New Device Announcement.
The twiist™ Automated Insulin Delivery (AID) system has received clearance from FDA 510(k), although the launch date is unclear. This insulin pump has been developed and produced by DEKA Research & Development Corporation in partnership with Sequel Med Tech. The device is intended for patients aged six years and above with type 1 diabetes. This is the first insulin pump to integrate the Tidepool loop algorithm in their automated insulin delivery system. This algorithm is the product of a patient-led initiative. The Tidepool algorithm also allows users to select the type of carbohydrate and meal composition (with help of emojis). Users can also set up the device to increase their insulin pre-meals automatically and can adjust the carbohydrate quantity before and after finishing a meal.
Twiist™ Automated Insulin Delivery
Twiist™ Automated Insulin Delivery is the first FDA automatic delivery device that can be controlled using an Apple watch. The pump measures every micro-dose of insulin provided to the patient. It can be reloaded with up to 300 units of insulin, the reservoir is disposable, and the device will be available through pharmacies to allow more access to the product. In addition, patients can trial the product before committing to it. They also do not need to commit for the entire 4 to 5-year period. An observational study that included 872 participants was divided into new and existing users and followed for 12 months. The study demonstrated an increase in time in range from 67% to 76% in the first 6 months in the new users’ group, and it remained constant between 78-79% in the existing users’ group.
Jonanlis Ramirez Alcantara, MD
Sowmya Krishnan, MD
Sources:
https://twiist.com/wp-content/uploads/sequel_twiist_510k-post-clearance-release-03182024-with-image.pdf
https://diatribe.org/fda-clears-twiist-automated-insulin-delivery-system
https://drive.google.com/file/d/1gEewNzwPmBQ6spn02EAigiRmp83t4t42/view