Tandem T:Slim X2 User Manual page 300

Chapter 30 – Technical Specifications
Agreement When CGM Reads
"LOW" or "HIGH"
The CGM reports glucose readings
between 40 and 400 mg/dL. When the
CGM determines the glucose reading
is below 40 mg/dL, it displays "LOW"
on the pump home screen. When the
CGM determines that the glucose level
is above 400 mg/dL, it displays "HIGH"
on the pump home screen. Because
the CGM does not display glucose val-
ues below 40 mg/dL or above 400 mg/
dL, the comparisons to the actual blood
glucose levels (as determined by the
YSI analyzer) when CGM is classified as
"LOW" or "HIGH" are included sepa-
rately in Tables 2-A and 2-B. The tables
include the numbers and the cumulative
percentages when YSI values were less
than certain glucose levels (for "LOW"),
and when YSI values were greater than
certain glucose levels (for "HIGH").
For example, in the Software 505
Adult Study (Table 2-A), when the CGM
displayed "LOW" (18 occasions), 100%
(18 out of 18) of the YSI values were
less than 80 mg/dL, and 94% (17 out
of 18) of the YSI values were less than
70 mg/dL. When the CGM displayed
300
"HIGH" (45 occasions), 100% (45 out of
45) of the YSI values were greater than
240 mg/dL, and 100% (45 out of 45) of
the YSI values were greater than 280
mg/dL.
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