Users Manual Part 7

Overview of Omnipod 5 System Pivotal Clinical Study 25
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25 Overview of Omnipod 5 System Pivotal Clinical Study
Glycemic Results at Target Glucose Settings in Pivotal Study
e tables below provide information on the glycemic results at various self-
selected Target Glucose settings during the 3-month Omnipod 5 System phase of
the pivotal study. Of the customizable Glucose targets, the most selected was 110
mg/dL.
Overall(24 hours)Glycemic Results at Target Glucose Settings
inChildren(6 to 13.9 years)from Pivotal Study
Characteristic 110mg/
dL Target
Glucose
(n=98)
120mg/dL
Target
Glucose
(n=74)
130mg/dL
Target
Glucose
(n=47)
140mg/dL
Target
Glucose
(n=12)
150mg/
dL Target
Glucose*
(n=9)
Avg % time 70-180
mg/dL
(std dev)
68.4%
( 9.1%)
67.5%
(9.7%)
64.2%
(14.3%)
59.2%
(16.9%)
53.3%
(18.2%)
Avg sensor glucose,
mg/dL
(std dev)
159
(17)
163
(16)
169
(24)
178
(24)
183.6
(23.9)
% Time in glucose
range
Median % <54 mg/
dL
(Q1, Q3)
0.22%
(0.06,
0.49)
0.18%
(0.05,
0.33)
0.09%
(0.00,
0.21)
0.04%
(0.00,
0.34)
0.00%
(0.00, 0.00)
Median % <70 mg/
dL
(Q1, Q3)
1.51%
(0.76,
2.38)
1.16%
(0.58,
1.94)
0.71%
(0.26,
1.63)
0.59%
(0.05,
1.52)
0.12%
(0.00, 0.21)
Avg % >180 mg/dL
(std dev)
29.7%
(9.6%)
31.1%
(10.0%)
34.5%
(14.8%)
39.9%
(16.6%)
46.4%
(18%)
Avg % ≥250 mg/dL
(std dev)
9.7%
(5.8%)
10.0%
(6.3%)
11.8%
(9.0%)
14.6%
(11.1%)
13.3%
(11.9%)
Cumulative number
of person-days
6,289 2,716 941 99 73