Omnipod 5 system

[podcast src=”https://html5-player.libsyn.com/embed/episode/id/21989750/height/90/theme/custom/thumbnail/yes/direction/forward/render-playlist/no/custom-color/3e9ccc/” width=”100%” scrolling=”no” class=”podcast-class” frameborder=”0″ placement=”top” primary_content_url=”http://traffic.libsyn.com/diabetesconnections/Ep_449_Final_Omnipod_5_approved_Ly.mp3″ libsyn_item_id=”21989750″ height=”90″ theme=”custom” custom_color=”3e9ccc” player_use_thumbnail=”use_thumbnail” use_download_link=”use_download_link” download_link_text=”Download” /]The US FDA has approved Insulet’s Omnipod 5 Automated Insulin Delivery System. This system was submitted more than a year ago but has been delayed due to COVID 19. Stacey talks to Dr. Trang Ly, Senior Vice President & Medical Director at Insulet Corporation who explains what makes this system different from the other AID systems on the market, what phone control means, what the roll out will look like, insurance issues, Medicare and more.

Omnipod 5 FAQs from Insulet 

DiabetesMine’s write up of Omnipod 5

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

 

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Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921 Where Diabetes Connections are made.
This is Diabetes Connections with Stacey Simms.
This week, the US FDA approves Insulet’s Omnipod 5 automated insulin delivery system. This was submitted more than a year ago but has been delayed due to COVID 19. Let’s hope this approval signals at least the beginning of the end of that logjam at the FDA.
Welcome to another week of the show. I am always so glad to have you here I am your host, Stacey Simms, and we aim to educate and inspire about diabetes with a focus on people who use insulin. If you are new to the show, my son was diagnosed with type one right before he turned two back in 2006. He is now 17. My husband lives with type two diabetes. I do not have any kind of diabetes. I have background in broadcasting. And that is how you get the podcast. And for this episode, I am so excited to speak to Dr. Trang Ly, Senior Vice President and medical director at Insulet Corporation. Insulet, of course, makers of the Omnipod. I asked for questions within our Facebook group. It’s Diabetes Connections, the group and boy to do come through. But because Dr. Ly is part of the medical side of Insulet, I’m sure you understand there are some questions she just can’t answer she it’s not her realm of expertise. But I promise we will follow up in the weeks and months to come. And I will do a deep dive into what is such a huge story for our community. I am always so excited to see more choice for people with diabetes and automated insulin delivery is a game changer.
Let’s go through the basics. Because while many of you just want to get to “when can I get this in my hands. And I’ve used this product for years. And it’s basic forms, I just want to get the loop..” Let me just take a quick second and set the table because there are a lot of people new to pumping and to pods. And I just want to be absolutely clear. And this is going to be very simplistic Dr. Ly we’ll get into many more details. But the pod is what sits on the body. That’s what holds the insulin and infuses the insulin into the body. There are no buttons, there’s no display, there is a separate handheld controller. This could be a phone, we will talk about that. And that is how you control the pod when it comes to giving insulin for meals, you still must give insulin for meals with this system. With Omnipod 5, you also have the Dexcom G6 that is the continuous glucose monitor. The pod and the CGM work together, it very simplistically gives you more or less insulin to try to keep you in range.
There are similar systems on the market already. The Medtronic 670 was the first like this in the United States. Now they have their 770 G system. Tandem has the control IQ system. For the record. That is what my son has used since January of 2020. And Omnipod system is a little different on these systems all have differences from one another. But as you’ll hear the Omnipod system is the first in the US that will actually learn from you. And we’ll talk about what that means Omnipod 5 is going to launch through the pharmacy channel just like previous products and will still have no contract. And they are offering what they’re calling a limited market release. So this is not going to be available tomorrow to most people Insulet has a Frequently Asked Questions section on their website that I got to say it is one of the most robust I have ever seen in my 15 years of diabetes. So please go there. If you don’t hear your question answered by Dr. Ly. I’m going to link it up at diabetes connections.com There will be a link in the show notes.
And as I said, we’re going to be covering this a lot more this year. And make sure you tune in every week I do a short newscast episode. We do that every Wednesday live at 430 on Facebook and YouTube. And then I turn that into an audio podcast which comes out on Friday. Those are five or six minutes long, and I’m sure we’re gonna have Omnipod updates there. Okay, usual disclaimer, this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Dr. Trang Ly, welcome back. And congratulations.

Dr. Trang Ly 4:28
Thank you, Stacey. I’m super excited to be here with you.

Stacey Simms 4:31
I feel like we should have a confetti cannon that started this episode.

Dr. Trang Ly 4:36
Just Oh, it’s been incredible few days.

Stacey Simms 4:39
I’d like to talk a little bit later, perhaps about more of your personal feelings. You’ve been involved in this for so long. And when we spoke in August, you were really generous about sharing some more of your experiences, but I know everyone who’s listening wants to get into the nuts and bolts. So let’s start by just jumping right in. Tell me what was approved by the US FDA. Let’s talk about what Omnipod five is.

Dr. Trang Ly 5:02
Yeah, so Omnipod five is our tubeless automated insulin delivery system that we’ve been working on for quite some time, and that the whole entire community is excited about. I’ll talk about it in terms of the components of the system. So we have the tubeless pod that many people will know and love today. And that essentially stays the same that has added features. So it has the smart adjust technology, which is our algorithm inside the pod, and that delivers insulin every five minutes and can increase decrease or pause insulin delivery based upon the CGM value, so the sensor glucose value, so we are connected to a very important part of the system, which is the Dexcom G6 sensor, great sensor accurate. And that is connected wirelessly to the pod, the person wears the pod and the CGM. And they can have on body closed loop control. Another key component is our controller device. So every person who is prescribed Omnipod 5 will have access to our Insulet provided controller, which is basically the remote controller for the system. And on that is our Omnipod 5 app, where they’re able to control their pod and do all their settings for the algorithm. And what is really quite unique about what got cleared and announced on Friday is that patients will also have the option to control their pods from compatible smartphones. And so that is really quite a unique advancement in technology in diabetes, for automated insulin delivery systems. You don’t have to use the smartphone to control the pods, but that optionality is there for compatible smartphones. So that would in certain cases, replace the need to carry the Insulet provided controller?

Stacey Simms 7:13
Yeah, we’ll definitely talk about the smartphone aspect. As you said, this is a first in many ways. So I want to talk about that in more detail a little bit later on. And another component of the system then is the Dexcom G6.

Dr. Trang Ly 7:25
That’s right. And I think what is unique about this is that you’ll be able to control the G6 from the G6 app. So all of that start stop sensor, all the calibration, all of that, and the Dexcom follow all that functionality that people are familiar with today stays the same in the Omnipod 5 system.

Stacey Simms 7:49
Okay, we know I needed to clear that up. Because you started off by saying you control it from the G6 app, do you control it from the Omnipod 5 app?

Dr. Trang Ly 7:56
No, you actually control it from the G6. Yeah, that is slightly different to other systems that are on the market, the G6 sensor is stopped and stopped through the G6 app. And then you have the functionality of the Dexcom follow with our system with Omnipod. Five, when you set it up, you enter in the transmitter ID for the Dexcom. And what that allows the Omnipod 5 system to do is connect to that transmitter and display that information front and center of the Omnipod 5 system.

Stacey Simms 8:37
You know, it’s funny, I’m sure as we’re talking, we’re gonna get into a lot of the weeds here because they went straight into the weeds. And I know that we’ll talk a lot more as this year goes on. And there’s more and more people use the system. But I do want to kind of try to stick to some of the nuts and bolts. Yeah, I’ll catch myself here. It’s definitely it’s not you, it’s me as we’re going through this. Let’s talk about how the system tries to keep people in range, because one of the things that many in my audience are watching very closely are the customizable targets. So you can take Omnipod 5 and customize your glucose target from 110 to 150. Is that still the case that that’s what was approved?

Dr. Trang Ly 9:14
Yes, that’s correct. That was what was approved. So you can set up see during the day, you want to be at 120. And then overnight, you want to be 110, you can set up a profile that would reflect that, you know, if you’re someone who is new to AI, D and you generally tend to run a little bit higher, you don’t want to be at 110 straightaway and you want to you know, run at 130. For a while you can set that profile, you can set that 24 hour profile with glucose targets. And that is a unique feature of our system. And that’s what was tested in our clinical trials and we’re really pleased to be able to offer this level of customization for our patients.

Stacey Simms 9:57
Tell me a little bit more about smart adjust, my listeners And I almost hesitate to ask this. But my listeners are incredibly in tuned to their devices. They have already taken so many of these devices and tried to customize them as much as possible. Many people are trying to adjust their glucose many times an hour. I wonder sometimes about the the adjustment, and no, no pun intended with smart adjust. But the adjustment of people who you kind of need to leave these systems alone, I guess is what I’m trying to get at Have you already come up against that? Or is there any advice you tell people to kind of like ease into the system like this when they’re used to making a ton of adjustments themselves?

Dr. Trang Ly 10:34
Yeah, I do think there is some adjustment that needs to be made when adapting to an automated insulin delivery system. But I think a lot of your listeners will be fairly familiar with this type of technology. And really, it is the ability for the system to react to the CGM that’s coming in and dynamically adjust insulin every five minutes. I mean, that is what is really the value here in within our system. So smart adjust is our algorithm. And the feature that is really going to set Omnipod 5, apart from the other systems out there. And it is what we tested in our clinical trials, which, as I mentioned, you on our last poll, you know really had extraordinary results in terms of timing range, a one seat reduction, and then that hyperglycemia profile, which was very low hypoglycemia. So I’m really proud of the system that we have built, it is something that we, you know, made improved upon, over the years through our clinical trials. And it was really developed from learning from our patients and all of the of the participants who took part in in our trial. So it really is a real love letter to the community who have advocated so hard for this level of innovation.

Stacey Simms 12:00
One of the very unique things about Omnipod 5 is that in reading about it, you always say it learns the user, right? It kind of changes as it goes in, it adapts which is brand new, this is not something that any of the other automated systems on the market commercial systems do. Can you explain what that means? Yes.

Dr. Trang Ly 12:18
What about design philosophies going into this is simplicity for the user. We know diabetes is an incredibly burdensome condition. And it was important for us that we did not, you know, through delivering automated insulin that we didn’t make life even more challenging for people and requiring more attention. We really wanted to create more headspace for people to forget about their diabetes and do other things. Omnipod 5 is a real advance on that front. What we talk about in terms of learning and adapting is that our system initially takes the basal rates that are entered by the system as a starting point for the automatic controller, and then the algorithm as more information comes in, which includes the CGM values, and then the total insulin that is delivered by the system. Based upon that information, the algorithm will augment how much insulin the patient needs at baseline, and then with hyperglycemia, and hypoglycemia as well. Perhaps the most stark example of this was when we had a adult patient who came in who had relatively high A1C, starting point, so probably was not getting as much insulin as she needed. And so had a starting insulin program of around 27 units a day. And then over time, it was about two weeks where the insulin delivered by the system actually ramped up to close to 70 units a day. And that’s just in basal insulin

Stacey Simms 14:03
from 27 to 70. Seven Zero. That’s correct. Wow.

Dr. Trang Ly 14:07
Yeah. And so that that’s a fairly extreme example. But what it shows is the capability of the system to take in new information and make adjustments along the way. And the whole point of that is really to reduce the work that people and parents have to make in terms of, you know, tweaking those basal rates, because, you know, we want to add a system that would reduce that type of burden for these. We’re doing as much as we can for our users in this first system. But there will still be the ability for, for users to augment the insulin to carb ratio and correction factor. That all works exactly the same. So if your insulin sensitivity changes over time, you may need to make those adjustments, but the ability for the algorithm to adjust that baseline insulin delivery that day Damage Control does adapt based on new information coming in over time.

Stacey Simms 15:04
I said, Wow. And I want to be very clear on why I am. So I want to stand remember the confetti cannon, I said at the beginning, I want to fire it again. I, I fought I mean, I can only speak to my personal experience. I’m not a health care provider, I’m not an endocrinologist. But I talk to so many parents who feel like their kids aren’t doing what they’re supposed to be doing, quote, unquote. And then the doctor says, Oh, my gosh, you have to double the basal rates. And suddenly, it’s working again, because things can change so much. And we don’t know exactly. I can just think of my family as an example, when Benny was a tween to teenager, his basal rate doubled within two years, and then doubled again. And he was getting these incredible amounts of insulin. And when I would tell my friends, a few of them would say like, I could never do that, that sounds so dangerous. I can’t believe how much he’s getting. And I mean, I’ve shared he was getting 80 units of basal a day of just basal. And he’s back down. It’s not it’s not even close to that anymore. But he needed it. And I just feel like, gosh, I was gonna ask you to give an example. And I’m so glad you gave that one. Because to know that the system can learn that much and safely give that big of a change is remarkable. I’m curious, did you have any changes in the other direction, like people who were really worried about people who were really experiencing? hyperglycemia?

Dr. Trang Ly 16:23
Yeah, Stacey, going down is easy. Going up is hard. It’s, you know, and I’ll tell you, it takes some courage to do these types of things. And people are scared, and I will share that I was scared in making, you know, some of these decisions. But, you know, I have learned so much from patients, I’ve taken care of teenage boys, like your soul, you know, who, who need more than 100 units a day who fluctuate between 70 and 120 units a day in a week. And that’s what we need to be doing is helping people like that, you know, who who really struggle and have different insulin sensitive Rudy’s on a daily basis and different requirements who are at risk of both hyperglycemia and hypo. And honestly, I carry that with me every day, you know, all those learnings and say, you know, we have to create products that can, you know, address this, because this is what we’re trying to help here

Stacey Simms 17:39
right back to Dr. Ly, in just a moment, but first Diabetes Connections is brought to you by Dexcom. If you’re a veteran, the Dexcom G6 continuous glucose monitoring system is now available at Veterans Affairs, VA pharmacies in the United States, qualified veterans with type one and type two diabetes may be covered. Picking your Dexcom supplies up at the pharmacy may save you a lot of time to connect with your doctor for more information. Dexcom even has a discussion guide you can bring with you get that guide and find out more about eligibility. Here’s the link, I’m going to put this in the show notes, it’ll be easy to find it’s dexcom.com backslash veterans. But if you don’t want to write that down again, it’ll be in our show notes at diabetes connections.com. And now back to our conversation with Dr. Trang Ly.

This next question may not make sense with the system. But you tell me, I wanted to know about the percentage of correction bolus that Omnipod 5 gives. And you know, my frame of reference is the Tandem control IQ which my son has used, which the system adjusts basal, if you get close to 160, it gives you a partial bolus if you get close to 180. Is there anything like that going on here?

Dr. Trang Ly 18:51
Yeah, for sure. And what I’d say is that rather than having that modular approach that the other system has, you know, als really has that dynamic insulin delivery every five minutes. And it’s pretty straightforward. Basically, whatever target you said, the system is always driving towards that target. So, you know, you can be 110 all day and do that. And, you know, when we did our clinical study, the adult and adolescent population, so this is the 14 and older age group, the target that they used most frequently was the 110 target. And in those patients during the time that they were using that lowest target of 110, they were able to achieve 76% time in range, really great to be able to do that. And so I would say it’s basically that straightforward. Whatever target you set the insulin, we’re going to adjust insulin to try and get you there as quickly and as safely as possible.

Stacey Simms 19:55
If I’m hearing correctly, though, maybe with this system, we don’t think about it as Adjusting basal giving a bolus. It’s more, there’s an algorithm in here. And it’s proprietary. But there’s an algorithm in here, and it’s just giving insulin as needed. Is that what I’m hearing?

Dr. Trang Ly 20:11
That’s right. It is a hybrid closed loop systems that people are still expected to bolus for meals. Right. So that’s really important for people to do. And you know, to in order to really get good glucose control, it’s important that people premium bolus and work with their healthcare providers to really optimize that insulin to carb ratio and correction factor that yes, our pancreas don’t think in terms of basal and correction, those are concepts that we made up, you know, as I tell my team insulin is insulin, you know, it’s basal correction, whatever, it’s really, you know, how much insulin on board there is, what the trajectory is, and you just make the adjustment accordingly. So, yeah, I don’t really separate it

Stacey Simms 20:57
out. new way of thinking really interesting. Again, I’m going to get us off topic here. But I am thinking of the people who’ve never pumped before and jumping into a system like this, and how much different that must be.

Dr. Trang Ly 21:08
Yeah, we always think about those patients, because we think pump therapy is just a much better therapy in terms of the physiology of insulin delivery, and it’s just a much safer, and modality there. So, you know, actually, in our clinical trial, we had about 15% of our users who were on multiple daily injections. So they came in, and we put them straight on Omnipod 5, so they didn’t have to first use a pump, or first use the CGM, they just came straight in, we put them on Omnipod, five, and they did really, really well. And we’ve presented that data at various conferences. So they really did, ultimately, just as well as the people who had previously been pumpers, it is very simple and easy to use. And that really, the simplicity of our system is what makes it so great. And it really reduces that burden of you know, having to pull out pens and syringes when you’re out and about and, and be able to discreetly deliver insulin from a phone device. I think, really, that is what sets our system apart from other systems is it’s the simplicity and ease of use.

Stacey Simms 22:23
I’m gonna give you a couple of specific questions from our listeners, if you can’t answer that. We understand. And I actually have worked in a bunch of questions already. As you listen, I’m getting to as many as I can. But one came up that I thought was interesting, which was, is the system robust enough to defeat a 350 blood sugar on its own, you know, I think everybody’s been there. They forget to bolus they’re eating a big meal, they realize it too late. And then with these automated systems, you have to be very careful about how much you correct. And then there’s a second part of this question, which is, if I do want to give an additional shot for any reason, will the system keep track of something like that?

Dr. Trang Ly 22:58
I guess it depends on why your 350 in the first place. So if it’s from food and underestimation of carbs, or you forgot to bolus then I will tell you that by the time you are 350, the algorithm has already known that and it has already delivered a bunch of insulin to bring you down, it will bring you down and it will generally do that in two to three hours and get you within range below 180. Within that time. And we know that because the development of Omnipod 5, we specifically gave people these large meals and didn’t bolus for them and watch the algorithm and see what it would do. And, and part of the reason why that’s so important is because we know this happens to people all the time, and we want to safely bring them down, but not cause rebound hypoglycemia, because that is not good. And people will not trust the system and will stop using it. So that is exactly the type of testing that we do. So I would say that it is very robust and is very specifically targeted for that in terms of the question of if you give a shot not through the pump, then no, the system would not know about that. But what it will detect is, you know, a falling blood glucose level, and it will be able to suspend insulin delivery very quickly. And depending on the rate of change of glucose, it could suspend, you know, even if it’s in the two hundreds, it could suspend very quickly. And as far as I’m aware, actually, none of the commercial systems are able to import that information. So you would have to do that very cautiously because the system isn’t aware of that external insulin.

Stacey Simms 24:51
It’s an interesting question. You know, we’ve we’ve done that, you know, sometimes there will be a bad infusion set or things will happen. I mean, obviously the pod it’s a little different and you’ll want to give them Manual injection. I understand what you’re saying. And I think it was, it was a good question, but it’s practically speaking, we’re not gonna be able to do every circumstance.

Dr. Trang Ly 25:07
That’s right. Yeah. Unless we had like this really special insulin detector.

Stacey Simms 25:16
Why don’t we have that yet? Special insulin detector get on that?

Dr. Trang Ly 25:21
Well, you know, well, technically, it’s very hard to do insulin assays. So, yeah, anyway.

Stacey Simms 25:28
I guess, you know, in layman’s terms, what I what I think of a lot is, okay, if my son needs to give an injection, can he just put in Okay, pump. I gave myself this much. Because with the older non smart pumps, or before there were any hyper close loops, you really could do that. You could kind of fake a dose.

Dr. Trang Ly 25:44
Yeah, you can’t with our system. Yeah. Yeah.

Stacey Simms 25:50
I don’t think you can do that with any of the automated systems. Now, another quick question, before we move on to smartphone, can you extend a bolus, this was something that came up, can you still do that, or if you can’t do you even need to, you can

Dr. Trang Ly 26:02
if you’re in manual mode. So manual mode is basically on the pod Dash. And that is when you set it up with the settings that, you know, you discuss with your healthcare provider, and they preset basals and bolus settings. So if you’re running that mode, or if you happen to, you know, not have a CGM and you don’t want to run an automated mode, then you will have that functionality to have extended bolus. And there are a number of reasons. But we actually looked at this in a clinical trial that we did specifically looking at high fat meals and using extended bolus with our algorithm versus just letting the algorithm work. And what the results showed was that with high fat meals, the algorithm was better in terms of figuring out how much insulin you needed, then a person trying to figure out okay, how much do I give up for and how much do I extend? And because of that data, we decided not to include the extended bolus with our algorithm. side. So in automated mode, extended bolus does not work.

Stacey Simms 27:17
Great. And, and you lead me then into the next point, which is, can you expLyn the manual mode? This is not something that the system decides you’re in, right? This is the user saying, okay, I’d like to be in manual mode or no, I’m going to be in auto mode. In other words, you can’t get kicked out like on the Medtronic system.

Dr. Trang Ly 27:31
Exactly. So the manual mode, as I mentioned, is all the preset settings that are programmed into the system. And then automated mode is when you have a CGM connected to it. And as long as you have CGM transmitter ID entered you are and you know, your targets set up, you can off you go. And so the setup of the system is very similar to Omnipod dash, except there is an additional step where you enter in the transmitter ID so that the pod knows which CGM to search for. And then once that value comes in, and in fact, you don’t actually have to wait for that value to come in, you can just start automated mode, and then the system will use the information that it has to augment insulin delivery. Got it?

Stacey Simms 28:25
Let’s talk about the phone. Because I think this is incredibly significant. It’s a first for the FDA, it’s just going to open the door in my opinion to so much other technology. Yes, right. Now, as you and I were talking, there’s only two smartphone models that works with that’s gonna change. But let’s go down and talk about these features. This is full control allowed from a smartphone, right?

Dr. Trang Ly 28:44
Yeah, I was so excited about this feature. I mean, see, it’s the number one feature that our patients ask for over ad over automated insulin delivery, which kind of really blows my mind. I will I

Stacey Simms 28:57
was, you know, I’ve shared with you, I was gonna say I’m actually a little bit more excited about this. And I, I kind of ended high because automated control is so is so incredible. But phone control is also I mean, my son is he cannot wait for this. It’s just, we don’t even again, we don’t use your system. But yeah, wait, it’s just such a great thing. So before I start getting all crazy, let’s go through some of the features full control from the phone.

Dr. Trang Ly 29:21
Yeah, and I want to say that, you know, as a pediatric endocrinologist, I totally under appreciated the how our patients valued having phone control, and being able to control their devices from their phone. And it wasn’t really until I saw the data that where everybody might have this is their number one request that I was like, huh, we better start listening to patients. Because in my mind, you know, if people aren’t using their devices, they’re not getting any benefit from automated insulin delivery. So it’s really important that we address all the pain points. For our patients, I am really proud of the team for getting this through and getting this clear, it is just so meaningful for our patients, I think it’s really important to clarify that if we don’t have the phones that we currently have available, it doesn’t mean you can’t use a ID, that you can’t use Omnipod 5, you know, our system will always come with an Insulet provided controller, and you know, you can use it as a separate device. But you know, very, very quickly, we’re going to have many phones available where you can download an app, it’s as simple as that it, it works on your phone, just like any other app, you open it up, and you input your settings, just like you would setting up a brand new controller, and then you start and stop your pods and manage everything just from your phone, and then you’re getting rid of that controller device, you know, you’re carrying fewer devices. That’s what it is. And you know, in future, we will have iOS and Apple devices in future. We haven’t set a timing for that. But you know, all of that is in the works. Because, you know, we care a lot about reducing the friction for people to use and access Apple devices. So I’m very excited about it. All right,

Stacey Simms 31:21
I know you can’t give me a timeline. But you said very quickly is very quickly this year for Android and next year for Omnipod is very quickly quarter two for Android and end of this year for kind of get any timeline for

Dr. Trang Ly 31:34
I know, I can’t provide any timelines. But you know, the team’s working on it. And you know, I get to see the prototypes, and I get to test things out. So it’s super fun for me, but I am sorry, I can’t provide any time timeline

Stacey Simms 31:47
updates. You know, one of the big questions that came up Omnipod, five is going to come out with limited release. What does that actually mean? And how do you decide who gets it first? And who gets it next? Is it geography? Is it when people signed up? How does it work?

Dr. Trang Ly 32:01
I know everyone is super excited about Omnipod. Five, and especially us as a company, I think it’s really best practice before we do anything big in life to start small and make sure that you know everything, all systems are working. And you know, we are doing a lot of innovation actually, not just with the product, but also the way we serve patients in terms of our onboarding platform, our self guided training, ordering, product support all of that. So it’s quite a large undertaking for our company. So what we’re doing here is making sure that everything goes well and, and is smooth for our users before we embark on the full launch. So right now, just in the next few days, we’ll be rolling out our limited market release. And then once we have all the information we need, and all the data to make sure that we can handle all the demand that comes in will be then announcing our full locker release. And we expect that to be in terms of timely, just shortly after the limited. Release is complete.

Stacey Simms 33:10
Okay, but I have to ask a follow up on that. But to be clear, then it’s a limited release for the people you’ve decided we’ll get it. Yes. And then it goes to everybody. So it’s not going to be a rolling limited release? No, it’s a so then my next question is the first question. How did you decide the limited release? Who are these people,

Dr. Trang Ly 33:29
we haven’t provided details about that. And part of it is really to make sure that we have, as I mentioned, you know, really assessed our full systems and making sure that, you know, we can address the demand that will be coming in. So I think what people what our patients really need to know is, you know, how did they get on products? That’s certainly the number one question that I’m getting is, how do I go on Omnipod? Five? And how do I prescribe it? So you know, for that, I would say that today, you know, getting on Omnipod dash is the fastest way to get Omnipod 5, because for those users, that means that they are most likely have access through the pharmacy channel. And then we expect that our Omnipod 5 coverage will be very similar to our Omnipod dash coverage. So if you’re already on the dash, it’s expected that you know once Omnipod 5 is available and there is insurance coverage which you know, we’re ramping and growing every day then that transition should be very very smooth. And also you know in terms of devices you know, if you’re already on and only Pradesh and you’re on a G6 you can go through our self guided training and so you know already being familiar with our system and devices that makes it a lot easier in terms of training and transition but also it in enables you to get onto our interest list for Omnipod. Five. And what we’ll be doing once it’s fully available is really going through that list in in order of people’s names on it to make sure that they have coverage and getting them Omnipod. Five as quickly as possible. We’re really committed to our current dash users. I mean, all of our new pod users were fully committed to

Stacey Simms 35:23
do people need a new prescription to move from Dash to Omnipod 5?

Dr. Trang Ly 35:27
yes, it’s a different product, it’s an entirely different product. So yes, they will need a new prescription. Okay,

Stacey Simms 35:33
because that was one of the interesting things with when Tandem rolled out control IQ. Sometimes as you listen, you know, you got to get in touch with your endocrinologist once once it starts rolling out. Right. That’s one piece of the puzzle we have to make sure to include, um, you mentioned Dexcom, questions came up Dexcom G7, knock on wood could be approved in the United States this year? What will that change over look like when it goes from G6 to G7 for Omnipod 5?

Dr. Trang Ly 35:57
Yeah, so were working on next in terms of integration of the physical integration with G seven. We’re working on that and future sensors. So we haven’t announced any timing in terms of when Omnipod 5 would be available with G seven. That is something that we’re working on. Even if G seven gets cleared this year. We certainly haven’t announced any thing in terms of Omnipod 5 compatibility with that, at this point in time

Stacey Simms 36:29
about Medicare, it is the Medicare coverage expected to be seamless, and supplies seamless for that population. Yeah,

Dr. Trang Ly 36:36
so in that population, you know, we have fairly good coverage for that. And again, growing and as well, and Omnipod dash is available through the pharmacy channel. And as I mentioned, we have great coverage. And already today with Omnipod. Five, we actually have more covered lives right now than we had even just, you know, a few months after Dash was launched. So the team has, you know, our team has made extraordinary progress on that front to ensure that you know, when we’re at for release, our patients can get access to that as quickly as possible.

Stacey Simms 37:19
And I should ask the clinical trials where ages six to 70, while the lower limit is something that you have talked to your endocrinologist about people over the age of 70 can still use this device, right?

Dr. Trang Ly 37:30
correct way, clade full six and over no problems for our 70 plus population.

Stacey Simms 37:36
Excellent. What about the rest of the world? The question was, has it been submitted for CE marking Europe, my friends in Australia, your friends in Australia are like what’s going on?

Dr. Trang Ly 37:45
I know I I’m like really behind in my emails. Because everyone in Australia wants it, it’s gonna come, we have to get it cleared. And you know, our first hurdle was getting across the line in the US. So you know, I’m just super, super excited to get it. And it means we have a great product and you know, our clinical trials prove it. And in time, it will get to all of those places.

Stacey Simms 38:16
I know have kept you longer. I have two more quick questions for you. The second last here is will Omnipod and Dexcom work together on the customer service side now that you are linked as a system? Will customers be able to work with both? If you’re not familiar, as you listen with Tandem? Sometimes you call Dexcom? Sometimes you call Tandem. When you have issues. The Tandem can send you replacement sensors, things like that. It’s not it’s not a seamless partnership. They want help with everything. But I’m curious if Omnipod and Dexcom will start working together in that way.

Dr. Trang Ly 38:47
Yeah, we have. We’ve been working together for years, in fact, to get this right, because we care a lot about customer service and taking care of our patients. So the teams have been working together very, very closely to make sure that there is warm transfer between both companies for our patients. And that means you know, whatever we can address we address and whatever Dexcom addresses they’ll be addressing. Yeah, so as you point out, it is different to some other models that are out there, in that these are really two separate devices. And that means that we’re not handling Insulet is not handling any of the sensor orders. But we’re just really focusing on on the pod. And I think what that allows us to do is you know, allows each company to do what we’re really good at and not like try and figure out how to be dispensers of sensors, that allows us to really scale and move quickly in this space. And again, it’s a different type of way to serve customers. But at the end of the day, we don’t want to be wasting our time. It’s time over these things because they got better things to

Stacey Simms 40:03
do. I meant to ask when we talked about the phone control, and the phone display is a follow feature going to be part of Omnipod 5? So caregivers, spouses can look, yes, we

Dr. Trang Ly 40:13
already have that today with Omnipod View app with the Omnipod dash. So, you know, that’s really great and really great, especially for our pediatric population. So that capability already exists today. And we will be providing that later in the year.

Stacey Simms 40:30
And then before I let you go, you and I’ve talked several times during this interview, and when we last spoke about how you have worked with patients for a very long time, you’ve seen the burden that diabetes puts on people and how systems like this can start to alleviate some of that. I can’t imagine that you’ve had that much time to reflect it just got approved last week. But you know, how are you feeling about this going forward? It’s a combination of so many people’s work over the last several years. I mean, I guess what I’m saying is, take a second take a victory lap.

Dr. Trang Ly 41:02
Yeah. See, it’s been a pretty emotional week for me to be able to bring this to fruition, I think I really carry the spirit of many of my patients, you know, those types of interactions just never leave you. And just a lot of gratitude this week for what we’ll be able to do for a lot of families. I love

Stacey Simms 41:28
it. I’d love to have you come back on or maybe when the system has been out for a while we can talk to some folks who’ve been using it and and kind of dig a little bit more into how it’s helping. But thank you so much for being so accessible for answering so many of my questions and congratulations, I it’s I know it’s been a long time coming. And I’m so excited for my friends who use Omnipod to have this new choice. Thank you so much.

Thanks, Stacey.
You’re listening to Diabetes Connections with Stacey Simms.
More information about this I know you probably still have questions, go to diabetes connections.com for a couple of links, including that frequently asked questions section, it really is very robust, and can answer a lot of what Dr. Ly was unable to get to. It’s so exciting. Boy, I know. You know, we’re not Podder’s, we have not used the Omnipod. But oh my gosh, I know the community has been waiting so long for this. I’m so thrilled for more people to get an automated insulin delivery system, it has made a huge difference with my son. And I can’t wait to hear what you all think I know some of you. And some of the people in our Facebook group were in the clinical trials. I don’t know how much you all can talk about that. But if you want to post about it, if you’d like to tell me more, you can shoot me an email Stacey at diabetes connections.com. I’m just so excited.
Two quick things before I let you go. First, at the top of the show, I briefly mentioned Club 1921. This is our brand new project, it is still in beta. And it is where anyone with any type of diabetes can find events anywhere in the United States. If you have diabetes, or you love someone who does, you are already a member of club in 1921. If you go to the website, club 1920 one.com, you will find that it’s very easy to sign up for free. And we will send you the events you’re interested in, you never have to come back to the website, you just click a couple of boxes, tell us what you’re interested in. And we will send you the events. If you’d like to list events, you can also sign up and this is for everything from big conferences, to educational events at hospitals, to you know, a Hangout moms at a playground, going for coffee, whatever you want for the diabetes community, any type of diabetes, any type of event anywhere in the United States. As I said, we’re still in beta, I’d love for you to sign up and let me know what you think. And if you haven’t already guessed why Club 1921 I’m sure most of you have guessed that is the year that Banting. And best and the rest of their team are credited with the discovery of insulin.
The second thing I want to address is it’s a little selfish, but I want to share the Omnipod story, this kind of breaking news. This kind of stuff is why I started the podcast. Many of you have heard the story before. But if you are new, I started the podcast in 2015. Because there were and there still are a lot of really good diabetes podcasts out there. But most of them were people telling their personal stories. And that’s great. And they were mostly adults. And you know, as a parent of a young child at the time with type one I could relate but it wasn’t exactly for me. But more to the point. There was nobody doing diabetes news and that’s my background. I was a local TV reporter and Radio News host for my entire career for 25 years plus, and I had just left a career in morning radio because I was so tired to get up at three o’clock in the morning. That’s I’m sure you can imagine I did that for 13 years. And I was trying to figure out what to do next. And I realized that There was no one covering diabetes news. And it’s not just saying, Oh Omnipod 5 is approved. It’s asking the questions that you just heard. I mean, I guess it kind of sounds kind of braggy to talk about this. But to be frank, as the parent of a child with type one, and as the spouse of somebody with type two, I want to know this information. I want to hear it from these companies, I want to ask follow up questions, I want to call them on it, when we have questions that they aren’t answering, or we have issues that they’re not addressing, whether that’s a technology company, or more to the point the insulin companies and things like that.
So if you’re new, I hope you go back, we have a great search box on diabetes connections.com. It’s in the upper right hand corner. And there’s if you click on the episode page, you can get there’s more than 400 episodes, you can go through the archive, but I urge you to search for what you like whether it’s technology or issues, that sort of thing. And you can really see these products, we started talking about them five or six years ago, and follow them through development, see how things have changed to me. It’s so interesting. And there are very few places to get our questions answered. Your a lot of these folks will go on the financial channels and talk about the company. And I’m thrilled, as you probably know, Omnipod stock went up, I don’t own Omnipod stock or Insulet stock, but it went up last week. Hurray, that’s fantastic. But I care less about that than I do about knowing what they mean by you know, the system learns you, right. So thanks for giving me the opportunity to just kind of share why I find this stuff. So exciting. This is why I started the show. And I hope you enjoy listening.
if you have questions, if there’s issues you want to hear more about, please let me know you can always reach me through diabetes connections.com or on social media. And boy, what do you think is next has this loosened up the logjam at the FDA are we gonna see other issues that have been waiting? We’ve got bullets by phone from Tandem. We’ve got stuff from Medtronic that’s out there waiting, we got tide pool loop. Oh my gosh, I hope 2022 proves as exciting as it has started out. Please join me every Wednesday for in the news. I do that live on Facebook, YouTube, LinkedIn, and at 445 on Instagram. And then we turn that into a regular podcast episode that comes out on Fridays. That’s just five or six minutes of the top news headlines in our community every week. And then on Tuesdays, I do these longer format interviews. They usually go up at four o’clock in the morning Eastern time. This was a little different if you’re listening as it is first released because I did the interview with Dr. Ly today. It did it at one o’clock this afternoon. And then we turned it around and got it out as quickly as possible.
Thank you as always, speaking of those kinds of audio heroics, to my editor, John Bukenas from audio editing solutions, and thank you so much for listening. I’m Stacey Simms. I’ll see you back here soon until then, be kind to yourself.

Benny 47:49
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