Launched earlier this year for people with type 1 diabetes, the company estimates the agency’s green light adds about 5.5 million people in the U.S. who manage their condition with insulin.
Available through pharmacies with a prescription, the twiist carries a 300-unit insulin reservoir and is compatible with continuous glucose monitors including Abbott’s FreeStyle Libre 3 Plus and Senseonics’ Eversense 365.
The device also carries onboard sensors to ensure accurate dose delivery and identify blockages, and continuously adjusts basal insulin levels through an algorithm based on the Tidepool Loop.
The FDA’s clearance was based on a pivotal study presented in June at the annual American Diabetes Association Scientific Sessions in New Orleans, and also published in the journal Diabetes Care.
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The trial enrolled 307 participants taking insulin for type 2 diabetes and showed HbA1c improvements by 0.7 percentage points after 13 weeks. Time in a target glucose range also rose from 57% to 73%.
Sequel noted that at the start of the study, just 11% of participants had experience counting carbs, while only 19% had previously used an automated insulin pump. In addition, people who had been taking basal-bolus insulin regimens needed 19.3 fewer units of insulin per day on average while using twiist.
“For many adults living with type 2 diabetes, insulin therapy can feel like one more thing to manage in an already busy life,” said Sequel co-founder and CEO Dr. Alan Lotvin. “With twiist, we’re bringing a personalized automated insulin delivery experience to the type 2 community that can help improve outcomes while reducing the day-to-day burden of diabetes management.”
