The clearance expands twiist beyond type 1 diabetes, with trial data showing improved glucose control and nearly four extra hours a day in the target range.
Sequel Med Tech has won US Food and Drug Administration clearance for its twiist automated insulin delivery system in adults aged 18 and over with insulin-treated type 2 diabetes, opening the device to a much broader patient group and allowing clinicians to prescribe it immediately. The decision extends the system beyond its initial national launch for type 1 diabetes in March 2026, according to company and industry reports.
The clearance is backed by a multicentre pivotal trial involving 307 adults at 30 sites in the US. Results published in PubMed showed that average HbA1c, a measure of long-term blood sugar control, fell by 0.7 percentage points from a baseline of 8.1%, while people starting with an HbA1c of at least 9% saw a 2.1 point reduction over 13 weeks. Time spent in the target glucose range of 70 to 180 mg/dL rose from 57% to 73%, equivalent to an extra 3.8 hours a day in range.
The study is notable because it included people already using newer diabetes medicines as well as insulin. According to the trial summary, 56% of participants were taking a GLP-1 receptor agonist, 37% were using an SGLT-2 inhibitor and 23% were on both alongside twiist. No severe hypoglycaemia was reported, and patients switching from basal-bolus insulin regimens used an average of 19.3 fewer units of insulin a day.
Sequel says twiist is designed to reduce the burden of day-to-day management by automating insulin delivery through its Loop-based algorithm and iiSure technology, which monitors microdose delivery and can detect line occlusions. The prescription-only system has a 300-unit reservoir, needs cassette changes every three days and works with Abbott’s FreeStyle Libre 3 Plus and Senseonics’ Eversense 365 glucose sensors. Chief executive and co-founder Alan Lotvin said the goal was to meet adults with type 2 diabetes where they are, rather than forcing them to adapt to 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.
