Automated Insulin Delivery Tech Okayed for Type 2 Diabetes

The US Food and Drug Administration (FDA) has expanded the indication for Tandem Diabetes Care’s Control-IQ+ Technology to include people with type 2 diabetes (T2D).

The next-generation Control-IQ+ algorithm, used to enable automated insulin delivery (AID) in conjunction with Tandem’s t:slim X2 and Mobi insulin pumps, was already approved for people with type 1 diabetes aged 2 years or older. The new indication is for people with T2D aged 18 years or older. The pumps are approved for both type 1 and T2D.

More than 2 million people with T2D in the United States require intensive insulin therapy, Tandem said in a statement.

This is the second clearance of an AID system algorithm for people with T2D. The first, Omnipod 5, was cleared by the FDA in August 2024.

This expanded label indication for T2D is based on results from a recently completed randomized, controlled pivotal trial of more than 300 people with T2D, comparing the t:slim pump with Control-IQ+ technology to multiple daily injection regimens, with both groups using the Dexcom G6 continuous glucose monitoring system. Full study results will be presented in March 2025 at the 18th International Conference on Advanced Technologies & Treatments for Diabetes in Amsterdam, the Netherlands.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape Medical News, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social.