Insulet (NSDQ:PODD) last week presented positive pivotal trial data for its Omnipod 5 automated insulin delivery system.
Acton, Massachusetts-based Insulet’s Omnipod 5 — which it touts as the world’s first tubeless wearable system for continuously adapting insulin delivery based on glucose levels and trends — significantly improved time in range and reduced HbA1c in the trial.
The trial evaluated children, adolescents and adults aged between six and 70 years old, with type 1 diabetes using the Omnipod 5 over the space of 12 months. Data was presented at the European Association for the Study of Diabetes (EASD) 2021 annual meeting, according to a news release.
After a three-month pivotal trial, 95% of study participants elected to continue the use of Omnipod 5 in an extension study. Participants used Omnipod 5 at home for 12 months after a 14-day period using their standard therapy, which included both pump therapy and multiple daily injections.
Data from the study includes a decrease in HbA1c from 7.2% to 6.8% maintained over 12 months of use in adults and adolescents. Time in range increased from 63.6% to 73.8% over the first three months, then persisted at 72.7% in months 10-12 of use.
Children’s HbA1c decreased from 7.7% to 7% after three months and maintained that decrease over 12 months. Time in range increased from 52.4% to 67.9% in the first three months, then persisted at 66.8% in months 10-12.
”Reducing burden and making diabetes management easier through innovative technology is our number one goal at Insulet,” Insulet SVP & medical director Dr. Trang Ly said in the release. “We are very pleased that the positive safety and efficacy outcomes resulting from our pivotal study continued for those patients who used Omnipod 5 for a total of 12 months. This product is having an enduring positive impact on trial participants’ health, and we couldn’t be more proud.”
Omnipod 5 holds FDA breakthrough device designation and is currently under premarket review. The company expects to launch the device in a limited U.S. release late in the fourth quarter of this year.
The company additionaly presented studies of Omnipod DASH, the current generation of the Omnipod platform on the market. One study found that Omnipod DASH was associated with significant reductions in HbA1c and hypoglycemic events after the initial 90 days of use for those with type 1 diabetes. The second study resulted in positive glycemic outcomes, including a low percentage of time in hypoglycemia across all age groups.