Omnipod 5 is a tubeless and wearable AID system that continuously adapts insulin delivery based on glucose levels and trends

insulin

Insulet recruited 80 preschool aged children across 10 US sites in the trial. (Credit: E Eeasyc from Pixabay)

Medical device firm Insulet announced that its Omnipod 5 automated insulin delivery system has showed improved outcomes in the company’s latest pivotal trial in very young children.

The study showed that Omnipod 5 has significantly enhanced time in range and reduced HbA1c in children aged two through 5.9 years with type 1 diabetes.

Omnipod 5 is claimed to be the world’s first tubeless and wearable automated insulin delivery (AID) system, which continuously adapts insulin delivery based on glucose levels and trends.

Insulet senior vice president and medical director Dr Trang Ly said: “Managing type 1 diabetes in very young children is particularly challenging due to their unpredictable eating patterns, erratic physical activity, and an increased fear of hypoglycemia from caregivers, since these patients often cannot self-treat or verbalize their symptoms.

“Omnipod 5 has tremendous potential to improve outcomes and ease of use for our youngest patients, and we are delighted to share these pivotal trial results.”

The company recruited a group of 80 preschool aged children across 10 US sites in the trial.

The children aged between two and 5.9 years of age with an HbA1c of under 10.0% used Omnipod 5 at home for a period of three months after a 14-day period using their standard therapy, which consisted of either pump therapy or multiple daily injections (MDI).

Insulet stated that the children have been unrestricted in eating and exercise across the trial.

The study demonstrated an overall reduction in HbA1c from an average of 7.4% to 6.9, as well as a significant increase in time in range from an average of 57.2% to 68.1% or additional 2.6 hours per day, said the company.

Insulet has also provided additional data from the Omnipod 5 pivotal study in people aged six through 70 years with type 1 diabetes, including clinical outcomes after transitioning from MDI.

The 33 participants in the trial transitioning from MDI to Omnipod 5 showed significant improvement in HbA1c and time in range after three months of use.