Insulet Corporation 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. 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. Additional Omnipod 5 Data Presented at ADA - Insulet also shared additional results from the Omnipod 5 pivotal study in people aged 6 through 70 years with type 1 diabetes, including clinical outcomes after transitioning from MDI, extension study results with 6 months of system use, and quality of life and user satisfaction data: Transition from MDI to Omnipod 5 Improves HbA1c - The 33 participants in the pivotal trial transitioning from MDI to Omnipod 5 achieved significant improvement in HbA1c (children: 7.73% to 6.74%, adolescents and adults: 7.57% to 6.97%) and time in range (children: 52.2% to 68.9%; adolescents and adults: 60.4% to 72.3%) after 3 months of use. These results support the feasibility of transitioning directly from MDI to automated insulin delivery with Omnipod 5. Improved Glycemic Outcomes over 6 Months with Omnipod 5 - A total of 224 pivotal study participants continuing use of Omnipod 5 in an extension study demonstrated sustained improvements in HbA1c over a total of 6 months of system use. Pediatric results decreased from an average of 7.7% at baseline to 6.9% at 6 months, and the adolescent and adult cohort decreased from an average of 7.2% to 6.7%. The extension study also revealed sustained improvements in time in range with minimal time below range. Adults, Adolescents, and Caregivers Report Improved System Usability, Satisfaction, and Quality of Life with Omnipod 5 - Equally as important as the glycemic outcomes are the results describing Omnipod 5 usability, user satisfaction, and impact on quality of life from the pivotal trial. Users reported significantly improved scores with the System Usability Scale following 3 months of Omnipod 5 use, with a mean baseline score of 75.9, 79.4 and 77.5 out of a maximum of 100 to a final score of 83.8, 86.3 and 89.0 for adults, teens, and caregivers of children, respectively. These results demonstrate that users perceived Omnipod 5 to be a more usable product compared to their prior therapy. Adults and caregivers of teens and children also reported increased satisfaction with their treatment as measured by the Insulin Delivery Satisfaction Survey and the Diabetes Treatment Satisfaction Questionnaire, suggesting that Omnipod 5 may alleviate some of the burdens associated with existing treatment options for type 1 diabetes both for adults and caregivers of younger users. Furthermore, Omnipod 5 led to significant improvements in quality-of-life measures, including reductions in diabetes-related distress across all groups, and improved hypoglycemic confidence among adults and caregivers of children. As indicated by these outcomes, reduced diabetes distress and improved quality of life are key benefits of using the Omnipod 5 AID system that are complementary to the glycemic benefits achieved. Omnipod System and Omnipod DASH®Improve Clinical Outcomes in Children and Adults Living with Type 1 Diabetes - Insulet also presented data related to the Company’s non-AID insulin delivery system products, the Omnipod System and Omnipod DASH System, both currently available in the U.S., Canada, and in several international markets. In the largest adult cohort study of 13,389 people with type 1 diabetes initiating therapy with the Omnipod System or Omnipod DASH System in the U.S. to date, HbA1c was reduced significantly (-0.8%), which was achieved with an 18% reduction in daily insulin dosage and a reduction in self-reported hypoglycemia from 3 episodes to 1.6 episodes per week. Similar results were seen in an analysis in 6,034 children, which included data from children below the age of 2 years.