Technical Information; Device Performance Characteristics - Dexcom stelo Manual

16 • Technical Information

Device performance characteristics

NOTE: We recommend you review the information in this chapter to understand how
well the Stelo Glucose Biosensor System performs.
The Stelo Glucose Biosensor System uses a glucose sensor to continuously measure
and monitor your glucose levels. The Stelo Glucose Biosensor System records glucose
readings (sensor readings) every 5 minutes. All the sensor readings are then displayed
on the mobile app every 15 minutes. The Stelo Glucose Biosensor System's
performance was evaluated in a clinical study in which sensor readings were
assessed against blood glucose values tested by a comparator method for subjects 18
years of age and older. The performance characteristics of the Stelo Glucose
Biosensor System presented in the following sections conform to the guidance for
devices in the same classification.
Clinical study overview
To demonstrate the safety and effectiveness of the Stelo Glucose Biosensor System, a
prospective clinical study was conducted at six (6) centers across the United States
with a total of 130 participants. The study included adult (18 years and older)
participants with Type 1 or Type 2 diabetes. Participants wore the sensors for up to
15.5 days with one approximately 12-hour clinic session at the beginning (Day 1 to 3),
early middle (Day 4 to 7), late middle (Day 9 to 12), and end (Day 13 to the first half of
Day 15) of the sensor wear period.
In the clinic sessions, subjects had their blood glucose measured every 10–15
minutes with a comparator method, the Yellow Springs Instrument 2300 STAT Plus™
Glucose Analyzer. This instrument is referred to as the YSI. Sensor readings were
reported every 5 minutes and paired with YSI values to characterize the accuracy of
the sensor reading.
16 • Technical Information | Stelo Glucose Biosensor User Guide 89