twiist™ Automated Insulin Delivery System is Now Cleared for Adults with Type 2 Diabetes

Clearance expands twiist's precise insulin delivery and personalized automation to the largest population of people treated with insulin, with time-in-range improvements seen in as little as one day in a pivotal trial¹

MANCHESTER, N.H., Oct. 16, 2026 (GLOBE NEWSWIRE) -- The twiist Automated Insulin Delivery (AID) System has been cleared by the U.S. Food and Drug Administration (FDA) for use in adults 18+ with insulin-treated type 2 diabetes. It is estimated that 31 million U.S. adults have type 2 diabetes, and about 5.5 million (1 in 6)² are treated with insulin. Following twiist's national launch for type 1 diabetes in March 2026, today's clearance expands the twiist AID system's indications to include type 2 diabetes, enabling immediate prescribing for this population.

Sequel recognizes that adults with insulin-treated type 2 diabetes face many of the same day-to-day insulin management challenges as those using insulin for type 1 diabetes, yet this community has historically had limited automated insulin delivery options. That’s where twiist comes in: designed to fit into daily life, twiist adjusts basal insulin around the clock based on targets set by the user and their care Team . In a pivotal study¹, only 11% of participants had prior carb-counting experience, and the majority were not actively using an AID system. Yet A1c and time in range improvements were seen. Time in range improvements were noticeable for many within 24 hours, showing that prior pump experience isn’t a prerequisite to see results¹.

Additionally, the system has an easy, low friction pharmacy start, one cassette change every three days, a 300-unit insulin capacity, and compatibility with Continuous Glucose Monitors (CGMs) many adults with type 2 diabetes already use, including Abbott 's FreeStyle Libre® 3 Plus sensor⁴ and Senseonics' Eversense® 365⁵.

"For many adults living with type 2 diabetes, insulin therapy can feel like one more thing to manage in an already busy life," said Sequel CEO and Co-Founder Alan Lotvin, MD. "At Sequel, we believe technology should meet people where they are, not the other way around. With twiist, we're bringing a personalized automated insulin delivery experience to the type 2 community that can help improve outcomes while reducing the day-to-day burden of diabetes management.”

The clearance was supported by data from a multicenter pivotal trial¹ evaluating the safety and efficacy of twiist in adults with insulin-treated type 2 diabetes. The study enrolled 307 adults across 30 U.S. sites, and results from the same pivotal trial were also published in Diabetes Care.

The population reflected contemporary type 2 diabetes care: 56% of participants were using a GLP-1 receptor agonist, 37% were using an SGLT-2 inhibitor, and 23% were using both. Glycemic improvement was observed while participants continued these therapies during the trial¹.

Key Findings¹:
Glycemic Improvements

• In the pivotal trial, just two of the participants were actively using an insulin pump when entering the study, yet participants spent a median 95% of the study in automated insulin delivery mode.
• HbA1c improved on average by 0.7% (p<0.001) from a baseline mean of 8.1%. Participants who started with the highest HbA1c saw the greatest improvement.
• People with an A1c of 9 or greater saw the greatest improvement over 13 weeks (2.1% A1c reduction).
• Mean time in Target glucose range (70 to 180 mg/dL) increased from 57% to 73%, an absolute improvement of 16 percentage points translating to 3.8 additional hours per day in a healthy glucose range.
• The proportion of participants achieving more than 70% time in range increased from 37% at baseline to 60% over 13 weeks.
• A1c improved across all bolus-frequency groups, with reductions ranging from 0.6% to 0.9%, regardless of bolus frequency.

Accessibility & Ease of Adoption

• Improvements were observed even though most participants entered the study without prior pump or carb-counting experience: only 11% had prior carb-counting experience, and 19% had prior AID system experience.
  

Safety

• No severe hypoglycemia events were reported during the study.
• Benefits were consistently positive across participant subgroups.

Easier Diabetes Management

• Patient-reported outcomes showed improved treatment satisfaction and sleep quality.
• Participants who were previously on basal-bolus insulin regimens required an average of 19.3 fewer units of insulin per day while using twiist.

"What we’re seeing with twiist represents a real inflection point for adults with type 2 diabetes who rely on insulin. Many people intensify therapy, adjust doses, and follow complex regimens but still struggle to reach glucose targets,” said Dr. Osama Hamdy, MD, PHD of Joslin Diabetes Center. “This trial shows how twiist can change that trajectory, where adults with type 2 diabetes can gain better time‑in‑range, lower A1c, and avoid severe hypoglycemia even without the prerequisite of prior pump experience. twiist is showing they can deliver the kind of burden free improvement this community has long needed. This combination is exactly what clinicians and patients need from automated insulin delivery.”

Prescribing information and product availability details for adults with type 2 diabetes are now available for healthcare providers and patients. To learn more about how twiist is transforming automated insulin delivery, visit https://www.twiist.com/.

About twiist
The twiist™ Automated Insulin Delivery (AID) System supports confident, flexible 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 with automated delivery. Powered by the twiist Loop™ algorithm (based on the community-driven Tidepool Loop), the system continuously adjusts basal insulin delivery to accommodate individual dosing needs—delivering personalized control. twiist is underpinned by its proprietary iiSure™ Technology, which includes checkpoints to ensure accurate delivery and detect blockages up to nine times faster than other AID systems.³ The twiist Automated Insulin Delivery (AID) System is for people with type 1 diabetes, ages 6 years and older, and type 2 diabetes, ages 18 years and older. It is available with a prescription, only in the U.S. For important safety information, please visit twiist.com/safety or learn more at 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.

Sequel Media Contact
Highwire
sequel.med.tech@teamhighwire.com

¹ Levy CJ, Kanapka L, Graham TE, et al. A Multicenter 13-Week Evaluation of the twiist Automated Insulin Delivery in Insulin-Treated Type 2 Diabetes: The twiist-T2D Pivotal Trial. Diabetes Care 2026; dc261270. https://doi.org/10.2337/dc26-1270

²Seagrove SIMM Market Model Updated March 2026

³When comparing user guides of all commercially available AID systems in the United States as of January 2026 - (at 1U/hr or 2 U/hr)

⁴ Product for prescription only, for Important Safety Information please visit FreeStyleLibre.us
‍The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission.

⁵The Eversense 365® Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to one year in people (18 years and older) with diabetes. For important safety information, see bit.ly/eversensesafety.