within 40-400 mg/dL, inclusive.
Table 1-C. Accuracy to comparator method within comparator method glucose
ranges (adults; n=130)
YSI
glucose
range
(mg/dL)
Number of
paired
Biosensor
1
-
YSI
Percent
within 15
mg/dL YSI
Percent
within 20
mg/dL YSI
Percent
within 40
mg/dL YSI
Percent
within
15% YSI
Percent
within
20% YSI
Percent
within
40% YSI
Mean
bias
(mg/dL)
MARD
(%)
<70 2,008 93.5
97.3
99.9 --- --- --- 2.3 10.5
70–180 10,463 --- --- --- 86.2
93.8 99.7
-0.3 8.2
180–250 2,988 --- --- ---
88.0
94.9 99.9 -6.5 7.4
>250 4,871 --- --- ---
86.1 92.5
99.9 -15.8 8.0
1
Biosensor readings are within 40-400 mg/dL, inclusive.