Dexcom SEVEN PLUS User Manual page 112

10
Hyperglycemic Alert Evaluation
Table 3.
Alert Setting True Alert Rate*
140 mg/dl
180 mg/dl
200 mg/dl
220 mg/dl
240 mg/dl
300 mg/dl
* True Alert Rate is the % of time when the blood glucose level was at or above the alert setting and the alert
sounded.
** False Alert Rate is the % of time when the device alarmed but the blood glucose level was below the alert
setting.
*** Missed Alert Rate is the % of time when the device failed to alarm when the blood
glucose level was at or above the alert setting.
Performance of High and Low Glucose Alerts at night comparing the
SEVEN PLUS to YSI data has not been established with the SEVEN Sensor. During use of the
SEVEN PLUS at home, the High Alert was set to 200 mg/dL and the Low Alert was set to 80
mg/dL. Subjects were asked to take a fingerstick each time a high or low glucose alert sounded.
The SEVEN PLUS and Meter readings were compared by pairing the SEVEN PLUS reading
that occurred on average 5 minutes after the fingerstick meter reading was taken during home
use. Analysis of the home use data showed that when the SEVEN PLUS was above 200 mg/dL,
77% of the OneTouch Ultra meter readings were above 200 mg/dL (True High Alert). When the
SEVEN PLUS read below 80 mg/dL, 73% of the time the OneTouch Ultra readings were below
80 mg/dL (True Low Alerts). The SEVEN PLUS notified the subject that their glucose levels were
falsely below the Low Alert level 27% of the time and notified the subject that their glucose levels
were falsely above the High Alert level 23% of the time.
Accuracy
Accuracy between matched pairs was also estimated by calculating the percent difference
between the SEVEN PLUS reading and the YSI reading. The SEVEN PLUS and YSI readings
were compared by pairing the SEVEN PLUS reading that fell approximately 5 minutes after the YSI
reading was collected. For example, if the YSI reading is 100 mg/dL and the SEVEN PLUS reading
is 90 mg/dL, a 10% difference between the SEVEN PLUS and the YSI Laboratory machine is
reported.
112 | SEVEN PLUS Continuous Glucose Monitoring System
False Alert Rate**
92 % 6 %
84 % 6 %
82 % 7 %
80 % 8 %
77 % 8 %
59 % 27 %
Missed Alert Rate***
8 %
16 %
18 %
20 %
23 %
41 %