Deka Research & Development has hade progress after receiving FDA clearance for the Twiist automated insulin delivery (AID) system. This clearance, obtained through the 510(k) pathway, marks the approval of a technology that promises to revolutionize insulin delivery for individuals with Type 1 diabetes. The Twiist system stands out as the first of its kind to directly measure the volume and flow of insulin with every micro-dose, a feat made possible by combining Deka’s drug delivery expertise with Tidepool’s patient-led algorithm.
This innovation comes through a collaboration between Deka, Sequel Med Tech, and Tidepool. Tidepool, a nonprofit organization born from the efforts of diabetes patients, introduced the Tidepool Loop algorithm, which received FDA clearance in early 2023. Loop empowered users to pair their preferred insulin pumps and continuous glucose monitors, albeit with limitations on third-party controllers. Twiist builds upon this foundation, integrating Tidepool’s algorithm with Deka’s drug delivery technology to create a system that offers precise insulin measurement and delivery, catering to the individual dosing needs of patients. The FDA clearance of Twiist positions Sequel as the distributor of an AID system equipped with Tidepool’s algorithm. Approved for use in individuals aged 6 years and older with Type 1 diabetes, Twiist fills a gap in the market, providing patients with another option for managing their condition effectively. In an area already populated with various insulin pumps, Twiist’s differentiation is its direct measurement of insulin doses and its integration capabilities with the latest advancements in diabetes care.
While the exact timeline for Twiist’s launch remains unspecified, Sequel has expressed its commitment to making the system accessible and affordable to a wider audience. CEO Alan Lotvin emphasized the company’s intent to distribute Twiist through the pharmacy channel, ensuring that more individuals with Type 1 diabetes have a convenient pathway to adopt an AID system. Lotvin’s vision aligns with Sequel’s mission to simplify life for diabetes patients through innovation and expanded access to cutting-edge technologies.
The FDA clearance of Twiist reflects a culmination of collaborative efforts aimed at advancing insulin delivery technology. Deka’s extensive experience, starting with the work of Dean Kamen, outlines a commitment to innovation for decades, from the invention of the first wearable infusion pump to the development of modern drug delivery devices. Deka’s prior collaborations, including the partnership with Eli Lilly on an investigational AID system, outline a dedication to advancing diabetes care through alliances and innovative solutions. As Twiist prepares for launch, stakeholders anticipate the system’s potential to redefine insulin delivery by offering a seamless, personalized experience that allows patients to better manage their condition and improve their overall quality of life.
Looking ahead, Sequel aims to further streamline the patient experience by directly marketing Twiist to individuals living with diabetes. By leveraging product innovation and strategic distribution channels, the company seeks to allow more patients to adopt AID systems, thereby enhancing their quality of life. As Twiist inches closer to its official launch, stakeholders eagerly anticipate the realization of its potential to transform insulin delivery and improve outcomes for those living with Type 1 diabetes.
