Insulet has reported that data from the first pivotal trial of the Omnipod 5 Automated Insulin Delivery System showed it significantly improved time in range and reduced HbA1c in patients suffering from type 1 diabetes (T1D).
The system received breakthrough device designation from the US Food and Drug Administration and is currently being reviewed by the agency.
Insulet senior vice-president and medical director Trang Ly said: “Our pivotal study has achieved remarkable improvement in glucose control, evidenced by an 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.”
The trial had two groups of T1D patients. It enrolled 128 adult and adolescent subjects aged between 14 and 70 years in one group while the other had 112 children aged six to 13.9 years.
Subjects used the Omnipod 5 System in an at-home setting for three months after 14 days of their standard therapy, which included both pump therapy and multiple daily injections.
According to the results, the system demonstrated a significant increase from 65% to 74% in time in range (70mg/dL-180mg/dL) in adults and adolescents or an additional 2.2 hours per day. Also, an overall reduction of HbA1c from 7.16% to 6.78% was observed.
A reduction in mean glucose from 161mg/dL to 154mg/dL was noted in subjects while median time below 70mg/dL improved from 2% to 1.1%.
Participants achieved 76% time in the range at a target glucose of 110mg/dL.
An improvement from 53% to 68% in time in range was observed in children which corresponded to an additional 3.7 hours per day in the target range.
Furthermore, HbA1c improved from 7.67% to 6.99% and a decrease from 183mg/dL to 160mg/dL was noted in the mean glucose level.
Insulet anticipates launching the Omnipod 5 system in limited release during the first half of this year.