Insulet has reported positive data from its pivotal extension trial of the Omnipod 5 Automated Insulin Delivery System conducted in children aged two to 5.9 years with type 1 diabetes.
The trial data demonstrated that the new system significantly improved glycemic outcomes in children of this age group with type 1 diabetes after more than 12 months of use.
Omnipod 5 is claimed to be the first wearable, tubeless automated insulin delivery (AID) system in the US.
It significantly improved time in range and lowered HbA1c in 80 children of the same age group in the original three-month pivotal trial.
The participants were later invited to continue using the Omnipod 5 system in an extension trial phase of more than 12 months.
They used the device for three months in the pivotal trial and nine months in the extension phase.
The data from the extension phase showed significant improvement in outcomes compared with baseline, including reduced HbA1c and increased time in range.
According to the results, the Omnipod 5 system demonstrated a reduction in HbA1c from 7.4% to 6.9% as against baseline.
Similarly, during ten to 12 months of use, the percent time in range was 67.6% against 57.2% during standard therapy and 68.1% during the pivotal trial of three months.
The percent time in hypoglycemia (<70 mg/dL) was reduced from 2.2% during standard therapy to 1.9%.
Insulet senior vice-president and medical director Dr Trang Ly said: “One of our biggest goals in the development of Omnipod 5 was to ease the burden that type 1 diabetes places on families and caregivers of this vulnerable age group.
“With these preschool extension trial results, we have demonstrated improved glycemic results over the long term for very young children managing diabetes.”
In January, the company received US Food and Drug Administration (FDA) clearance for its Omnipod 5 system with smartphone control.