Dexcom SEVEN User Manual page 111

CLINICAL STUDY RESULTS
To evaluate performance of the Seven System, 72 participants were enrolled in a clinical
study conducted at 5 centers. All participants had Type 1 or Type 2 diabetes mellitus, and
required insulin to manage their diabetes. About 75% of participants had Type 1 diabetes
and about 25% had Type 2 diabetes. Subjects ranged in age from 18 to 71.
Participants used the Seven System for approximately seven days (each participant wore
1 or 2 Sensors for 7 days.) Receivers were calibrated approximately 2-3 times per day, on
average, over the 7-day period using the LifeScan OneTouch Ultra meter. Throughout the
7-day wear period, the Receiver was calibrated the most on day 1, with an average of 4
fingersticks per day, and was calibrated with an average of 2 fingersticks per day for days
2-7.
All participants used the Seven System in a controlled clinic environment on Day 1, Day
4, or Day 7 of the 7-day wear period. The remainder of the study took place at home.
While using the Seven System in the clinic, 69 of the 72 participants had their blood
glucose measured every 20 minutes with a reliable laboratory method, the Yellow Springs
Instrument 2300 STAT Plus glucose analyzer. This instrument is referred to as the "YSI."
Readings from the Seven System were paired with YSI readings in order to characterize
how well Seven System results agreed with blood glucose results. For the remainder of
the study, participants used the Seven System at home and results were paired with
OneTouch Ultra blood glucose meter results (1 OneTouch meter was used to calibrate
the Seven System, while a different OneTouch meter was used to collect the comparison
blood glucose results). During Initial Calibration, participants were able to calibrate
on the first attempt 98% of the time. Two-percent (2%) of the time one more attempt
was required for calibration. For Re-Calibration and Calibration Updates 98% of the
time participants only needed one attempt to update calibration. One-percent (1%) of
participants required a second attempt, and less than one-percent (<1%) of participants
needed 3-5 additional attempts for re-calibration.
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