Sequel Med Tech's twiist Automated Insulin Delivery (AID) System received FDA approval on October 16 for use in adults aged 18 or older with insulin-treated type 2 diabetes (T2D), making it the first AID system specifically approved for this population.
The twiist system continuously adjusts basal insulin delivery based on glucose sensor data, directly measures the volume of insulin delivered, and can be used with insulin pens. The system has a 300-unit capacity and is changed every three days. It is compatible with Abbott FreeStyle Libre 3 Plus and Senseonics' Eversense 365 but does not support Dexcom, according to Sequel's website.
The system uses "proprietary iiSure Technology," which incorporates multiple checkpoints to ensure accurate delivery and detect occlusions up to nine times faster than other AID systems.
The twiist system was previously FDA-cleared in 2024 for people aged 6 years and older with type 1 diabetes.
FDA approval for T2D was based on a multicenter trial that included 307 adults with insulin-treated T2D. After 13 weeks, participants saw a reduction in average A1c levels from 8.1% to 7.4% (P < .001), with a greater improvement among those starting with an A1c of 9% or higher. Average time in range increased from 57% to 73% (P < .001), and no episodes of severe hypoglycemia were reported.
Other AID systems available for people with insulin-treated T2D include Omnipod 5, Tandem Control-IQ+ algorithm, and Minimed 780G.
Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape and has written for the Washington Post, NPR's Shots blog, and Diatribe. Follow her on Twitter @MiriamETucker or on BlueSky @miriametucker.bsky.social