User's Manual

G4-Global System User’s Guide | 133

Table 3. Hyperglycemic Alert Evaluation

Alert Setting True Alert Rate* False Alert Rate**

Missed Alert

Rate***

140 mg/dL 92 % 6 % 8 %

180 mg/dL 84 % 6 % 16 %

200 mg/dL 82 % 7 % 18 %

220 mg/dL 80 % 8 % 20 %

240 mg/dL 77 % 8 % 23 %

300 mg/dL 59 % 27 % 41 %

* 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

G4-Global Receiver to YSI data has not been established with the G4-Global

Receiver Sensor. During use of the G4-Global Receiver 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 ﬁ ngerstick each time a high or low glucose alert sounded.

The G4-Global Receiver and Meter readings were compared by pairing the

G4-Global Receiver reading that occurred on average 5 minutes after the

ﬁ ngerstick meter reading was taken during home use. Analysis of the home

use data showed that when the G4-Global Receiver was above 200 mg/dL,

77% of the OneTouch Ultra meter readings were above 200 mg/dL (True High

Alert). When the G4-Global Receiver read below 80 mg/dL, 73% of the time the

OneTouch Ultra readings were below 80 mg/dL (True Low Alerts).

The G4-Global Receiver notiﬁ ed the subject that their glucose levels were

falsely below the Low Alert level 27% of the time and notiﬁ ed the subject that

their glucose levels were falsely above the High Alert level 23% of the time.

Section 11.1

Placeholder for G4-Global Receiver Pivotal Study Results