Sequel Twist Type 2 clearance adds a new adult indication
The FDA has cleared Sequel’s Twist automated insulin delivery system for adults with insulin treated Type 2 diabetes, after a 13 week trial. Medigear.uk covers the clearance.
The Food and Drug Administration (FDA) has issued the Sequel Twiist Type 2 clearance. It opens the Twiist automated insulin delivery (AID) system to adults who take insulin for Type 2 diabetes. On Friday, 16 October 2026, Sequel Med Tech, the device's seller, announced the 510(k) clearance. The agency granted it to Deka Research and Development, Sequel's partner on Twiist.
What the clearance changes
Twiist first won clearance, through Deka, in March 2024 for Type 1 diabetes. Sequel went national with it for that group two years later. The new clearance lets doctors prescribe it to Type 2 patients straight away, Sequel said.
The system tunes basal insulin to goals that the user and their care team choose.
Trial results behind the decision
Sequel announced the label expansion soon after researchers published pivotal data in Type 2 patients. Over 13 weeks on the system, mean blood sugar fell from 8.1% to 7.4%. Time spent in the target range rose from 57% to 73%.
Patients rated Twiist higher than their previous insulin delivery method, and they slept better. Most had never used an AID system or counted carbs. Still, many saw their time in range improve within the first 24 hours.
Technology behind Twiist
The algorithm builds on Tidepool Loop, a patient led insulin dosing tool that won 510(k) clearance in 2023. Sequel paired it with Deka's drug delivery technology, which put the company in the AID market, first in Type 1 diabetes.
Twiist works with continuous glucose monitors. It is compatible with Abbott's FreeStyle Libre 3 Plus sensor and Senseonics' Eversense 365.
What a clinician said
Dr Osama Hamdy of Joslin Diabetes Centre said clinical data show Twiist can improve outcomes without adding burden for patients.
Competitive backdrop
Beta Bionics, Insulet, MiniMed and Tandem Diabetes Care all sell rival AID systems. Like them, Sequel has tied its technology to continuous glucose monitors.
Why it matters
The Sequel Twiist Type 2 clearance widens the pool of patients who can use the system. Medigear.uk follows the Sequel Twiist Type 2 clearance and wider AID market news.
Source: MedTech Dive
Sourcing medical equipment?
Tell us the model and destination — our sourcing team will respond within one business day.
Actalent medtech cybersecurity talent is now a strategic issue
Actalent medtech cybersecurity talent is in short supply just as AI plans depend on secure data, say…
Masimo Radius VSM AFib detection gains FDA clearance
The Food and Drug Administration (FDA) has cleared Masimo Radius VSM AFib detection. The feature add…
Private equity hospital AI adoption matches nonprofits, study finds
Private equity hospital AI adoption runs far above that of other for profit hospitals, a study in He…
Medical device news, once a week.
Approvals, trials, recalls and market moves — the essentials for procurement and clinical teams.