Hybrid Closed Loop System Shows Improved Glycemic Control in T1D


Patients spent 11.2% more time in their target glucose range, and hypoglycemia was reduced from 5.1% to 1.9% overall, and 5.7% to 0.7% overnight.

Trang Ly, MBBS, FRACP, PhD, the senior vice president and medical director at Insulet Corp., sat with MD Mag to talk about the new additions to the Omnipod DASH insulin management system, which were presented in a product theater at the American Diabetes Association's 78th Annual Scientific Session in Orlando, Florida. Data from a clinical trial of the product was also presented at the conference.

That study, of 11 adults aged 18-65 years with type 1 diabetes, took place over a 5-day period in a supervised hotel setting with free-living conditions. The average hemoglobin A1C of the group was 7.4%, with participants administering a mean dose of 0.67 U/kg of insulin daily. Patients meals were unrestricted, and exercise of moderate intensity was performed for 30 minutes daily.

Results were compared to a 7-day open-loop (OL) period of standard therapy—either continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI)—plus continuous glucose monitor (CGM) use at home. They revealed that patients spent 11.2% more time in their target glucose range (defined as 70-180 mg/dL), up to 73.7% from 62.5%. Overnight, patients were in range 13.2% of the time (73.9% compared to 60.7%).

Additionally, hypoglycemia was reduced from 5.1% to 1.9% overall, and 5.7% to 0.7% overnight.

Ly also spoke about the addition of a cloud-to-cloud wireless data sharing capability to the device, as well as a new touch-screen manager for the patient to utilize. She also discussed the importance of thinking about how to eliminate burden for both the patient and the provider.

Trang Ly, MBBS, FRACP, PhD:

Omnipod DASH is our new insulin management system and it's a next-generation platform for our cheapest insulin pump. As a standalone product for our patients, we have the pod, which is the cheapest waterproof insulin pump, that holds 200 units of insulin. It can be worn for 72 hours continuously. That product is the same size and footprint as the product that we have today on the market. We have over 150,000 patients already on our new pod, and that's the feature that they love.

What's new in our product is the Omnipod remote controller—or the PDM, which is our personal diabetes manager—that's now on a sleek touchscreen interface with a vibrant intuitive user interface, and that has all the benefits of mobile technology. It will have wireless connectivity to Insulet’s Cloud, and Bluetooth connectivity as well. That allows us to integrate with other blood glucose meters through Bluetooth syncing, and also allow remote monitoring through our Omnipod display and view apps as well. The Bluetooth and the wireless connectivity enables us to support that whole suite of remote monitoring. It is available in other pumps, in very limited capacity.

Being able to remotely monitor your child's insulin delivery from the ease of your iPhone or smartphone devices brings enormous value to our patients and families, so I would say that those are the key advances with Omnipod DASH.

When we look at innovating in this space, it's about reducing burden for our patient and our clinician as well. In terms of our patients, having the ability to remotely monitor or to even view your insulin data on your personal device so that you don't have to pull out your remote controller or your pump all the time—to be able to see that information together with CGM data on your personal phone allows you to make diabetes a more integrated and seamless part of your day, so that you're not having to constantly think about it all the time. It just makes life a lot easier. And it's not just about that, it's about ease of use for the patient as well as for their families. To have that peace of mind and comfort of being able to know exactly what insulin is being delivered, [and] when, is of enormous benefit.

Then, for our doctors, the really the huge benefit is the cloud-to-cloud integration. Patients don't have to physically upload their pumps to a device that has outdated software, for instance. Clinicians don't have to physically connect it up to a transmitter. The data goes straight up to the cloud and there's cloud-to-cloud integration with Glooko for intellect-provided glucose, so that physicians can see this in their office remotely. That's enormous benefit for our patients and clinicians.

Any technology that helps our patients be more engaged with their therapy is going to lead to better outcomes. CGMs that are easier to use, pumps that are easy to use, that give information will help adoption and adherence, and therefore better engagement in their condition, and better care and outcomes.

Clinicians need to be aware of the newer technologies and applications, digital apps, such as SHARE Follow app and our Omnipod Display View app, that really have a great impact on our families. They need to be aware of those things.

A key difference for our clinician is the fact that Omnipod is available through the pharmacy channel, and so it makes it as easy as writing a prescription for a drug. You can now write one through that channel—that means no prior [authorizations] and no extended wait time that's needed for the current devices today, that need to be accessible through the [durable medical equipment] channel.

Transcript edited for clarity.

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