FDA Clears Twiist Insulin System for Type 2 Diabetes
The automated system is authorized for use in adults 18 and older managing insulin-treated type 2 diabetes.
Updated on Oct. 16, 2026 in Diabetes
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The FDA has granted clearance for the twiist Automated Insulin Delivery System to support adults with insulin-treated type 2 diabetes. The system utilizes proprietary technology to adjust insulin levels around the clock.
Why it matters
This clearance provides a new management option for the approximately 5.5 million U.S. adults treated with insulin for type 2 diabetes. Clinical trial results showed improved time-in-range and A1c levels for participants using the system.
A pivotal trial involving 307 adults across 30 U.S. sites demonstrated a median 95 percent time in automated insulin delivery mode. Participants saw an average 0.7 percent HbA1c improvement and a 16 percentage point increase in time in target range.
The players
FDA
The federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human drugs and biological products.
Sequel Med Tech
The Manchester, New Hampshire-based company that developed the twiist Automated Insulin Delivery System.
The details
The twiist system integrates the Tidepool Loop algorithm and iiSure Technology to monitor insulin volume and detect potential blockages. It is compatible with the FreeStyle Libre 3 Plus sensor and the Eversense 365 CGM and utilizes a cassette that requires replacement every three days.
Timeline
October 16, 2026: FDA clearance granted for type 2 diabetes usage.
March 2026: Anticipated national launch of the twiist system for type 1 diabetes.
The Big Picture
The integration of the Tidepool Loop algorithm expands the range of automated delivery systems available for adults with type 2 diabetes. This marks a shift in standard care as more medical device companies leverage open-source algorithm frameworks to improve patient glycemic control.
Patients using the system benefit from an automated delivery mode that adjusts basal insulin around the clock based on personalized targets. The device supports a 300-unit insulin capacity and requires a cassette change every three days to maintain operational status.
The takeaway
This new FDA-cleared option demonstrates the growing trend of utilizing automated delivery systems to help manage insulin-treated type 2 diabetes. Patients should consult with their healthcare teams to determine if the device compatibility and cassette-change requirements fit their daily routine.
What happens next
The national launch of the twiist system for type 1 diabetes is scheduled to take place in March 2026.
Further reading
For more information on managing glucose levels, visit the United States Diabetes section.
More information
View full product details on the twiist official product information site.
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