Sequel's twiist AID System Shows Significant Blood Sugar Improvements in Type 2 Diabetes Trial
Sequel Med Tech reported positive pivotal trial results for its twiist Automated Insulin Delivery System in adults with type 2 diabetes. The 13-week study showed meaningful improvements in HbA1c and time in range with no severe hypoglycemia events. Separately, Sequel and Senseonics launched the twiist system integrated with Eversense 365 CGM across the U.S.
Sequel Med Tech announced positive results from a pivotal trial of its investigational twiist Automated Insulin Delivery System in adults with insulin-treated type 2 diabetes. The 13-week, multi-center study presented at the American Diabetes Association’s Scientific Sessions showed significant improvements in blood glucose control with no severe hypoglycemia events.
The trial enrolled 307 adults with type 2 diabetes across 30 U.S. sites. Participants experienced a mean reduction of 0.7 percentage points in HbA1c from a baseline of 8.1%, a statistically significant improvement. Time spent in the target glucose range (70–180 mg/dL) increased from 57% to 73%, an absolute improvement of 16 percentage points that translates to nearly 4 additional hours per day in a healthy glucose range.
Safety findings included no reported severe hypoglycemia events. One case of diabetic ketoacidosis was reported but was determined to be unrelated to the study device. Fourteen serious adverse health events occurred but were also unrelated to the twiist system. The cohort was diverse, with 26% identifying as Black or African-American and 13% as Hispanic, and included a wide range of insulin regimens.
The twiist system is currently FDA-cleared for people with type 1 diabetes ages 6 and older but remains investigational for type 2 diabetes use. A company executive noted the technology aims to reduce the management burden for insulin users by having the system take on more of the work.
Separately, Sequel Med Tech and Senseonics announced the full U.S. availability of the twiist system integrated with the Eversense 365 continuous glucose monitor. This combination makes twiist the first automated insulin delivery system compatible with the one-year Eversense 365 CGM. Users can now choose between two compatible sensors: Senseonics’ Eversense 365 or Abbott’s FreeStyle Libre 3 Plus.
The twiist system is powered by the Tidepool Loop algorithm and features proprietary iiSure technology that directly measures the volume of insulin delivered with every microdose. The integration with Eversense 365 aims to reduce the daily burden of frequent sensor changes while maintaining exceptional glucose monitoring accuracy.