Tandem Diabetes Care has secured a new FDA clearance for its insulin dose-calculating algorithm, opening up its use to adults with Type 2 diabetes.
The Control-IQ+ program—now with the added “plus”—helps control the company’s automated t:slim X2 and Mobi insulin pumps with the help of a wearable continuous glucose monitor. It previously obtained a green light for people with Type 1 diabetes ages 6 and up.
The expanded label was based on data from a pivotal, randomized trial of more than 300 people with Type 2 diabetes, comparing its use to manual multiple daily injections. Tandem said it plans to present the study’s results at the annual Advanced Technologies & Treatments for Diabetes meeting scheduled for next month in Amsterdam.
“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,” President and CEO John Sheridan said in a statement.
“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,” Sheridan added.
Moving into Type 2 diabetes greatly expands the company’s potential commercial reach. The Centers for Disease Control and Prevention has estimated that people with Type 1 only represent about 5% of the total U.S. population of people with diabetes, though not all require daily insulin.
“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,” said Tandem’s chief medical officer, Jordan Pinsker, M.D.