The twiist Automated Insulin Delivery (AID) System has received FDA clearance for adults 18 and older with insulin-treated type 2 diabetes. Previously cleared for people ages 6 and older with type 1 diabetes, the system uses the twiist Loop algorithm, to automatically adjust insulin delivery throughout the day using continuous glucose monitor data. The expanded clearance gives adults with type 2 diabetes another option for AID joining Tandem and MiniMed.

The clearance was supported by a 13-week pivotal trial involving 307 adults across 30 U.S. sites. Participants increased their time in range from 57% to 73%, gaining an average of 3.8 additional hours per day between 70 and 180 mg/dL. A1c decreased by an average of 0.7 percentage points, with participants who started at 9% or higher seeing an average reduction of 2.1 percentage points.

The expanded clearance follows several recent updates to the twiist system. The pump now supports Android phone compatibility for select devices, expanding options beyond iPhone users. Sequel has also updated its twiist insiights app to let caregivers and other followers receive alerts for low and high glucose, urgent lows, pump alarms, and lost connections. Additional improvements include customizable alarm volumes, alert snoozing, sleep schedules, and a phone widget, adding more flexibility for people using the system and those who help manage their diabetes.