Use Instructions

296
Appendix
CGM-Informed Bolus Calculator Clinical Study
A study was conducted in 25 participants with type 1 diabetes aged 6-70 years
to assess the Omnipod 5 CGM-informed Bolus Calculator. During Phase 1,
participants used the Omnipod 5 system in Manual Mode for the rst 7 days
without a connected CGM (standard Bolus Calculator). In Phase 2, participants
used the Omnipod 5 system in Manual Mode with a connected CGM (CGM-
informed Bolus 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 Bolus Calculator) or an imported current CGM value and
trend (CGM-informed Bolus Calculator). Both versions of the Bolus 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 Bolus Calculator was associated with less time in
hypoglycemia within 4 hours of bolusing.
Comparison of Glycemic Outcomes from Phase 1 (Standard Bolus
Calculator) and Phase 2 (CGM-Informed Bolus Calculator) for the 4 hours
After any Bolus (N=25)
Percent time in glucose
range as measured by CGM
Standard Bolus
Calculator
CGM-Informed
Bolus Calculator
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.
Effective Date: 22DEC2020, PCO-000267