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False Predictive Hyperglycemic alert rate alerted 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.
For example, per the following table, when wearing the sensor in the buttock, 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.
predictive only), or both (threshold and predictive) 10.3%, 15.2% or 14.3% of the
time within 30 minutes (or 10.3%, 18.2%, or 16.1% of the time within 15 minutes)
when the user had blood glucose less than 180 mg/dL.
Table I-2. Glucose FALSE Alert Performance using Calibration every 12 hours
mg/dL Insertion Site Glucose FALSE Alert Rate
Threshold Only Predictive Only Threshold & Predictive
30 min 15 min 30 min 15 min 30 min 15 min
50 Abdomen - - - - - -
Buttock 100.0% (1/1) 100.0% (1/1) 100.0% (1/1) 100.0% (1/1) 100.0% (2/2) 100.0% (2/2)
60 Abdomen - - 100.0% (1/1) 100.0% (1/1) 100.0% (1/1) 100.0% (1/1)
Buttock 0.0% (0/1) 0.0% (0/1) 75.0% (3/4) 75.0% (3/4) 60.0% (3/5) 60.0% (3/5)
70 Abdomen 100.0% (1/1) 100.0% (1/1) 100.0% (4/4) 100.0% (4/4) 100.0% (5/5) 100.0% (5/5)
Buttock 0.0% (0/2) 0.0% (0/2) 60.0% (3/5) 60.0% (3/5) 42.9% (3/7) 42.9% (3/7)
80 Abdomen 75.0% (3/4) 75.0% (3/4) 83.3% (5/6) 100.0% (6/6) 80.0% (8/10) 90.0% (9/10)
Buttock 60.0% (3/5) 60.0% (3/5) 66.7% (6/9) 77.8% (7/9) 64.3% (9/14) 71.4% (10/14)
90 Abdomen 50.0% (2/4) 50.0% (2/4) 50.0% (3/6) 66.7% (4/6) 50.0% (5/10) 60.0% (6/10)
Buttock 0.0% (0/8) 0.0% (0/8) 18.2% (2/11) 36.4% (4/11) 11.1% (2/18) 22.2% (4/18)
180 Abdomen 0.0% (0/7) 0.0% (0/7) 20.0% (2/10) 30.0% (3/10) 14.3% (2/14) 21.4% (3/14)
Buttock 10.3% (3/29) 10.3% (3/29) 15.2% (5/33) 18.2% (6/33) 14.3% (8/56) 16.1% (9/56)
220 Abdomen 0.0% (0/4) 0.0% (0/4) 50.0% (5/10) 50.0% (5/10) 38.5% (5/13) 38.5% (5/13)
Buttock 10.0% (2/20) 15.0% (3/20) 37.9% (11/29) 44.8% (13/29) 29.5% (13/44) 36.4% (16/44)
250 Abdomen 0.0% (0/5) 0.0% (0/5) 16.7% (1/6) 16.7% (1/6) 9.1% (1/11) 9.1% (1/11)
Buttock 20.0% (3/15) 26.7% (4/15) 34.8% (8/23) 43.5% (10/23) 29.7% (11/37) 37.8% (14/37)
300 Abdomen 40.0% (2/5) 40.0% (2/5) 60.0% (3/5) 60.0% (3/5) 50.0% (5/10) 50.0% (5/10)
Buttock 33.3% (2/6) 33.3% (2/6) 65.0% (13/20) 70.0% (14/20) 57.7% (15/26) 61.5% (16/26)
MiniMed 770G System Performance Data and Technical Information
MiniMed 770G System Performance Data and Technical Information 399
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