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Diabetes Connections | Type 1 Diabetes
Eversense 365 + twiist: exploring the newest CGM/pump combo
00:42:29
This week on Diabetes Connections, the Eversense CGM gets its first pump partner. This is the implantable CGM sensor – it now lasts for a year.. and it will soon connect with the twist.. a brand new insulin pump. I’m joined by Brian Hansen, the...
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- [00:05]
A
This week on Diabetes Connections, the Eversense CGM gets its first pump partner. This is the implantable CGM sensor. It now lasts for a year and it will soon connect with the Twist, a brand new insulin pump just rolling out in the United States. I'm joined by Brian Hanson, the president of CGM at Essencia, that's the company that distributes Eversense, to talk about how this will work, what's changed forever since besides the much longer wear and what the future holds, this was a wide ranging conversation and a fun one. I love an executive who's not afraid to say stuff. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your healthcare provider. Welcome to another week of the show. I am always so glad to have you here. I'm your host Steve Stacey Sims and we aim to educate and inspire about diabetes with a focus on people who use insulin. My son was diagnosed with type 1 diabetes back in 2006 just before he turned 2. He's now 20. My husband lives with type 2 diabetes. I don't have any kind of diabetes, but I have a background in broadcasting and that is how you get the podcast. And I have been saying all that information on almost every episode for 10 years now. We didn't officially launch the show in May of 2015, but this is about the time when I started to release episodes quietly because back then it took forever. It took up to two to three weeks for shows to get accepted on podcast apps like Apple or Spotify or Pandora or some that don't even exist anymore. But now it's like 24 hours and you're good to go. Very different time. I'm going to be talking more about the decade long run of this show and the anniversary a little bit later in the summer. I'm not worried about hitting that exact anniversary, especially because I'm going to be traveling a lot in the next couple of weeks. I don't plan on any interruptions for the podcast. From the listener standpoint, you really shouldn't notice anything different, but you never know. So I'm going to try to update on social if there are any issues. Frankly, this is my fun travel before the the summer conference season begins, so I'm really excited about it. I'll tell you more later as we gear up for summer. I know it's really hard to think about the fall, but pretty please, if you are at all interested in Mom's Night out. We will be in Minneapolis in September, Phoenix in October. The sooner you register the better for you. Our early bird specials are still going on for both locations but not for much longer, so please check that out. You can go to diabetes-connections.com, click on the Moms Night out tab. These events are for moms of kids with diabetes and for women with Type one. They are so much fun. They get bigger and better in every location and I really hope to see you at one of them. All right, let's talk about Eversense and Twist Integration. You will get some very basic details during the interview. So if this is your first time hearing about either of these products, I think we will paint the picture for you. But you should know that the first version of Eversense was Approved back in 2018 as an implantable three month sensor. It gradually was approved for longer periods of time and then in 2024 the FDA approved a year long 365 day version of Eversense and also approved it as an ICGM, which means it can work with automated insulin delivery systems. The first Aid pump partner will be the Twist. This is a new pump from SQL MedTech which is just beginning its US rollout. My guest, Brian Hanson was appointed the President of cgm, a new role that I don't think has been created anywhere else in early 2024. Before that, among other jobs, he was the Chief Commercial Officer at Tandem. We have followed Eversense for a long time, including talking to people who have worn it for a long time, and we have followed the Twist. I will link up our previous episodes on all of that in the show Notes and I mentioned in the opening tease that Brian says stuff and he really does. He's very open. He answered a lot of your questions and he gave timelines for the upcoming technology, which is very unusual for these guys. So I appreciate that and I hope you enjoy the conversation. It's coming up right after this. Did you hear the pod drop? Did you know all the sounds used to make that song come from a sight? Change with the Omnipod 5 automated insulin delivery system Pretty cool, huh? With Omnipod 5 pump site changes are simple. The pod lasts up to 3 days 72 hours and to change it, you just fill up the pod with insulin, place it on your body, tap a few buttons in the Omnipod 5 app and you're ready to go. There's no tubing to prime like with traditional insulin pumps and it's virtually pain free so you never have to see or handle the insertion needle. Want to try Omnipod 5 for yourself? Request a free Omnipod 5 starter kit today by visiting omnipod.com diabetesconnections Terms and conditions apply. Eligibility may vary. Brian, welcome back to Diabetes Connections. Lots of good stuff to talk about today. Thanks for being here, Stacey.
- [05:12]
B
Thanks for having me. And I just want to say, before we start, I've told you this a couple times along the way. Congratulations on all your success, and thank you for all you do. I enjoy listening. The enthusiasm, the energy. It's rare to have educational, entertaining, and, quite frankly, inspiring altogether. So I'm enjoying it. And I listened to quite a few of them before I got on today, and I'm actually a little bit. You've had storm chasers, you've had golf pros, so I had a chance to do that. You got my good friends Jake Leach and Kevin Sayer on there all the time, which I enjoyed. Jake's interview here just shortly, John Scholen from Luna, who I was just on the phone with yesterday. Dr. David Ahn, who I adore. I mean, talk about an entertaining and informative session you had with him. And then obviously, our favorite, Chris Rudin, who you've spoken to before. I can listen to your stuff all day, so thanks for having me.
- [05:59]
A
Okay, interview's over. Thanks for the commercial. We're clipping that. No, really, that's very kind and I appreciate.
- [06:04]
B
No, it's awesome, right? And I think I said this to you before. I mean, to have so many folks listening outside the United States is a pretty wild thing, too. I had no idea until I was looking up some of the stats, and I'm like, dang, you got over 40% of your listeners coming from outside our borders. That's pretty darn cool. Your reach is amazing.
- [06:18]
A
Let me tell you. I started this podcast almost 10 years ago now. 10 years ago, probably by the time this airs. And it's not. I don't know what I expected, but, man, it's been amazing. So thank you for that, Brian.
- [06:30]
B
You got me fired up, so let's go.
- [06:32]
A
All right, let's go. Enough buttering up of the host. We have a lot to talk about with Eversense, integrating with Twist, other things for Eversense. Where do you want to start? What do you want people to know off the bat?
- [06:42]
B
I want to tell a couple stories real quick, and I won't take a lot of time, but a couple of these are fun for me. So the story behind the sequel pump is Dean Kamen, right? Serial entrepreneur, prolific investor. Hard for me, even say that. Those are two big words for me. I met him in 2006. I met him at a dinner and sat at his table up front in San Diego. My CEO at the time had taken me to a dinner, and he was promoting stem, right? His robotics competitions, his first nonprofit that he runs so massively. Right? And he was amazing, and I didn't know who it was. I talked to him for 20 minutes. The guy had jeans on. And I was talking to him, and Hank Nordoff, our CEO and chairman, came over and said, how was your conversation with Dean? I'm like, dean who? And he said, dean came. And I'm like, oh, dang. You know, so now we come full circle. I've known Dean for quite a while. We're working together. I think you know his history in insulin pumps. I know Dr. Arnold Kadish, you know, started the first insulin pump that we all have pictures of wearing on the backpack.
- [07:37]
A
Right.
- [07:38]
B
But Dean came shortly thereafter, in mid-70s, with the first wearable insulin pump. And then MiniMed came and desitronic camera. But then all of a sudden, here we are in 2025, and his pump is going to come to life here with SQL, you know, their engineering firm, deca, and all the work that they had done over the years, here it comes. And we're very lucky to partner with them. So it's funny how life comes full circle for me almost 20 years later.
- [08:02]
A
Was there anything in particular about the technology that drew you to this pump as your partner, or was it the relationships that you had? Is there anything you can tell us about that?
- [08:12]
B
Yeah, it's a great question. When you and I spoke last, we talked about some of the real fun happenings. I think you and I were together in October. Prior to that, we got our ICGM designation exactly a year ago this time. And so that allowed us to have some meaningful conversations with pump companies. And that was really our outward message to the street was we're having those conversations and we'll see who actually comes to the table. But we've got a couple in flight. One that we had quite a ways down the path. That was sequel with deca then. So Tim Goodenow in the Senso Se, Onyx CEO at Senseonics. They. They had been working together, the engineering teams, for quite a, you know, quite a while. So there was a head start already. And so then we get our approval for 365 in September. We launch in October, November, we get rolling days start rolling, and we get a little bit more serious about our conversations. And here a few weeks ago, we finally got all that kind of put in place we met in Amsterdam at attd and it just all fell nicely for their timing, our timing and it's great. They'll launch here shortly with the Libre 3. You've heard me say this many times, choice is important, right? When you have more choices, you make better decisions. I say that to my kids all the time. So big advocate for choice and we're going to jump on this one. And so yes, I've known Dean. I know several of their senior folks. Their head of marketing came from Insulin. I know Chris pretty well. Jen LeBlanc was at Joslin for many years and was in the pump business before with Medtronic. Know her well. So it was just a natural fit. And quite a few of my peers and folks from around Tandem and other pump companies have joined now to launch this product. They're going to go out big and so we're pretty excited and happy to be able to partner with them. But has also made it easy is not the right term, but comfortable is the right term. We came to terms fairly quickly and you want to do fairly quickly. So first mover advantage. We're going to have a lot of fun here. We're going to lean in and they're going to get a very, very excited salesforce and my team out talking about their stuff. They're going to attend our meeting next weekend, get us trained on it already. So we're full flight.
- [10:09]
A
That's great. For people who may not be familiar and I will link up our previous episodes. Can you give us some of the features of the 365ICGM now what does this do for people who may not be familiar with the insertion and everything else?
- [10:24]
B
Yeah, no, great question. So we started several years ago with a 90 day sensor that transitioned over to the 180 day sensor. Both those sensors had to be calibrated daily to make sure that the sensor was giving you the best readings, accurate readings that you could get. Now that we've moved to the 365 sensor and again general availability and that was early November of 2024. So we've had out for roughly six months now you've got an implantable sensor that lasts a full year. So there's a minor slit here done on the back of the arm. It's inserted. It's a little bit bigger than a grain of rice. So it's a very small sensor inserted just underneath the skin and it will sit there now for a year and it will transmit via a transmitter on the outside of that sensor. Any readings from the Implanted sensor to a phone or now shortly to a puma. And so it's pretty simple. I mean, I say simple because I listen to Tim Goodenow and all the engineers. But, you know, an implantable fluorescent glucometer, basically underneath the skin with a really smart transmitter doing all the work and you're off to the races. The feedback we've had is one procedure a year is fantastic. That makes it even more desirable. I don't go every six months or, you know, every three months. Once a year that starts to really pique my interest. But I think the thing that we were surprised about is the once a week calibration. Now, after having to do it once a day for the first 13 days, has quite frankly been a game changer. They're like, okay, now it's more in line with traditional CGMs. Makes a little bit more sense to me. The advantage of having it, you know, for a full year has really changed. And I would be remiss not to say that there are some challenges with traditional CGMS for some folks. Right. Not lasting the term, not sticking on, not doing well with the adhesive compression lows. Right. Results outside of the norm. I can go on. Right? False alerts or disruptive false alerts. I'm not knocking them, quite frankly. Both companies are very good friends of mine. I've known them for many years from my time at Tandem. Right. But it's a large market, 10 million folks using CGMS worldwide. Stacy, we just want a little bit of that. We just want to sit at the table and play. And now we're starting to see some of that. So it's getting to be a little bit more fun.
- [12:27]
A
Well, and it went by quickly. Let's repeat that again about the calibration. I don't wanna say I told you so, but, you know, we all could have told you that once a day is a lot different than once a week. But it has to be once a day for the first 13 days. Walk us through that again.
- [12:42]
B
Yeah, it's 13 days, once a day for the first 13 days. And that's just to ensure that, you know, once it's inserted, it's working properly, it's calibrated properly, we get it off on the best possible foot and then you're off. And so day 14, now you get to wait a full seven days. It will alert you. Finger stick, insert the value you get from the blood glucose monitor. And again, now you have a seven day period. Unless you're outside what you would expect, it to be giving you from a glucose value pretty trouble free.
- [13:08]
A
I know it's hard to say real world because you got this ICGM and365 designation not yet a year ago, but are people fine with once a week? Are they doing it? Are they having issues if they don't do it?
- [13:21]
B
A couple thoughts on that. First off, it's certainly much better. Our cancellations because of calibrations are down 91%. How's that for a good fact?
- [13:30]
A
That's telling.
- [13:32]
B
Most people are pretty happy with it. That is not the leading reason why someone would not do it or stop using it. That tells you a lot. And I would say most people, if you do user experience or user surveys, most people will stick their finger once in a while anyway to make sure if their CGM is giving them. If it's saying it's 185 and like just not buying that. Right. I feel like a 110 right now. I feel pretty good. I think most people are okay with sticking their fingers once a week and for that very reason, we are not seeing really any negative feedback on that one particular piece.
- [14:04]
A
All right, I have to ask, what happens if you don't do it? Is the system like, you must. Is the system like, we'll see.
- [14:11]
B
Nope, nope, you must. It'll basically tell you and it will shut down if it doesn't do it. And you know, I guess the way around that is put in a fake value. But we certainly, we teach against that because we want this to be the most accurate sensor on the market. We feel it is and the numbers will support that. So therefore, what's treated the way it's supposed to be treated and get you the numbers that you're expecting and let's make sure that we can keep you in range with the most accurate sensor. Let's just do a finger stick. Come on.
- [14:37]
A
Yeah, yeah. It's interesting. It's like you've already mentioned choices and things. One of the things I like about Omnipod is that it will not work. Like you must change it. And with my not anymore a teenager, but when my son was a teenager, letting infusion sets go for a very long time. You know, there's flexibility and then there's being a doofus 15 year old, you know, who's on day five or six. Why isn't the insulin working? I don't know. Maybe the infusion set is hanging like flapping out of your skin. So we get it as a community. We all have stuff we have to do.
- [15:07]
B
You know, it's even crazy Stacy, back in the day with pump trials. You do these pump trials through our key opinion leaders and big centers around the world and you'd get a decent subset of folks in the clinical trial that never bullish for a meal. Oh, yeah, you're like, what are you doing? I mean, this is a clinical trial and stuff, but that's just the way it works out there. So the best laid plans don't always come through, even in a very structured format.
- [15:28]
A
I love to hear that. More mistakes, less perfection. It's reality. It's the way this all works. Which is why I'd like to try to ask as many questions about real world use as I can. But I know it can be difficult. So again, for people who may not be familiar, are we still charging the transmitter? How does all of the external stuff work?
- [15:47]
B
A little easier. Charge now. It's a usb. You don't have to have the cradle anymore. So that's super simple. Most people charge it when they jump in the shower. You know, there's a simple patch that you put on an adhesive, a very mild silicone adhesive that most people just love and that comes on and off daily. And so you put it right over the site and that's what the transmitter sits over the top of of your, you know, implanted sensor. So most people, when they jump in the shower or doing something for, you know, five or ten minutes a day, they simply plug it in, it gets charged and it goes. It'll last for several days. That's not the issue. But most people, people are pretty used to just having it charged, feeling good about it and moving on.
- [16:21]
A
Great. Any issues or changes, anything you want to talk about with the adhesive because it's a different kind of adhesive than most people think of with cgm. Right back to our conversation. But first, Diabetes Connections is brought to you by Dexcom. I've been talking about integration for years and it's just been wonderful to see it all happening. Dexcom G6 is part of Tandem Diabetes Control IQ system and part of the Omnipod 5 system. My son has been using Control IQ for more than four years now. These systems are really amazing. He sleeps better and the system has his back when he doesn't get his meal bowl is exactly right. As a mom, I will never stop worrying, but I worry a lot less. We all just think about diabetes less, which is really amazing. Learn more. Go to diabetes-connections.com and click on the Dexcom logo.
- [17:14]
B
Foreign. Yeah, definitely. We have not changed it. It's quite proprietary. It's quite pleasing. So we get a lot of requests from folks. Can they get it? Can they have it? Even folks like, well, there's some pump companies with smaller pumps, let's put it that way, that would love to use it, to adhere to. And so, yeah, that's a, that's a lovely thing for us. And again, we get some folks over from a traditional CGM where the adhesive is just too strong or too, too challenging for their skin. And so this makes it wonderful. And you can take the transmitter off at any time. If it gets knocked off, you put it right back on. So that's certainly an advantage if you want different discretion. If it gets knocked off, you're not wasting a cgm. Yeah, the adhesive's a good, it's a good part.
- [17:57]
A
Okay. I think most people now in the community are very familiar with automated insulin delivery systems. A couple of questions I got was, and again, it hasn't been launched yet, so I don't know how much you can answer, but one of the questions that came up was connectivity. Right. There are some pump systems with CGM where they are like adamant, it must be on the same side of the body where the pump has to be worn with the face turned out. Things like that are getting better, but there are still issues. Anything to know about connectivity here?
- [18:24]
B
Certainly remember that from my prior life. So that is all being worked into the functionality right now. The hard lifting is done. We're in that validation verification stage. So some of that will come about now with walk around or walkabout testing, some of the user and humor factors testing, which has been done and I'm pleasantly surprised to say we haven't seen too many connectivity issues. So let's hope that all that stuff is fairly simplistic. Again, a lot depends on the reception on the pump, the casing on the pump, and like you said, to some extent where they wear the pump and then the strength of that Bluetooth and the, you know, going from one side of the body through the body, which is mostly water, to the other hip can be problematic at times. And then the tech support call would probably go like you just said, try wearing it and aligning it with the side of the body that you have your sensor and let's see if that changes things. If not, we'll troubleshoot from there. But certainly that's not our anticipation at launch. We'll see how it goes.
- [19:18]
A
Yeah, it's a little concerning. Right. Because you can't move it.
- [19:20]
B
No, no, you would have to wear it on that side if that was truly the case. But again, we're going to assume that's not going to be the direction we're heading, but we'll see.
- [19:28]
A
Okay, fair enough. Fair enough. I'm reading through some listener questions and one of the first that came up is asking about pediatric approval because this is not approved for kids. Right.
- [19:39]
B
Sensors approved down to 18. So we do have some work going on. It's for type one and type two today, but we only have it to 18. So we do have some work to get it down, hopefully to 12 is the age that we're looking at. But that is the. That is the latest that we've shared publicly.
- [19:53]
A
All right. You know, you started off talking about the international audience. The Canadians are weighing in and they want to know when they are going to get it.
- [20:01]
B
That's a good question. We have applied for Cemart, so let's start there. That went in earlier this year. We hope to have it soon. So let's just Hope the next 30, 45 days we get our positive back from BSI, our notified body that we've filed with. And if that happens, we will commence our launch in the six countries in Europe that we currently offer the Eversense 180 product, the E3. We hope to do that starting in Germany mid summer, and then we'll launch out based on the tenders and the, you know, timing and vacations, obviously, and what have you. It is interesting from the Canadian side because we were very successful there with the tandem pump and really enjoyed our launch there. There's a little bit of a process with Health Canada, so that's something that we'll have to figure out what type of trial they're looking for. It's a little different than the ICGM that we get to enjoy here in the United States now with the good work that the FDA has done, leaning into diabetes. And so Canada actually has a pretty high bar now of launching a product north of the border, a little bit different than the States if you have icgm, which we have, or with the CE marking process in Europe now. So that tends to be a little bit of a. A decision point of, you know, do we want to do all that work? And at some point we definitely want to.
- [21:12]
A
Interesting. Yeah. It's. The regulatory side is a whole other.
- [21:16]
B
Bag of beans would be nice if they would lean into the ICGM here and partner a little bit more with the fda. I know they talk a lot and I know that they're, um. You know, I wouldn't say in cahoots, but they're. They tend to follow one another pretty well. But they do have a fairly long process in Health Canada does. And. But once you're in, then it's really good, obviously. So we hope to do that at some point, but I don't have a date on that today.
- [21:37]
A
You know, it's a hard question for me to ask. Cause I'm not quite sure what to ask in terms of the twist pump itself. You know, from my experience being a caregiver for a kid with diabetes, it's like you put the CGM on, you have the pump, and then with updates you say, okay, we're using this kind of sensor and hopefully it gets the signal. And that's pretty much it from my perspective of how the CG and the pump work together. Can you speak to that though? Because the twist is, you know, it's tide pool loop. It was diy, it's Dean Kamen. It's a different form factor of a pump. It's very different. Anything you want to say from your.
- [22:09]
B
Perspective, Would love to, if you gimme a few minutes. I've been playing with this quite a bit. I really do enjoy it and I was more than pleasantly surprised when I got a chance to see it all working together when I was in Amsterdam for attd. I was like, wow, guys, this really is slick. So let's start with the pump functionality. It's round, it has 300 units, so it holds a nice volume of insulin. Right. It's not going to limit type twos or, you know, type ones that are using that much insulin. You see others that are at the 200, 180, 160 range. Right. Which can be limiting for some. I think the stats are, Stacey, the 60% of insulin users are at 200, the rest are above. So there's a big piece that you would miss or you have to change out, you know, know quite, quite often. So the 300 units I think is good. It appears to have very good accuracy. That's something that Dean came and prided himself in in the pump. And so they already are talking about. And analysts have been talking about superior accuracy. They've been talking about really solid occlusion detection, which we all know is a challenge. And so it's another piece. I saw a nice write up about that the other day. You know, you get those two pieces solved, that translates into greater reliability and obviously trust that comes from your patient or your healthcare provider. And so that's awesome. And then you already said it, you've got the folks from Tide Pool. And there's my second part of my story. Howard, look and Brandon Arbiter are two dear, dear friends. I was talking to Brandon yesterday forever, right? And you know, Howard's background coming from, I think, TiVo, right? Pixar. I think he did Amazon. He didn't need to do this. He didn't need to work. This was a passion, right? His daughter has Type one. He wanted to lean into precision medicine. He wanted to make a difference in the world and he wanted to free the data for everybody. I never forget my first meeting with him. Brian, that data is not yours, right? Everybody should have that data. It should be actionable. We should be able to do something with it. Let's go. Right? Make it accessible. And so I always tried to listen to Howard and I always was empowered when I was speaking with him because his passion's a lot like yours, right? It's just bubbling and you just want to talk to him forever. And Brandon, too. My gosh, talk about an amazing person, leader, collaborator, right? Wonderful to do work with. His passion just overflow with. So you take all their work on the data repository side, all their work on the Tide pool loop side, and I think they've brought a product now to the pump that offers a whole lot of personalization for someone who's using it, right? You can customize this thing to your ideal target setting, your range. There's features that you can do for your lifestyle. I think that part of it is different than some of the other pumps on the market and what people have been asking for, can I set my target? Can I do certain things? There's quite a few of those options on this pump. And then the way it can be worn is it's pretty, it's round, and it's not that big. So it can be worn on body with a short infusion set. It can be worn traditionally with a clip or in your pocket, can easily tuck that round little puck in your undergarment, right? We have a lot of clothes now with those little sleeves underneath and stuff. So I think people are going to like the way that that operates. And then the phone interface is one that the Loop folks developed with the SQL folks, so many folks will be familiar with that. It's really well done. You can bolus from your phone, you can bowl, you can operate it from the phone. That's a full phone control pump. Now you can bolus from an Apple watch. It has a bolus button on it. If you don't have a watch or phone with you, which is always nice to have. Right. And so I think the way that you can use it, the way you can wear it, the way that you can personalize it, I think it's easy. From what I can tell, it seems to check a lot of boxes. Stacy, from what, you know, from what I have seen and what I've read about it. We'll see once it gets. I mean, they just launched it this last week with the inner circle. Right now you'll start to see it roll out. I'm hearing rave reviews and I'm looking forward to learning more and looking forward to partnering.
- [25:55]
A
Boy lot there. We'll talk about Howard and Tidepool forever all day long. You know, they're just wonderful people. Let's let me follow up on something you mentioned there because this was on my list. When you're talking about data, tell me about Eversense and Data. Who owns that? What are you doing with the CGM readings you're getting? We know all the companies, you know, have access to this, usually blinded. But talk to us about that.
- [26:17]
B
That's really what it is, right? It's not anonymized. Anonymized. I can't even say it. Right. It is blinded at the end of the day. Right. We don't and will not let anyone's personal data be seen for any type of connective tissue there. Connection there. Right. So. But yes, we are. And I think the other CGM companies and pump companies are leaning more and more into getting their information into a tide pool database, a glucose database, into whatever they want to use. We have our own database that someone can monitor their glucose ranges and certainly share with their healthcare provider. The healthcare provider can see it in numerous ways as well. So we certainly are not holding that data hostage by any means and willing to share. Where we all get a little protected about is not only the privacy of the patient, but we also don't want it out there for nefarious reasons. Right. If someone's going to start doing some crazy comparisons without the proper context and the proper controls, it doesn't make sense with all the work that we put into it. So we are willing to share for academic reasons and other areas and stuff. But Dr. Fran Kaufman does a lot of that from the senseonics end. She's amazing, right. I used to compete against her for years as she was at Medtronic and I was at Tandem and she was throwing all that dirt on me as we were in our early stages, not doing so well. And I tell her all the time I couldn't stand her. If I saw her in the street, I might have hit the gas instead of you.
- [27:38]
A
Take that back.
- [27:40]
B
She's my best friend today and I tell her that all the time. We laugh about it. She is my partner in crime. I take her everywhere I could possibly take her with me because she is so smart and well connected. And the thing that people don't know about Dr. Kaufman, she's funny. Like, funny funny.
- [27:56]
A
Right. I'm making a note for next time I have her on the show.
- [27:59]
B
Oh, please do. She's a funny lady. And man, is she passionate.
- [28:02]
A
She sure is. One of the fun things that happens when I talk to you is you have a lot of, you know, a lot of people. You've been in this world a long time and you dropped a name at the beginning that I have to follow up on. You said the folks at Luna. Are you talking to Luna as a friendly conversation from Brian. Are you talking to Luna with the Eversense product?
- [28:20]
B
That's a good question. That is a loaded question, by the way. There's a lot of answers to that question. First, John Scholen and John Brilliant are two very close friends of mine. And so I knew John all the way back when he worked for Jeffrey Brewer. I knew him when he was working with the folks at Biolink and came down to San Diego. So he would come in the Tandem office, we'd sit around and talk at different times about what was going on. And now he's embarked on this new venture and, you know, for a little while it was under the covers and now it's wide open. You've spoken to them? They're in full fundraising mode right now. So I spent some time with them in Amsterdam. I spent some time looking at the product and helping them a little bit with a few of their conversations. From my perspective, if I were to be an investor, would I put my money and trying to help some friends out and stuff? And I think they're making some nice progress on getting their product closer to where it's ready for prime time. And yeah, was on the phone with John and John yesterday, just enjoying some time catching up on what they're doing. Are we interested in potentially partnering or connecting with them at some point? Absolutely. Why not have that conversation? But they're conversations today. Right. And quite frankly, I've said this a few times that I've been asked in the last couple of weeks. We're really far ahead here with SQL and we really have a first mover advantage with SQL. So I'm wickedly excited about that. Will those other meaningful conversations, you know, continue? Sure. Right. SQL is going to connect with other CGMs along the way. But you know, in this one case, we are quite a head start here and we're going to have quite a bit of fun with our partner where Luna goes and what that kind of different differentiated product looks like and stuff. And if that could use something with Senseonics, that would be interesting down the road. But I wish John and John all the success in the world here. They again are very passionate. Obviously John Scholling has wore many of the products, played with many of the products and stuff and knows diabetes inside and out. So I'm excited about where they're heading.
- [30:09]
A
I should mention, if you're not at all familiar with Luna, we did a full episode with them. They've been in our in the News episodes many times. I'll link that up in these show notes as well. But basically this is a product really just for overnight management. You, you would use your MDI or, or pens during the day and this is for overnight. I'm not going to get into it.
- [30:26]
B
You can, we can use the Pretty cool. I think there's a place for it. And I mean, you know, there's still a lot of folks who aren't using a, you know, fully automated pump today of a 40% do, 60% don't. So those other 60% would be a real good candidate for overnight control with a pump like that.
- [30:42]
A
It's really interesting.
- [30:43]
B
Yeah.
- [30:44]
A
I remember years and years ago when this product was first being talked about, people saying things like, I can't even imagine. I'm going to have a big scar on my arm. This is terrible. Why would you do that when you can just put a little CGM on it? And the conversation has changed right now, especially with the one year insertion. I think a lot of people feel very differently. What do you hear? Do you know people who have started, like, there's people who've been there since the beginning who were doing it when it was a lot shorter. Is there feedback that you hear from real people using this? And I'm not asking you this, you can do a big commercial for it. Like I, I know I'm setting you up as a softball here to say nice things, but I am wondering like someone who used the product years ago and is using it now, like, what does he like about it?
- [31:21]
B
You know, Stacy, we have folks and I'm not sure what the exact number is, but I know we have some folks that are well over 20 insertions. Right. And what you see with our product is once they get past the first term again, it's been six months, we're now into the year. And they move to the second sensor and then the third sensor. Every sensor they move towards, they're more likely to put another one in. Right. So our reinsertion or renewal rates go up exponentially as you move up that food chain. Accuracy, flexibility. Right. Being able to take it on and off. Simple. Don't have to go get now one for 365 days. Every 14 days, 15 days. The things we talked about before. But they just love how easy and convenient it is. And I think one of the things we didn't talk about, there's only one day one which you know what that is, right. When you put the sensor on, it doesn't always behave that first 6 hours, 12 hours, 24 hours. Right. Part of the reason we calibrate a little more frequently on the front end is to counterbalance that day one phenomena. But now you've got very level performance for the next 300. And in our case, 50 some days right after that early period of when it's not saying it's bad for 13 days, but that's why we calibrate to kind of get through that early period because you're getting some healing going on. That insertion is only a few millimeters, right. Three, four millimeters. It's tiny. The scarring is something that's.04%. Like it's nothing. Yeah. You rarely hear anybody talking about that. So the negatives, I think, are more in people's mind. If it's a procedure, it's a little bit out of my way. I got to schedule that differently. Does a doctor do it? Does a healthcare provider do it outside of the office? We have over 400 inserters that do insertions for us around the United States. If the doctor doesn't want to do it in the office, we can schedule outside. So we're trying to take that barrier or make it easier. The user experience a little bit better on that front. But quite frankly, we don't get a lot of negativity. Where it is, is, hey, I want to use a pump and it's not connected. Or paying for 365 days up front versus every 90 days might be a little bit more expensive. Right. So we have a PASS program to help with some of that. And we're trying to do things to kind of make that a little less demanding on the front end. But we're starting to see some real Good adherence here with our product.
- [33:32]
A
Do you have information, do you have data on people who get 30, 60 days in and want it taken out? Do there. Are there?
- [33:39]
B
I don't see too many people get it taken out. But it's funny you say that. And I won't give you all the stats because we've done this work here and we've done it actually very, very recently in a deep way. We call them silent quitters, right? Folks that don't call in, folks that just. So when the transmitter is on, it is transmitting to the phone, the values are being uploaded into the cloud and you can see it, your healthcare provider can see it. And clearly we have it in our database. And so if we want to troubleshoot, we can go in when somebody calls in and see what their values look like. We can see if they're not using their transmitter, if the sensor, quite frankly, is not doing anything. And so there are times when we've not gotten calls from folks yet, we're getting no values in their, in the system. So after a certain period of time, we want to make sure we call that individual and ask if there's anything we can do on behalf of that patient to, you know, get them to use it. Right. They're pod committed. They've got a sensor in their arm, they've got a transmitter that hopefully has got battery all fired up and we want them to stick that bad boy back on and get going. And so thankfully that's a small percentage, but that does happen. And then we have other folks who once it's through the term, which had either been 90 days or up until now 180 days, for whatever reason, they didn't renew, but they also didn't get it taken out. And it doesn't do anything, it just stays there. There's no. You can't see it, right? You can maybe feel it if you rub your finger on it. But my head of sales has had his in as a, as a demo for like, you know, four years. I don't think that's what you're supposed to do, but.
- [35:08]
A
I like that you share all the information.
- [35:10]
B
But we watch all that, we watch it very closely. We want to reach out to that patient because quite frankly, a payer made an investment, a physician made an investment, and that that customer made an investment. And we want to make sure they're happy with our product.
- [35:22]
A
Just to poke a little more though. People who have a problem with it get it with their numbers on that. Like I assume it's a pretty low.
- [35:29]
B
Percentage but doesn't it very small percentage. Right. Because again they've invested in it time.
- [35:34]
A
No, I mean if there's a problem, like if there's. Are there problems it happen?
- [35:38]
B
Sure. Oh, it happens. So just in the clinical trial. So this is valid open data. In the clinical trial we had survivability for 365 days at 90%. That was very similar to the data for the 180 but real world data once it was kind of all compiled was closer to 95%. So there is a percentile there where you have what we would call an early retirement. And if it happens too early, you want to go back in and you get a replacement. Right. So basically you're going to X Planet the same pocket, most likely you're going to put it back in or maybe you switch to the other arm and then you give them a new sensor. And that new sensor starts from day one again and off they go. And if that were to happen with the365, they now have 365 days of the one that we've put back in. We don't give them a, a shorter sensor or we don't try to truncate it in any way. It's, you know, it just happens, knock on wood. That is certainly not high on our list of complaints today. We don't have a lot of that going on but it certainly happens no different than a pump has an out of box failure or an early retirement. From a mechanical perspective on any other CGM or product, I'm going to adopt that terminology.
- [36:40]
A
My son has had several pumps early retired because he has run them over with his chair. He has gone to the beach and had incidents. Early retirement, I like that term.
- [36:52]
B
That's the worst case, right? We don't want to inconvenience a patient like that. That's not fun. And there is no charge to a patient for that. There's only inconvenience. We do everything in our power to make sure that we get someone to that patient so they don't have a disruption right in their, in their service and get them a new sensor implanted and hopefully they're off to the races for a full year. So I'm going to find some wood over here and just say that that for now has been a good. I said this on the last session you and I did. I was so impressed with the fact they could take 180 sensor, turn it into a full year sensor and still maintain the robust performance characteristics of that existing sensor. Both survivability as well as the low mar, the accuracy, all the things that we came to expect from the senseonics product over the years. That was pretty impressive engineering. Yeah.
- [37:39]
A
Before I let you go, I know better than to ask for timelines. So this is not that kind of a question, but give me some pie in the sky stuff. Are we thinking that maybe someday this product will be entirely under the skin? Are there other changes that you can talk about again, without a timeline?
- [37:57]
B
Give you the three timelines that I can share publicly today. And we've shared publicly in many different venues. One is we hope to have the sequel Eversense combination sometime this fall. And if we can pull that in, that's great. There's a lot of work going on and that's not that far away. So we're pretty excited about that. Then we've said out loud that Gemini is the next product. And Gemini will be implanted and it will have a battery. So today the sensor that's under the skin is passive. It's powered by the transmitter. So if you don't have the transmitter on, the sensor is not powered up. We will put a battery to that sensor now and insert it under the skin. And so then you can do two things with it going forward that will be either scanning it with your phone. Very similar to what the Libre one did, right? The near field communication, or you can still wear the transmitter and it would then automatically send it to a pump or a phone. Right. Now we've said we hope to have that product at the end of 2026. Okay. And there's work going on that fairly well characterized. Tim and the team at Senseonics has shared that very publicly. And then there is a product called Freedom. And Freedom is exactly what you're talking about. Now you have the Gemini product, the sensor with the battery, but you also add the Bluetooth to it. So you take out the near field communication that's in there and you put the Bluetooth in and now it's underneath the skin. Nothing on the outside of the skin. It'll still maintain it for a year, is the plan for both of them. But it's transmitting from underneath the skin to your phone or your pump continuously. And it will do so for a year. That obviously is what most people are extremely excited about, let alone us. I love that that's the end of 2027.
- [39:33]
A
Well, you did give me a timeline, Brian. You could knock me over with a feather.
- [39:38]
B
You asked. I got to answer or you won't have me on again. I appreciate the time I Appreciate the opportunity just to give your listeners something fun and educational and a little bit more out there. Right. I mean, again, I said this earlier. If you can go in and just click through, you've got so many unique, very educational pieces in there. You know, if a few people gain something from this, it's great. I love talking about it. I'm very passionate about it. We're making some nice progress. And I appreciate, like I said, you giving us the time and, and the opportunity to talk about a little bit. And we look forward to being able to present this to the. To the community soon. Right. It's going to be awesome.
- [40:13]
A
Very cool. Brian, thanks so much for joining me.
- [40:16]
B
Always. Thank you, Stacy.
- [40:22]
A
It is always very nice to hear very nice things like that. I very much appreciate it. Brian. Thank you for going out of your way before the interview to listen to all of those episodes and to say what you did. I very much appreciate it. You can learn more about Eversense and about the Twist. As I said, I'm gonna link up all of our previous episodes. We also have a very robust search box@diabetes-connections.com. just go to the website, upper right hand corner there is a box and you can put in ever since. Or Twist. Twist has two eyes, by the way. Or maybe you want to learn more about Dr. Fran Kaufman, who we mentioned you could put in Kaufman. I'm mentioning this because I think I mentioned the search box last week or the week before. I hadn't talked about it in a while and I heard from a lot of people who do not listen to the show through the website. And I get that. I don't listen to any podcasts through the actual website. I'm always on Apple podcasts or Spotify or another podcast app. And it was interesting. They were kind of surprised that it was such a robust search. But we do have 10 years of episodes on the website. So it's kind of fun to go back and look at the history of some of these products. You can see how they began and where they are now. We also have talked about products that no longer exist. We did a lot with Animus at the very beginning of this podcast. Animus is a company that no longer exists. It was part of Johnson and Johnson had a great pump. No longer. And I gotta tell you, I love that Diabetes Connections is a kind of a history of this period of time, these 10 years of diabetes technology and people in the community. It's amazing to me that I've been able to do this for this long and I'm still excited to tell stories and ask questions and bring information to you. All right, so I feel like I'm getting a little on about myself here, so we'll wrap it up. Thank you to my editor, John Bukennes from Audio Editing Solutions. Thank you so much for listening. I'm Stacey Sims. I'll see you back here soon. Until then, be kind to yourself. Diabetes Connections is a production of Stacy Sims Media. All rights reserved.
- [42:20]
B
All wrongs avenged.