Product Info

Table F-1: Glucose TRUE Alert Performance using Calibration every 12 hours
Glucose TRUE Alert Rate
mg/dL Insertion Site Threshold Only Predictive Only Threshold & Predictive
30 min 15 min 30 min 15 min 30 min 15 min
90 Abdomen 55.0% 55.0% 46.2% 30.8% 47.7% 38.6%
Buttock 70.8% 70.8% 58.3% 44.4% 62.5% 53.6%
180 Abdomen 78.4% 78.4% 66.2% 66.2% 70.5% 70.5%
Buttock 83.3% 81.3% 64.3% 62.9% 70.6% 68.8%
220 Abdomen 87.5% 87.5% 60.0% 57.8% 68.2% 66.7%
Buttock 75.0% 75.0% 51.0% 49.0% 58.3% 56.9%
250 Abdomen 81.3% 81.3% 53.1% 46.9% 63.0% 58.7%
Buttock 73.3% 73.3% 41.2% 35.3% 50.0% 45.7%
300 Abdomen 77.8% 77.8% 44.4% 44.4% 55.6% 55.6%
Buttock 57.1% 57.1% 31.3% 31.3% 38.1% 38.1%
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 FALSE Alert Rate
The glucose false alert rate is the rate at which the BG did not confirm that the
CGM alert was triggered correctly. For example:
False Threshold Hypoglycemic alert rate alerted when the CGM system read that
the user was below the low threshold but the user's BG was actually above that
low threshold.
False Threshold Hyperglycemic alert rate alerted when the CGM system read that
the user was above the high threshold but the user’s BG was actually below that
high threshold.
False Predictive Hypoglycemic alert rate alerted when the CGM system predicted
that the user would be below the low threshold but the user’s BG was actually
above that low threshold within 15 or 30 minutes.
The false alert rate is important because it is necessary that users be correctly
notified when their BG is low (or high) so that they can correct the low (or high)
BG. A low false alert rate indicates that when the CGM system says that their
glucose values are, or will reach a specified threshold, the user’s BG is likely to be
at or approaching that threshold.
For example, per the following table, when wearing the sensor in the abdomen,
the high glucose threshold alerts would have incorrectly indicated that the user
was above (i.e. threshold only), or predicted to reach above the threshold (i.e.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 369