Omnipod® 5 RADIANT Trial Shows Significant Glycemic Improvements Following Direct Transition from MDI
Insulet Corporation, a leader in tubeless insulin pump technology, has released groundbreaking results from its RADIANT clinical trial, which were presented at the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Amsterdam, Netherlands. The trial demonstrated that the Omnipod® 5 Automated Insulin Delivery (AID) System significantly improves glycemic control in adults and children with type 1 diabetes (T1D) following a direct transition from Multiple Daily Injections (MDI). The study highlights the effectiveness and safety of the Omnipod® 5 system, especially for individuals struggling with suboptimal HbA1c levels using traditional MDI therapy.
Key Findings from the RADIANT Study
The RADIANT study is the first randomized controlled trial (RCT) to evaluate the direct switch from MDI to an AID system in patients with type 1 diabetes. The study also marked the first clinical evaluation of an AID system paired with Abbott’s FreeStyle Libre® 2 sensor for glucose monitoring. The research involved 188 participants, aged 4 to 70, with HbA1c levels between 7.5% and 11% who had been using MDI combined with a Continuous Glucose Monitor (CGM) for at least three months prior.
Participants were randomly assigned to two groups: one group used the Omnipod 5 AID system (125 participants) and the other continued with their usual MDI plus CGM therapy (63 participants) for three months. The results revealed that the Omnipod 5 system provided significant glycemic improvements over MDI plus CGM therapy.
Significant HbA1c Reductions and Improved Time in Range
The participants using the Omnipod 5 system demonstrated an average HbA1c reduction of 0.8% after three months, with a final HbA1c level of 7.2%. For those with baseline HbA1c levels above 8.0%, the improvement was even more pronounced, with a 1.0% reduction. Achieving an HbA1c of 7.2% is clinically significant, as it lowers the risk of diabetes-related complications such as cardiovascular disease, kidney disease, and retinopathy.
In addition to improved HbA1c, Omnipod 5 users also experienced a substantial improvement in their Time in Range (TIR). Participants using the Omnipod 5 system spent an additional 5.4 hours per day within the target glucose range of 70-180 mg/dL compared to those on MDI plus CGM, resulting in a final TIR of 65%, up from a baseline of 39%. There was also a marked reduction in time spent with high glucose levels (>180 mg/dL and >300 mg/dL), and no increase in time spent with dangerously low glucose (<70 mg/dL or <54 mg/dL).
Safety and Efficacy: No Serious Adverse Events
The trial also showed that both treatment groups experienced no life-threatening adverse events such as severe hypoglycemia or diabetes-related ketoacidosis. These findings underscore the safety of the Omnipod 5 system, which effectively improved glycemic control without introducing new risks to patients.
Expert Opinions on the Impact of the Omnipod 5 System
Dr. Trang Ly, Senior Vice President and Chief Medical Officer at Insulet, emphasized that the Omnipod 5 is transforming the lives of individuals with type 1 diabetes by eliminating the need for injections and reducing the burden of managing the condition. “The results from the RADIANT trial clearly demonstrate the significant therapeutic benefits for people requiring insulin therapy who switch from injections to Omnipod 5,” she said.
Dr. Emma Wilmot, Chief Investigator for the RADIANT study, also highlighted the ease of transition for MDI users to Omnipod 5, noting that many of the study’s participants were eager to switch to an automated insulin delivery system. “These participants, who had struggled with achieving optimal HbA1c on MDI, were able to safely transition directly to Omnipod 5 and achieve significant improvements in glucose levels,” said Dr. Wilmot.
Professor Hélène Hanaire, another investigator in the trial, pointed out that the Omnipod 5 system provides clinical efficacy and excellent results for those new to insulin pumps. “It encourages us to pursue a direct switch from MDI to automated insulin delivery so patients can immediately benefit without a long manual pump treatment period,” she added.
The Growing Need for Effective Type 1 Diabetes Management
Approximately 5.2 million people live with type 1 diabetes in the 25 countries where Insulet operates. Despite the availability of insulin therapy and glucose monitoring tools, many patients struggle to achieve target HbA1c levels. The RADIANT trial’s results highlight the need for more efficient and user-friendly insulin delivery systems that offer significant clinical benefits and improve overall quality of life for people with type 1 diabetes.
MDI remains the most common treatment approach for type 1 diabetes worldwide. However, studies have shown that many individuals using MDI plus CGM are unable to meet the recommended HbA1c goal of less than 7%, with average levels reported at 8.7%. The RADIANT study demonstrated that switching to an AID system like Omnipod 5 could significantly reduce HbA1c levels and improve overall diabetes management.
Moving Forward: The Future of Automated Insulin Delivery
With the success of the RADIANT trial, Insulet plans to submit these results for publication later this year. The company is committed to advancing the field of diabetes management by providing people with type 1 diabetes innovative solutions that are both clinically effective and user-friendly. As the adoption of automated insulin delivery systems grows, Omnipod 5 is expected to play a significant role in improving the lives of millions of individuals living with type 1 diabetes.
In summary, the RADIANT trial’s findings underscore the substantial benefits of the Omnipod 5 system for individuals with type 1 diabetes, particularly for those transitioning from MDI. The study’s positive outcomes offer hope for improving blood sugar control, reducing diabetes-related complications, and enhancing the overall quality of life for people living with type 1 diabetes.
About Insulet Corporation:
Insulet Corporation, headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle.
Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, visit Insulet.com or omnipod.com.
