Saturday, April 20, 2024

FDA Clears Deka’s Automated Insulin Delivery System Integrated with Patient-Driven App

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In a significant development within the field of diabetes management, Deka Research & Development has achieved 510(k) clearance for its groundbreaking Twiist automated insulin delivery system (AID), as revealed by Sequel Med Tech, the esteemed partner company. Through a collaborative effort involving Deka, Tidepool, and Sequel, this cutting-edge system is set to revolutionize the landscape of diabetes care.

Deka, founded by the visionary inventor credited with introducing the world’s first wearable insulin pump, brings its wealth of expertise in drug delivery technology to the table. Meanwhile, Tidepool, renowned for its pioneering patient-led automated insulin dosing app Loop, contributes its advanced algorithmic solutions to power the Twiist system. This strategic collaboration harnesses the collective strengths of these innovative entities to create a next-generation automated insulin delivery solution.

The convergence of Deka’s established legacy in insulin delivery technology and Tidepool’s trailblazing algorithmic advancements heralds a new era in diabetes management. By seamlessly integrating cutting-edge technology and patient-centric design principles, Twiist represents a paradigm shift in the approach to insulin delivery systems.

This groundbreaking achievement underscores the commitment of all stakeholders involved to drive forward transformative innovations in diabetes care. Through their combined efforts, Deka, Tidepool, and Sequel are poised to redefine standards of excellence in the realm of automated insulin delivery systems, ultimately empowering individuals living with diabetes to lead healthier, more fulfilling lives.

Twiist’s Market Debut Sets New Standards in Automated Insulin Delivery Technology

As Twiist prepares to enter the market, it holds the promise of providing individuals with diabetes access to a state-of-the-art solution that seamlessly integrates into their daily lives. With its user-friendly design and advanced functionality, Twiist aims to enhance the quality of care and improve outcomes for patients managing diabetes worldwide.

The successful clearance of Twiist marks a significant milestone not only for Deka, Tidepool, and Sequel but also for the broader diabetes community. It represents a testament to the power of collaboration, innovation, and unwavering dedication to advancing the field of diabetes management. As Twiist prepares to make its debut, it stands poised to make a lasting impact on the lives of individuals living with diabetes, setting new standards of excellence in automated insulin delivery technology.

Twiist stands out as the inaugural system to directly measure the volume and flow of insulin delivered with each micro-dose, thanks to its integration of Deka’s drug delivery technology with the Loop algorithm. This innovation marks a significant advancement in insulin delivery technology.

Tidepool, initially a grassroots effort by diabetes patients to construct their systems, evolved into a nonprofit organization. The collaboration resulted in the 510(k) clearance for Tidepool Loop in early 2023. This clearance allowed users to pair their preferred insulin pumps and continuous glucose monitors, although insulin pumps were not authorized for use with third-party controllers at the time.

Automated Insulin Delivery

Expanding Horizons in Diabetes Care: Next-Gen Automated Insulin Delivery System for Type 1 Diabetes

The FDA’s clearance of Twiist positions Sequel to offer an automated insulin delivery system leveraging Tidepool’s algorithm. Twiist is approved for individuals aged 6 years and older with Type 1 diabetes, expanding treatment options for this population.

While individuals with Type 1 diabetes already have a range of pump options to choose from, Twiist’s unique feature of directly measuring every micro-dose of insulin sets it apart. Sequel highlights this capability, along with its compatibility with the latest innovations, as key differentiators. The company plans to release more details closer to the system’s launch.

However, Sequel has not provided a specific timeline for the launch, and the Twiist website only mentions that it is “coming soon.” Despite this, Sequel anticipates distributing the device through the pharmacy channel to ensure more individuals with Type 1 diabetes have convenient and affordable access to automated insulin delivery systems. CEO and co-founder Alan Lotvin emphasized the importance of expanding access to AID systems, underscoring Sequel’s commitment to providing a practical solution for individuals managing Type 1 diabetes.


Resource: Med Tech Dive, March 20, 2024

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