San Diego-based Tandem already has FDA clearance for its AID algorithm for type 1 diabetes. It now joins Insulet in offering AID technology for the type 2 population. Medtronic plans to file with the FDA to expand its AID technology to type 2 later this year as well.
Control IQ+ builds on the company’s proven Control-IQ algorithm. It also includes enhancements to accommodate input of expanded weight and total daily insulin ranges. Tandem expects to make Control IQ+ available for new and existing customers in the U.S. 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 CEO. “It is a natural evolution of our mission to bring the same AID technology that helped to make Tandem the No. 1-recommended insulin pump brand by both healthcare providers and people living with type 1 diabetes to adults with type 2.”
Control-IQ powers the t:slim X2 and Mobi, both of Tandem’s available automated insulin delivery systems. The compay says major studies of its technology in type 1 diabetes demonstrate immediate and sustained glycemic improvements.
Expanding to type 2 comes on the back of a recently completed pivotal trial. Tandem said it represents the first large-scale, randomized, controlled study of an automated insulin delivery system completed in more than 300 people with type 2 diabetes.
The study compared t:slim X2 with Control-IQ+ to a control group continuing multiple daily injections (MDI). Both groups in the study used a Dexcom G6 continuous glucose monitor (CGM). Tandem plans to present full study results next month at the 18th International Conference on Advanced Technologies & Treatments for Diabetes taking place in Amsterdam.
“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 Dr. Jordan Pinsker, Tandem 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.”
