Product Info

Table I-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
220 Abdomen 100.0% 100.0% 50.0% 50.0% 61.5% 61.5%
Buttock 90.0% 85.0% 62.1% 55.2% 70.5% 63.6%
250 Abdomen 100.0% 100.0% 83.3% 83.3% 90.9% 90.9%
Buttock 80.0% 73.3% 65.2% 56.5% 70.3% 62.2%
300 Abdomen 60.0% 60.0% 40.0% 40.0% 50.0% 50.0%
Buttock 66.7% 66.7% 35.0% 30.0% 42.3% 38.5%
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 FALSE Alert Rate
The glucose false alert rate is the rate at which the blood glucose did not confirm
that the CGM alert was triggered correctly. For example:
False Threshold Hypoglycemic alert ratealerted when the CGM read that the user
was below the low threshold but the users blood glucose was actually above that
low threshold.
False Threshold Hyperglycemic alert ratealerted when the CGM read that the
user was above the high threshold but the user’s blood glucose was actually
below that high threshold.
False Predictive Hypoglycemic alert ratealerted when the CGM predicted that the
user would be below the low threshold but the user’s blood glucose was actually
above that low threshold within 15 or 30 minutes.
False Predictive Hyperglycemic alert ratealerted when the CGM predicted that
the user would be above the high threshold but the user’s blood glucose was
actually below the high threshold within 15 or 30 minutes.
The false alert rate is important because it is necessary that users be correctly
notified when their blood glucose is low (or high) so that they can correct the low
(or high) blood glucose. A low false alert rate indicates that when the CGM says
that their glucose values are, or will reach a specified threshold, the user’s blood
glucose is likely to be at or approaching that threshold.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 395