The US Food and Drug Administration (FDA) has cleared the twiist automated insulin delivery (AID) system (Sequel Med Tech, LLC; Manchester, NH) for people aged 6 years or older with type 1 diabetes.
The system comprises a novel insulin pump developed by Sequel’s research and development partner DEKA and uses the FDA-cleared Tidepool Loop algorithm that was originally developed through patient-led, open-source initiatives.
The twiist AID system has the capacity to work interchangeably with different integrated continuous glucose monitors (iCGMs), and Sequel will announce their initial iCGM partner closer to market launch, Sequel CEO and co-founder Alan Lotvin, MD, told Medscape Medical News.
It is the first AID system that directly measures volume and flow of insulin delivery, which enables it to rapidly detect obstructions or occlusions, usually within about 20 minutes, Lotvin explained.
Glucose targets can be customized down to 87 mg/dL. Although the system works best when users give premeal boluses, if they don’t do so the algorithm will continuously adjust insulin to bring the glucose level into the target range. Boluses can be delivered from the smartphone app, a smartwatch, or the pump itself.
Sequel plans to make the product available through patient’s pharmacy benefit plans. “As we get closer to launch, we will share more details about additional initiatives designed to expand access and simplify the patient experience,” Lotvin said.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and diaTribe. She is on X (formerly Twitter) @MiriamETucker.
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