User's Manual

140 | Continuous Glucose Monitoring System
11
Sensor Stability
Sensors can be worn for up to 7 days. To verify that sensors perform consistently
over the 7-day period, 71 Sensors were evaluated across the 7-day wear
period. Performance was estimated by calculating the percentage of G4-Global
Receiver readings within 20%, 30% and >40% of the YSI readings at the
beginning (Day 1), middle (Day 4) and end (Day 7) of the G4-Global Receiver
lifecycle. Results are shown in the table below.
Precision of G4-Global Receiver System Readings
In the same study, 18 of the subjects wore two G4-Global Receiver
’
. This was
done to look at how similarly two G4-Global Receiver
’
on the same person
function (Sensor Precision). Precision was evaluated by comparing the glucose
readings from the two G4-Global Receiver
’
worn on the same subject at the
same time. Results showed that G4-Global Receiver readings from the two
sensors generally agreed with each other within 15%.
Table 9. G4-Global Receiver System Sensor Stability (Accuracy Over Time)
Day of Wear
(40-400
mg/dL)
Number
of Paired
Readings
% of Readings
within 20%
of YSI
% of Readings
within 30%
of YSI
% of Readings
within 40%
of YSI
Day 1 637 77% 91% 3%
Day 4 635 80% 94% 3%
Day 7 533 70% 86% 8%
Section 11.1
Placeholder for G4-Global Receiver Pivotal Study Results