Tandem T:Slim X2 User Manual page 332

Chapter 30 – Technical Specifications
Agreement and Accuracy
Relative to SMBG
Agreement between the CGM and
blood glucose values is also charac-
terized using paired CGM and SMBG
results (Tables 11-A/B to 12-A/B).
The CGM and SMBG values were
compared by pairing the comparative
SMBG value to a CGM glucose reading
that occurred immediately after the
SMBG was collected. These results
characterize the performance subjects
expect during real-time use of the CGM
in their daily diabetes management
when comparing the CGM readings to
their home blood glucose meter results.
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 differ-
ence (%) from the SMBG values was
calculated. The percentages of total
readings within 15 mg/dL or 15%, 20
mg/dL or 20%, 30 mg/dL or 30%, 40
mg/dL or 40% or greater than 40 mg/
dL or 40% were then calculated.
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For example, if the CGM reads 100 mg/
dL, it is between 81-180 mg/dL range
and you can expect the CGM readings
to be within 20% of the SMBG values
85% of the time for the Software 505
Adult Study, as seen in Table 11-A.
Overall, the CGM in the Software 505
Adult Study reads, on average, 2.6%
lower (Mean Percent Difference) than
SMBG values and 11.3% absolute
different (Mean Absolute Percent Differ-
ence) than the SMBG values. The Medi-
an Percent Difference shows that half of
the time the CGM reads lower in 2.7%
or less than the SMBG values and the
Median Absolute Percent Difference
shows that half of the time the CGM
reads about 8.6% or less different than
SMBG values, as seen in Table 12-A.
Adverse Events
No serious adverse events or device-re-
lated serious adverse events occurred
during the studies. Mild to moderate
skin irritation, such as erythema or
edema, occurred at the sensor needle
insertion area or around the adhesive
area. No infection, bruising, or bleeding
occurred at the sensor needle insertion
area or the adhesive area.
Customer Technical Support: (877) 801-6901