Key takeaways:

• The FDA has cleared twiist for adults aged 18 years and older with insulin-treated type 2 diabetes.
• The system improved time in range by 16 percentage points at 13 weeks in a multicenter trial.

The FDA has cleared an automated insulin delivery system for adults with type 2 diabetes who are treated with insulin, according to an industry press release.

As Healio previously reported, the system (twiist, Sequel Med Tech) was cleared by the FDA in March 2024 for children and adults aged 6 years and older with type 1 diabetes. The FDA’s newest clearance expanded the system’s indication to include adults aged 18 years and older with type 2 diabetes.

The FDA has cleared the twiist automated insulin delivery system for adults with insulin-treated type 2 diabetes.

The FDA’s clearance followed findings from a 13-week multicenter trial of 307 adults. As Healio previously reported at the American Diabetes Association Scientific Sessions in June, adults using twiist had a 0.7 percentage point drop in HbA1c from baseline to 13 weeks (P < .001), with the largest declines seen among those with an HbA1c of 9% or higher at baseline. Mean time in range with glucose of 70 mg/dL to 180 mg/dL increased from 57% at baseline to 73% at 13 weeks, and the percentage of adults who had a time in range of greater than 70% increased from 37% at baseline to 60% at 13 weeks.

According to the press release, the glycemic benefits observed with twiist were consistent across subgroups. Participants had improvements in treatment satisfaction and sleep quality while using the system.

There were no severe hypoglycemia events reported during the trial.

According to Sequel Med Tech, twiist is the first automated insulin delivery that directly measures the volume of insulin delivered with every microdose. The system continuously adjusts basal insulin to meet the user’s needs.

"What we’re seeing with twiist represents a real inflection point for adults with type 2 diabetes who rely on insulin,” Osama Hamdy, MD, PhD, senior staff physician and medical director of the obesity clinic program and inpatient diabetes program at Joslin Diabetes Center in Boston, said in a press release. “Many people intensify therapy, adjust doses and follow complex regimens, but still struggle to reach glucose targets. This trial shows how twiist can change that trajectory, where adults with type 2 diabetes can gain better time in range, lower HbA1c and avoid severe hypoglycemia even without the prerequisite of prior pump experience. Twiist is showing they can deliver the kind of burden-free improvement this community has long needed. This combination is exactly what clinicians and patients need from automated insulin delivery.”