Insulet said that its Omnipod 5 automated insulin delivery (AID) System has improved clinical outcomes and quality of life in the SECURE-T2D trial of patients with type 2 diabetes.
The Massachusetts-based tubeless insulin pump technology developer presented the positive data at the American Diabetes Association Scientific Sessions in Orlando, Florida.
Insulet had recently submitted these study findings to the US Food and Drug Administration (FDA) seeking to expand the indications of Omnipod 5 for individuals with type 2 diabetes.
Pending FDA clearance, the Nasdaq-listed Insulet anticipates a commercial launch in the US for type 2 diabetes by early 2025.
Currently, Omnipod 5 is FDA-cleared and has received CE marking for use in individuals aged two years and older with type 1 diabetes.
SECURE-T2D assessed the impact of Omnipod 5 in a diverse group of type 2 diabetes patients aged 18-75 years and who require insulin.
It involved 305 individuals from 21 sites across the US, including 24% Black and 22% Hispanic participants.
The trial revealed that the usage of Omnipod 5 led to better glycaemic control compared to previous insulin injections or pump therapy in these adults.
The findings included notable reductions in HbA1c levels, time spent in hyperglycaemia, and total daily insulin requirements.
Additionally, there was a significant increase in time spent within the target glucose range (TIR), without an accompanying rise in hypoglycaemic episodes.
Furthermore, the study highlighted a meaningful decrease in diabetes-related distress among participants.
Insulet senior vice president and medical director Trang Ly said: “These data demonstrate that simple, easy-to-use AID technology, such as Omnipod 5, can be adopted by a broad population of people with type 2 diabetes and improve their lives.
“A major strength of this study is the diversity of the enrolled population in terms of varying education level, income, ethnicity, and race.”
Separately, Insulet has collaborated with Optum Health Economics and Outcomes Research for a retrospective, real-world assessment of GLP-1 and non-GLP-1 patient cohorts.
Last year, the medical device company received FDA clearance for its Omnipod GO insulin delivery device to treat people with type 2 diabetes aged 18 or older.
