Insulet Corporation, a global developer of tubeless insulin pump technology with its Omnipod brand of products, has 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. 
 
“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, Ph.D., 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 percent, used Omnipod 5 at home for a period of three 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 percent to 6.9 percent, and a significant increase in time in range (70-180 mg/dL), from an average of 57.2 percent to 68.1 percent, or an additional 2.6 hours per day. Median time in hypoglycemia (<70 mg/dL) was reduced, from 2.2 percent to 1.9 percent 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 percent at baseline to 90 percent at the end of the study.
 
“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 percent 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 
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 six 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 percent to 6.74 percent, adolescents and adults: 7.57 percent to 6.97 percent) and time in range (children: 52.2 percent to 68.9 percent; adolescents and adults: 60.4 percent to 72.3 percent) after three months of use. These results support the feasibility of transitioning directly from MDI to automated insulin delivery with Omnipod 5.

 
Improved Glycemic Outcomes Over Six 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 six months of system use. Pediatric results decreased from an average of 7.7 percent at baseline to 6.9 percent at six months, and the adolescent and adult cohort decreased from an average of 7.2 percent to 6.7 percent. 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 three 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 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 United States, 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 United States to date, HbA1c was reduced significantly (-0.8 percent), which was achieved with an 18 percent reduction in daily insulin dosage and a reduction in self-reported hypoglycemia from three 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.
 
The Omnipod 5 System received breakthrough device designation from the U.S. Food and Drug Administration and is currently under review. The company expects to launch Omnipod 5 in the United States in limited release during the second half of 2021.

Reference 
¹ The Pittsburgh Sleep Quality Index: A New Instrument for Psychiatric Practice and Research (Authors Daniel J. Buysse, Charles F. Reynolds III, Timothy H. Monk, Susan R. Berman, and David J Kupfer, © 1989 and 2010, University of Pittsburgh. All rights reserved.)