Insulet's RADIANT Trial Results Highlight Significant Glycemic Benefits From Omnipod 5 Transition

(RTTNews) - The RADIANT trial conducted by Insulet Corp. (PODD) highlighted significant glycemic improvements with the use of the Omnipod 5 Automated Insulin Delivery System. These improvements were observed following a direct transition from multiple daily injections.

The company said 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 multiple daily injections, Insulet's Omnipod 5 AID System provided clinically significant improvements in HbA1c compared with multiple daily injections used with a continuous glucose monitor (CGM).

Data from the U.S. show that many using multiple daily injections plus continuous glucose monitor are not meeting the recommended goal of HbA1c levels less than 7%, with average HbA1c levels of 8.7% reported. Increased HbA1c is associated with a greater risk of developing complications related to diabetes.

The company noted that Participants in the RADIANT study 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 multiple daily injections plus continuous glucose monitor, 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.

In addition to improving their HbA1c, Omnipod 5 users spent an additional 5.4 hours per day with glucose levels in the target range 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, and no increase in time spent with dangerously low glucose. There were no life-threatening acute events involving severe hypoglycemia or diabetes-related ketoacidosis in either treatment group during the three-month study.

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