The US Food and Drug Administration (FDA) has cleared Tandem Diabetes Care’s Control-IQ+ technology, an automated insulin delivery algorithm, for use in individuals aged 18 and above with type 2 diabetes (T2D).
The technology, which is already approved for type 1 diabetes (T1D), has been enhanced to include a broader range of weight and total daily insulin inputs.
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Control-IQ+ will be available to current and new US customers by next month. The technology is said to “power” the t:slim X2 and Tandem Mobi, the company’s insulin delivery systems.
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 T1D.
“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 T1D to adults with T2D.”
According to the findings from studies involving the technology, significant glycaemic improvements were observed in subjects with T1D.
The latest FDA approval for T2D use is based on outcomes from a randomised trial involving over 300 participants.
This controlled, “large-scale” trial for an automated insulin delivery system in T2D, compared the outcomes of patients using the t:slim X2 pump with Control-IQ+ technology against a control group progressing with the current daily injection regimens.
During the trial, both groups were monitored using the Dexcom G6 continuous glucose monitoring system.
Headquartered in the US, Tandem specialises in manufacturing and selling advanced automated insulin delivery systems designed to alleviate the challenges of diabetes management.
Last September, Tandem’s t:slim X2 insulin pump, which utilises Control-IQ technology, was approved for use with Eli Lilly’s ultra-rapid-acting insulin, Lyumjev, in the European Union.
