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the current sensor glucose level has not crossed the high or low limit. The
predicted sensor glucose level is calculated using the current sensor glucose level,
the derivative of previous sensor glucose readings (the trend or slope of the sensor
glucose readings) and the amount of early warning duration the user selects.
The device will always alert the user when the CGM reads that the user is below
50 mg/dL, regardless of the high/low threshold and/or predictive alerts that the
user sets.
Glucose TRUE Alert Rate
The glucose true alert rate is the rate at which the blood glucose confirmed that
the CGM alert was triggered correctly. For example:
True Threshold Hypoglycemic alert rate alerted when the CGM read that the user
was below the low threshold and the user’s blood glucose was actually below that
low threshold.
True Threshold Hyperglycemic alert rate alerted when the CGM read that the
user was above the high threshold and the users blood glucose was actually
above that high threshold.
True Predictive Hypoglycemic alert rate alerted when the CGM predicted that the
user would reach below the low threshold and the users blood glucose was
actually below that low threshold within 15 or 30 minutes.
True Predictive Hyperglycemic alert rate alerted when the CGM predicted that
the user would reach above the high threshold and the users blood glucose was
actually above that high threshold within 15 or 30 min.
The true alert rate is 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 true 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.
For example, per the following table, when wearing the sensor in the Buttocks, the
low glucose alerts would have correctly indicated that the user was below (i.e.
threshold only), or predicted to reach below the threshold (i.e. predictive only) or
both (predictive and threshold) 100%, 40%, or 57.1 % of the time within 30
minutes (or 100%, 40% or 57.1% of the time within 15 minutes) when the user had
blood glucose values lower than 70 mg/dL.
MiniMed 770G System Performance Data and Technical Information
MiniMed 770G System Performance Data and Technical Information 397
415


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