Additional Analysis Of Sensor Glucose Value Auto-Population With Cgm - Tandem t:slim X2 User Manual

32.10 Additional Analysis of Sensor Glucose Value Auto-Population with CGM

Upon completion of the Pivotal Study, an evaluation of the auto-population of CGM readings into the bolus calculator was
performed. The results of the analysis indicate, when a sensor glucose value was >250 mg/dL, there was an increased incidence of
CGM values <70 mg/dL five hours after a bolus was delivered using auto-populated CGM readings compared to the five hours after
the bolus was delivered using manually entered sensor glucose values.
DCLP3: Post-Correction Bolus CGM Readings (5 hours): All Boluses
Entry Type
Automatically Populated
(n=17,023)
Manually Entered
(n=1,905)
DCLP5: Post-Correction Bolus CGM Readings (5 hours): All Boluses
Entry Type
Automatically Populated
(n=12,323)
Manually Entered
(n=1,630)
CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies
One or More CGM
Reading <54 mg/dL
(95% CI)
4%
(3.6, 4.2)%
5%
(3.8, 5.7)%
One or More CGM
Reading <54 mg/dL
(95% CI)
6%
(5.7, 6.5)%
6%
(4.9, 7.3)%
Three Consecutive CGM
Readings <70 mg/dL
(95% CI)
8%
(7.5, 8.3)%
9%
(7.4, 10.0)%
Three Consecutive CGM
Readings <70 mg/dL
(95% CI)
15%
(14.4, 15.6)%
14%
(12.1, 15.5)%
Five or More CGM
Readings <70 mg/dL
(95% CI)
12%
(11.2, 12.2)%
12%
(10.3, 13.2)%
Five or More CGM
Readings <70 mg/dL
(95% CI)
9%
(8.4, 9.4)%
9%
(7.4, 10.2)%
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