Omnipod® 5 App 3.1.1

The Omnipod® 5 Automated Insulin Delivery System represents a significant advancement in diabetes management, being the only FDA-cleared, tubeless automated insulin delivery solution that aligns seamlessly with Dexcom G6 and G7 continuous glucose monitoring systems. This system delivers insulin in response to real-time blood glucose data, eliminating the need for multiple daily injections and fingerstick tests under certain conditions.*

The integration of the tubeless Omnipod 5 Pod with the Dexcom G6 and G7 monitoring technology allows for an automated approach to insulin delivery. Users can manage their therapy through the Omnipod 5 App, which is available on either a controller provided by Insulet or compatible personal smartphones**. The app offers various functionalities, including the selection of basal profiles, target glucose settings, bolus adjustments, Pod management, and connectivity with continuous glucose monitoring systems.

For a more in-depth understanding of the Omnipod 5 System, potential users are encouraged to download the Omnipod 5 Simulator App or visit their official website for extensive resources.

*Fingersticks may still be necessary for diabetes treatment decisions if there are discrepancies between symptoms or expectations and device readings.

**For information regarding compatible smartphones, please refer to the Insulet website.

Intended Use:
The Omnipod 5 App functions as part of the Omnipod 5 Automated Insulin Delivery System, which is intended solely for prescription use by individuals diagnosed with Type 1 diabetes mellitus aged two years and older. This system is designed for single-patient home use and requires a valid prescription. It is compatible with U-100 insulins such as NovoLog®, Humalog®, and Admelog®.

It is advisable to consult the Omnipod 5 Automated Insulin Delivery System User Guide available at www.omnipod.com for comprehensive safety information, including indications, contraindications, and instructions. Proper training from a healthcare provider is essential before utilizing the Omnipod 5 App.

For any technical or customer service inquiries while using Insulet products, users should contact Insulet Customer Support directly at 1-800-591-3455 or via their website to ensure privacy and effective resolution of any issues.

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