FDA OKs Tandem Diabetes’ Control-IQ+ Algorithm for Type 2 Diabetes

Tandem Diabetes Care has earned U.S. Food and Drug Administration (FDA) clearance for its next-gen automated insulin delivery (AID) algorithm, Control-IQ+, for adults with type 2 diabetes.

Already FDA cleared for type 1 diabetes, Control-IQ+ includes enhancements to accommodate input of expanded weight and total daily insulin ranges. It’s expected to become available for new and existing U.S. customers in March 2025.

Control-IQ powers the company’s t:slim X2 and Mobi insulin delivery systems. Tandem said results from its tech in type 1 diabetes demonstrated immediate and sustained glycemic improvements, including more time in range and improved sleep. This expanded label indication for type 2 diabetes is based on results from a recently completed pivotal trial.

The study of over 300 people with type 2 diabetes compared use of a t:slim X2 pump with Control-IQ+ to multiple daily injections regimens. Both groups used a Dexcom G6 continuous glucose monitor (CGM) for the study’s duration.

“We have seen firsthand, through numerous clinical and real-world studies, how Control-IQ has improved health outcomes and quality of life for our users with type 1 diabetes,” said John Sheridan, Tandem Diabetes’ president and CEO. “It is a natural evolution of our mission to bring the same AID technology that helped to make Tandem the #1 recommended insulin pump brand by both healthcare providers and people living with type 1 diabetes to adults with type 2.”

“Type 2 diabetes affects millions of Americans and increases the risk of serious health conditions, including heart disease, stroke, kidney disease, and nerve damage, reinforcing the importance of consistent management of blood sugar,” said Jordan Pinsker, MD, Tandem Diabetes’ chief medical officer. “More than 2 million people in the U.S. rely on intensive insulin therapy to manage their type 2 diabetes, and we are proud to bring this life-changing technology to a group that has historically had limited options for diabetes management.”

Last month, the company revealed it had begun a multi-year collaboration agreement with the University of Virginia Center for Diabetes Technology (UVA) to advance research and development efforts on fully automated closed-loop insulin delivery systems.