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 first
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 different 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 difference in mg/dL between the CGM and YSI blood glucose values
was calculated. For values ≥ 70 mg/dL, the relative difference (%) 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
.
187