Users Manual Part 7

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25 Overview of Omnipod 5 System Pivotal Clinical Study
CGM-Informed SmartBolus Calculator Clinical Study
A study was conducted on 25 participants with type 1 diabetes aged 6-70 years
to assess the Omnipod 5 CGM-informed SmartBolus Calculator. During
Phase 1, participants used the Omnipod 5 system in Manual Mode for the
rst 7 days without a connected CGM (standard SmartBolus Calculator). In
Phase 2, participants used the Omnipod 5 system in Manual Mode with a
connected CGM (CGM-informed SmartBolus Calculator) for 7 days. Boluses
were calculated using stored pump settings plus user-estimated meal size and/
or either a manually entered glucose value (standard SmartBolus Calculator)
or an imported current CGM 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 CGM trend. e primary analysis of the study was to compare the percent
of time spent < 70 mg/dL and > 180 mg/dL for the 4 hours aer any bolus as
measured by CGM between the two study phases. e results indicate that the
use of the CGM-informed SmartBolus Calculator was associated with less time in
hypoglycemia within 4 hours of bolusing.
Comparison of Glycemic Measures from Phase 1 (Standard SmartBolus
Calculator) and Phase 2 (CGM-Informed SmartBolus Calculator) for the 4
hours After any Bolus (N=25)
Percent time in glucose
range as measured by CGM
Standard Smart-
Bolus Calculator
CGM-Informed
SmartBolus Calcu-
lator
Dierence
70-180 mg/dL
65.1%
(15.4)
63.8%
(15.7)
-1.3%
< 70 mg/dL
2.8%
(2.7)
2.1%
(2.0)
-0.6%*
< 54 mg/dL
0.5%
(1.0)
0.3%
(0.7)
-0.2%
> 180 mg/dL
32.1%
(15.7)
34.0%
(16.0)
1.9%
≥ 250 mg/dL
8.2%
(6.9)
9.7%
(10.3)
1.4%
≥ 300 mg/dL
2.0%
(2.6)
2.6%
(3.7)
0.6%
Data is presented as average (standard deviation). Signicant dierences (p<0.05)
are highlighted with an asterisk.