Tandem T:Slim X2 User Manual page 312

Chapter 30 – Technical Specifications
Low and High Glucose Alerts
The ability of the CGM to detect high
and low glucose levels is assessed by
comparing CGM results to YSI results
at low and high blood glucose levels
and determining if the alert may have
sounded. The CGM and YSI values
were compared by pairing the CGM
reading that occurred immediately after
the YSI value was collected. We sug-
gest that you ask your doctor what alert
settings would be best for you.
The Low Glucose Alert
Estimates of how well the adjust-
able Low Glucose Alert performs are
presented in Tables 5-A, 5-B and 5-C.
Table 5-A represents the hypoglycemic
alert evaluation within 15 minutes of the
YSI value in the adult studies. Table 5-B
represents the alert evaluation within 15
minutes of the YSI value for a subset of
the pediatric population—subjects age
6 to 17 years who had YSI measure-
ments every 15 minutes. Table 5-C
represents the alert evaluation within
30 minutes of an SMBG reading for
2- to 5-year old subjects in the
pediatric studies.
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Hypoglycemia Alert Rate
The Alert Rate shows how often
the alert is right or wrong. The True
Alert Rate is the % of time the device
alarmed when the blood glucose level
was at or below the alert setting within
15 or 30 minutes before or after the de-
vice alarmed. The False Alert Rate is the
% of time the device alarmed when the
blood glucose level was above the alert
setting within 15 or 30 minutes before
or after the device alarmed.
For example, if you set the Low Glu-
cose Alert to 70 mg/dL and your alarm
sounds, how often can you expect your
blood sugar to actually be low? In the
Software 505 Adult Study (Table 5-A),
when your alarm sounds, you can ex-
pect your blood sugar to be below 70
mg/dL approximately 92% of the time
and above 70 mg/dL approximately 8%
of the time within the 15 minute period
before or after your alarm sounds.
Hypoglycemia Detection Rate
The Detection Rate shows how often
the device recognizes and alerts you
to an episode of hypoglycemia or how
often it misses such an event. The
Hypoglycemia Detection Rate is the %
of time the blood glucose level was at
or below the alert setting and device
alarmed within 15 or 30 minutes before
or after the blood glucose was at or be-
low the alert settings. The Hypoglyce-
mia Missed Detection Rate is the % of
time the blood glucose was at or below
the alert setting, but the device did not
alarm within 15 or 30 minutes before or
after the blood glucose was at or below
the alert setting.
For example, if you set the Low Glucose
alert to 70 mg/dL, how often will your
alarm alert you if your blood glucose
goes below 70 mg/dL? In the Software
505 Adult Study (Table 5-A), when your
blood sugar goes below 70 mg/dL, you
can expect your alarm to sound 91%
of the time and not to sound approxi-
mately 9% of time within the 15 minute
period before or after your blood sugar
goes below 70 mg/dL.
Customer Technical Support: (877) 801-6901