Dexcom stelo - Page 96

Accuracy
The Stelo Glucose Biosensor System accuracy was assessed with paired sensor
readings to YSI blood glucose values. For YSI blood glucose values less than 70
mg/dL, the absolute difference in mg/dL between the two glucose results was
calculated. For values greater than or equal to 70 mg/dL, the absolute difference (%)
relative to the YSI value was calculated. In addition, the mean absolute relative
difference (MARD) shows the average amount the sensor readings differ from the YSI
glucose. The percentages of total readings within 20 mg/dL or 20% (20/20%) are
provided in Table 1-A. The tables are further categorized within Biosensor glucose
ranges (Table 1-B) and categorized within YSI glucose ranges (Table 1-C). When you
see a sensor reading on your mobile app, these tables show you how likely it is that
the reading matches your blood glucose level (measured by YSI in the study).
For example, the total number of data pairs considered in the analysis was 20,330. Of
these, 94.0% of the sensor readings fall within ± 20 mg/dL of the YSI blood glucose
values < 70 mg/dL and within ± 20% of YSI blood glucose values ≥ 70 mg/dL.
Table 1-A. Overall accuracy to comparator method (n=130)
Population
Number of
subjects
Number of paired
Biosensor
1
-YSI
Percent within
20/20% YSI
Percent within 20/20%
YSI on Day 1
MARD
(%)
Adults 130 20,330 94.0 88.6 8.3
1
Biosensor readings are within 40-400 mg/dL, inclusive.
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