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
Omnipod 5 System Use
e table below provides information on the average % of time study subjects
used the Omnipod 5 System in Automated Mode.
Percent Time Spent in Automated Mode
Children
(6 to 13.9 years)
n=112
Adolescents & Adults
(14 to 70 years)
n=128
% Time in Automated
Mode
(std dev)
95.2%
(4.0%)
94.8%
(6.0%)
Adverse Events
e table below provides a full list of the adverse events that occurred during the
3-month Omnipod 5 System treatment phase. ere were 3 severe hypoglycemia
events not attributable to the Omnipod 5 System automated insulin delivery
or system malfunction and 1 DKA event from a suspected infusion site failure.
Other related, but non-glycemic adverse events included infection or irritation at
infusion site (2 children, 2 adolescents/adults).
Adverse Events during the Omnipod 5 System Phase
Adverse Event Type Children
(6 to 13.9
years)
(n=112)
Adolescents &
Adults
(14 to 70 years)
(n=128)
Total
(6 to 70 years)
(N=240)
Hypoglycemia
‡
1 0 1
Severe Hypoglycemia
§
1 2 3
DKA 1 2 1
Hyperglycemia
‖
1 2 3
Prolonged Hyperglycemia
**
13 5 18
Other 8 8 16
Results reported as number oif events.
‡
Hypoglycemia resulting in a serious adverse event, but otherwise not meeting the denition of severe
hypoglycemia.
§
Required the assistance of another person,
‖
Hyperglycemia requiring evaluation, treatment or guidance from intervention site, or hyperglycemia
resulting in a serious adverse event.
**
Meter blood glucose measuring ≥300mg/dL and ketones >1.0mmol/L