User`s guide
Dexcom G4 PLATINUM User’s Guide | 155
16
Agreement Relative to YSI
Agreement between the System and blood glucose values is
characterized using paired System and YSI values. The System and
YSI results were compared by pairing the YSI blood glucose value
to a System glucose reading that occurred immediately after the YSI
was collected.
The agreement of the System to blood glucose 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% were
then calculated in Table 1. Table 1 is categorized within CGM glucose
ranges. When you see a CGM reading on your receiver, this table
shows you how likely that reading matches your blood glucose level
(measured by YSI in the study).
Original Study (SW10050): The total number of data pairs considered
in the analysis was 9152. Of these, 82% of the System readings fall
within±20mg/dLoftheYSIbloodglucosevalues≤80mg/dLand
within ± 20% of YSI blood glucose values > 80 mg/dL.
Software 505 Study (SW10505): The total number of data pairs
considered in the analysis was 2263. Of these, 93% of the System
readingsfallwithin±20mg/dLoftheYSIbloodglucosevalues≤80
mg/dL and within ± 20% of YSI blood glucose values > 80 mg/dL.