Users Manual Part 7

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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 Pivotal Study
Characteristic 110 mg/dL
Target Glucose
(n=121)
120 mg/dL
Target Glucose
(n=54)
130 mg/dL
Target Glucose*
(n=9)
Avg % time 70-180 mg/dL
(std dev)
75.6%
(9.9%)
73.4%
(12.1%)
63.6%
(25.9%)
Avg sensor glucose, mg/dL
(std dev)
151
(15)
156
(18)
172
(33)
% Time in glucose range
Median % <54 mg/dL
(Q1, Q3)
0.16%
(0.05, 0.26)
0.11%
(0.00, 0.33)
0.00%
(0.00, 0.00)
Median % <70 mg/dL
(Q1, Q3)
0.99%
(0.47, 1.67)
0.91%
(0.31, 1.68)
0.26%
(0.05, 0.63)
Avg % >180 mg/dL
(std dev)
23.1%
(10.2%)
25.4 %
(12.3%)
35.9%
(26.1%)
Avg % ≥250 mg/dL
(std dev)
5.1%
(4.6%)
5.8%
(6.4%)
9.6%
(12.3%)
Cumulative number of
person-days
9,278 1,827 178
*Results for the 140 mg/dL and 150 mg/dL (with the Activity feature OFF) Target Glucose settings in
adults are not shown due to too few subjects selecting them (n≤2).