New Insulin Delivery System Cleared for Type 2 Diabetes
The FDA-cleared device provides an automated option for adults managing type 2 diabetes with insulin therapy.
Updated on Oct. 16, 2026 in Diabetes
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The FDA has cleared the twiist Automated Insulin Delivery System for use by adults 18 and older with insulin-treated type 2 diabetes. This new technology offers a fresh option for the 5.5 million U.S. adults who currently manage their type 2 diabetes with insulin.
Why it matters
Managing blood glucose levels remains a challenge for many insulin-dependent adults, and this automated delivery system provides a tool to improve glycemic control. The clearance is based on clinical evidence showing improved time-in-range for users compared to previous methods.
A pivotal trial involving 307 adults across 30 U.S. sites demonstrated that the system enabled a 16 percentage point improvement in time-in-range. While participants showed significant glycemic improvements, long-term effectiveness in diverse real-world environments remains under investigation.
The players
FDA
The federal agency responsible for evaluating the safety and efficacy of medical devices in the United States.
Sequel Med Tech
The Manchester, N.H.-based medical technology company that developed the twiist automated insulin delivery system.
The details
The twiist system uses the Tidepool Loop algorithm paired with proprietary iiSure Technology to monitor insulin delivery and detect potential blockages. Users set personalized glycemic targets, and the system automatically adjusts basal insulin levels around the clock. The device includes a cassette with a 300-unit capacity that must be replaced every three days and is compatible with the FreeStyle Libre 3 Plus and Eversense 365 sensors.
Timeline
October 16, 2026: FDA clearance of the twiist system for type 2 diabetes.
March 2026: Anticipated national launch of the device for type 1 diabetes.
Health Landscape
The integration of the Tidepool Loop algorithm reflects a broader trend of incorporating shared software protocols into commercial diabetes management hardware. This clearance marks a significant shift by bringing automated delivery platforms to the broader population of adults with type 2 diabetes.
If you use insulin to manage your type 2 diabetes, you may want to discuss with your physician whether an automated delivery system is appropriate for your care plan. The device's integration with specific continuous glucose monitors means you should check for compatibility with your current sensor.
The takeaway
Automated insulin delivery systems can offer a more consistent way to manage blood glucose for those with type 2 diabetes. Talk to your healthcare team about whether a device like this might help reduce your daily insulin units and improve your time-in-range goals.
Further reading
For more information on managing glucose levels, see our guide on Diabetes.
More information
For official information on the device's capabilities and system requirements, visit the twiist official product information site.
Live Poll
Do you trust automated delivery systems to help manage chronic health conditions like diabetes?
