Key Highlights
01:00 - Lotvin Introduction
03:25 - Differences from Current AIDs
08:15 - Compatible CGMs
10:25 - Plans for Launch
12:05 - Design Discussion
16:50 - iPhone vs Android Compatibility
19:50 - Clinical Trials
22:20 - Tidepool Loop Algorithm
27:45 - Accuracy of Current Pumps
The diabetes community welcomed an additional tool to the armamentarium with the US Food and Drug Administration’s clearance of the twiist automated insulin delivery (AID) system on March 18, 2024.1
Cleared for use in patients aged 6 years and older with type 1 diabetes, the twiist, which is marketed by Sequel Med Tech, is billed as the first drug delivery system that directly measures volume and flow of inulin delivered with every micro-dose. Leveraging the Tidepool Loop algorithm, which enables the system to automatically adjust insulin delivery based on CGM readings and predicted glucose levels, the AID system was designed by Dean Kamen, the inventor of the world’s first wearable infusion insulin pump, with the intent of broadening patient choice and providing the most precise insulin delivery system to date, according to a press release from Sequel Med Tech.1,2
“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. 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, chief executive officer and co-founder Sequel Med Tech.1 “Sequel is working to simplify living with diabetes by introducing product and process innovation while expanding access for all."
In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, Lotvin joins hosts 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, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, for a deep dive into the latest AID to receive approval, including the pump’s patient-centric design, why they chose to leverage the Tidepool Loop algorithm, plans for device launch, and more.
Relevant disclosures for Dr. Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Dr. Bellini include Abbott Diabetes Care, MannKind, Sanofi, and others.
References:
- Sequel Med Tech. Sequel’s twiistTM automated insulin delivery system receives FDA 510(k) clearance. GlobeNewswire News Room. March 18, 2024. Accessed March 30, 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.
- Campbell P. Tidepool loop mobile app receives FDA Marketing Clearance. HCP Live. January 26, 2023. Accessed March 30, 2024. https://www.hcplive.com/view/tidepool-loop-mobile-app-receives-fda-marketing-clearance.