Omnipod 5 Automated Insulin Delivery System Approval 'Exciting'

This transcript has been edited for clarity.

The Omnipod 5 automated insulin delivery system is finally FDA approved. I've done a video on Omnipod 5 outcomes. To refresh your memory, it is an automated insulin delivery system that uses the Omnipod pump plus the Dexcom to deliver insulin in an automated fashion.

In the pivotal study for this system, they found an improvement in A1c levels, an improvement in time in range from 65% to 74%, and a reduction in the time below range in people — both children and adults — with type 1 diabetes. Now we have it available for general use. Well, we will soon.

To refresh your memory about the pieces of the system, it starts with the Omnipod pod (which is filled with insulin) which the individual places on their body. Additionally, the individual uses the Dexcom G6, which is used just like the regular Dexcom G6 system, but now it communicates with the pod, and the pod in this system is where the algorithm lives.

These two now talk to each other in order to deliver the basal rates of insulin. The pod is able to give insulin based on the Dexcom readings, and it adjusts how much insulin it gives based on whether the Dexcom readings are going up, staying flat, or going down.

The system is controlled by the controller, which is either this locked Android phone or an individual's Android phone. It allows for the person to set up the system and then give bolus doses for meals and corrections as necessary. They're working on having this available on an Apple phone as well. It's the first system that allows for a patient to use their own phone to control what's happening with the pump.

One of the most important things for us as clinicians to realize is that each one of these automated insulin delivery systems works differently. I was able to do a research study using the Omnipod 5 system, and it took me a while to get the hang of it. You change different things here than you change in, say, the Tandem Control-IQ system or the Medtronic 670G system.

First, it has five different algorithm basal targets so a person can set it to a target of 110, 120, 130, 140, or 150. I was chicken at first because I didn't know quite how this system worked, so I tended to start people off at a target of around 130. You can also set different targets for the correction doses, so that's also adjustable, and you can adjust the active insulin time. The only things you really can't adjust are the basal rates because they're determined through the algorithm with this system.

The system does not give autocorrect boluses, but as I said, it adjusts the basal rate based on the rising and falling of the person's glucose levels. It also adjusts the recommended doses for carbs and correction based on the CGM trends. The automated basal insulin delivery is calculated from the total daily insulin given since the last pod change, which is the prior 3 days, and this is called an adaptive basal.

It has a mode called hypocorrect, which raises the target to 150, and this is what our patients are likely to use when they exercise and need a higher target.

It's going to launch through pharmacies as a pharmacy benefit, and as I said, it works directly either through an Android phone or the Omnipod 5 controller. Unfortunately, at the moment, it is not available in Spanish, but they're working on that and hopefully will have it out soon.

It's planned to start with a limited launch that will be followed by a general launch. Remember, it's very important to provide patients with initial training. I think it's pretty simple and intuitive to follow the steps that they give you on the controller, but still, education is key for any of this to work.

For providers, we need to put in the initial settings for the system, and it takes some time of watching patients on the system to understand what we can and can't adjust in order to help patients reach their target.

I'm really excited to finally have this on the market and I can't wait to start using it in my patients.

Thank you. This is Dr Anne Peters for Medscape.

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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