DEKA Research and Development Corp has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the twiist Automated Insulin Delivery (AID) system powered by Tidepool.

The twiist AID system, which will be commercialized by Sequel Med Tech, is a first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose. Cleared for people ages 6 and up with type 1 diabetes, the twiist AID system offers the capability and flexibility to address each patient’s individual dosing needs.

AID systems integrate data from a continuous glucose monitoring (CGM) device, a control algorithm, and an insulin pump to automate insulin delivery, providing patients with the ability to manage their blood sugar levels more effectively. The twiist AID system takes advantage of the FDA’s medical device interoperability standards designed to help patients better tailor their treatments to their individual needs.

“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 Alan Lotvin, MD, Sequel CEO and co-founder. “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..”

The twiist system incorporates FDA-cleared Tidepool Loop technology, which enables the system to automatically adjust insulin delivery based on CGM readings and predicted glucose levels. Sequel chose to partner with Tidepool, a diabetes-focused non-profit organization, because the underlying technology is community driven, designed for and by people living with diabetes, provides individuals with a high degree of customization and most importantly – delivers the clinical results patients are looking for.

The underlying drug delivery technology was developed by DEKA Research & Development Corp. DEKA was founded by Dean Kamen, an American inventor and entrepreneur who commercialized the first wearable insulin pump for diabetes, which he developed while still in high school.

“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.”