Sequel's twiist™ Aims to Automate the Burden of Type 2 Diabetes Care

NEW ORLEANS, LA – June 08, 2026 – For the millions of people living with insulin-treated type 2 diabetes, daily life is a constant balancing act of calculations, injections, and vigilance. This week, at the American Diabetes Association’s 86th Scientific Sessions, Sequel Med Tech presented compelling data suggesting that much of this burden could soon be automated. The company unveiled pivotal trial results for its investigational twiist™ Automated Insulin Delivery (AID) System, showcasing significant improvements in glucose control and safety for a population that has long been underserved by the latest advancements in diabetes technology.

From the Engine Room, where we focus on the architecture of innovation, this represents more than just a new device. It signals a critical expansion of a technology class—hybrid closed-loop systems—into a vast new market. More importantly, it reflects a philosophical shift in care, where the goal is not to ask more of the patient, but to build technology that takes on more of the work.

A Breakthrough for an Underserved Population

The results from the 13-week, multi-center pivotal trial were both statistically significant and clinically meaningful. The study, which enrolled 307 adults with insulin-treated type 2 diabetes across 30 U.S. sites, demonstrated a powerful impact on key health metrics. Participants saw their HbA1c—a measure of long-term blood sugar control—improve by an average of 0.7 percentage points from a baseline of 8.1%. For those starting with the highest blood sugar levels, and thus the highest risk for long-term complications, the improvements were even more pronounced.

Perhaps more impactful on a day-to-day basis was the dramatic increase in Time in Range (TIR). Participants spent an average of nearly four additional hours per day within their target glucose range (70–180 mg/dL), with mean TIR increasing from 57% to 73%. This shift represents a profound improvement in quality of life, reducing the exhausting metabolic rollercoaster that many with diabetes experience.

Critically, these gains did not come at the cost of safety. The trial reported no instances of severe hypoglycemia (dangerously low blood sugar), a common fear and risk associated with insulin therapy. In fact, time spent in a hypoglycemic state decreased. “We saw meaningful glycemic improvement from Day 1 in glucose levels that was sustained through 13 weeks, with no severe hypoglycemic events,” said Dr. Carol Levy, the study's lead investigator and Professor of Medicine at the Icahn School of Medicine at Mount Sinai. “For people with insulin-treated type 2 diabetes, achieving better control without added risk of lows is a meaningful step forward.”

The trial cohort’s diversity—with 26% Black or African-American and 13% Hispanic participants, and a wide range of ages, diabetes durations, and concurrent therapies—suggests these benefits could be broadly applicable across the real-world patient population.

The Machinery of Simplicity

At the heart of Sequel Med Tech's approach is a commitment to reducing the cognitive load of diabetes management. “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, Sequel’s Chief Medical Officer. "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."

This philosophy is engineered directly into the twiist™ system. Already FDA-cleared for type 1 diabetes, the system is a tubeless patch pump that integrates with a continuous glucose monitor (CGM). It uses the twiist Loop™ algorithm, which is based on the community-driven and FDA-cleared Tidepool Loop, to automatically adjust basal insulin delivery every few minutes. This constant, quiet modulation helps keep glucose levels stable without requiring constant patient input.

What sets the twiist system apart is its proprietary iiSure™ Technology. It is the first AID system to directly measure the volume of insulin delivered with each microdose. This provides an added layer of precision and a crucial safety check, allowing the system to detect potential pump blockages up to nine times faster than other commercially available systems. For the user, this means greater confidence that the system is working as intended. For the engineers behind it, it represents a robust solution to a critical point of failure in insulin pump therapy.

By automating the background work and building in advanced safety checks, the system frees patients from a significant portion of the mental and logistical burden of their disease, which patient-reported outcomes from the trial confirmed through improved treatment satisfaction and sleep quality.

A Strategic Shift into a Vast New Market

Sequel's successful trial is a key indicator of a larger industry trend: the expansion of AID systems beyond their initial beachhead in type 1 diabetes. While the T1D community has benefited from these closed-loop systems for years, the approximately 5.5 million adults in the U.S. with insulin-treated type 2 diabetes represent a much larger, and largely untapped, market.

Sequel Med Tech is not alone in recognizing this opportunity. The competitive landscape is heating up as major players pivot to address this population. Insulet's Omnipod 5 gained an FDA indication for T2D in 2024, Medtronic's MiniMed 780G system followed in 2025, and Tandem Diabetes Care's t:slim X2 with Control-IQ+ technology recently received CE Mark approval in Europe for T2D. This race to market underscores the profound unmet need and commercial potential.

To carve out its position, Sequel is building an ecosystem around its device. The Manchester, New Hampshire-based company has forged strategic partnerships, including one with Arecor Therapeutics to explore the use of a novel, ultra-concentrated rapid-acting insulin. This could be a game-changer for T2D patients who often require higher insulin doses. This forward-thinking strategy shows an understanding that a device alone is not a complete solution; it must be part of a holistic platform that addresses the full spectrum of patient needs.

The Road to Clearance and Beyond

While the twiist™ system is commercially available for individuals with type 1 diabetes, its use in type 2 diabetes remains investigational in the United States. The positive pivotal trial data presented this week is the cornerstone of the evidence package Sequel will need to secure FDA clearance for this expanded indication. The company has not yet announced a formal submission timeline, but given the precedent set by competitors, it will likely pursue a 510(k) regulatory pathway, which is used for moderate-risk devices that can demonstrate substantial equivalence to an existing approved device.

Navigating this final regulatory gauntlet is the last major step before this technology can be put into the hands of the millions of T2D patients who stand to benefit. The journey from a complex engineering challenge to a simple, life-changing patient experience is nearing a pivotal milestone. With these compelling trial results in hand, Sequel Med Tech is now poised to bring its vision of less demanding, more personal diabetes care to a population that has waited long enough.