Sensor life
A subsequent study was conducted in 108 participants in the intended user population
to assess the sensor life. A total of 110 sensors were evaluated. 77.9% of the sensors
lasted until Day 15. In other words, when using the product per the package labeling,
approximately 20% of sensors may not last for the full 15 days, 10% of these sensors
may last less than 12 days.
Number of readings provided
Stelo Glucose Biosensor System is capable of recording up to 288 valid sensor
readings per day. For a variety of reasons, Stelo Glucose Biosensor System may be
unable to provide a valid sensor reading. The percentage of valid sensor readings you
can expect from Stelo Glucose Biosensor System over the sensor life is 99.3% (data
not presented in a table). All sensors (100%) had valid sensor readings available at
least 90% of the time (data not presented in a table). Table 4 below describes the data
availability rate by each wear day over the sensor life.
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