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For example, per the following table, when wearing the sensor in the abdomen,
the threshold alert, predictive alert, or both alerts (threshold and predictive) did not
sound 0%, 0%, or 0% of the time within 30 minutes (or 0%, 0%, or 0% within 15
minutes) when the user had BG less than 50 mg/dL.
Table F-4: Glucose Missed Detection Alert Performance using Calibration every 12 hours
Glucose Missed Detection 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 0.0% 0.0% 0.0% 0.0% 0.0% 0.0%
Buttock 0.0% 0.0% 0.0% 0.0% 0.0% 0.0%
60 Abdomen 50.0% 50.0% 50.0% 50.0% 50.0% 50.0%
Buttock 0.0% 0.0% 0.0% 33.3% 0.0% 0.0%
70 Abdomen 20.0% 20.0% 20.0% 60.0% 20.0% 20.0%
Buttock 14.3% 14.3% 14.3% 28.6% 14.3% 14.3%
80 Abdomen 33.3% 33.3% 16.7% 50.0% 16.7% 33.3%
Buttock 14.3% 14.3% 14.3% 21.4% 14.3% 14.3%
90 Abdomen 8.3% 8.3% 8.3% 33.3% 8.3% 8.3%
Buttock 13.6% 13.6% 9.1% 27.3% 4.5% 13.6%
180 Abdomen 4.9% 4.9% 0.0% 0.0% 0.0% 0.0%
Buttock 2.5% 5.0% 0.0% 0.0% 0.0% 0.0%
220 Abdomen 7.4% 14.8% 3.7% 11.1% 3.7% 11.1%
Buttock 4.3% 4.3% 0.0% 4.3% 0.0% 0.0%
250 Abdomen 22.2% 22.2% 11.1% 16.7% 11.1% 16.7%
Buttock 31.3% 37.5% 0.0% 6.3% 0.0% 0.0%
300 Abdomen 20.0% 20.0% 0.0% 10.0% 0.0% 10.0%
Buttock 40.0% 40.0% 0.0% 0.0% 0.0% 0.0%
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.
III. Performance data for users 2 through 6 years old
G. Device Performance data for users ages 2 through 6
The SmartGuard technology has two levels that include the 1) Suspend on low
and Suspend before low that automatically suspends insulin based on CGM and 2)
Auto mode that automatically calculates insulin dosing using CGM. A study was
performed to evaluate for safety in a multi-center, single arm, clinical investigation.
Study subjects included persons aged 2 to 6 years of age diagnosed with type 1
372 Chapter 17