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

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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 18th 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 (

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