Abbott FreeStyle Libre 2 - Page 193

Table 1a: Overall Accuracy to YSI
Subject
Group
Number of
CGM-
Reference
Pairs
Number of
Subjects
Percent
Within
±20% /
±20 mg/dL
Percent
Within
±20% /
±20 mg/dL
on Day 1
Percent
Within
±20% /
±20 mg/dL
in rst
12 hours
MARD (%)
Adults 18735 144 92.4 87.5 81.7 9.2
Children
(age 6-17)
6546 129 91.6 84.1 80.3 9.7
Children
(age 4-5)*
341 8 85.9 87.9 90.9 11.8
* No YSI measurements were obtained for children ages 4-5; results displayed are from CGM-SMBG matched
paired measurements.
The accuracy of dierent CGM glucose ranges versus YSI reference was assessed by calculating the
percentage of System readings that were within 15%, 20%, and 40% for reference values
≥ 70 mg/dL, and within 15 mg/dL, 20 mg/dL, and 40 mg/dL for values < 70 mg/dL. For blood
glucose values < 70 mg/dL, the dierence in mg/dL between the CGM and YSI blood glucose values
was calculated. For values ≥ 70 mg/dL, the relative dierence (%) to the YSI blood glucose values
was calculated. The results categorized within CGM glucose ranges are presented in Tables 1b and
1c. The results categorized within YSI glucose ranges are presented in Tables 1d and 1e.
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