FDA cleared Sequel Med Tech's twiist automated insulin delivery system for adults 18 and older with insulin-treated type 2 diabetes. Sequel announced it on October 16. The pump already carried a type 1 label down to age 6 and launched nationally in March.
The pivotal trial ran 13 weeks at 30 US sites with 307 adults, and the results are published in Diabetes Care. HbA1c fell an average of 0.7 points from a baseline of 8.1 percent, and 2.1 points in participants who started at 9 percent or higher. Time in range rose from 57 percent to 73 percent, about 3.8 more hours a day. No severe hypoglycemia was reported. Participants on basal-bolus insulin needed 19.3 fewer units a day on average.
Only 11 percent of the cohort had counted carbohydrates before and 19 percent had used automated delivery. That is the population the label now covers, and it is the hard case for a dosing algorithm, so running it in the pivotal rather than extrapolating from type 1 data is what made the submission work. twiist pairs with Abbott's FreeStyle Libre 3 Plus and the Senseonics Eversense 365, holds 300 units, takes a cassette change every three days and runs an algorithm derived from Tidepool Loop. It ships by prescription through pharmacies.