Users Manual Part 7

321
Overview of Omnipod 5 System Pivotal Clinical Study 2525 Overview of Omnipod 5 System Pivotal Clinical Study
Overall (24 hours) Glycemic Results at Target Glucose Settings in
Adolescents and Adults (14 to 70 years) from Pre-Pivotal Study
Characteristic 110mg/dL
Target
Glucose
(n=12)
120mg/dL
Target
Glucose
(n=7)
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)
72.5%
(9.4%)
70.9%
(11.3%)
75.1%
(11.6%)
67.6%
(9.2%)
63.7%
(7.8%)
Avg sensor glucose,
mg/dL
(std dev)
153.8
(14.8)
159.7
(11)
153.8
(14.9)
165.4
(11.5)
169.8
(9.4)
% Time in glucose
range
Median % <54 mg/dL
(Q1, Q3)
0.0%
(0.0, 0.0)
0.0%
(0.0, 0.0)
0.0%
(0.0, 0.2)
0.0%
(0.0, 0.1)
0.0%
(0.0, 0.2)
Median % <70 mg/dL
(Q1, Q3)
0.5%
(0.0, 1.4)
0.4%
(0.0, 0.6)
0.9%
(0.4, 1.2)
0.1%
(0.0, 0.6)
0.2%
(0.0, 0.9)
Avg % >180 mg/dL
(std dev)
26.4%
(10.0%)
28.7%
(11.2%)
23.4%
(11.4%)
31.7%
(9.2%)
35.7%
(7.9%)
Avg % ≥250 mg/dL
(std dev)
4.1%
(3.4%)
5.2%
(5.5%)
5.0%
(4.6%)
5.1%
(4.5%)
6.0%
(4.8%)
Cumulative number
of person-days
41.1 28 58.8 58.4 60.3
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.