Adverse Events - Dexcom stelo Manual

Sensor insertion experience
Enrolled subjects in the clinical study were asked to complete questionnaires on
comfort and ease of use of sensor insertion. The questionnaires were completed by
the subjects.
Ninety-six percent (96%) of subjects responded that the sensor insertion was
painless. A total of 98% subjects found that the device was easy to use and 96% of
subjects found the IFU easy to understand.
Table 5. Survey of sensor insertion experience (n=130)
Question
Comfort: painless (mild, no pain)
Ease of use: easy (somewhat or very)
IFU ease of use: easy (somewhat or very)
*The percentage was based on the evaluation of 171 sensors.

Adverse events

No serious adverse events (AEs) occurred during the clinical studies. There was a total
of four mild to moderate device related AEs. Two AEs were due to local infection, 1
was due to pain or discomfort, and 1 AE was due to skin irritation, specifically edema
(swelling) at the sensor needle insertion area or around the adhesive area.
96
Number of subjects
130
128
108
Percent
96%*
98%
96%