US-based medical device manufacturer Tandem Diabetes Care has received the US Food and Drug Administration (FDA) approval for its Control-IQ+ technology.
Control-IQ+ is the company’s next-generation automated insulin delivery (AID) algorithm, intended for people with type 2 diabetes, aged 18 years and above.
Already approved for people with type 1 diabetes, Control-IQ+ builds on Tandem’s Control-IQ algorithm, with enhancements for expanded weight and total daily insulin ranges.
The company is planning to commercialise Control-IQ+ for new and existing customers in the US in March 2025.
Tandem Diabetes Care president and CEO John Sheridan said: “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.”
Control-IQ powers both Tandem insulin delivery systems, the t:slim X2 and Tandem Mobi, to provide proven, best-in-class outcomes.
Major studies on the technology in type 1 diabetes showed immediate and sustained glycemic improvements, including more time in range and improved sleep.
The expanded label indication to include type 2 diabetes is based on results from a recently completed clinical trial in more than 300 people with type 2 diabetes.
The study compared the use of a t:slim X2 pump with Control-IQ+ technology against a control group who continued their existing multiple daily injection regimens.
Both study groups used a Dexcom G6 Continuous Glucose Monitoring (CGM) System.
Tandem Diabetes Care chief medical officer Jordan Pinsker said: “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.
“More than two million people in the US 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.”
