Insulet’s Omnipod 5 Automated Insulin Delivery System Pivotal Studies Demonstrate Improved Outcomes Across the Lifespan from Ages 2 to 70 years

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod brand of products, today announced promising results from its latest pivotal trial for the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) in very young children. Omnipod 5, the world’s first tubeless, wearable automated insulin delivery (AID) system that continuously adapts insulin delivery based on glucose levels and trends, significantly improved time in range and reduced HbA1c in children aged 2 through 5.9 years with type 1 diabetes. These pivotal study data from the preschool age group were presented at the American Diabetes Association (ADA) Virtual 81st Scientific Sessions.

“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,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “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.”

Omnipod 5 Preschool Pivotal Study Overview

Insulet enrolled a group of 80 preschool aged children across 10 U.S. sites for this study. The participants, who were between 2 and 5.9 years of age with an HbA1c of under 10.0%, used Omnipod 5 at home for a period of 3 months after a 14-day period using their standard therapy, which included either pump therapy or multiple daily injections (MDI). The children were unrestricted in eating and exercise throughout the study.

The study showed an overall reduction in HbA1c from an average of 7.4% to 6.9%, and a significant increase in time in range (70-180 mg/dL), from an average of 57.2% to 68.1%, or an additional 2.6 hours per day. Median time in hypoglycemia (<70 mg/dL) was reduced, from 2.2% to 1.9% overall.

In addition, parents and caregivers of study participants reported improved sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)¹, a questionnaire considered to be the gold standard in measuring subjective sleep quality. Parents and caregivers reporting “very good” or “fairly good” sleep increased from 65% at baseline to 90% at the end of the study.