Dexcom SEVEN PLUS User Manual page 110

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The SEVEN PLUS reports glucose concentrations between 40 and 400 mg/dL. When the
SEVEN PLUS determines the glucose level is below 40 mg/dL, it displays "LOW" in the
Receiver Status Box. When the SEVEN PLUS determines that the glucose level is above
400 mg/dL, it displays "HIGH" in the Receiver Status Box. The ability of the SEVEN PLUS
to accurately report these occurrences is assessed by looking at the actual blood glucose
concentrations (as determined by the YSI analyzer) when "LOW" or "HIGH" are reported.
On 19 occasions, the SEVEN PLUS indicated the glucose reading was less than 40 mg/dL
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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.
On 39 occasions, the SEVEN PLUS 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 SEVEN PLUS 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 SEVEN PLUS to detect high and low glucose levels (concentrations) is
assessed by comparing SEVEN PLUS results to YSI results at low and high blood glucose
levels and determining if the alert may have sounded. The SEVEN PLUS and YSI readings
were compared by pairing the SEVEN PLUS reading that occurred approximately 5 minutes
after the YSI reading was collected. There were 1,827 pairs of paired SEVEN PLUS 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 SEVEN PLUS 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 SEVEN PLUS 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 SEVEN PLUS 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
110 | SEVEN PLUS Continuous Glucose Monitoring System