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ART46983-001_rev-A 24-Aug-2022 2:30pm
400 mg/dL).
Pediatric study: The Pediatric study was conducted at 4 centers with 139 subjects in total (98.6% Type 1,
1.4% Type 2), all aged four to seventeen. Subjects age six and older had their venous blood glucose
analyzed for up to 16 hours over one or two separate visits to the clinical center. Each visit lasted up to
eight hours. During each visit, subjects age 11 and older had their glucose levels deliberately
manipulated per the study protocol to raise or lower glucose. This was done to assess performance of
the System over the range that the System measures glucose (40 – 400 mg/dL). 48 subjects were
analyzed during the beginning of the Sensor wear period (day 1 or 2), 50 subjects were analyzed during
the early middle period (day 7 or 8), 51 subjects were analyzed during the late middle period (day 9 or
12), and 51 subjects were analyzed during the end period (day 13 or 14). All subjects tested their blood
glucose using fingerstick capillary samples at least four times during each day of the study.
Accuracy
Accuracy of the System was measured by comparing paired System Glucose Measurement (CGM) and
YSI blood glucose values. The percentage of total System readings that were within 20 mg/dL for YSI
blood glucose values < 70 mg/dL or 20% of YSI for blood glucose values ≥ 70 mg/dL is displayed in
Table A-1a. The Mean Absolute Relative Di!erence (MARD) gives an indication of the average percent
disagreement between the CGM and the reference. For example, in the Adult study, 92.4% of the
readings fell within ± 20 mg/dL of YSI blood glucose values < 70 mg/dL and within ± 20% of YSI blood
glucose values ≥ 70 mg/dL. The total number of data pairs considered in the analysis was 18,735. In the
Adult study, the Mean Absolute Relative Di!erence was 9.2% for the comparison with YSI reference. In
the Pediatric study, the Mean Absolute Relative Di!erence was 9.7% for the comparison with YSI
reference.
Table A-1a: Overall Accuracy to YSI
* 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 A-1b and A-1c. The results
categorized within YSI glucose ranges are presented in Tables A-1d and A-1e.
Table A-1b: Accuracy to YSI within CGM Glucose Ranges (Adult; n=144)
† System range is 40-400 mg/dL.