Product Info

Table C-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
50 Abdomen 25.0% 25.0% 15.2% 12.3% 18.2% 16.2%
Arm 36.8% 36.8% 21.9% 16.7% 26.1% 22.4%
60 Abdomen 53.5% 51.9% 40.7% 37.1% 46.2% 43.4%
Arm 69.0% 67.8% 47.5% 45.6% 55.1% 53.5%
70 Abdomen 66.9% 66.9% 52.7% 47.7% 58.3% 55.2%
Arm 77.4% 75.3% 57.4% 54.5% 65.6% 63.0%
80 Abdomen 69.3% 69.3% 57.8% 51.1% 62.2% 58.2%
Arm 77.5% 76.4% 59.9% 53.0% 66.5% 61.9%
90 Abdomen 75.1% 74.4% 64.0% 58.5% 67.9% 64.3%
Arm 74.9% 74.9% 69.0% 63.2% 71.3% 68.0%
180 Abdomen 93.7% 92.8% 70.5% 66.9% 78.0% 75.4%
Arm 92.9% 92.9% 68.0% 63.2% 76.5% 73.7%
220 Abdomen 91.9% 91.9% 68.9% 66.3% 76.6% 74.8%
Arm 92.2% 92.2% 65.7% 62.2% 74.5% 72.2%
250 Abdomen 90.2% 90.2% 64.0% 60.1% 72.5% 69.8%
Arm 91.4% 91.4% 62.0% 59.8% 71.1% 69.6%
300 Abdomen 81.3% 81.3% 57.8% 54.0% 65.4% 62.7%
Arm 81.9% 80.6% 51.7% 49.7% 61.2% 59.3%
Glucose FALSE Alert Rate
The glucose false alert rate is the rate at which the BG did not confirm that the
CGM alert was triggered correctly. For example:
False Threshold Hypoglycemic alert rate alerted when the CGM system read that
the user was below the low threshold but the user's BG was actually above that
low threshold.
False Threshold Hyperglycemic alert rate alerted when the CGM system read that
the user was above the high threshold but the user’s BG was actually below that
high threshold.
False Predictive Hypoglycemic alert rate alerted when the CGM system predicted
that the user would be below the low threshold but the user’s BG was actually
above that low threshold within 15 or 30 minutes.
False Predictive Hyperglycemic alert rate alerted when the CGM system
predicted that the user would be above the high threshold but the user’s BG was
actually below the high threshold within 15 or 30 minutes.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 345