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Overview of the Omnipod 5 System Pivotal Clinical Study 2525 Overview of the Omnipod 5 System Pivotal Clinical Study
Omnipod 5 System Pre-Pivotal Glycaemic Results at Target
Glucose Settings
Glycaemic Results at Target Glucose Settings in the 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, multicentre,
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 7.2 mmol/L
(130 mg/dL), 7.8 mmol/L (140 mg/dL) and 8.3 mmol/L (150 mg/dL) for a
total of 9 days, followed by 5 days of free choice of Target Glucose ranging
from 6.1–8.3 mmol/L (110–150 mg/dL).
Overall (24 hours) Glycaemic Results at Target Glucose Settings in
Children (6 to 13.9 years) from the Pre-Pivotal Study
Characteristic
6.1 mmol/L,
110 mg/dL
Target
Glucose
(n=11)
6.7 mmol/L,
120 mg/dL
Target
Glucose
(n=3)
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)
71.2%
(10.2%)
66.8%
(12.9%)
61.5%
(7.7%)
64.8%
(11.6%)
53.5%
(11.0%)
Avg sensor glucose,
mmol/L, mg/dL
(std dev)
8.6, 155.2
(1.0, 18.2)
9.4, 170
(0.9, 16)
9.7, 174.1
(0.6, 11.4)
9.6, 172.7
(1.0, 17.2)
10.2, 182.9
(0.9, 15.3)
% Time in glucose range
Median %
<3 mmol/L,
<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 %
<3.9 mmol/L,
<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 % >10 mmol/L,
>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 % ≥13.9 mmol/L,
≥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 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.