Insulet Corporation (PODD) the Omnipod ® brand, with tubeless insulin pump technology, released new Omnipod 5 clinical findings from its RADIANa T research. The findings of this international randomized controlled study were shared online and at the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Amsterdam, the Netherlands.
In addition to being the first to examine the safety and effectiveness of an automated insulin delivery (AID) system in conjunction with an Abbott FreeStyle Libre® 2 family sensor, the RADIANT study is the first randomized controlled trial to examine the direct switch from multiple daily injections (MDI) to an AID system in adults and children with type 1 diabetes. When compared to MDI utilized with a continuous glucose monitor (CGM), the study discovered that Insulet’s Omnipod 5 AID System produced clinically significant improvements in HbA1c for both adults and children who had not previously met clinical targets for HbA1c on MDI.
Despite advancements in diabetes technology, MDI remains the most common treatment choice for type 1 diabetes, which is thought to be responsible for the average loss of 35 years of healthy life per person worldwide. With average HbA1c levels of 8.7% recorded, data from the United States indicates that many people taking MDI plus CGM are not reaching the recommended target of HbA1c levels less than 7%. 3 A higher HbA1c is linked to an increased risk of diabetes-related complications.
All 188 participants in the RADIANT study, who were between the ages of 4 and 70, had type 1 diabetes with HbA1c levels between 7.5% and 11%. They had all been using MDI with a CGM for at least three months before. The Omnipod 5 AID System (N=125) or standard MDI plus CGM therapy (N=63) was administered to the participants, who were recruited at 19 clinical sites in France, the United Kingdom, and Belgium. The participants were randomized to start the Omnipod.
The average HbA1c level of the participants was 8.1% at the start. In comparison to those using MDI plus CGM, individuals who used the Omnipod 5 System saw an average improvement in their HbA1c of 0.8% after three months, resulting in a final HbA1c of 7.2%. The impact was considerably larger for those who started with a HbA1c level above 8.0%, improving by 1.0% when compared to MDI with CGM. This level of HbA1c reduction can reduce the chance of future diabetes complications, including kidney illness, eye issues, and cardiovascular disease.
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.
Dr. Trang Ly
Compared to MDI + CGM users, Omnipod 5 users improved their HbA1c and spent an extra 5.4 hours a day with glucose levels in the target range (70-180 mg/dL). This resulted in a final average time in range of 65%, up from 39% at baseline. Alongside this, there was no increase in the amount of time spent with dangerously low glucose levels (<70 mg/dL or <54 mg/dL) and a significant decrease in the amount of time spent with high glucose levels (>180 mg/dL and >300 mg/dL) throughout the day. Over the course of the three-month research, neither treatment group experienced any potentially fatal acute episodes involving severe hypoglycemia or diabetes-related ketoacidosis.
The RADIANT population was a cohort of individuals who, despite multiple daily injections and CGM, were not achieving target HbA1c levels. 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.
Dr. Emma G. Wilmot
Also Read: Eli Lilly Launches Their Blockbuster Weight-loss and Diabetes Drug Mounjaro in India
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.
Professor Hélène Hanaire
Source: Insulet
Last Modified:
