Dive Brief:

• The Food and Drug Administration has cleared the Twiist automated insulin delivery, or AID, system for use in adults with insulin-treated Type 2 diabetes. 
• Sequel Med Tech, which sells the device, disclosed the 510(k) clearance on Friday. The FDA granted the clearance to Deka Research and Development, Sequel’s partner on Twiist.
• The FDA cleared Twiist after researchers linked the AID system to reduced blood sugar and increased time in the target glycemic range in a clinical trial.

Dive Insight:

Deka received clearance for the system in Type 1 diabetes in March 2024. Sequel launched the product nationally in the indication two years later. The latest clearance will enable immediate prescribing of the system for Type 2 diabetes patients, Sequel said. 

The product’s algorithm is based on Tidepool Loop, a patient-led automated insulin dosing tool that received 510(k) clearance in 2023. Combining Deka drug delivery technology with the Loop algorithm positioned Sequel to compete for the AID market, initially in Type 1 diabetes. 

Sequel disclosed the label expansion shortly after researchers published pivotal data on the system in Type 2 diabetes patients. Mean blood sugar fell from 8.1% at baseline to 7.4% after 13 weeks using the AID system. The percentage of time patients spent in the targeted blood sugar range increased from 57% to 73%. 

Patients were more satisfied with the system than with their old insulin delivery method and reported improved sleep quality. Most patients had no experience with AID systems or carb counting at the start of the trial. Despite not being familiar with the technology, many patients experienced improved time in range within 24 hours of starting to use the AID system. 

Clinical data show Twiist “can deliver the kind of burden-free improvement this community has long needed,” Joslin Diabetes Center’s Dr. Osama Hamdy said in a statement. The system adjusts basal insulin based on targets set by the user and their care team.

Beta Bionics, Insulet, MiniMed and Tandem Diabetes Care sell rival AID systems. Like its rivals, Sequel has integrated its technology with continuous glucose monitors. Twiist is compatible with Abbott's FreeStyle Libre 3 Plus sensor and Senseonics’ Eversense 365.