OmniPod 5 - Page 304

Overview of the Omnipod 5 System Pivotal Clinical Study 25
296
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 Pivotal Study
Characteristic 6.1 mmol/L,
110 mg/dL
Target Glucose
(n=121)
6.7 mmol/L,
120 mg/dL
Target Glucose
(n=54)
7.2 mmol/L,
130 mg/dL
Target Glucose*
(n=9)
Avg % time
3.9–10 mmol/L,
70–180 mg/dL (std dev)
75.6%
(9.9%)
73.4%
(12.1%)
63.6%
(25.9%)
Avg sensor glucose,
mmol/L, mg/dL (std dev)
8.4, 151
(0.8, 15)
8.7, 156
(1.0, 18)
9.6, 172
(1.8, 33)
% Time in glucose range
Median % <3 mmol/L,
<54 mg/dL (Q1, Q3)
0.16%
(0.05, 0.26)
0.11%
(0.00, 0.33)
0.00%
(0.00, 0.00)
Median % <3.9 mmol/L,
<70 mg/dL
(Q1, Q3)
0.99%
(0.47, 1.67)
0.91%
(0.31, 1.68)
0.26%
(0.05, 0.63)
Avg % >10 mmol/L,
>180 mg/dL
(std dev)
23.1%
(10.2%)
25.4 %
(12.3%)
35.9%
(26.1%)
Avg % ≥13.9 mmol/L,
≥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 7.8 mmol/L (140 mg/dL) and 8.3 mmol/L (150 mg/dL) (with the Activity feature OFF).
Target Glucose settings in adults are not shown due to too few participants selecting them (n≤2).