Dive Brief:

• Deka Research & Development has received 510(k) clearance for the Twiist automated insulin delivery (AID) system, the company’s partner Sequel Med Tech said Monday.
• Sequel, which will sell the system, worked with Deka and Tidepool on the product. Deka was founded by the inventor who commercialized the first wearable insulin pump. Tidepool is behind Loop, a patient-led automated insulin dosing app.
• Twiist combines Deka drug delivery technology with the Loop algorithm to create what Sequel says is the first system that directly measures the volume and flow of insulin delivered with every micro-dose.

Dive Insight:

Tidepool is a nonprofit that grew out of grassroots work by diabetes patients to build their own systems. The work resulted in 510(k) clearance for Tidepool Loop at the start of 2023. In theory, Loop gave users the option to pair their preferred insulin pumps and continuous glucose monitors. The caveat was that no insulin pumps were authorized for use with third-party controllers. 

The Food and Drug Administration’s clearance of Twiist positions Sequel to sell an AID system powered by Tidepool’s algorithm. Twiist is cleared for use in people aged 6 years and older with Type 1 diabetes. 

People with Type 1 diabetes can already choose between multiple pumps. Deka cited Tandem Diabetes Care’s T:slim X2 insulin pump as the predicate device when it received clearance for its Ace Pump System in 2023. Companies including Medtronic and Insulet compete with Tandem for the market. 

Sequel sees Twiist’s direct measurement of every micro-dose of insulin and its ability to “integrate with the latest available innovation” as differentiators. Sequel plans to provide more information as it gets closer to launching the system.

The company’s statement lacks a timeline for launch and the Twiist website only says “coming soon.” Sequel expects to distribute the device through the pharmacy channel so more people with Type 1 diabetes have a “convenient, affordable way to get started on an AID system,” CEO and co-founder Alan Lotvin said in a statement.