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News
The FDA has cleared the twiist automated insulin delivery system (Sequel Med Tech) for adults aged 18 and older with insulin-treated type 2 diabetes. A 13-week trial of 307 adults showed a 16-percentage-point jump in time in range and a meaningful drop in HbA1c — with zero severe hypoglycemia events. This marks a significant expansion from its 2024 clearance for type 1 diabetes.
The FDA has cleared the twiist automated insulin delivery (AID) system by Sequel Med Tech for adults aged 18 and older with insulin-treated type 2 diabetes — expanding on its March 2024 clearance for children and adults with type 1 diabetes. The system continuously adjusts basal insulin delivery and is notable for being the first AID to directly measure the volume of insulin delivered with every microdose.
The clearance was supported by results from a 13-week multicenter trial of 307 adults, which showed consistent glycemic improvements across subgroups, along with gains in treatment satisfaction and sleep quality — and no severe hypoglycemia events reported.
By the Numbers:
Why it matters: Millions of adults with type 2 diabetes struggle to hit glucose targets despite complex regimens. An AID system that delivers meaningful, burden-free glycemic control — no prior pump experience required — could be a significant step forward for this underserved population.
