Tandem Diabetes (TNDM) Care Announces FDA Clearance of Control-IQ+ Automated Insulin Delivery Technology for People with Type 2 Diabetes

Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a leading insulin delivery and diabetes technology company, today announced that its next-generation automated insulin delivery (AID) algorithm, Control-IQ+ technology (Control-IQ+), has been cleared by the United States Food and Drug Administration (FDA) for use by people with type 2 diabetes ages 18 and older. Control-IQ+, already cleared for use by people with type 1 diabetes, builds on the company’s proven Control-IQ algorithm and includes enhancements to accommodate input of expanded weight and total daily insulin ranges. Control-IQ+ is expected to be available for new and existing customers in the United States in March 2025.

“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, president and chief executive officer. “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.”1,2

Control-IQ powers both Tandem insulin delivery systems – the t:slim X2 and Tandem Mobi – to provide proven, best-in-class outcomes. Results from major studies of Tandem’s technology in type 1 diabetes, including those published by the New England Journal of Medicine (October 2019, August 2020, March 2023), show immediate and sustained glycemic improvements, including more time in range and improved sleep.3

This expanded label indication for type 2 diabetes is based on results from a recently completed pivotal trial, representing the first large-scale, randomized, controlled study of an automated insulin delivery system, completed in more than 300 people with type 2 diabetes. The trial compared use of a t:slim X2 pump with Control-IQ+ technology to a control group who continued their existing multiple daily injections regimens. Both groups used a Dexcom G6 Continuous Glucose Monitoring (CGM) System for the duration of the study. Full study results will be presented at the 18th International Conference on Advanced Technologies & Treatments for Diabetes taking place in Amsterdam, the Netherlands in March 2025.

“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, 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.”

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