Investigational study marks Sequel’s first pivotal data in type 2 diabetes, the largest population on insulin therapy and one of the most under-served by automated insulin delivery
NEW ORLEANS, June 08, 2026 (GLOBE NEWSWIRE) -- Sequel Med Tech, LLC, today announced results from a multi-center pivotal trial evaluating the safety and efficacy of the investigational twiist™ Automated Insulin Delivery (AID) System in adults with insulin-treated type 2 diabetes. Presented at the American Diabetes Association’s 86th Scientific Sessions in New Orleans, the findings showed significant improvements in blood glucose levels from baseline by measuring HbA1c and time in range over 13 weeks, with no severe hypoglycemia events reported.
Type 2 diabetes represents the largest population of people using insulin, yet it has historically had the fewest automated delivery options. Approximately 31 million U.S. adults have type 2 diabetes, and about 5.5 million (1 in 6)* are treated with insulin. Many people with type 2 diabetes still struggle to reach their blood sugar targets even with currently available medications, underscoring the need for more treatment options. This trial reflects Sequel’s commitment to expanding access to automated insulin delivery to everyone who can benefit.
Key Findings
HbA1c, a key measure of long-term blood sugar control, on average improved by 0.7 percentage points (95% CI, −0.9 to −0.6; P<0.001 superiority), from a baseline mean of 8.1%, showcasing a statistically significant improvement. Participants who started with the highest HbA1c saw the greatest improvement, underscoring the potential impact for those at the highest risk for long-term complications.
Time in Range. Participants also spent significantly more time with their blood sugar in a healthy range. Mean time in target glucose range (70–180 mg/dL) increased from 57% to 73%, an absolute improvement of 16 percentage points (95% CI, 14 to 18; P<0.001), which translates to nearly 4 additional hours per day in a healthy glucose range.
Safety. No severe hypoglycemia events were reported during the study, and one case of diabetic ketoacidosis was reported that was not device related. Continuous Glucose Monitor (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 and 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 were consistent across participant subgroups, including both 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.
“For people with type 2 diabetes who depend on insulin, progress has too often meant more: more decisions, more complexity, more to manage," said Dr. 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.”
Trial Details
The trial, led by Dr. Carol Levy and the twiist-T2D investigators, enrolled 307 adults with insulin-treated type 2 diabetes across 30 U.S. sites in a 13-week, single-arm study. Ninety-three percent of participants (286 of 307) completed the 13-week visit. The cohort was notably diverse: 26% Black or African-American and 13% Hispanic, with a mean age of 58 years (range 19–85), 47% female, a mean diabetes duration of 19 years, and a mean BMI of 34 kg/m². Participants spanned a broad range of regimens including 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.
“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.
The twiist AID System is investigational for type 2 diabetes and is not cleared by the U.S. Food and Drug Administration for this use. twiist is currently FDA-cleared for people with type 1 diabetes ages 6 and older.
About twiist
The twiist™ Automated Insulin Delivery (AID) System supports confident, flexible type 1 diabetes management designed to fit real life. As the first automated insulin delivery system that directly measures the volume of insulin delivered with every microdose, twiist combines accuracy and precision to achieve a breakthrough in type 1 diabetes management.
twiist offers the flexibility to address individual dosing needs by automatically adjusting basal insulin delivery via the twiist Loop™ algorithm (based on the diabetes community-driven Tidepool Loop) using real-time CGM data, and offers unique features like activity presets, the widest1 glucose target range, and the ability to edit carb entries or meal timing. twiist is underpinned by its proprietary iiSure™ Technology which includes checkpoints to help ensure accurate insulin delivery and detect potential blockages up to nine times faster than other AID systems2. twiist is cleared for people ages six and up with type 1 diabetes, available with a prescription. For important safety information, please visit twiist.com/safety. For additional details, visit www.twiist.com.
About Sequel Med Tech
Headquartered in Manchester, N.H., Sequel Med Tech, LLC is developing the next generation of transformative drug-delivery advancements. Sequel’s approach is to look at disease management holistically to advance systems that make living with disease simpler and easier for all. Its FDA-cleared innovation, the twiist® Automated Insulin Delivery (AID) system, integrates novel technologies to reimagine insulin delivery and sets a new standard for drug delivery. Sequel is bringing the latest developments in science and technology to help drive more accessible drug delivery. For more information, visit sequelmedtech.com and twiist.com.
Forward-Looking & Investigational Statement
This release describes investigational use of the twiist AID System in type 2 diabetes. The system is not FDA-cleared for type 2 diabetes, and nothing herein should be interpreted as a claim of safety, efficacy, availability, or regulatory approval for that use.
Media Contact
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Sequel.med.tech@teamhighwire.com
* Seagrove SIMM Market Model Updated March 2026
1. When comparing user guides of all commercially available AID systems in the United States as of January 2026
2. When comparing user guides of all commercially available AID systems in the United States as of January 2026 - (at 1U/hr or 2 U/hr)
