Investigators shared data from the RADIANT study at the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Amsterdam. The randomized controlled trial evaluated the direct transition from MDI to automated insulin delivery (AID). Insulet says it marks the first study to do so — and is the first to assess the safety and efficacy of an AID system paired with the Abbott FreeStyle Libre 2 family sensor.
The study evaluated adults and children with type 1 diabetes not previously meeting clinical targets for HbA1c on MDI. It observed clinically significant improvements in HbA1c compared to MDI used with a CGM.
“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, Insulet SVP and chief medical officer.
Details from the Insulet RADIANT study
RADIANT included 188 people aged four to 70 years old with type 1 diabetes. They presented HbA1c levels of between 7.5% and 11%. All subjects used MDI with a CGM for at least three months prior. The study recruited at 19 clinical centers in France, the UK and Belgium. It randomized subjects to Omnipod 5 therapy (125 people) or continued MDI plus CGM (63) for three months.
Participants began with an average HbA1c level of 8.1%. After three months, people who used Omnipod 5 improved HbA1c by an average of 0.8% compared to those using MDI plus CGM. For those with an HbA1c level above 8%, the benefit proved even greater, with a 1% improvement compared to MDI plus CGM.
In addition to improving HbA1c, Omnipod 5 users spent an additional 5.4 hours per day in target glucose range compared to MDI. This resulted in a final time in range of 65%, up from 39% at baseline. The study also showed less time per day with high glucose levels and no increase in time spent with dangerously low glucose.
Insulet reported no life-threatening acute events involving severe hypoglycemia or diabetes-related ketoacidosis in either treatment group during the three-month 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.
