OmniPod 5 - Page 316

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25 Overview of the Omnipod 5 System Pivotal Clinical Study
CGM-Informed SmartBolus Calculator Clinical Study in Very
Young Children
A study was conducted on 5 participants with type 1 diabetes aged 2-5.9 years to
assess the Omnipod 5 CGM-informed SmartBolus Calculator in Manual Mode.
During Phase 1, participants used the Omnipod 5 system in Manual Mode for
the rst 7 days without a connected Sensor (standard SmartBolus Calculator).
In Phase 2, participants used the Omnipod 5 system in Manual Mode with a
connected Sensor (CGM-informed SmartBolus Calculator) for 7 days. Boluses
were calculated using stored pump settings plus a user-estimated meal size
and/or either a manually entered glucose value (standard SmartBolus Calculator) or
an imported current sensor glucose value and trend (CGM-informed SmartBolus
Calculator). Both versions of the SmartBolus Calculator considered insulin on
board (IOB) in the bolus calculations. e CGM-informed calculator automatically
increased or decreased the suggested bolus amount based on the sensor glucose
trend. e primary analysis of the study was to compare the percentage of time spent
<3.9 mmol/L (<70 mg/dL) and >10 mmol/L (>180 mg/dL) for the 4 hours aer any
bolus, as measured by the Sensor between the two study phases. e results showed
that the CGM-informed SmartBolus Calculator provided similar glycaemic results
to the standard SmartBolus calculator when used in Manual Mode.
Comparison of Glycaemic Measures from Phase 1 (Standard SmartBolus
Calculator) and Phase 2 (CGM-Informed SmartBolus Calculator) for the
4 hours After any Bolus (n=5)
Percentage time
in glucose range as
measured by the Sensor
Standard
Smart- Bolus
Calculator
CGM-Informed
SmartBolus
Calculator
Difference
3.9–10 mmol/L
(70–180 mg/dL)
59.6%
(7.1%)
62.8%
(15.5%)
3.15%
<3.9 mmol/L
(<70 mg/dL)
5.16%
(4.99%)
4.03%
(3.28%)
-1.13%
<3 mmol/L
(<54 mg/dL)
1.47%
(1.88%)
0.81%
(0.91%)
-0.66%
>10 mmol/L
(>180 mg/dL)
35.2%
(10.3%)
33.2%
(18.5%)
-2.03%
≥13.9 mmol/L
(≥250 mg/dL)
9.4%
(5.7%)
7.9%
(6.4%)
-1.55%
≥16.7 mmol/L
(≥300 mg/dL)
2.33%
(2.69%)
1.99%
(2.05%)
-0.34%
Data is presented as average (standard deviation).