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After the first successful calibration, 50% of sensors worn in the abdomen operated
more than six days and up to the full seven days of wear (144 to 168 hours). The
mean functional sensor life for sensors worn in the abdomen insertion site over
the course of the study was 142.1 hours, with a median functional life of 163.2
hours.
After the first successful calibration, 72.2% of sensors worn in the buttock operated
more than six days and up to the full seven days of wear (144 to 168 hours). The
mean functional sensor life for sensors worn in the buttock insertion site over the
course of the study was 146.4 hours, with a median functional life of 166.8 hours.
Safety
There were no moderate or severe device-related or procedure-related adverse
events, device- related or procedure-related serious adverse events, or
unanticipated adverse device effects through seven days of use.
I. Alert performance for users ages 2 through 6
CGM enables your device to display sensor glucose readings, glucose trend arrows,
glucose trend graphs, and sensor glucose alerts (for example, High and Low Limit
Threshold alerts, High and Low Predictive alerts, and Rise and Fall rate-of-change
alerts).
The high and low limit alerts (Threshold alerts) let the user know when the sensor
glucose is at or above the high limit or at or below the low limit. Using only a high
or low limit alert may reduce the number of false alerts, but does not provide a
warning before reaching a high or low limit.
Predictive alerts notify users that their sensor glucose level may soon reach a high
or low limit setting. Users may select how early they would like to be notified
before their sensor glucose level reaches a high limit setting. The earliest warning
is 30 minutes before reaching a high, but users can reduce the amount of warning
time down to 5 minutes. Users will receive a warning approximately 30 minutes
prior to when their sensor glucose level is predicted to reach their low limit
setting. In general, the earlier the warning, the more time a user will have to react
to a potential high or low, but this also increases the potential for false alerts.
A predictive alert is simply an estimation of a future sensor glucose level compared
to the high or low limit setting. If the predicted sensor glucose value is above the
high limit or below the low limit, then a predictive alert is sounded even though
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