User's Manual

130 | Continuous Glucose Monitoring System
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On 19 occasions, the G4-Global Receiver indicated the glucose reading was
less than 40 mg/dL and displayed “LOW”. Of these, the YSI blood glucose
readings were never below 40 mg/dL and ranged between 43 mg/dL up to 141
mg/dL.
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On 39 occasions, the G4-Global Receiver indicated the glucose reading
was greater than 400 mg/dL and displayed “HIGH”. Of these, the paired YSI
glucose reading was also above 400 mg/dL twelve (12) times. When the
G4-Global Receiver read more than 400 mg/dL, the range of the YSI blood
glucose readings at that time was 264-438 mg/dL.
LOW AND HIGH GLUCOSE ALERTS
The ability of the G4-Global Receiver to detect high and low glucose levels
(concentrations) is assessed by comparing G4-Global Receiver results to YSI
results at low and high blood glucose levels and determining if the alert may
have sounded. The G4-Global Receiver and YSI readings were compared by
pairing the G4-Global Receiver reading that occurred approximately 5 minutes
after the YSI reading was collected. There were 1,827 pairs of paired G4-Global
Receiver and YSI results evaluated. We suggest that you ask your doctor what
Alert settings would be best for you.
The Low Glucose Alert
Estimates of how well the adjustable Low Glucose Alert performs are presented
in the table on the next page. For example, the data in the table shows that if
you set the Low Glucose Alert to 70 mg/dL, the G4-Global Receiver will alert
you of a blood glucose measurement of 70 mg/dL or lower 57% of the time
within 5 minutes of reaching that blood glucose level (True Alert Rate). The table
also shows that at the same Alert setting (70 mg/dL), the Low Alert may not
alert you 44% of the time (“Missed Alert Rate***”) within 5 minutes of the blood
glucose reading. Also at the 70 mg/dL alert level, 46% of the time the G4-Global
Receiver may falsely alert you that your glucose level is at or less than 70 mg/dL
when your actual blood glucose level is above 70 mg/dL.
If you set the Low Glucose Alert to 90 mg/dL, the G4-Global Receiver should
alert you 73% of the time within 5 minutes of when your glucose levels are at
or below 90 mg/dL. The table also shows that at the same Alert setting (90 mg/
dL), the Low Alert may not alert you within ~5 minutes of the low blood glucose
event 27% of the time (“Missed Alert Rate***”).
11
Section 11.1
Placeholder for G4-Global Receiver Pivotal Study Results