Tandem Diabetes Care Expands Control-IQ+ Algorithm to Type 2 Diabetes Patients

Tandem Diabetes Care has secured FDA clearance for its Control-IQ+ insulin-dosing algorithm, marking a significant expansion in the management of Type 2 diabetes. This development represents a major step forward in automated insulin delivery systems, potentially benefiting millions of patients requiring intensive insulin therapy.

FDA Clearance Opens New Markets

The FDA's recent decision extends the use of Tandem's Control-IQ+ program to adults with Type 2 diabetes, building upon its previous approval for individuals with Type 1 diabetes aged 6 and above. This expansion significantly broadens Tandem's potential market, as Type 2 diabetes accounts for approximately 95% of diabetes cases in the United States, according to Centers for Disease Control and Prevention estimates.

John Sheridan, President and CEO of Tandem Diabetes Care, emphasized the importance of this development: "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. 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."

Advanced Technology for Insulin Management

The Control-IQ+ algorithm is designed to work in conjunction with Tandem's automated t:slim X2 and Mobi insulin pumps, integrating data from continuous glucose monitors to optimize insulin delivery. This closed-loop system aims to simplify diabetes management and improve glycemic control for patients.

Dr. Jordan Pinsker, Tandem's chief medical officer, highlighted the significance of this technology for Type 2 diabetes patients: "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."

Clinical Evidence and Future Presentations

The FDA's decision was based on data from a pivotal, randomized trial involving over 300 people with Type 2 diabetes. The study compared the use of the Control-IQ+ system to manual multiple daily injections. While detailed results have not yet been released, Tandem plans to present the findings at the upcoming Advanced Technologies & Treatments for Diabetes meeting in Amsterdam next month.

This presentation is expected to provide valuable insights into the efficacy of automated insulin delivery systems for Type 2 diabetes management, potentially influencing future treatment guidelines and patient care strategies.