FDA clears Sequel Med Tech’s Twiist system for type 2 diabetes

The Food and Drug Administration granted clearance to Sequel Med Tech’s Twiist automated insulin delivery (AID) system for adults 18 years and older with insulin‑treated type 2 diabetes. Sequel announced the decision on Friday, following the system’s 2026 national launch for type 1 diabetes. The clearance was awarded to Deka Research & Development, Sequel’s partner on Twiist.

Trial outcomes

A multicentre study across 30 US sites enrolled 307 adults and showed that mean haemoglobin A1c fell by 0.7% from 8.1% to 7.4% over 13 weeks. Participants whose baseline A1c was 9 or higher experienced a 2.1% drop.

The Twiist device contains a 300‑unit drug reservoir and requires cassette changes every three days. It is compatible with Abbott’s FreeStyle Libre 3 Plus and Senseonics’ Eversense 365 continuous glucose monitors. Twiist employs the Loop algorithm and proprietary iiSure technology to measure microdose volumes and detect line occlusions. The prescription‑only system is cleared for children with type 1 diabetes and adults with type 2 diabetes.

CEO and co‑founder Alan Lotvin said that technology should meet people where they are, not the other way around. Twiist aims to reduce the daily burden of insulin therapy for adults living with type 2 diabetes. The device’s FDA clearance allows clinicians to prescribe it immediately to this patient group, following its 2026 launch for type 1 diabetes.

The FDA’s approval follows clinical data that showed Twiist can improve outcomes without increasing hypoglycaemia risk. Sequel’s partnership with Deka and the integration of the Loop algorithm positioned the product to compete in the AID market, which also includes rivals such as Beta Bionics, Insulet, MiniMed and Tandem Diabetes Care.

Sequel’s launch for type 1 diabetes in March 2026 was followed by the recent clearance for type 2, expanding the device’s availability to a broader adult population.