twiist AID System Improves HbA1c, Time in Range in Insulin-Treated Type 2 Diabetes

The twiist™ Automated Insulin Delivery (AID) system significantly improved glycemic control over 13 weeks in adults with insulin-treated type 2 diabetes, with no severe hypoglycemia events reported, according to trial data presented at the 2026 Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, Louisiana.¹

“We saw meaningful glycemic improvement from Day 1 in glucose levels that was sustained through 13 weeks, with no severe hypoglycemic events. For people with insulin-treated type 2 diabetes, achieving better control without added risk of lows (hypoglycemia) is a meaningful step forward," said Carol Levy, MD, Professor of Medicine, Mount Sinai Diabetes Center Icahn School of Medicine at Mount Sinai.

Type 2 diabetes represents the largest population of adults on insulin therapy in the US, yet has historically had the fewest AID options available. The 2026 ADA Standards of Care now designate AID as the preferred insulin delivery method over multiple daily injections, continuous subcutaneous insulin infusion, and sensor-augmented pumps for adults with type 2 diabetes on insulin, marking the first time AID has received the highest-grade recommendation for this population.

The twiist-T2D trial represents Sequel Med Tech's first pivotal data in type 2 diabetes and adds to a growing body of evidence supporting AID deployment in this historically underserved population.

The single-arm, multicenter trial, led by Carol Levy, MD, a professor of medicine at the Icahn School of Medicine at Mount Sinai, enrolled 307 adults with insulin-treated type 2 diabetes across 30 US sites.¹ Among the cohort, the mean age was 58 years (range 19–85), 47% of participants were female, the mean was BMI 34 kg/m², the mean diabetes duration 19 years, and 26% of patients were Black or African American and 13% were Hispanic. Participants included both basal-only and basal-bolus insulin users, and 93% (n = 286) completed the 13-week study visit.

Results showed mean HbA1c improved by 0.7 percentage points from a baseline of 8.1% (95% CI, −0.9 to −0.6; P <.001), with the greatest improvements observed in participants with the highest baseline HbA1c.¹ Mean time in the target glucose range of 70 to 180 mg/dL increased from 57% to 73%, an absolute gain of 16 percentage points (95% CI, 14 to 18; P <.001), equivalent to nearly 4 additional hours per day in range.¹

The safety profile was favorable, with no severe hypoglycemia events occurring during the trial period.¹ Time below 70 mg/dL decreased from 0.66% at baseline to 0.36% at 13 weeks, and time below 54 mg/dL remained unchanged at 0.02%. A single case of diabetic ketoacidosis was reported but was determined to be unrelated to the device. A total of 14 serious adverse health events were reported, with none attributable to the study device.¹

Glycemic benefits were consistent across clinically relevant subgroups, including users and non-users of metformin, GLP-1 RAs, and SGLT2 inhibitors.¹ Patient-reported outcomes showed improvements in both treatment satisfaction and sleep quality.

“For people with type 2 diabetes who depend on insulin, progress has too often meant more: more decisions, more complexity, more to manage," said Joanna Mitri, Chief Medical Officer of Sequel. "We think it's time to change that. This isn't about asking more of the person; it's about the technology taking on more of the work, so care becomes more personal, more practical, and less demanding, without observing any increased risk of hypoglycemia. These data are an important step in building the evidence it takes to bring that kind of progress to a population that's been underserved for far too long.”

These findings arrive in the context of a rapidly expanding evidence base for AID in type 2 diabetes. A randomized controlled trial published in the New England Journal of Medicine found that AID reduced HbA1c by 0.9 percentage points versus 0.3 percentage points in the control group over 13 weeks in insulin-treated adults with type 2 diabetes.

A separate pivotal trial of the Omnipod 5 system in 305 adults with type 2 diabetes showed time in range improve from 45% to 66% and HbA1c decrease from 8.2% to 7.4% over 13 weeks, including in a subgroup of 164 participants concurrently using GLP-1 RAs.

The 2026 ADA Standards of Care removed C-peptide and autoantibody requirements as barriers to AID access, reinforcing that insulin use, not diabetes type, should guide eligibility. This guideline shift has direct implications for how clinicians approach AID prescribing in insulin-treated type 2 diabetes.

The twiist AID system remains investigational for type 2 diabetes and is not currently FDA-cleared for this indication; it is cleared for type 1 diabetes in patients ≥ 6 years of age.¹

References

1. Sequel Med Tech. Sequel presents pivotal trial of the twiist™ Automated Insulin Delivery System in adults with insulin-treated type 2 diabetes at the ADA 86th Scientific Sessions. Published June 8, 2026. Accessed June 8, 2026. https://www.globenewswire.com/news-release/2026/06/08/3307938/0/en/

2. Randomized trial of automated insulin delivery in type 2 diabetes. N Engl J Med. https://doi.org/10.1056/NEJMoa2415948

3. American Diabetes Association. Standards of Care in Diabetes — 2026. Diabetes Care. 2026;49(Suppl 1).