Omnipod 5 received the US Food and Drug Administration (FDA) breakthrough device designation and is currently under review
Insulet’s Omnipod 5 System shows positive outcomes. (Credit: Chokniti Khongchum from Pixabay.)
US-based medical device company Insulet has unveiled positive outcomes for its Omnipod 5 Automated Insulin Delivery System in a clinical study.
The automated insulin delivery system has been granted the US Food and Drug Administration (FDA) breakthrough device designation and is currently under review.
Insulet claimed that its Omnipod 5 system is the first tubeless, wearable system in the world to offer continuously adapted insulin delivery based on glucose levels and trends.
Also, the system is the first to significantly improve time in range and reduced HbA1c in children, adolescents, and adults with type 1 diabetes, aged between six and 70 years.
Insulet senior vice president and medical director Trang Ly said: “Our team has been committed to developing a hybrid closed-loop insulin delivery system to advance the treatment of insulin-dependent diabetes.
“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.”
Insulet presented the study data in two groups – 128 adults and adolescents with type 1 diabetes, aged between 14 and 70 years, and 112 children aged between six and 13.9 years.
In the study, participants were treated with Omnipod 5 System at home for three months, following standard therapy, including both pump therapy and multiple daily injections, for 14 days.
Treatment with Omnipod 5 System significantly increased time in the range from 65% to 74%, and reduced HbA1c from 7.16% to 6.78%, in adults and adolescents.
Also, the study participants also experience a decrease in mean glucose from 161 to 154 mg/dL, said the company.
In children, the time in range improved from 53% to 68%, and HbA1c reduced from 7.67% to 6.99%, while the mean glucose level decreased from 183 to 160 mg/dL.
Principal investigator of the study Gregory Forlenza said: “The Omnipod 5 System is phenomenal, improving diabetes outcomes for children and adults while greatly reducing the burden of diabetes management.
“With the algorithm built into the Pod itself, it is easier than ever for people with diabetes to rely on automated insulin delivery to manage their blood glucose levels and keep them in range. Insulet has created a very impressive device that will surely change lives.”
The insulin pump technology company is planning to roll out the Omnipod 5 on a limited scale during the first half of 2021.