COMMENTARY

The Omnipod 5 System: Trial Results From ENDO 2021

Anne L. Peters, MD

Disclosures

April 02, 2021

This transcript has been edited for clarity.

I was incredibly excited to see the results of the Omnipod 5, also known as the Horizon, trial at the Endocrine Society meeting. Many of my patients and I have been waiting for this technology to become available. It's not yet approved by the US Food and Drug Administration (FDA), but at least we have the trial results.

So what is the Omnipod 5 system? There are three components: the Omnipod tubeless insulin pump, the Dexcom G6 continuous glucose monitor (CGM), and the Omnipod control algorithm. This system can be completely controlled from an individual's smartphone, but it has to be an Android phone. If someone doesn't have an Android phone, then they're given a locked Android phone for the purpose of controlling this system.

Basically, it's a hybrid closed-loop system. But the key here is that it uses the Omnipod, so patients don't have to use a tethered pump. This is a different system.

What I really like about it is that unlike other systems that are similar, it has customizable targets so people can change the targets between 110 and 150 mg/dL. So, if you have a patient whose glucose levels is higher coming into this, you may not want to use such a low target as 120 or 110 mg/dL. But for patients whose levels already are well-controlled, you may opt for that lower target. It gives flexibility to targets. It has a temporary glucose target mode where it raises the target to 150 mg/dL, and there's restricted insulin delivery. So that's good for situations such as exercise or others where people don't want as much insulin delivered.

And finally, the bolus calculator uses CGM values, which is what the other systems do, but it also looks at the trends. It looks at whether the glucose levels are going up and down and then adjusts accordingly.

Trial Results From ENDO

Three trials were presented [at ENDO 2021]. The first trial was in 128 adults and adolescents, and the data were presented by Dr Sue Brown. This was a 3-month, single-arm study, so patients were compared with their historical controls. The A1c fell from 7.2% to 6.8%, which was statistically significant. These are obviously well-controlled patients coming into this, but they were able to reach their target of < 7% in many cases. The time in range started at 65%, which again is pretty darn good, and rose to 74%, with the highest time in range achieved at night.

And that's what these hybrid closed-loop systems basically do. In addition to what they do in the day, they do the nights really well. They are able to smooth out people's nights and keep them in the target range much more effectively than when they're eating and going about their life during the day. There was also a significant reduction in the time spent low, and two thirds of the patients on the system had an A1c < 7%.

Bruce Buckingham presented the data from the Omnipod 5 pivotal trial in 113 children. Again, this was a 3-month, single-arm study. These kids had a higher A1c going in (7.7%), and their A1c fell on average to 7%. Time in range increased from 52% to 68%, and the kids did well. This seemed to be very well accepted in that population.

The final data were presented by Dr Bruce Bode. He presented data from a clinical trial using the Omnipod 5 system in people with type 2 diabetes. These are individuals who are either on basal insulin or multiple daily injections, with an A1c > 8.5%. These are patients who we really want to get under better glycemic control. The study is meant to look at whether providing them with a system that can do adjustments in terms of their basal rates and help them with premeal boluses can make a significant difference in their glycemic control. I'm one of the investigators on this study, and I'm really enjoying the process of doing the study. Hopefully, it will turn out that we can help these patients as well.

I'm very much looking forward to the FDA approval of the Omnipod 5 system, and I look forward to using it in my patients in the future. Thank you very much.

Anne L. Peters, MD, is a professor of medicine at the University of Southern California (USC) Keck School of Medicine and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts, and three books, on diabetes, and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations.

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