The US Food and Drug Administration (FDA) has cleared Sequel Med Tech’s twiist automated insulin delivery (AID) system for adults aged 18 years and older with insulin-treated type 2 diabetes.
The decision allows clinicians to prescribe the device immediately to this patient group.
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It broadens the indications for twiist following its national launch for type 1 diabetes in March 2026.
Clinical evidence from a multicentre pivotal trial across 30 US sites involving 307 adults supported the regulatory clearance.
The trial evaluated the safety and efficacy of the device in patients continuing modern diabetes medications.
During the study, 56% of participants took a glucagon-like peptide-1 (GLP-1) receptor agonist, 37% used a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, and 23% received both therapies alongside twiist.
Participants spent a median of 95% of the evaluation period in automated delivery mode, although only two individuals were using an insulin pump when the study began.
Baseline experience with diabetes technology was low, with 19% reporting previous AID experience and 11% having carbohydrate-counting experience.
Average haemoglobin A1c (HbA1c) fell by 0.7% from a baseline mean of 8.1%, with participants holding initial levels of 9 or higher experiencing a 2.1% reduction across 13 weeks.
Mean time in target glucose range between 70 and 180mg/dL rose by 16 percentage points from 57% to 73%, giving patients 3.8 additional hours per day in range.
No severe hypoglycaemia occurred during the trial, and participants switching from basal-bolus regimens used an average of 19.3 fewer insulin units each day.
Sequel CEO and co-founder Alan Lotvin said: “For many adults living with type 2 diabetes, insulin therapy can feel like one more thing to manage in an already busy life.
“At Sequel, we believe technology should meet people where they are, not the other way around.
“With twiist, we’re bringing a personalised automated insulin delivery experience to the type 2 community that can help improve outcomes while reducing the day-to-day burden of diabetes management.”
The twiist device carries a 300-unit drug reservoir, requires cassette changes every three days, and connects with continuous glucose monitors with Senseonics’ Eversense 365 and Abbott’s FreeStyle Libre 3 Plus sensor.
The technology uses the twiist Loop algorithm and proprietary iiSure Technology to measure microdose volumes directly and detect line occlusions.
Developed by Manchester, New Hampshire-based Sequel Med Tech the prescription-only system is cleared in the US for individuals aged six and older with type 1 diabetes and adults aged 18 and older with type 2 diabetes.
