FDA approves Tandem's closed-loop artificial pancreas to automatically control insulin doses

The FDA approved its first automatic insulin dosing system designed to deliver correction boluses as well as adjust background insulin levels to help prevent bouts of high and low blood sugar in people with Type 1 diabetes.

Tandem Diabetes Care’s Control-IQ artificial pancreas system also includes the agency’s first interoperable automated dosing controller, making it capable of connecting with different continuous glucose monitors (CGMs) and alternate controller-enabled insulin pumps, or ACE pumps.

The company plans to make the new software features available free of charge as a update in January 2020 for current users of its t:slim X2 insulin pumps, which received de novo clearance this past February. New pumps equipped with the Control-IQ algorithm are expected to begin shipping at the same time.

“With this clearance, we will be launching the most advanced automated insulin dosing system commercially available in the world today,” Tandem’s president and CEO, John Sheridan, said in a statement.

The pump and controller aim to predict a person’s glucose levels a half-hour ahead and adjust its doses automatically using blood sugar data from Dexcom’s G6 monitoring system. This includes reducing or halting basal insulin delivery if glucose levels drop too low, or calculating an hourly correction bolus if they’re too high—without the need for fingerstick draws or mealtime calibration. The device also includes tailored settings for periods of sleep or exercise.

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In a clinical study published earlier this year, the system outperformed current treatments and helped users keep their blood glucose levels within a healthy range an average of 2.6 hours longer. It also had fewer sharp spikes or drops over a 24-hour period.

“Regulatory authorization of the Tandem Control-IQ algorithm for use as part of a hybrid closed-loop system is a huge win for the Type 1 diabetes community and a critical step forward in making day-to-day life better for people living with the disease,” said Aaron Kowalski, president and CEO of the Juvenile Diabetes Research Foundation.

The initial approval of Tandem’s t:slim X2 pump established the new regulatory category of plug-and-play devices known as ACE pumps, allowing users to link their preferred diabetes devices such as CGMs and connected meters.

The latest approval, through the de novo premarket review pathway, does the same. Control-IQ’s interoperable software status now completes the modular trio—alongside swappable ACE pumps and integrated CGMs—paving the way for what the FDA describes as the creation of a complete automated insulin dosing, or AID system, and the faster clearance of similar devices.

“The marketing authorization of this first stand-alone interoperable automated glycemic controller also allows substantially equivalent controller technologies that are developed for diabetes in the future to go through the 510(k) review process, helping to promote timely patient access to innovative technologies that can improve their care and quality of life,” said Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health in the agency’s device center.