FDA Grants Clearance to Sequel's twiist AID System for Type 1 Diabetes

The US Food and Drug Administration has approved a new automated insulin delivery system for people with type 1 diabetes in the form of Sequel’s twiist, according to an announcement from Sequel Med Tech.

Billed by Sequel Med Tech as the first drug delivery system with the ability to directly measure the volume and flow of insulin delivered with every micro-dose, the FDA’s 510(k) clearance was announced on March 18, 2024, and indicates the device, which is powered by Tidepool Loop, for use in people with type 1 diabetes aged 6 years and older.¹

“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, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, in an interview with HCPLive. “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.”

According to the release from Sequel Med Tech, the twiist AID system takes advantage of the Tidepool Loop technology to adjust insulin delivery based on CGM readings and predicted glucose values. Tidepool Loop technology received FDA clearance in January 2023 for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in people 6 years and older. The 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.^1,2

“It will give people with diabetes a choice,” Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, told HCPLive. “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.”

According to the release from Sequel Med Tech, the delivery technology used in the device was developed by DEKA Research and Development Corp and Dean Kamen, who invented the first insulin pump for people with diabetes.¹

“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,” Kamen said.¹ “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.”

References:

1. ^{Sequel Med Tech. Sequel’s twiistTM automated insulin delivery system receives FDA 510(k) clearance. GlobeNewswire News Room. March 18, 2024. Accessed March 19, 2024. https://www.globenewswire.com/news-release/2024/03/18/2847675/0/en/Sequel-s-twiist-Automated-Insulin-Delivery-System-Receives-FDA-510-k-Clearance.html.}
2. ^{Campbell P. Tidepool loop mobile app receives FDA Marketing Clearance. HCP Live. January 26, 2023. Accessed March 19, 2024. https://www.hcplive.com/view/tidepool-loop-mobile-app-receives-fda-marketing-clearance.}