FDA Clears Tandem’s Automated Insulin Delivery Algorithm For T2D
The technology will be available to patients in the United States in March 2025.
The FDA has cleared the automated insulin delivery (AID) algorithm Control-IQ+ for use in adult patients with type 2 diabetes (T2D), Tandem Diabetes Care said in a release.1 The company said the technology, which is already approved for patients with type 1 diabetes (T1D), is expected to be available in the United States in March 2025.
FDA Clears Tandem’s Automated Insulin Delivery Algorithm For T2D / Grandbrothers - stock.adobe.com
Control-IQ+ is based on Tandem’s Control-IQ algorithm and includes several improvements that accommodate input of expanded weight and total daily insulin ranges. The technology is used in the company’s t:slim X2 and Mobi insulin delivery systems. Control-IQ+ is intended to be used only with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps.
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“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," Jordan Pinsker, MD, chief medical officer at Tandem, said in a release.1 “More than 2 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.”
The expanded label indication for Control-IQ+ in T2D was based on positive data from a recently completed trial. The study included 300 patients with T2D and compared the use of a t:slim X2 pump with Control-IQ+ to a regimen of multiple daily injections. Both groups of patients used a Dexcom G6 CGM. According to Tandem, it was the first large scale, randomized, controlled study of an AID system. The company said that results from the study will be presented at the 18th International Conference on Advanced Technologies & Treatments for Diabetes.
Previous studies of the Control-IQ technology have shown significant benefits for patients with T1D. Data from the Protocol 3 study (DCLP3) of the International Diabetes Closed Loop (iDCL) trial found that patients using the t:slim X2 with Control-IQ had a higher percentage of time spent in range, less hyper- and hypoglycemia, and better HbA1c levels compared to patients using a sensor augmented pump.2
“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,” John Sheridan, president and CEO at Tandem, said in a release.1 “It is a natural evolution of our mission to bring the same AID technology that helped to make Tandem the number 1 recommended insulin pump brand by both healthcare providers and people living with type 1 diabetes to adults with type 2 [diabetes].”
AID systems have proven to be effective at improving glycemia control in patients with T1D, but data in patients with T2D has been limited. However, a recent study published in JAMA Network Open found that, among 305 adult patients with T2D, HbA1c levels in those using AID decreased from 8.2% to 7.4% after 13 weeks. The authors concluded that AID may be a beneficial and safe for patients with T2D.3
READ MORE: Diabetes Resource Center
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