Abbott FreeStyle Libre 2 User Manual page 72

Table 1b: Accuracy to YSI within CGM Glucose Ranges (Adult; n=144)
CGM Number
Percent Percent Percent
Glucose of CGM-
Within Within
†
Level Reference
±15 mg/dL ±20 mg/dL ±40 mg/dL
(mg/dL) Pairs
<54 518 85.9 93.8
54-69 3012 89.5 94.2
70-180 7785
181-250 3037
>250 4383
†
System range is 40-400 mg/dL.
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Percent Percent Percent Mean
MARD
Within Within Within Within bias
(%)
±15% ±20% ±40% (mg/dL)
99.4 -6.4 13.8
99.1 -3.3 10.8
76.5 86.6 99.2 -4.8 10.6
89.1 95.0 99.9 -10.1 7.8
94.0 97.9 100.0 -6.3 6.1
Table 1c: Accuracy to YSI within CGM Glucose Ranges (Pediatric*; n=129)
CGM Number
Percent Percent Percent
Glucose of CGM-
Within Within Within
†
Level Reference
±15 mg/dL ±20 mg/dL ±40 mg/dL
(mg/dL) Pairs
<54 139 71.9 79.1 97.1
54-69 863 86.4 90.5 97.1
70-180 2690
181-250 1236
>250 1618
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
†
System range is 40-400 mg/dL.
Percent Percent Percent Mean
MARD
Within Within Within bias
(%)
±15% ±20% ±40% (mg/dL)
-9.9 17.1
-4.9 12.0
77.4 87.6 98.7 -3.4 10.6
86.0 94.7 99.7 -8.9 8.3
92.2 97.7 99.8 -2.2 7.2
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