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Table I-1. Glucose TRUE Alert Performance using Calibration every 12 hours
mg/dL Insertion Site Glucose TRUE Alert Rate
Threshold Only Predictive Only Threshold & Predictive
30 min 15 min 30 min 15 min 30 min 15 min
50 Abdomen - - - - - -
Buttock 0.0% (0/1) 0.0% (0/1) 0.0% (0/1) 0.0% (0/1) 0.0% (0/2) 0.0% (0/2)
60 Abdomen - - 0.0% (0/1) 0.0% (0/1) 0.0% (0/1) 0.0% (0/1)
Buttock 100.0% (1/1) 100.0% (1/1) 25.0% (1/4) 25.0% (1/4) 40.0% (2/5) 40.0% (2/5)
70 Abdomen 0.0% (0/1) 0.0% (0/1) 0.0% (0/4) 0.0% (0/4) 0.0% (0/5) 0.0% (0/5)
Buttock 100.0% (2/2) 100.0% (2/2) 40.0% (2/5) 40.0% (2/5) 57.1% (4/7) 57.1% (4/7)
80 Abdomen 25.0% (1/4) 25.0% (1/4) 16.7% (1/6) 0.0% (0/6) 20.0% (2/10) 10.0% (1/10)
Buttock 40.0% (2/5) 40.0% (2/5) 33.3% (3/9) 22.2% (2/9) 35.7% (5/14) 28.6% (4/14)
90 Abdomen 50.0% (2/4) 50.0% (2/4) 50.0% (3/6) 33.3% (2/6) 50.0% (5/10) 40.0% (4/10)
Buttock 100.0% (8/8) 100.0% (8/8) 81.8% (9/11) 63.6% (7/11) 88.9% (16/18) 77.8% (14/18)
180 Abdomen 100.0% (7/7) 100.0% (7/7) 80.0% (8/10) 70.0% (7/10) 85.7% (12/14) 78.6% (11/14)
Buttock 89.7% (26/29) 89.7% (26/29) 84.8% (28/33) 81.8% (27/33) 85.7% (48/56) 83.9% (47/56)
220 Abdomen 100.0% (4/4) 100.0% (4/4) 50.0% (5/10) 50.0% (5/10) 61.5% (8/13) 61.5% (8/13)
Buttock 90.0% (18/20) 85.0% (17/20) 62.1% (18/29) 55.2% (16/29) 70.5% (31/44) 63.6% (28/44)
250 Abdomen 100.0% (5/5) 100.0% (5/5) 83.3% (5/6) 83.3% (5/6) 90.9% (10/11) 90.9% (10/11)
Buttock 80.0% (12/15) 73.3% (11/15) 65.2% (15/23) 56.5% (13/23) 70.3% (26/37) 62.2% (23/37)
300 Abdomen 60.0% (3/5) 60.0% (3/5) 40.0% (2/5) 40.0% (2/5) 50.0% (5/10) 50.0% (5/10)
Buttock 66.7% (4/6) 66.7% (4/6) 35.0% (7/20) 30.0% (6/20) 42.3% (11/26) 38.5% (10/26)
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.
Note: For the blank cells (-), there are no evaluable events in this reference range.
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 rate alerted 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 rate alerted when the CGM read that the
user was above the high threshold but the users blood glucose was actually
below that high threshold.
False Predictive Hypoglycemic alert rate alerted 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.
398 Chapter 17
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