The US Food and Drug Administration has granted 510(k) clearance to Sequel Med Tech's twiist automated insulin delivery (AID) system, marking a significant advancement in type 1 diabetes management technology. The clearance, announced on March 18, 2024, approves the device for use in patients aged 6 years and older with type 1 diabetes.
Revolutionary Measurement Technology
The twiist system distinguishes itself as the first drug delivery system capable of directly measuring the volume and flow of insulin delivered with every micro-dose. This precision measurement capability represents a fundamental advancement over existing insulin pump technology, according to Sequel Med Tech's announcement.
"The twiist AID system reimagines how insulin is measured and delivered for more personalization with a simpler design," said Dean Kamen, who developed the delivery technology through DEKA Research and Development Corp. "I believe the twiist AID system will set a new standard for precise, dependable insulin delivery going forward."
Kamen, who invented the first insulin pump for people with diabetes, designed the twiist system with the intent of broadening patient choice and providing the most precise insulin delivery system to date.
Tidepool Loop Integration
The twiist AID system is powered by Tidepool Loop technology, which received FDA clearance in January 2023 for use with compatible devices for automated insulin dosing. The Tidepool Loop algorithm enables the system to automatically adjust insulin delivery based on continuous glucose monitor (CGM) readings and predicted glucose values.
As a product of a patient-led project, Tidepool Loop allows compatible integrated continuous glucose monitors and alternate controller-enabled pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values.
Clinical Perspective on Patient Choice
Healthcare professionals emphasize the importance of expanding treatment options for diabetes patients. "I like having the spectrum of options available for people so they can really choose what works best for them," said Diana Isaacs, PharmD, an endocrine clinical pharmacist and director of Education and Training in Diabetes Technology at the Cleveland Clinic. "We know there's a lot of people with diabetes that do really like to be able to fine tune things and to customize things. So, it's exciting."
Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, echoed this sentiment: "It will give people with diabetes a choice. This will be nice to say 'I have this option and this option' because that is what we do [as clinicians]: we empower people with diabetes to make their own treatment decisions."
Company Leadership Vision
Alan Lotvin, MD, chief executive officer and co-founder of Sequel Med Tech, positioned the clearance as a foundational step in the company's mission. "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," Lotvin stated. "The twiist system combines drug delivery technology that directly and precisely measures each dose of insulin, providing the opportunity for better control and flexibility."
Regulatory and Industry Impact
The FDA's clearance reflects the agency's vision of interoperability in insulin delivery systems. "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," Kamen noted.
The twiist system was designed from the start to integrate with the latest available innovation, representing what the company describes as the next generation of insulin delivery technology. Sequel Med Tech states that the company is working to simplify living with diabetes by introducing product and process innovation while expanding access for all patients.
