FDA Approves twiist™ Insulin Delivery for Type 2 Diabetes Patients

In a significant advancement for diabetes care, the U.S. Food and Drug Administration (FDA) has granted clearance for the twiist Automated Insulin Delivery (AID) System to be used by adults over 18 with insulin-dependent type 2 diabetes. This decision is expected to benefit approximately 5.5 million individuals in the U.S. who are managing their condition with insulin.

Expanding Access to Advanced Technology

Sequel Med Tech, the company behind twiist, originally launched the system in March 2026 for those with type 1 diabetes. The recent FDA approval enhances its use to a broader audience, allowing healthcare providers to prescribe this innovative system immediately for adults with type 2 diabetes.

Addressing Diabetes Management Challenges

Managing diabetes can be particularly demanding, especially for adults using insulin. Research suggests that insulin-treated type 2 diabetes patients encounter many challenges similar to those with type 1 diabetes, yet they often lack access to automated insulin delivery systems. The twiist device aims to alleviate some of this burden by offering a user-friendly solution.

The system is designed to blend seamlessly into daily routines, automatically adjusting basal insulin throughout the day based on individual targets established by users and their healthcare teams. Out of the participants in a pivotal trial, only 11% had prior experience with carb counting, and many had not utilized an automated system, yet improvements in A1c and time spent in the target glucose range were observed quickly, some within just 24 hours.

Study Results and Patient Experience

The twiist AID system was evaluated in a multicenter pivotal trial involving 307 adults across 30 U.S. locations. Notably, the study reflected contemporary diabetes care trends, with participants using additional medications such as GLP-1 receptor agonists and SGLT-2 inhibitors.

Key findings from the trial include:

• Participants spent a median of 95% of their time in automated insulin delivery mode.
• Average HbA1c levels dropped by 0.7%.
• Participants with an A1c above 9 experienced a significant reduction of 2.1% over 13 weeks.
• Median time in the target glucose range increased from 57% to 73%, correlating to an additional 3.8 hours daily in a healthy range.
• The percentage of participants achieving over 70% time in range rose from 37% to 60% over the course of 13 weeks.
• No severe hypoglycemia events occurred during the trial, and patient satisfaction regarding treatment and sleep quality improved.

Moreover, individuals transitioning from a basal-bolus insulin regimen noted a reduction of 19.3 units of insulin per day while utilizing the twiist system.

Innovative Features of the twiist System

The twiist system offers an easy start with low friction, as it requires one cassette replacement every three days and has a capacity of 300 units of insulin. It also integrates well with Continuous Glucose Monitors (CGMs) that many type 2 diabetes patients are already using, such as Abbott's FreeStyle Libre® and Senseonics' Eversense® 365.

Alan Lotvin, MD, CEO and Co-Founder of Sequel, emphasized the importance of making technology accessible to those managing diabetes. He stated, "For many adults living with type 2 diabetes, insulin therapy can feel like one more thing to manage in an already busy life. At Sequel, we believe technology should meet people where they are, not the other way around."

Looking Ahead

The twiist AID system is now available by prescription for adults with type 2 diabetes. Healthcare providers and patients looking for more information can visit twiist.com for comprehensive details on how the system can innovate diabetes management.

About Sequel Med Tech

Located in Manchester, N.H., Sequel Med Tech is on a mission to transform drug delivery technologies. The twiist Automated Insulin Delivery System stands as a testament to their commitment to sustainability, convenience, and effectiveness in diabetes care. For more information about Sequel and their innovative products, visit sequelmedtech.com.