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

“These results are impressive, not only for our youngest patients, but also for their families,” said Dr. Jennifer Sherr, Principal Investigator and Associate Professor, Yale University School of Medicine. “Diabetes is a team sport — all members of the family are impacted, often with far-reaching consequences. Caregivers often have poor sleep quality as they strive for safety, with ensuing fatigue that affects family dynamics. These results show that Omnipod 5 can have a positive impact on the entire family.”

It is also noteworthy that 100% of the preschool pivotal trial participants opted to continue using Omnipod 5 in a 12-month extension phase, which demonstrates their overall satisfaction with the system and the clinical outcomes achieved.

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