Deka’s automated insulin delivery system, powered by a patient-led app, acquires FDA clearance

Tidepool, a nonprofit born from grassroots efforts by diabetes patients, obtained 510(k) clearance for Tidepool Loop in early 2023, allowing users to pair preferred insulin pumps and continuous glucose monitors. However, no insulin pumps were officially approved for third-party controllers.

FDA clearance for Twiist enables Sequel to market an AID system powered by Tidepool's algorithm, approved for individuals aged 6 years and older with Type 1 diabetes.

Individuals with Type 1 diabetes can choose from various pumps, with Deka referencing Tandem Diabetes Care's T: slim X2 insulin pump as the predicate device for its Ace Pump System clearance in 2023. Medtronic and Insulet also compete for market share.

Sequel distinguishes Twiist with its direct measurement of every micro-dose of insulin and its adaptability to the latest innovations. Although lacking a launch timeline, Sequel plans to distribute Twiist through pharmacies, offering a convenient and affordable route for Type 1 diabetes patients to access an AID system.