Product Info

Glucose detection rates are important because it is necessary that users be notified
when their blood glucose is low (or high) so that they can correct the low (or
high) blood glucose. A high glucose correct detection rate indicates that users can
have confidence that they will be notified by the device if their blood glucose is
low or high.
For example, per the following table, when wearing the sensor in the buttock, the
threshold alert, the predictive alert, or both (threshold and predictive) notified the
user 50.0%, 50.0% or 50.0% of the time within 30 minutes (or 50.0%, 50.0% or
50.0% within 15 minutes) when the user had blood glucose less than 60 mg/dL.
Table I-3. Glucose Correct Detection Alert Performance using Calibration every 12 hours
Glucose Correct Detection Rate
mg/dL Insertion Site Threshold Only Predictive Only Threshold & Predictive
30 min 15 min 30 min 15 min 30 min 15 min
50 Abdomen N/A* N/A* N/A* N/A* N/A* N/A*
Buttock N/A* N/A* N/A* N/A* N/A* N/A*
60 Abdomen N/A* N/A* 100.0% 100.0% 100.0% 100.0%
Buttock 50.0% 50.0% 50.0% 50.0% 50.0% 50.0%
70 Abdomen N/A* N/A* N/A* N/A* N/A* N/A*
Buttock 66.7% 66.7% 66.7% 66.7% 66.7% 66.7%
80 Abdomen 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%
Buttock 40.0% 40.0% 60.0% 40.0% 60.0% 40.0%
90 Abdomen 66.7% 66.7% 100.0% 66.7% 100.0% 100.0%
Buttock 80.0% 80.0% 90.0% 60.0% 90.0% 80.0%
180 Abdomen 84.6% 84.6% 92.3% 84.6% 92.3% 84.6%
Buttock 100.0% 98.3% 100.0% 91.4% 100.0% 100.0%
220 Abdomen 100.0% 100.0% 100.0% 87.5% 100.0% 100.0%
Buttock 91.7% 86.1% 97.2% 86.1% 100.0% 94.4%
250 Abdomen 100.0% 100.0% 100.0% 87.5% 100.0% 100.0%
Buttock 84.0% 84.0% 96.0% 84.0% 96.0% 88.0%
300 Abdomen 100.0% 100.0% 100.0% 75.0% 100.0% 100.0%
Buttock 62.5% 62.5% 100.0% 87.5% 100.0% 100.0%
Note: Given the small sample size of data available in the low range, the alert performance in the 50 mg/dL and 60 mg/dL should be interpreted
with caution and may not reflect actual use performance.
*There is no evaluable events in this reference range so it is N/A.
Glucose Missed Detection Rate
■
670G Performance Data and Technical Information
670G Performance Data and Technical Information 397