Users Manual Part 7

Overview of Omnipod 5 System Pivotal Clinical Study 25
320
25 Overview of Omnipod 5 System Pivotal Clinical Study
Omnipod 5 System Pre-Pivotal Glycemic Results at Target
Glucose Settings
Glycemic Results at Target Glucose Settings in Pre-Pivotal Study
e goal of the pre-pivotal study of the Omnipod 5 System was to assess the
safety and ecacy of the system. is single-arm, multicenter, prospective study
enrolled 18 children (6 to 13.9 years) and 18 adults (14 to 70 years) with type 1
diabetes. A 2-week standard therapy phase (usual insulin regimen) was followed
by 2 weeks of Omnipod 5 System use in Automated Mode. e 2-week Omnipod
5 phase included 3 days of required use at each of the Target Glucose settings of
130 mg/dL, 140 mg/dL, and 150 mg/dL for a total of 9 days, followed by 5 days of
free choice of Target Glucose ranging from 110-150 mg/dL.
Overall (24 hours) Glycemic Results at Target Glucose Settings in Children
(6 to 13.9 years) from Pre-Pivotal Study
Characteristic 110mg/dL
Target
Glucose
(n=11)
120mg/dL
Target
Glucose
(n=3)
130mg/dL
Target
Glucose
(n=18)
a
140mg/dL
Target
Glucose
(n=18)
150mg/dL
Target
Glucose
(n=18)
b
Avg % time 70-180
mg/dL
(std dev)
71.2%
(10.2%)
66.8%
(12.9%)
61.5%
(7.7%)
64.8%
(11.6%)
53.5%
(11.0%)
Avg sensor glucose,
mg/dL
(std dev)
155.2
(18.2)
170
(16)
174.1
(11.4)
172.7
(17.2)
182.9
(15.3)
% Time in glucose
range
Median % <54 mg/dL
(Q1, Q3)
0.1%
(0.0, 0.4)
0.2%
(0.0, 0.3)
0.0%
(0.0, 0.3)
0.0%
(0.0, 0.0)
0.0%
(0.0, 0.1)
Median % <70 mg/dL
(Q1, Q3)
0.9%
(0.4, 2.8)
0.3%
(0.2. 2.2)
0.5%
(0.1, 0.8)
0.1%
(0.0, 0.5)
0.5%
(0.0, 0.8)
Avg % >180 mg/dL
(std dev)
27.1%
(11.4%)
32.3%
(11.9%)
37.7%
(7.9)
34.6%
(12.1%)
45.9%
(11.0%)
Avg % ≥250 mg/dL
(std dev)
6.8%
(6.3%)
14.4%
(6.2%)
13.2%
(5.8%)
10.6%
(7.3%)
12.8%
(8.1%)
Cumulative number
of person-days
47.7 8.7 73.3 56.3 61.5
a
All subjects initiated the system at the 130 mg/dL Target Glucose for 3 days.
b
e glycemic results at the 150 mg/dL Target Glucose setting include times with the Activity feature
ON and OFF, meaning the results recorded during this time may include those when subjects felt their
insulin needs were reduced.