Insulet's Omnipod 5 Shows Promising Results in Type 1 Diabetes Study

Insulet Corporation has announced positive results from its RADIANT study, demonstrating significant improvements in glucose control for Type 1 diabetes patients transitioning from multiple daily injections (MDI) to the company's automated insulin delivery system, Omnipod 5.

Study Outcomes and Clinical Significance

The randomized controlled trial, which included 188 participants aged 4 to 70 across France, the UK, and Belgium, showed marked improvements in key diabetes management metrics. After three months of using the Omnipod 5 system:

• Participants experienced an average decrease in HbA1c levels of 0.8 percentage points from a baseline of 8.1%.
• Time in range increased by 5.4 hours per day, reaching a daily average of 65% compared to 39% at the study's outset.
• Patients with initial HbA1c levels above 8% saw even greater improvements, with an average reduction of 1 percentage point.

Dr. Hélène Hanaire, study investigator and professor at the University Hospital of Toulouse, emphasized the ease of implementation and encouraging results, stating, "The RADIANT experience showed us that it was easy to implement in pump naïve patients, with very good results."

Technical Details and System Integration

The Omnipod 5 system, described as a tubeless automated insulin delivery system, was paired with Abbott's Freestyle Libre 2 continuous glucose monitor for the study. This combination represents a significant advancement in diabetes management technology, offering an alternative to traditional multiple daily injections.

Dr. Trang Ly, Insulet's chief medical officer, highlighted the study's importance, saying, "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."

Global Expansion and Market Developments

Concurrent with the study results, Insulet announced plans to expand the Omnipod 5's commercial reach to several new international markets:

• Australia, Belgium, Canada, and Switzerland are slated for upcoming launches.
• The system will be compatible with CGMs including Dexcom's G6 and G7, as well as Abbott's FreeStyle Libre 2 Plus.
• Recent launches have occurred in Italy, Denmark, Finland, Norway, and Sweden.
• Future debuts are planned for Israel, Saudi Arabia, the United Arab Emirates, Qatar, and Kuwait.

To support this expansion and manage existing financial obligations, Insulet has proposed a $450 million offering and modifications to its revolving credit facility.