FDA clears Tandem Diabetes Care’s Control-IQ+ for type 2 diabetes

Author(s):

Austin Littrell

Key Takeaways

Tandem's Control-IQ+ technology, now FDA-approved for type 2 diabetes, automates insulin delivery using continuous glucose monitoring data.
The technology will be available in the U.S. by March 2025, expanding options for adults with type 2 diabetes.
A large-scale trial showed Control-IQ+ outperformed traditional multiple daily injection therapy in managing type 2 diabetes.
The approval highlights the need for effective insulin management tools for millions of Americans with type 2 diabetes.

New automated insulin delivery system expands access to advanced diabetes technology.

Tandem Diabetes Care, Inc. has secured U.S. Food and Drug Administration (FDA) clearance for its Control-IQ+ automated insulin delivery (AID) technology for patients with type 2 diabetes, ages 18 and older, the company announced Tuesday. Control-IQ+, previously cleared for use by patients with type 1 diabetes, is expected to be available to new and existing customers in the U.S. in March 2025.

Control-IQ+ builds on the company's proven Control-IQ algorithm, which is integrated into both Tandem insulin delivery systems — the t:slim X2 and Tandem Mobi insulin pumps. The algorithm is designed to enhance glycemic control by automating insulin delivery adjustments based on continuous glucose monitoring (CGM) data.

Control-IQ+ includes enhancements accommodating for expanded weight and total daily insulin ranges, according to a company news release.

The t:slim X2 insulin pump with Control-IQ+ technology from Tandem Diabetes Care

“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 CEO of Tandem Diabetes Care. “It is a natural evolution of our mission to bring the same AID technology... to adults with type 2 [diabetes].”

The FDA’s decision follows the results of a large-scale, randomized controlled trial involving over 300 individuals with type 2 diabetes. The study compared the use of the t:slim X2 pump with Control-IQ+ to traditional multiple daily injection therapy, with both groups utilizing the Dexcom G6 CGM system.

Full findings from the study will be presented at the 18^th International Conference on Advanced Technologies & Treatments for Diabetes in Amsterdam this March.

Jordan Pinsker, MD, chief medical officer at Tandem Diabetes Care, emphasized the significance of this approval, citing the growing need for effective insulin management tools.

“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,” Pinsker said.

“More than two 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.”