OmniPod 5 - Page 311

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Overview of the Omnipod 5 System Pivotal Clinical Study 2525 Overview of the Omnipod 5 System Pivotal Clinical Study
Glycaemic Results Overnight (12:00AM to 6:00AM)
Characteristic
Standard
Therapy
Omnipod 5 Change
Avg % time
3.9–10 mmol/L,
70–180 mg/dL (std dev)
58.2%
(18.7%)
81.0%
(10.0%)
22.8%*
Avg sensor glucose,
mmol/L, mg/dL, (std
dev)
9.3, 168.1
(1.8, 33.3)
7.8, 140.7
(0.9, 16.4)
-1.5, -27.4*
Avg standard deviation
of sensor glucose,
mmol/L, mg/dL
(std dev)
3.2, 58.0
(0.8, 14.0)
2.5, 45.5
(0.6, 10.8)
-0.7, -12.5*
Avg coefcient of
variation of sensor
glucose, % (std dev)
34.7%
(6.6%)
32.1%
(5.2%)
-2.6%*
% Time in Glucose
Range
Median %
<3 mmol/L,
<54 mg/dL
(Q1, Q3)
0.00%
(0.00, 0.97)
0.18%
(0.06, 0.53)
0.00%
Median %
<3.9 mmol/L,
<70 mg/dL
(Q1, Q3)
1.66%
(0.40, 4.21)
1.58%
(0.65, 2.89)
-0.44%*
Avg %
>10 mmol/L,
>180 mg/dL
(std dev)
38.4%
(20.1%)
16.9%
(10.3%)
-21.5%*
Avg %
≥13.9 mmol/L,
≥250 mg/dL
(std dev)
13.0%
(13.2%)
3.9%
(3.9%)
-9.1%*
Avg %
≥16.7 mmol/L,
≥300 mg/dL
(std dev)
4.3%
(6.7%)
1.2%
(1.6%)
-3.1%*
*Change between the standard-therapy phase and the Omnipod 5 System phase was
statistically signicant