Insulet (NSDQ:PODD) touted positive results from the first pivotal trial for its Omnipod 5 automated insulin delivery system.
Omnipod 5 is the world’s first tubeless, wearable system designed to continuously adapt insulin delivery based on glucose levels and trends, according to a news release.
Acton, Mass.-based Insulet said the device, which has FDA breakthrough device designation, significantly improved time in range and reduced Hba1c in children, adolescents and adults between age six and 70 with Type 1 diabetes. Insulet expects to launch the device in a limited release in the first half of this year.
The study observed 128 adults and adolescents between 14 and 70, then 112 children between six and 13.9 years old, all using the Omnipod 5 at home for a period of three months after a 14-day period using their standard therapy, whether that be pump therapy or multiple daily injections.
Omnipod 5 delivered a significant increase in time in range in adults and adolescents, increasing from 65% to 74%, or a difference of 2.2 hours per day, plus an overall reduction of HbA1c from 7.16% to 6.78%. Participants also saw a decrease in mean glucose from 161 to 154 mg/dL, with the median time below 70 mg/dL improving from 2% to 1.1%.
In the children group, time in range went up from 53% to 68%, marking a change of 3.7 more hours per day in the target range. HbA1c improved from 7.67% to 6.99%, and mean glucose level decreased from 183 to 160 mg/dL.
Almost all study participants (98%) completed the study and virtually all of them opted to continue use of the Omnipod 5 during an extension phase of the study.
“Our team has been committed to developing a hybrid closed-loop insulin delivery system to advance the treatment of insulin-dependent diabetes,” Insulet SVP & medical director Trang Ly said in the release. “Our pivotal study has achieved remarkable improvement in glucose control, evidenced by impressive reduction in HbA1c and improved time in range, together with the lowest rates of hypoglycemia.
“We are incredibly proud of these results, which demonstrate the system is safe and effective across a wide range of age groups. This is another step forward in our mission to simplify life for people with diabetes.”
