Deka-designed, Tidepool-powered automated insulin pump looks to make waves in Type 1 diabetes

A new automated insulin pump designed by Deka Research & Development and powered by Tidepool’s […]

A new automated insulin pump designed by Deka Research & Development and powered by Tidepool’s data and dosing platform has cleared the FDA and is now on its way to support children and adults with Type 1 diabetes.

Deka’s president and founder, Dean Kamen, may be more mainstream famous for creating the Segway, but in medtech circles he’s well known as the inventor of the first wearable infusion pump. His early work with his company AutoSyringe also included the first insulin pumps for people with diabetes. Deka, meanwhile, has since developed personal mobility systems and prosthetic arms as well as other drug delivery devices.

Now, Kamen serves as co-founder of Sequel Med Tech, the firm that will commercialize the newly greenlighted insulin delivery device dubbed the twiist.

Also based in Deka’s hometown of Manchester, New Hampshire, Sequel describes the twiist as the “first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose.” 

The automated insulin delivery device, or AID, also incorporates the FDA-cleared Tidepool Loop software program that lets users connect and construct their own closed-loop artificial pancreas systems—allowing them to take blood sugar readings from a range of different continuous glucose monitors and adjust insulin levels accordingly.

“The FDA’s clearance marks a transformative moment, and we would like to thank the FDA for their vision of interoperability in insulin delivery that will help improve diabetes therapies for years to come,” Kamen said in a statement.

“The twiist system was designed from the start to integrate with the latest available innovation, and it represents the next generation of insulin delivery,” said Kamen. “The twiist AID system reimagines how insulin is measured and delivered for more personalization with a simpler design. I believe the twiist AID system will set a new standard for precise, dependable insulin delivery going forward.”

Deka previously worked with Eli Lilly on the development and clinical testing of an investigational AID system for people with Type 1 diabetes, but that venture ended in 2020. Eli Lilly would also later discontinue its internal insulin pump efforts in 2022, as well as its collaboration with the diabetes developer Ypsomed, in order to instead focus on its digital insulin pen platform.

Meanwhile, Deka would first put its AID system up for FDA review in late 2021. After an initial OK in July 2023, it received a new 510(k) clearance earlier this month—expanding its use from children as young as 13 to those as young as 6—alongside additional regulatory nods for the bundled Loop controlling software and insulin administration tubing sets.

“There’s been a real need for continued innovation in insulin delivery, and the twiist AID system powered by Tidepool represents a substantial leap forward,” said Howard Look, president and CEO of the nonprofit Tidepool, a former Fierce 15 winner. “The twiist AID system takes advantage of the Tidepool Loop algorithm, the first and only FDA-cleared glycemic controller that originated as a patient-led initiative.”

Going forward, Sequel aims to take that approach a step further with plans to market the twiist as directly to patients as possible.

“Sequel is working to simplify living with diabetes by introducing product and process innovation while expanding access for all. It’s why we expect to distribute twiist through the pharmacy channel so more people with type 1 diabetes have a convenient, affordable way to get started on an AID system,” said Sequel’s co-founder and CEO, Alan Lotvin, M.D. “As we get closer to launch, we will share more details about additional initiatives designed to expand access and simplify the patient experience.”

Original Article: (https://www.fiercebiotech.com/medtech/deka-designed-tidepool-powered-automated-insulin-pump-looks-make-waves-type-1-diabetes)