Sequel’s twiist Automated Insulin Delivery System Wins FDA OK

Sequel Med Tech announced its partner DEKA R&D has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its twist automated insulin delivery (AID) system powered by Tidepool.
 
According to the company, the twiist AID system is the first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose. It’s cleared for type 1 diabetes patients aged six and up and offers the ability to address individual dosing needs.
 
AID systems combine data from a continuous glucose monitoring (CGM) device, a control algorithm, and an insulin pump to automate insulin delivery. The twiist AID system leverages the FDA’s medical device interoperability standards to help patients better tailor their treatments.
 
Its Tidepool Loop technology lets the system automatically adjust insulin delivery based on CGM readings and predicted glucose levels.
 
“The clearance of the twiist AID system is a pivotal first step in Sequel’s quest to make day-to-day life easier for people with type 1 diabetes. The twiist system combines drug delivery technology that directly and precisely measures each dose of insulin, providing the opportunity for better control and flexibility,” said Sequel CEO and co-founder, Alan Lotvin, MD. “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. As we get closer to launch, we will share more details about additional initiatives designed to expand access and simplify the patient experience.”
 
The underlying drug delivery technology was developed by DEKA R&D, founded by American inventor and entrepreneur Dean Kamen. Kamen helped commercialize the first wearable insulin pump for diabetes while still in high school. He’s a co-founder of Sequel.
 
“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. 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.”

Find more information about CGM and insulin delivery technology here!