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For example, per the following table, when wearing the sensor in the abdomen,
the threshold alert, the predictive alert, or both (threshold and predictive) notified
the user 100%, 100%, or 100% of the time within 30 minutes (or 100%, 100%, or
100% within 15 minutes) when the user had BG less than 50 mg/dL.
Table F-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 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%
Buttock 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%
60 Abdomen 50.0% 50.0% 50.0% 50.0% 50.0% 50.0%
Buttock 100.0% 100.0% 100.0% 66.7% 100.0% 100.0%
70 Abdomen 80.0% 80.0% 80.0% 40.0% 80.0% 80.0%
Buttock 85.7% 85.7% 85.7% 71.4% 85.7% 85.7%
80 Abdomen 66.7% 66.7% 83.3% 50.0% 83.3% 66.7%
Buttock 85.7% 85.7% 85.7% 78.6% 85.7% 85.7%
90 Abdomen 91.7% 91.7% 91.7% 66.7% 91.7% 91.7%
Buttock 86.4% 86.4% 90.9% 72.7% 95.5% 86.4%
180 Abdomen 95.1% 95.1% 100.0% 100.0% 100.0% 100.0%
Buttock 97.5% 95.0% 100.0% 100.0% 100.0% 100.0%
220 Abdomen 92.6% 85.2% 96.3% 88.9% 96.3% 88.9%
Buttock 95.7% 95.7% 100.0% 95.7% 100.0% 100.0%
250 Abdomen 77.8% 77.8% 88.9% 83.3% 88.9% 83.3%
Buttock 68.8% 62.5% 100.0% 93.8% 100.0% 100.0%
300 Abdomen 80.0% 80.0% 100.0% 90.0% 100.0% 90.0%
Buttock 60.0% 60.0% 100.0% 100.0% 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.
Glucose Missed Detection Rate
The Missed Detection Rate is the rate that the device did not alert when it should
have. For example, the BG was below the hypoglycemic threshold, or above the
hyperglycemic threshold, and the device did not sound a threshold or predictive
alert.
Missed detection rates are important because it is necessary that users be notified
when their BG is low (or high), so that they can correct the low (or high) BG. A low
missed detection rate indicates that users can have confidence that they will be
notified by the device if their BG is low or high.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 371