RADIANT Trial Shows Significant Glycemic Gains with Omnipod® 5 After MDI Transition
Insulet Corporation (NASDAQ: PODD), a global leader in tubeless insulin pump technology through its Omnipod® brand, has released new clinical data from its RADIANT study, demonstrating significant glycemic improvements for users transitioning from multiple daily injections (MDI) to the Omnipod 5 Automated Insulin Delivery (AID) System. The findings were presented at the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Amsterdam and online.
Groundbreaking RADIANT Study: A First-of-Its-Kind Analysis
The RADIANT study is the first randomized controlled trial (RCT) to evaluate the direct transition from MDI to an AID system in adults and children with type 1 diabetes. It is also the first to assess the safety and efficacy of an AID system paired with the Abbott FreeStyle Libre® 2 family sensor. The study found that for individuals who were not meeting their HbA1c clinical targets on MDI, the Omnipod 5 AID System provided clinically significant improvements in HbA1c levels compared with those who continued using MDI with a continuous glucose monitor (CGM).
Despite significant advancements in diabetes technology, MDI remains the predominant therapy for type 1 diabetes. Globally, individuals with type 1 diabetes lose an estimated 35 years of healthy life on average. In the U.S., many people using MDI alongside CGM fail to achieve the recommended HbA1c goal of below 7%, with average HbA1c levels reported at 8.7%. Elevated HbA1c levels are associated with an increased risk of complications such as cardiovascular disease, kidney disease, and eye problems.
Study Design and Participants
The RADIANT study included 188 participants between the ages of 4 and 70 with type 1 diabetes and HbA1c levels ranging from 7.5% to 11%. All participants had been using MDI with a CGM for at least three months prior to the study. The trial was conducted across 19 clinical centers in France, the U.K., and Belgium. Participants were randomized to either begin using the Omnipod 5 AID System (N=125) or continue with their standard MDI plus CGM therapy (N=63) for three months.
Participants had an average baseline HbA1c of 8.1%. After three months, those using the Omnipod 5 AID System experienced an average HbA1c reduction of 0.8% compared with MDI plus CGM users, bringing their HbA1c down to 7.2%. For those who started with an HbA1c above 8.0%, the reduction was even greater, with an average decrease of 1.0%. This level of improvement significantly reduces the risk of developing long-term diabetes complications.
Improved Time in Range and Reduced Hyperglycemia
In addition to lowering HbA1c, Omnipod 5 users spent an additional 5.4 hours per day with glucose levels within the target range (70-180mg/dL) compared to MDI plus CGM users. This resulted in an average final time-in-range of 65%, up from a baseline of 39%. The study also found a significant reduction in time spent with high glucose levels (>180mg/dL and >300mg/dL), while there was no increase in time spent with dangerously low glucose (<70mg/dL or <54mg/dL). Notably, there were no severe hypoglycemic events or diabetes-related ketoacidosis cases reported in either treatment group during the study period.
Expert Endorsements
Dr. Trang Ly, MBBS, FRACP, PhD, Senior Vice President and Chief Medical Officer of Insulet, emphasized the impact of Omnipod 5: “Omnipod 5 is transforming the lives of an estimated 365,000 users worldwide by eliminating the need for injections and reducing the burden of diabetes. The RADIANT study builds upon our previous research and further demonstrates the significant therapeutic benefits of switching from MDI to Omnipod 5.”
Dr. Emma G. Wilmot, Associate Professor at the University of Nottingham and Chief Investigator for the RADIANT study, highlighted the study’s real-world relevance: “The RADIANT participants were individuals who, despite using MDI and CGM, were not reaching their HbA1c targets. Many had been waiting for a tubeless AID option. This study demonstrates that they could safely transition directly to Omnipod 5 and achieve significant glycemic improvements.”
Professor Hélène Hanaire, head of the Department of Diabetology at the University Hospital of Toulouse, France, added: “Omnipod 5 has demonstrated clinical efficacy in people living with type 1 diabetes. The RADIANT study showed that the system was easy to implement in pump-naïve patients, leading to very positive outcomes. This encourages us to advocate for a direct transition from MDI to AID so patients can immediately benefit without a prolonged period of manual pump therapy.”
A Broader Global Impact
Approximately 5.2 million people live with type 1 diabetes in the 25 countries where Insulet operates. Omnipod 5 is currently commercially available in the U.S. and 10 additional countries. The results of the RADIANT study will be submitted for publication later this year, further solidifying Omnipod 5’s position as a leading solution for insulin delivery.
References:
- Seagrove Partners LLC, Data on File, 2024.
- Type 1 Diabetes Index. https://www.t1dindex.org. Accessed February 11, 2025.
- Gandhi et al., T1D Exchange Quality Improvement Collaborative; Insulin Pump Utilization in 2017–2021. Clin Diabetes, 2024.
- DCCT Research Group, Intensive Treatment of Diabetes and Long-Term Complications. NEJM, 1993.
- Insulet Data on File, January 2025.
The RADIANT study underscores the potential of Omnipod 5 to enhance diabetes management by simplifying insulin delivery, improving glycemic outcomes, and reducing the daily burden of diabetes care. As Insulet continues expanding its reach, the impact of automated insulin delivery will likely become even more profound for people with type 1 diabetes worldwide.
