FDA Clears Insulet’s Omnipod 5 for People with Type 2 Diabetes

Insulet Corporation has received FDA approval to expand the use of its Omnipod 5 automated insulin delivery system to include adults with type 2 diabetes.

This new clearance marks a significant milestone for the Acton, Massachusetts-based company, broadening its potential customer base.

The approval follows a recent study demonstrating that Omnipod 5 significantly improves blood-sugar control in poeople with type 2 diabetes. Key findings from the study include:

• Reductions in A1C levels
• Less time spent in hyperglycemia, and
• A decreased need for daily insulin

All while maintaining safe blood-sugar levels and reducing diabetes-related stress.

Currently, more than 30 million people in the U.S. have type 2 diabetes, and approximately 6 million require insulin therapy.

Of these, around 2.5 million manage their condition with multiple daily injections.

Insulet aims to offer these individuals a more convenient and effective alternative with the Omnipod 5 system.

WRITTEN BY Daniel Trecroci, POSTED 08/27/24, UPDATED 08/27/24

Dan has written about diabetes for more than 20 years. He was one of Diabetes Health's first recruits, and throughout his 10 + years as Managing Editor he wrote/published thousands of articles and helped establish Diabetes Health as the premiere resource for people with diabetes. He later became the Content Manager for OneTouchGold—Johnson & Johnson/LifeScan’s official digital publication for its metering-technology customers. Under his leadership, OneTouchGold received the Web Marketing Association’s award for “Best Health & Wellness" web site. Dan has also written for the Diabetes Research Institute, dLife, diaTribe, Healthline, CareDx, Pendulum Therapeutics, and Hero Bread.