Sequel Med Tech wins FDA clearance for twiist AID in type 2 diabetes
Sequel Med Tech has secured FDA clearance to market its twiist Automated Insulin Delivery (AID) system to adults aged 18 and over with insulin-treated type 2 diabetes. The Manchester, New Hampshire-based company launched twiist for type 1 diabetes in March 2026; this expanded clearance addresses a substantially larger patient pool. Approximately 5.5 million US adults with type 2 diabetes currently use insulin, according to Sequel's cited market data, making the indication commercially significant.
The clearance was supported by the twiist-T2D pivotal trial, a 13-week multicenter study enrolling 307 adults across 30 US sites, with results simultaneously published in Diabetes Care. Mean HbA1c fell by 0.7 percentage points from a baseline of 8.1% (p<0.001), and mean time in the target glucose range of 70 to 180 mg/dL rose from 57% to 73%, equivalent to roughly 3.8 additional hours per day within range. Participants entering with an HbA1c of 9% or above saw the greatest benefit, averaging a 2.1 percentage-point reduction over the study period. Notably, no severe hypoglycaemia events were recorded, and the proportion of participants achieving more than 70% time in range rose from 37% at baseline to 60% at week 13.
Trial population and usability findings
The trial's participant profile is likely to be a key selling point to prescribers. Only 11% of participants had prior carb-counting experience, and just 2 of the 307 were actively using an insulin pump at enrolment. Despite that, participants spent a median 95% of the study period in automated delivery mode. The company reports that time-in-range improvements were observable in some participants within 24 hours of system initiation.
The trial population also reflected the polypharmacy typical of contemporary type 2 diabetes management: 56% of participants were using a GLP-1 receptor agonist and 37% an SGLT-2 inhibitor, with 23% on both. Glycaemic improvements were observed while those therapies continued, which Sequel argues demonstrates additive rather than substitutive benefit.
Alan Lotvin, CEO and co-founder of Sequel Med Tech, said the company's goal was to "meet people where they are," framing the technology as a way to reduce the daily cognitive burden of insulin management rather than requiring patients to adapt their behaviour to the system.
Market context and competitive landscape
The automated insulin delivery market has until recently been dominated by type 1 diabetes devices, with Insulet's Omnipod 5, Medtronic's MiniMed series, and Tandem Diabetes Care's Control-IQ the established names. Regulatory agencies and manufacturers alike have been slow to extend AID indications to type 2 diabetes, partly because the population is more heterogeneous and less experienced with pump technology. Sequel's clearance, backed by prospective pivotal data published in a peer-reviewed journal, puts pressure on competitors to demonstrate similar evidence in the type 2 setting.
The twiist system uses a pharmacy-start model, cassette changes every three days, and a 300-unit insulin reservoir. It is compatible with Abbott's FreeStyle Libre 3 Plus sensor and Senseonics' Eversense 365 CGM, both of which have meaningful installed bases in the type 2 population. That CGM compatibility is strategically important: patients already wearing a sensor face a lower barrier to adopting an AID system.
The next commercial milestone will be real-world uptake data, payer formulary positioning, and whether the pharmacy-start model achieves the accessibility Sequel claims relative to traditional durable medical equipment channels.