OmniPod 5 - Adverse Events

Overview of the Omnipod 5 System Pivotal Clinical Study 25
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25 Overview of the Omnipod 5 System Pivotal Clinical Study
Adverse Events
e table below provides a full list of the adverse events that occurred during the
3-month Omnipod 5 System treatment phase. Other related, but non-glycaemic
adverse events included skin irritation (n=2), cellulitis (n=1) and ketosis not
meeting the DKA denition (n=2).
Adverse Events during the Omnipod 5 System Phase
Adverse Event Type Omnipod 5
Hypoglycaemia ‡ 0
Severe Hypoglycaemia §
0
DKA 0
Hyperglycaemia ‖ 4
Prolonged Hyperglycaemia ** 20
Other 5
Results reported as number of events.
‡ Hypoglycaemia resulting in a serious adverse event, but otherwise not meeting the
denition of severe hypoglycaemia.
§ Required the assistance of another person.
‖ Hyperglycaemia requiring evaluation, treatment or guidance from the intervention site, or
hyperglycaemia resulting in a serious adverse event.
** Meter blood glucose measuring ≥16.7 mmol/L (≥300 mg/dL) and ketones >1.0 mmol/L