Important Safety Information

The Omnipod 5 Automated Insulin Delivery System is a single hormone insulin delivery system intended to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in persons aged 2 and older requiring insulin. 

The Omnipod 5 System is intended to operate as an automated insulin delivery system when used with compatible Continuous Glucose Monitors (CGM). When in automated mode, the Omnipod 5 system is designed to assist people with type 1 diabetes in achieving glycaemic targets set by their healthcare providers. It is intended to modulate (increase, decrease or pause) insulin delivery to operate within predefined threshold values using current and predicted CGM values to maintain blood glucose at variable target glucose levels, thereby reducing glucose variability. This reduction in variability is intended to lead to a reduction in the frequency, severity, and duration of both hyperglycaemia and hypoglycaemia. 

The Omnipod 5 System can also operate in a manual mode that delivers insulin at set or manually adjusted rates. 

The Omnipod 5 System is intended for single patient use. The Omnipod 5 System is indicated for use with NovoLog®/NovoRapid®, Humalog® / Liprolog®, Admelog® / Insulin lispro Sanofi®, Trurapi® / Insulin aspart Sanofi®, and Kirsty® U-100 insulin. Warning: SmartAdjust™ technology should NOT be used by anyone under the age of 2 years old. SmartAdjust™ technology should also NOT be used in people who require less than 5 units of insulin per day as the safety of the technology has not been evaluated in this population. 

The Omnipod® 5 System is NOT recommended for people who are unable to monitor glucose as recommended by their healthcare provider, are unable to maintain contact with their healthcare provider, are unable to use the Omnipod® 5 System according to instructions, are taking hydroxyurea and using a Dexcom Sensor as it could lead to falsely elevated CGM values and result in over-delivery of insulin that can lead to severe hypoglycaemia, and do NOT have adequate hearing and/or vision to allow recognition of all functions of the Omnipod® 5 System, including alerts, alarms, and reminders. Device components including the Pod, CGM transmitter, and CGM sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. In addition, the Controller and smartphone should be placed outside of the procedure room. Exposure to MRI, CT, or diathermy treatment can damage the components. 

Warning: DO NOT start to use the Omnipod® 5 System or change settings without adequate training and guidance from a healthcare provider. Initiating and adjusting settings incorrectly can result in over-delivery or under-delivery of insulin, which could lead to hypoglycaemia or hyperglycaemia.

The Omnipod DASH® Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Additionally, the Omnipod DASH® System permits manual entry of readings from blood glucose meters, enabling storage and display of blood glucose measurements. The Omnipod DASH® System has been tested and found to be safe for use with the following: NovoRapid® (insulin aspart), Fiasp® (insulin aspart), Humalog® (insulin lispro), Admelog® (insulin lispro), Lyumjev® and Apidra® (insulin glulisine). Refer to the Omnipod DASH® Insulin Management System User Guide for complete safety information including indications, contraindications, warnings, cautions, and instructions. This User Guide is periodically updated. Visit Omnipod.com to see the most recent version and to find other helpful information. To access this User Guide in other languages, see Omnipod.com.