Sequel Med Tech twiist AID System cuts HbA1c in type 2 pivotal trial
Sequel Med Tech has presented pivotal trial data for its twiist Automated Insulin Delivery (AID) System in adults with insulin-treated type 2 diabetes, reporting statistically significant improvements in glycaemic control without any severe hypoglycaemia events. The findings were disclosed at the American Diabetes Association's 86th Scientific Sessions in New Orleans on 8 June 2026.
The 13-week, single-arm study enrolled 307 adults across 30 US sites, with 93% completing the full study period. The cohort was notably diverse: 26% Black or African-American, 13% Hispanic, with a mean age of 58 years and a mean diabetes duration of 19 years. Participants used a range of regimens including basal-bolus and basal-only insulin, and many were co-treated with GLP-1 receptor agonists or SGLT-2 inhibitors.
Trial findings
Mean HbA1c fell by 0.7 percentage points from a baseline of 8.1% (95% CI −0.9 to −0.6; P<0.001), with participants starting at the highest baseline HbA1c showing the greatest reductions. Time in the target glucose range of 70–180 mg/dL improved from 57% to 73%, an absolute gain of 16 percentage points equating to nearly four additional hours per day within range (95% CI 14 to 18; P<0.001). Time below 70 mg/dL fell from 0.66% to 0.36%, and time below 54 mg/dL held stable at 0.02%. One case of diabetic ketoacidosis was reported and adjudicated as unrelated to the device; 14 serious adverse events were similarly deemed device-unrelated. Patient-reported outcomes indicated improved treatment satisfaction and sleep quality.
Carol Levy, Professor of Medicine at the Mount Sinai Diabetes Center, Icahn School of Medicine, and lead investigator, said: "We saw meaningful glycaemic improvement from Day 1 in glucose levels that was sustained through 13 weeks, with no severe hypoglycaemic events. For people with insulin-treated type 2 diabetes, achieving better control without added risk of lows is a meaningful step forward."
The twiist system remains investigational for type 2 diabetes and has not yet received FDA clearance for that indication. It is currently cleared for type 1 diabetes in patients aged six and older.
Market context and regulatory path
Automated insulin delivery has expanded rapidly in type 1 diabetes over the past decade, with systems from Insulet, Medtronic, Tandem Diabetes Care and others now competing for market share. Type 2 diabetes — which accounts for the large majority of insulin-using patients, estimated at around 5.5 million adults in the US alone — has historically been underserved by AID technology, making it an attractive commercial opportunity if regulatory clearance can be secured.
Sequel will need to submit a de novo or 510(k) application to the FDA covering the type 2 indication, and a pivotal single-arm trial of this design is typically a prerequisite for that submission. The diversity of the enrolled cohort — a dimension that regulators and payers have increasingly scrutinised — could support a broader label. The consistency of benefit across metformin, GLP-1 and SGLT-2 co-therapy subgroups also strengthens the case for a label that accommodates the heterogeneous real-world type 2 population.
Commercially, a cleared type 2 indication would substantially enlarge the addressable market for the twiist platform. Investors and business development teams will be watching for a regulatory submission timeline and, eventually, payer coverage negotiations — reimbursement for AID in type 2 has lagged type 1 in the US market, and expanded clinical evidence of this kind is often a prerequisite for coverage decisions by major insurers and the Centers for Medicare and Medicaid Services.