twiist Pivotal Trial Reports Improved Glycemia in Insulin-Treated Type 2 Diabetes

The twiist-T2D pivotal trial evaluated efficacy, safety, and user satisfaction with the twiist automated insulin delivery system in 307 adults aged 19–85 years with insulin-treated type 2 diabetes. Participants used the system for 13 weeks after baseline continuous glucose monitoring (CGM) data collection. The primary outcome was change in HbA1c in this single-arm, multicenter study, reported in Diabetes Care.

Mean HbA1c declined from 8.1% to 7.4%, a reduction of 0.7 percentage points (95% CI −0.9 to −0.6). The largest reduction occurred among participants with baseline HbA1c ≥9.0%. Reductions were also reported among participants continuing prestudy GLP-1 receptor agonist or SGLT2 inhibitor therapy. Mean CGM time in range of 70–180 mg/dL increased from 57% to 73%, a 16-percentage-point improvement (95% CI 14–18).

CGM-measured hypoglycemia remained low. One participant experienced diabetic ketoacidosis; no severe hypoglycemia events occurred. Participant satisfaction was higher than with prestudy insulin delivery, and sleep quality improved (both P < 0.001). These findings support potential glycemic benefits in insulin-treated type 2 diabetes, but the uncontrolled design and 13-week duration limit conclusions about comparative effectiveness and longer-term safety. Only the abstract was available for assessment.