How the Omnipod 5 – The Tubeless Closed-Loop Insulin Pump

Here comes the Omnipod 5! The brand new system, the first tubeless closed-loop insulin delivery system with smartphone control, has been FDA-approved, and is now finding its way to lucky early American customers through a limited market release. It should be widely available in the United States later this year.

The new Omnipod syncs directly with a Dexcom G6 continuous glucose monitor: every five minutes, the Omnipod receives a new blood sugar measurement and adjusts insulin delivery in response.

In theory, the two devices work together to keep your blood sugar in range, with hardly any effort at all, and without the need for a dedicated third device.

We spoke with Eric Benjamin, Insulet’s Senior Vice President of Innovation & Strategy, about the new system.

If there was one feature of the Omnipod 5 that Eric stressed again and again, it was simplicity. Everything about the Omnipod 5 was designed to be as streamlined and simple as possible to reduce effort, stress, and cognitive burden.

“In order for it to have the impact that we wanted it to have on the diabetes community, we designed the system so that it would work for everybody. We wanted everybody to be able to use Omnipod 5, whether they were experienced pumpers or were coming from multiple daily injections [MDI].

“The intent of the design of the Omnipod 5 was to simplify life.”

Adaptive Learning

If the Omnipod 5 works the way it’s intended to—and the pivotal trial that led to FDA approval showed that the vast majority of users stayed in auto mode the vast majority of time—you’ll be able to forget all about basal rates and insulin doses entirely. You just set a blood sugar target (the smartphone app allows you to choose targets from 110 mg/dL to 150 mg/dL), and the system does the rest.

How does it do it? The Omnipod 5 has a machine learning component. It only takes a handful 3-day pod sessions for the system to get up to speed on your basal insulin needs, your insulin-to-carb ratio, and your correction factor.

“We had to have some technology in place that would let the system learn the insulin needs for new users even if they themselves didn’t have a great sense of what their actual insulin needs were. And so in order to achieve that, we created this adaptive learning system that basically learns the patient’s insulin requirements.

“It’s learning how insulin sensitive you are, so that it can tune the automated delivery to the needs of the individual.”

Eric says that the system has worked extremely well for patients with no prior experience with insulin pumps, and therefore no knowledge of usual pump inputs.

“We saw that in the pivotal trial. We saw folks come straight off of injections, who may not have known exactly what traditional pump parameters they should use, and they had a great onboarding experience.”

And the adaptive learning never stops, so users with frequently changing insulin needs (such as growing children and teens) benefit when the system adjusts on the fly.

“We believed throughout design that if folks didn’t know their parameters, or their parameters changed over time, that they would have a great automated insulin delivery experience.”

Food & Exercise

Simplicity also guides the mealtime design functions. Experienced pump users may be used to having an arsenal of techniques to handle unpredictable blood sugar rises, such as square/dual wave or extended boluses. The Omnipod 5 does away with all of that. When you eat a meal, there is exactly one input: “The user only has to enter carbs.”

When you eat, you simply enter the number of carbs you’re about to enjoy, and the system does the rest:

“What’s different is that the SmartBolus calculator will connect to the Dexcom G6 CGM, take both the glucose value and the trend information, and adjust that carb entry on the basis of both of those pieces of information.”

“After that, the system will keep doing what it’s supposed to be doing,” adjusting insulin delivery rates up or down every 5 minutes in response to blood sugar changes. Ideally, a user won’t have to worry about especially tricky foods like pizza or sushi—the system should keep you in range. If you want to learn how much insulin was required, you can find out, but “that kind of information is deliberately not on the homescreen. The user interface is really simple.”

The system only kicks the user out of automatic mode during “exceptional circumstances,” such as low- or high-blood sugar emergencies.

I suggested to Eric that some of our readers, a group uncommonly dedicated to very tight glucose management, might be hesitant to give up the level of detail that they’ve become accustomed to. He responded with an anecdote:

“I had the chance to speak to someone who fits the description of your readers earlier this week. He had recently started using the Omnipod 5. He said to me, “Eric, it’s interesting, I thought I loved all the details, and I actually didn’t appreciate how much time I was spending thinking about all this stuff. I don’t think I’m gonna miss that.’

Exercise is similarly streamlined. No more setting different basal rates for different types of activities. There is one activity mode, and it’s called “activity mode.” It temporarily raises the blood sugar target and tells the system to be less aggressive in dosing insulin.

“If you’re going to do an activity, the only thing you tell the system is how long you’re going to do it. There’s no more tweaking than that.”

A Few Details

Now that the Omnipod 5 has been approved, it’s been released to a small list of consumers in a limited number of markets. While Insulet is confident in their tech, they want to test their capability to roll out the product on a massive scale, and are gearing up their distribution, insurance support, and service experience. Eric couldn’t give me an estimate of when the device will be fully available, and could only promise that “we know there are lots of people waiting and we can’t wait to get it to them.”

When it is available, patients will fill their Omnipod 5 prescriptions through the pharmacy, not a durable medical equipment supplier.

The Omnipod 5 is currently indicated for patients with type 1 diabetes ages six and up, but Insulet expects that it will eventually be approved for smaller children and for people with insulin-dependent type 2 diabetes.

At the moment, the Omnipod 5 can only work with Android smartphones; iPhone users can still use the system, but need to use the dedicated controller to set blood sugar targets and input carb counts. A fully functional iPhone app is in the works.

Today, the Omnipod 5 requires Dexcgom G6 CGM to work (and it should be compatible with the G7 when it’s released). It’s not an exclusive partnership; Eric stressed to me that Insulet is committed to consumer choice, and that it is currently collaborating with Abbott to sync the Omnipod up with the Freestyle line of continuous glucose monitors.

Omnipod 5 users can still make use of the Dexcom G6 features they’re used to, like low blood sugar alarms, but the idea is that it should only be necessary to use the Dexcom app when starting a new sensor session. “We didn’t want users to interact with the system any more than they had to.”

The system is designed to work even when there are technological hiccups. If you have to switch CGM sensors, or lose connectivity for some reason, the Omnipod will continue to secrete insulin. If you forget your phone, the CGM and the Omnipod can still communicate to keep you in range.

Takeaways

Expect the Omnipod 5 to be very popular. People with diabetes already love the Omnipod insulin pump, the only tubeless pump on the market. When we surveyed our community on the best insulin pumps, the Omnipod DASH was the top choice of many readers, even above pumps that do offer automatic insulin control, such as the Tandem t:slim X2 and the Medtronic 770G.

Some of our readers already use the Omnipod in a closed-loop system, which requires them to follow the principles of do-it-yourself looping. But we know that most of our readers are not anxious to take that plunge.

As the first tubeless pump on a closed-loop system, the Omnipod 5 arguably represents a big step forward to the dream of an artificial pancreas, a device that could take care of all of your diabetes management for you. It’s not quite there—you still need to count carbs and type them into the app—but it’s light years ahead of what was available only recently.

Eric says, “It’s the killer app, it’s the thing that everybody wants.”

“We believe that most people don’t want to spend all their thinking about their diabetes. We want to build products that let people choose to do other things, and to simplify their lives to the greatest extent that they possibly can.”



Post Views:
5

Read more about Abbott, Android, closed loop, closed-loop system, Dexcom, exercise, freestyle, Insulet, insulin, insulin pump, insulin pumps, Intensive management, iOS, iPhone, low blood sugar (hypoglycemia), Medtronic, Omnipod, Tandem, type 1 diabetes, U.S. Food & Drug Administration (FDA).

Author: Mabel Freeman