OmniPod 5 - Page 306

Overview of the Omnipod 5 System Pivotal Clinical Study 25
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25 Overview of the Omnipod 5 System Pivotal Clinical Study
Overall (24 hours) Glycaemic Results at Target Glucose Settings in
Adolescents and Adults (14 to 70 years) from the Pre-Pivotal Study
Characteristic
6.1 mmol/L,
110 mg/dL
Target
Glucose
(n=12)
6.7 mmol/L,
120 mg/dL
Target
Glucose
(n=7)
7.2 mmol/L,
130 mg/dL
Target
Glucose
(n=18)
a
7.8 mmol/L,
140 mg/dL
Target
Glucose
(n=18)
8.3 mmol/L,
150 mg/dL
Target
Glucose
(n=18)
b
Avg % time
3.9–10 mmol/L,
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,
mmol/L, mg/dL
(std dev)
8.5, 153.8
(0.8, 14.8)
8.9, 159.7
(0.6, 11)
8.5, 153.8
(0.8, 14.9)
9.2, 165.4
(0.6, 11.5)
9.4, 169.8
(0.5, 9.4)
% Time in glucose
range
Median %
<3 mmol/L,
<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 %
<3.9 mmol/L,
<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 % >10 mmol/L,
>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 % ≥13.9 mmol/L,
≥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 participants initiated the system at the 7.2 mmol/L (130 mg/dL) Target Glucose for 3 days.
b
e glycaemic results at the 8.3 mmol/L (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
participants felt their insulin needs were reduced.