User's Manual

Dexcom G5x System User Guide
Technical Information
286
Agreement Relative to YSI
Agreement between the System and BG values is characterized using paired
System and YSI values. The System and YSI results were compared by
pairing the YSI BG value to a System glucose reading that occurred
immediately after the YSI was collected.
The agreement of the System to BG value was assessed by calculating the
percentage of System readings that were within 15%, 20%, 30% and greater
than 40% of the YSI values. For readings less than or equal to 80 mg/dL the
absolute difference in mg/dL between the two glucose results was calculated.
For values greater than 80 mg/dL the absolute percent difference (%) from the
YSI values was calculated. The percentages of total readings within 15 mg/dL
or 15%, 20 mg/dL or 20%, 30 mg/dL or 30% or greater than 40 mg/dL or 40%
are provided in Table 1-A and 1-B. The tables are categorized within CGM
glucose ranges. When you see a CGM reading on your receiver, this table
shows you how likely that reading matches your BG level (measured by YSI in
the study).
For example, in the SW10505 Adult Study (Table 1-A), the total number of
data pairs considered in the analysis was 2263. Of these, 93% of the System
readings fall within ± 20 mg/dL of the YSI BG values ≤ 80 mg/dL and within ±
20% of YSI BG values > 80 mg/dL.
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