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predictive only), or both (threshold and predictive) 21.6%, 33.8%, or 29.5% of the
time within 30 minutes (or 21.6%, 33.8%, or 29.5% of the time within 15 minutes)
when the user had BG less than 180 mg/dL.
Table F-2: Glucose FALSE Alert Performance using Calibration every 12 hours
Glucose FALSE Alert Rate
mg/dL Insertion Site Threshold Only Predictive Only Threshold & Predictive
30 min 15 min 30 min 15 min 30 min 15 min
50 Abdomen 66.7% 66.7% 87.5% 87.5% 81.8% 81.8%
Buttock 75.0% 75.0% 88.9% 88.9% 83.3% 83.3%
60 Abdomen 75.0% 75.0% 91.7% 91.7% 87.5% 87.5%
Buttock 40.0% 40.0% 75.0% 83.3% 64.7% 70.6%
70 Abdomen 55.6% 55.6% 71.4% 85.7% 63.6% 72.7%
Buttock 40.0% 40.0% 63.2% 73.7% 59.3% 66.7%
80 Abdomen 66.7% 66.7% 68.4% 84.2% 67.7% 77.4%
Buttock 38.9% 38.9% 53.8% 61.5% 48.8% 53.5%
90 Abdomen 45.0% 45.0% 53.8% 69.2% 52.3% 61.4%
Buttock 29.2% 29.2% 41.7% 55.6% 37.5% 46.4%
180 Abdomen 21.6% 21.6% 33.8% 33.8% 29.5% 29.5%
Buttock 16.7% 18.8% 35.7% 37.1% 29.4% 31.2%
220 Abdomen 12.5% 12.5% 40.0% 42.2% 31.8% 33.3%
Buttock 25.0% 25.0% 49.0% 51.0% 41.7% 43.1%
250 Abdomen 18.8% 18.8% 46.9% 53.1% 37.0% 41.3%
Buttock 26.7% 26.7% 58.8% 64.7% 50.0% 54.3%
300 Abdomen 22.2% 22.2% 55.6% 55.6% 44.4% 44.4%
Buttock 42.9% 42.9% 68.8% 68.8% 61.9% 61.9%
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 Correct Detection Rate
Glucose Correct Detection Rate is the rate that the device alerted when it should
have alerted. For example, the BG was below the hypoglycemic threshold, or
above the hyperglycemic threshold, and the device sounded an alert.
Glucose detection rates are important because it is necessary that users be notified
when their BG is low (or high) so that they can correct the low (or high) BG. A
high glucose correct detection rate indicates that users can have confidence that
they will be notified by the device if their BG is low or high.
370 Chapter 17