Omnipod 5 System Leads to Significant Glycemic Improvements After Direct Transition from MDI Insulin with CGM
Mean reduction in HbA1c was nearly 1% after transition from MDI plus CGM to Omnipod 5 in the first randomized trial to evaluate the shift in mode of insulin delivery.
The first randomized controlled trial evaluating direct transition from multiple daily injections (MDI) to automated insulin delivery (AID) has demonstrated that Insulet's Omnipod 5 System significantly improves glycemic control in children and adults with type 1 diabetes not previously meeting clinical targets, according to an Insulet news release.1
The RADIANT study showed that participants using Omnipod 5 achieved an average HbA1c reduction of 0.8% compared to those continuing MDI with continuous glucose monitoring (CGM) over 3 months. For participants with baseline HbA1c levels above 8.0%, the improvement after transition was even more pronounced at 1.0% compared to the control group, the company reported.1
Most notably, participants in the group using the Omnipod 5 System spent an additional 5.4 hours per day with glucose levels in target range (70 to 180mg/dL) without experiencing increased hypoglycemia. The greater time in range reflected a rise from a baseline of 39% to 65% in the Omnipod 5 group.
The findings were presented at the 18th International Conference on Advanced Technologies & Treatments for Diabetes.
RADIANT Outcomes
The RADIANT trial enrolled 188 participants aged 4 to 70 years with type 1 diabetes and suboptimal glycemic control (HbA1c 7.5-11%). Of the group, more than half (58%) were aged 4 to 17 years. All participants had been using MDI with CGM for at least 3 months before the study. The multinational trial was conducted across 19 clinical centers in France, the United Kingdom, and Belgium.1
Participants were randomly assigned to either initiate the Omnipod 5 AID System (n = 125) or continue their usual MDI plus CGM therapy (n = 63) for 3 months. The average baseline HbA1c was 8.1% across both groups.
After the 3-month intervention period, participants in the Omnipod 5 group achieved a final mean HbA1c of 7.2%, representing a 0.8% reduction compared to the control group. The study also documented significant reductions in time spent with hyperglycemia (greater than 180 mg/dL and less than 300 mg/dL) without any increase in hypoglycemic events.1
"The RADIANT population was a cohort of individuals who, despite multiple daily injections and CGM, were not achieving target HbA1c levels," Emma G. Wilmot, MB ChB, BSc (hons), PhD, associate professor at the University of Nottingham, founder of the Diabetes Technology Network UK, and chief investigator for the RADIANT study, said in the press release. "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."1
Estimates are that type 1 diabetes is responsible for approximately 35 years of healthy life lost on average per person globally.2 In the US, MDI continues to be the therapy option for most people with the disease even though there have been significant advances in technology. Moreover, many using MDI plus CGM still do not meet the guideline-recommended goal of HbA1c less than 7%, with mean levels nearly 2% higher, at 8.7%.3
"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," Hélène Hanaire, MD, from the University Hospital of Toulouse, an investigator in the study, said. "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."1
The Omnipod 5 System is currently commercially available in the United States and 10 other countries. The RADIANT study is also notable for being the first to assess the safety and efficacy of an AID system paired with the Abbott FreeStyle Libre 2 family sensor.
According to Insulet, complete results from the RADIANT trial are expected to be published later this year.
