118 | SEVEN PLUS Continuous Glucose Monitoring System
Precision of SEVEN PLUS System Readings
In the same study, 18 of the subjects wore two SEVEN PLUS
’
. This was done to look at how similarly
two SEVEN PLUS
’
on the same person function (Sensor Precision). Precision was evaluated by
comparing the glucose readings from the two SEVEN PLUS
’
worn on the same subject at the same
time. Results showed that SEVEN PLUS readings from the two sensors generally agreed with each
other within 15%.
Sensor Life
During the trial there were no Sensor insertion problems and Sensors may be worn for up to 7 days (168
hours). To estimate how long a SEVEN Sensor will work over 7 days, the 71 Sensors were evaluated to
determine how many Days (hours) of readings each Sensor provided. Table 10, below, displays how long
you can expect a Sensor to last after insertion. For example, 89% of the sensors lasted more than 6 and up
to the full 7 days (144-168 hours).
Table 10. Estimated SEVEN Sensor Life
Number of Days of Use (Hours) Percentage of Sensors
1 (24 hours) 1%
2 (48 hours) 1%
3 (72 hours) 6%
4 (96 hours) 0%
5 (120 hours) 0%
6 (144 hours) 3%
7 (168 hours) 89%
There were 6 Sensors that did not last at least 6 days or more than 144 hours. Five (5) of those sensors
became non-functional due to an Early Sensor Shut-off, and 1 Sensor ended before 6 days because the
subject bumped the Sensor and it fell off.
10