* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
† Levels out of System dynamic range.
Glucose Rate of Change Accuracy
The System’s glucose rate of change (ROC) accuracy, as assessed by concurrence
analysis, is presented in Tables 4a and 4b. For example, in the Adult subject group,
when the Sensor glucose ROC indicated that glucose was changing slowly
downward (-1 to 0 mg/dL/min), actual glucose levels in the body were falling
quickly (<-2 mg/dL/min) 1.0% of the time, falling (-2 to -1 mg/dL/min) 7.7% of the
time, changing slowly downward (-1 to 0 mg/dL/min) 68.0% of the time, changing
slowly upward (0 to 1 mg/dL/min) 19.9% of the time, rising (1 to 2 mg/dL/min)
2.3% of the time, and were rising quickly (>2 mg/dL/min) 1.0% of the time.
Table 4a: Concurrence Analysis by Glucose Rate of Change (Adult; n=200)
DOC44383_rev-C 1:14pm 22-SEP-2021
