FDA Approves Insulet's Omnipod 5 Automated Insulin Delivery System for People with Type 2 Diabetes

WASHINGTON (dpa-AFX) — Insulet Corp. (PODD) said the U.S. Food and Drug Administration has approved the company’s Omnipod 5 automated insulin delivery system for people with type 2 diabetes. It is the first device to enable automated insulin dosing for people with type 2 diabetes.

According to the company, the Omnipod 5 System simplifies diabetes management and improves outcomes by eliminating the need for multiple daily injections and automatically adjusting insulin delivery every 5 minutes using advanced SmartAdjust technology.

Previously, insulin therapy options for people with type 2 diabetes were limited to methods such as injection with a syringe, an insulin pen or an insulin pump. These methods require the patient to self-administer insulin one or more times per day and to regularly monitor blood glucose levels to achieve the best results.

The FDA has expanded the indications for Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the treatment of type 1 diabetes in persons two years of age and older, to include the treatment of type 2 diabetes in persons 18 years of age and older.

An interoperable automated glycemic controller is software that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternative insulin pump with controller and an integrated continuous glucose monitor.

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