Issue: May 2024
Fact checked byJill Rollet

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March 18, 2024
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FDA clears automated insulin delivery system for children and adults with type 1 diabetes

Issue: May 2024
Fact checked byJill Rollet
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Key takeaways:

  • The twiist automated insulin delivery system utilized Tidepool Loop technology to adjust insulin doses.
  • FDA clearance was granted for people aged 6 years and older with type 1 diabetes.

The FDA granted 510(k) clearance for an automated insulin delivery system that can measure the volume and flow of insulin within every micro-dose, according to an industry press release.

The twiist automated insulin delivery system (Sequel Med Tech) was cleared for people aged 6 years and older with type 1 diabetes. Benefiting from the medical device interoperability standards adopted in 2017, the system uses Tidepool Loop technology to automatically adjust insulin delivery based on continuous glucose monitoring readings and predicted glucose levels. Twiist, which was developed by DEKA Research & Development Corp., was designed to offer greater flexibility for users to address individual dosing needs through the direct measurement of insulin volume and flow, according to the release.

Generic FDA News infographic
The twiist automated insulin delivery system received 510(k) clearance for the FDA for children and adults aged 6 years and older with type 1 diabetes. Image: Adobe Stock

“The clearance of the twiist automated insulin delivery system is a pivotal first step in Sequel’s quest to make day-to-day life easier for people with type 1 diabetes,” Alan Lotvin, MD, CEO and co-founder of Sequel Med Tech, said in the release. “The twiist system combines drug delivery technology that directly and precisely measures each dose of insulin, providing the opportunity for better control and flexibility. 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 automated insulin delivery system.”

Lotvin said the company will release more details about initiatives designed to expand access to the system as the launch date for the device approaches.