
twiist, which works with the twiist Loop algorithm, powered by Tidepool, directly measures the volume of insulin delivered with every microdose. The system offers the capability and flexibility to address each patient’s individual dosing needs. Sequel’s system utilizes sound waves that measure each pulse of insulin. This enables precision and helps understand exactly how much insulin the patient receives in a dose.
Manchester, New Hampshire-based Sequel currently offers twiist for type 1 diabetes, launching earlier this year. It shared findings for the investigational indication of insulin-treated type 2 diabetes at the American Diabetes Association Scientific Sessions (ADA 2026) in New Orleans.
Findings demonstrated significant improvements from baseline by measuring HbA1c and time in range over 13 weeks. The study also saw zero severe hypoglycemia events reported. Sequel said its trial reflects its commitment to expanding access to AID for everyone who can benefit.
A look at the findings from Sequel Med Tech
Dr. Carol Levy led Sequel’s study, which enrolled 307 adults with insulin-treated type 2 diabetes across 30 U.S. sites over a 13-week period. In total, 93% (286 of 307) completed the 13-week visit.
The cohort included a diverse patient population, with 26% Black or African-American enrollees and 13% Hispanic subjects. Patients had a mean age of 58 years (ranging between 19 and 85), 47% were female and subjects had a mean diabetes duration of 19 years with a mean BMI of 34 kg/m². Participants spanned a wide range of regimens. That included basal-bolus and basal-only insulin users, and both users and non-users of metformin, or GLP-1 receptor agonists and/or SGLT-2 inhibitors.
HbA1c improved by 0.7% on average from a baseline mean of 8.1%, demonstrating a statistically significant improvement. Participants starting with the highest HbA1c saw the greatest improvement, investigators said.
Sequel also reported significantly higher time in range, as mean time in target glucose range (70-180 mg/dL) increased from 57% to 73%. That improvement translates to nearly four additional hours per day in a healthy glucose range.
The study saw no cases of severe hypoglycemia and one case of diabetic ketoacidosis (DKA), which was not device-related. CGM data showed low rates of hypoglycemia both before and during the study with time below 70 mg/dL decreasing from 0.66% at baseline to 0.36% at 13 weeks. Time below 54 mg/dL remaining unchanged at 0.02%. Fourteen serious adverse health events were reported but were determined to be unrelated to the study device.
Benefits remained consistent across participant subgroups, including users and non-users of metformin or GLP-1 receptor agonists and/or SGLT-2i therapies. Patient-reported outcomes showed improved treatment satisfaction and sleep quality.
Commentary from company officials and investigators
Dr. Joanna Mitri, chief medical officer of Sequel, said:
“For people with type 2 diabetes who depend on insulin, progress has too often meant more: more decisions, more complexity, more to manage. 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.”
Levy, who serves as a professor of medicine at the Mount Sinai Diabetes Center Icahn School of Medicine at Mount Sinai, said:
“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.”
