The clearance extends Sequel’s twiist system beyond type 1 diabetes after a trial found improved blood glucose control among adults using insulin-treated type 2 diabetes.
Sequel Med Tech said its twiist automated insulin delivery system has been cleared by the US Food and Drug Administration for adults aged 18 and over with insulin-treated type 2 diabetes, extending a device that had already been launched for type 1 diabetes earlier this year. The company said the clearance opens the door to a much larger group of insulin users, although the practical impact will depend on how widely clinicians adopt the system and how it fits into existing diabetes care.
The move comes as regulators and manufacturers continue to push automated insulin dosing tools into type 2 diabetes, a market that has historically had fewer pump-based options than type 1 care. In a separate FDA announcement, the agency recently said it had expanded the indications of Insulet’s SmartAdjust technology for adults with type 2 diabetes, underscoring a broader regulatory shift towards algorithm-driven insulin management.
Sequel said the clearance was backed by a 13-week multicentre trial involving 307 adults at 30 US sites. The company and the published study in Diabetes Care said participants reduced average HbA1c by 0.7 percentage points, from a mean of 8.1%, while time in the target glucose range rose from 57% to 73%. The company also said some participants saw improvements within a day, and the published findings reported no severe hypoglycaemia events during the trial.
The trial population reflected current treatment patterns more closely than older pump studies. According to the company’s announcement, many participants were already using GLP-1 drugs or SGLT-2 inhibitors alongside insulin, while relatively few had prior experience with pumps or carbohydrate counting. That may matter for physicians weighing whether automated insulin delivery can be introduced more widely among people with type 2 diabetes, many of whom manage their condition with multiple therapies and limited exposure to diabetes technology.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
