User's Manual

128 | Continuous Glucose Monitoring System
11
Clinical Study Results
To evaluate performance of the G4-Global Receiver, 53 participants were
enrolled in a clinical study conducted at 3 clinics. All participants had Type 1 or
Type 2 diabetes mellitus, and required insulin to manage their diabetes. About
81% of participants had Type 1 diabetes and about 19% had Type 2 diabetes.
Subjects ranged in age from 23 to 72 years old.
Participants used the G4-Global Receiver for approximately 7 days (each
participant wore 1 or 2 Sensors for 7 days.) Receivers were calibrated
approximately 2 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 3 fi ngersticks per
day (2 to start up and 1 in the evening), and was calibrated with an average of 2
fi ngersticks per day for days 2-7 (approximately every 12 hours).
All participants used the G4-Global Receiver 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 G4-Global Receiver in the clinic 49 of
the 53 participants had their blood glucose measured every 15 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 G4-Global Receiver were paired with YSI readings in order to characterize
how well G4-Global Receiver results agreed with blood glucose results. For
the remainder of the study, participants used the G4-Global Receiver at home
and results were paired with OneTouch Ultra blood glucose meter results.
During Start-Up Calibration (see Chapter 4), all participants (100%) were able to
calibrate successfully after the 2 hour Start-up period. For Calibration Updates/
Re-Calibration (see Chapter 4) 97% of the time participants only needed one
attempt to update calibration. Two-percent (2%) of Calibration Updates required
a second attempt, and less than one-percent (<1%) of Calibration Updates
needed more than three attempts.
Agreement
Agreement between the G4-Global Receiver and glucose levels is
characterized using paired G4-Global Receiver and YSI results. The G4-Global
Receiver and YSI readings were compared by pairing the YSI blood glucose
reading to a G4-Global Receiver glucose reading that occurred approximately
5 minutes after the YSI reading was collected.
Section 11.1
Placeholder for G4-Global Receiver Pivotal Study Results