FDA Clears Sequel Med Tech System for Type 2 Diabetes
The twiist system received approval in October 2026 to assist adults managing insulin-treated type 2 diabetes.
Updated on Oct. 23, 2026 in Diabetes
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In October 2026, the FDA granted clearance to the Sequel Med Tech twiist system for adults diagnosed with insulin-treated type 2 diabetes. The regulatory approval follows a 13-week pivotal trial involving 307 participants.
Why it matters
The clearance introduces new automated insulin delivery technology aimed at improving glycemic control for patients who require insulin therapy. Ongoing trials are investigating whether reduced user input requirements will maintain or improve long-term outcomes for users.
The twiist pivotal trial enrolled 307 adults and observed an HbA1c reduction of 0.7% over 13 weeks. Participants demonstrated improved glucose management, with time-in-range metrics rising from 57% to 73% during the study.
The players
Sequel Med Tech
The medical technology manufacturer responsible for developing the twiist insulin delivery system.
Food and Drug Administration
The federal agency responsible for regulating medical devices and granting clearance for new healthcare technology in the United States.
The details
The twiist system utilizes programmed basal rates and specific insulin sensitivity factors to manage glucose levels. Additionally, the associated MiniMed Vivera algorithm can support glucose targets as low as 90 mg/dL by initiating automated mode directly from the total daily dose.
Timeline
The FDA cleared the twiist system for use in the United States in October 2026.
Health Landscape
This clearance represents an evolution in automated insulin delivery technology, moving toward systems that require less manual user intervention. The approval aligns with the FDA's regulatory framework for AID systems by validating that automated algorithms can safely maintain glycemic targets.
This technology provides adult patients with insulin-treated type 2 diabetes a new automated option for managing their daily glycemic targets. Users can expect the system to use specific sensitivity factors to automate insulin delivery without requiring constant manual mode run-in periods.
The takeaway
Automated systems like the twiist platform are designed to simplify insulin therapy by reducing the need for manual meal announcements. Patients should consult their healthcare providers to determine if automated insulin delivery features align with their specific glycemic targets.
Further reading
For more information on current treatment trends, visit the Diabetes section.
Source note: This article includes information reported by Hcplive.
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