FDA Approves Embecta’s New Insulin-Delivery System for Both Type 1 and Type 2 Diabetes

In a significant development for diabetes care, Embecta Corp. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking disposable insulin-delivery system, designed for adults with both type 1 and type 2 diabetes.

This innovative system features a tubeless patch pump with a 300-unit insulin reservoir, making it particularly suitable for people with type 2 diabetes who require higher daily doses of insulin.

The new system addresses a major gap in diabetes management tools. Although nine out of 10 people with diabetes have type 2 diabetes, most existing automated-insulin-delivery solutions are primarily designed for type 1 diabetes.

Embecta’s new patch pump meets this unmet need with a larger insulin capacity, offering a more convenient option for those moving from multiple daily injections to pump therapy.

A recent study showed that this 300-unit reservoir could meet the insulin needs of 64% of adults with type 2 diabetes for a three-day wear period, compared to just 38% with a 200-unit reservoir.

The fully disposable patch pump provides adjustable basal and bolus insulin delivery for up to three days, offering flexibility and ease of use. The accompanying locked-down controller with Bluetooth® wireless technology and a color touchscreen further enhances the user experience, simplifying diabetes management.

Embecta plans to develop a closed-loop system that includes an insulin-dosing algorithm, aiming for future FDA submissions to expand its product offerings even further.

For more details, visit embecta.com.

WRITTEN BY Daniel Trecroci, POSTED 09/03/24, UPDATED 09/03/24

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.