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News
The FDA has cleared the twiist Automated Insulin Delivery (AID) System for adults aged 18 and older with insulin-treated type 2 diabetes (T2D). The system continuously adjusts basal insulin delivery and directly measures insulin volume — a first for AID devices. In a 13-week pivotal trial of 307 adults, mean A1c dropped from 8.1% to 7.4% and time in range jumped from 57% to 73%, with no severe hypoglycemia reported.
The FDA has cleared the twiist Automated Insulin Delivery (AID) System (Sequel Med Tech) for adults aged 18 and older with insulin-treated type 2 diabetes (T2D) — expanding on its 2024 clearance for type 1 diabetes in patients aged 6 and up. The system stands out as the first AID device to directly measure the volume of insulin delivered with every microdose, and it detects blockages up to nine times faster than other AID systems. It holds 300 units, requires an infusion set change every three days, and is compatible with the Abbott FreeStyle Libre 3 Plus and Senseonics' Eversense 365 CGMs.
The clearance was backed by a 13-week multicenter pivotal trial of 307 adults with insulin-treated T2D, which showed meaningful glycemic improvements — even among patients without prior pump experience. Participants also reported better treatment satisfaction and sleep quality.
By the Numbers:
Why it matters: The twiist joins Omnipod 5, Tandem Control-IQ+, and MiniMed 780G as FDA-cleared AID options for T2D — a growing toolkit for clinicians managing patients who struggle to hit glucose targets despite complex insulin regimens.
