Insulet’s RADIANT Trial Demonstrates Meaningful Glycemic Improvements with the Omnipod® 5 Automated Insulin Delivery System Following Direct Transition from Multiple Daily Injections

Rhea-AI Summary

Insulet (NASDAQ: PODD) announced significant results from its RADIANT study of the Omnipod 5 Automated Insulin Delivery System. The multinational randomized controlled trial evaluated direct transition from multiple daily injections (MDI) to automated insulin delivery in type 1 diabetes patients.

Key findings from the 188-participant study showed:

• Average HbA1c reduction of -0.8% compared to MDI with continuous glucose monitor
• Additional 5.4 hours per day with glucose levels in target range (70-180mg/dL)
• Final average time in range improved to 65% from 39% baseline
• No life-threatening events or severe hypoglycemia reported

The study, conducted across 19 clinical centers in France, UK, and Belgium, included participants aged 4-70 years with HbA1c levels of 7.5% to 11%. Patients using Omnipod 5 with initial HbA1c above 8.0% showed even greater improvement of 1.0% compared to MDI plus CGM.

Positive

• Significant HbA1c improvement of -0.8% compared to MDI users
• Increased time in target glucose range by 5.4 hours per day
• Strong safety profile with no severe adverse events
• Greater benefit (1.0% improvement) for patients with HbA1c above 8.0%
• Successfully expanded to 11 countries with 365,000 users worldwide

Negative

• None.

Insights

Medical Technology Analyst

Insulet's RADIANT trial results represent a significant clinical milestone for the company's Omnipod 5 Automated Insulin Delivery System. The trial demonstrated an average 0.8% reduction in HbA1c compared to patients continuing with multiple daily injections (MDI) plus CGM, with even greater benefits (1.0% improvement) for patients starting with HbA1c above 8.0%.

The most compelling aspect of these results is the dramatic increase in time-in-range, with patients gaining an additional 5.4 hours daily in the target glucose range (70-180mg/dL) without increased hypoglycemia risk. This improvement from 39% to 65% time-in-range represents a transformative quality-of-life enhancement for patients.

What makes this trial particularly noteworthy is its pioneering design - the first randomized controlled trial examining direct transition from injections to automated insulin delivery, eliminating the traditional intermediate step of manual pump therapy. This streamlined adoption pathway significantly expands Insulet's addressable market by removing a key barrier to adoption for the estimated 5.2 million type 1 diabetics in Insulet's global markets.

The integration with Abbott's FreeStyle Libre 2 sensors also represents the first validated AID system with this particular CGM technology, potentially broadening the ecosystem compatibility of Omnipod 5 beyond previous studies that utilized Dexcom sensors.

Healthcare Market Strategist

The RADIANT trial results create meaningful competitive differentiation for Insulet in the increasingly crowded automated insulin delivery market. With MDI remaining the dominant therapy approach despite technological advances, Insulet is strategically targeting the largest segment of potential pump adopters - those currently using injections who haven't met clinical targets despite CGM use.

The multinational nature of this study (conducted across France, UK, and Belgium) aligns with Insulet's global commercialization strategy, where Omnipod 5 is currently available in the US and 10 international markets. The company's disclosure of 365,000 current users worldwide provides a valuable baseline against which to measure future adoption growth.

Insulet's tubeless design appears to be a critical differentiator for injection users hesitant to adopt traditional pumps with tubing. The demonstrated ability to successfully transition these patients directly to automated delivery without an interim step of manual pumping significantly reduces the adoption friction and training requirements.

The magnitude of clinical improvement (0.8% HbA1c reduction, 5.4 additional hours in range) is substantial enough to potentially influence treatment guidelines and payer decisions. The study population's baseline characteristics (HbA1c 7.5-11% despite CGM use) represent a substantial subgroup of patients who could immediately benefit from this technology.

Omnipod 5's performance in this challenging patient population strengthens Insulet's value proposition to both clinicians and payers by demonstrating improved outcomes for previously suboptimally controlled patients while potentially reducing long-term complications associated with sustained elevated glucose levels.

• First randomized controlled trial to evaluate direct transition from multiple daily injections to automated insulin delivery in adults and children with type 1 diabetes who were not meeting glycemic targets with injections
• People using Omnipod 5 had significantly improved HbA1c levels (average reduction of -0.8%) compared with those using multiple daily injections with a continuous glucose monitor at the end of the three-month study period
• Omnipod 5 was also linked to dramatic improvements in glucose with people spending an average of +5.4 hours more per day with glucose levels in the target range without an increase in hypoglycemia

ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod^® brand of products, today shared new Omnipod 5 clinical data from its RADIANT study. Results from this multinational randomized controlled trial were presented at the 18^th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Amsterdam, the Netherlands, and online.

The RADIANT study is the first randomized controlled trial to evaluate the direct transition from multiple daily injections (MDI) to an automated insulin delivery (AID) system in adults and children with type 1 diabetes, as well as being the first to assess the safety and efficacy of an AID system paired with an Abbott FreeStyle Libre^® 2 family sensor. The study found that for adults and children not previously meeting clinical targets for HbA1c on MDI, Insulet’s Omnipod 5 AID System provided clinically significant improvements in HbA1c compared with MDI used with a continuous glucose monitor (CGM).

Despite advances in diabetes technology, MDI is the predominant therapy option for type 1 diabetes¹, and it is estimated that 35 years of healthy life are being lost on average per person globally due to this condition². Data from the U.S. show that many using MDI plus CGM are not meeting the recommended goal of HbA1c levels less than 7%, with average HbA1c levels of 8.7% reported.³ Increased HbA1c is associated with a greater risk of developing complications related to diabetes.⁴

The RADIANT study included 188 people aged 4 to 70 years with type 1 diabetes and HbA1c levels of 7.5% to 11%, all of whom were using MDI with a CGM for at least three months prior. Participants, recruited at 19 clinical centers in France, the U.K., and Belgium, were randomized to initiate the Omnipod 5 AID System (N=125) or to continue with their usual MDI plus CGM therapy (N=63) for three months.

Participants began with an average HbA1c level of 8.1%. After three months, people who used the Omnipod 5 System improved their HbA1c by an average of 0.8% compared with those using MDI plus CGM, resulting in a final HbA1c of 7.2%. For those beginning with an HbA1c level above 8.0% the benefit was even greater, with an improvement of 1.0% compared with MDI plus CGM. Lowering HbA1c by this amount can decrease the risk of developing diabetes complications in the future, such as cardiovascular disease, kidney disease, and eye problems.⁴

“Omnipod 5 is changing the lives of an estimated 365,000 users worldwide by eliminating the need for injections and reducing the burden of diabetes. Results from this randomized controlled trial build on our previous studies and once again clearly demonstrate the significant therapeutic benefits for people who require insulin to live and switch from injections to Omnipod 5,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Chief Medical Officer.

In addition to improving their HbA1c, Omnipod 5 users spent an additional 5.4 hours per day with glucose levels in the target range (70-180mg/dL) compared with MDI plus CGM users, resulting in a final average time in range of 65%, up from 39% at baseline. This was accompanied by significantly less time per day with high glucose levels (>180mg/dL and >300mg/dL), and no increase in time spent with dangerously low glucose (<70mg/dL or <54mg/dL). There were no life-threatening acute events involving severe hypoglycemia or diabetes-related ketoacidosis in either treatment group during the three-month study.

“The RADIANT population was a cohort of individuals who, despite multiple daily injections and CGM, were not achieving target HbA1c levels. These participants, many of whom were waiting for a tubeless AID option, were able to safely transition directly from MDI to Omnipod 5 and achieve significant improvements in glucose levels,” said Dr. Emma G. Wilmot, Associate Professor at the University of Nottingham, Honorary Consultant Diabetologist in Derby and founder of the Diabetes Technology Network U.K. Dr. Wilmot served as a Chief Investigator for the RADIANT study.

“Omnipod 5 has proved clinical efficacy in people living with type 1 diabetes. The RADIANT experience showed us that it was easy to implement in pump naïve patients, with very good results. It encourages us to pursue a direct switch from multiple daily injections to automated insulin delivery so patients can immediately receive the clear benefits, without a long period of manual pump treatment,” said Professor Hélène Hanaire, head of the Department of Diabetology, Metabolic Diseases and Nutrition of the University Hospital of Toulouse, France and an investigator for the RADIANT study.

Approximately 5.2 million people live with type 1 diabetes in the 25 countries Insulet currently serves globally.⁵ That includes the U. S. and 10 countries outside the U.S. where Omnipod 5 is commercially available today. RADIANT results will be submitted for publication later this year.

1. 2024. Data on file. Seagrove Partners LLC.
2. Type 1 Diabetes Index. https://www.t1dindex.org Accessed February 11, 2025
3. Gandhi et al. T1D Exchange Quality Improvement Collaborative; Insulin Pump Utilization in 2017–2021 for More Than 22,000 Children and Adults With Type 1 Diabetes: A Multicenter Observational Study. Clin Diabetes 15 January 2024; 42 (1): 56–64. https://doi.org/10.2337/cd23-0055.
4. DCCT Research Group; The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. NEJM 30 September 1993; 329 (14): 977-86. https://doi.org/10.1056/nejm199309303291401
5. Insulet data on file, January 2025

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), 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.

©2025 Insulet Corporation. Omnipod is a registered trademark of Insulet Corporation. All rights reserved. The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission.

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Investor Relations:

June Lazaroff

Senior Director, Investor Relations

(978) 600-7718

jlazaroff@insulet.com

Media:

Angela Geryak Wiczek

Senior Director, Corporate Communications

(978) 932-0611

awiczek@insulet.com

Source: Insulet Corporation

FAQ

What were the main results of Insulet's RADIANT trial for Omnipod 5 (PODD)?

The trial showed an average HbA1c reduction of 0.8% compared to MDI users, with patients spending 5.4 more hours daily in target glucose range, achieving 65% time in range.

How many patients participated in the RADIANT study for Omnipod 5 (PODD)?

188 participants aged 4-70 years with type 1 diabetes and HbA1c levels of 7.5% to 11% participated in the study across 19 clinical centers.

What safety outcomes were reported in the Omnipod 5 RADIANT trial (PODD)?

No life-threatening acute events, severe hypoglycemia, or diabetes-related ketoacidosis were reported in either treatment group during the three-month study.

How many countries currently have access to Insulet's Omnipod 5 (PODD)?

Omnipod 5 is commercially available in the U.S. and 10 other countries, serving markets with approximately 5.2 million type 1 diabetes patients.