Do We Need an At-Home A1C Test in the Age of CGM? Orange Biomed Says Yes

Making the case for a better at home A1C test. Orange Biomed is developing a compact, one-drop, at-home A1C testing device they say could make frequent A1C checks easier and more accessible than ever. They're passionate about closing the gap for people who struggle to get to clinics regularly… and the research they share is compelling: four A1C tests a year can lead to a nearly 4% reduction in A1C levels. We'll talk about why more frequent A1C monitoring matters—even in the era of continuous glucose monitoring—how their new device works, and what early clinical trial results look like. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. More about Orange BioMed here Announcing Community Commericals! Learn how to get your message on the show here. Learn more about studies and research at Thrivable here Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com    Episode transcript:   Stacey Simms  00:05 Today on diabetes connections, making the case for a better at home A1C test. Orange biomed is developing a compact, one drop device that they say could make frequent A1C checks easier and more accessible. They're sharing research that four A1C tests a year can lead to a nearly 4% reduction in A1C levels, but they say a lot of people can't get to the clinic that much. We'll talk about why this matters, even in the era of CGM, how the device works and what the early clinical trial results look like.   This podcast is not intended as medical advice. If you have those kinds of questions, please contact your healthcare provider.   Welcome to a bonus episode of diabetes connections. I hope your December is going well and that you know somehow you're able to take some time for yourself in the middle of all the holiday rushing around this time of year can be magical and stressful and exhausting and wonderful, and you know, all the things. And it's the same thing over here, super busy getting all this stuff done before the end of the year. Love it. But, you know, getting podcast episodes out, writing all the things we write and planning for next year, as they say, We're staying booked and busy.   But quick behind the scenes here to better explain this episode, I taped this interview way back over the summer during the ADA Scientific Sessions conference. I had some technical problems. I actually thought I lost this interview. There were two interviews that seemed to have gone missing. We're going to air the other one very soon. But thankfully, I do have backups upon backups. So all the info that you're going to hear today is still relevant.   This product, a small A1C test, is still in development. The only dated bit is about their follow up event that took place in August. Orange Biomed was launched in 2021 in South Korea, with its US headquarters in Providence, Rhode Island. Its founders are two Duke University alums, and they're my guests, CEO Yeaseul Park and Co-President Unghyeon Ko, We are also joined by Janice Dru-Bennett. She is a senior advisor at the company. Now, English is not the first language of two of these three speakers. This is a good time to remind you that most podcasting platforms have pretty good transcription services these days, especially Apple, I think they have a fantastic real time transcription service for podcasts that has been impressive to me in how they translate diabetes language. They're getting better at it. But I am also going to put a transcript of the interview in the show notes, which I don't normally do because the podcast services have gotten so good at it, but I think it could be helpful for at least a few of you out there. Okay, here is my conversation from the floor of ADA from the team at Orange biomed.   Yeaseul Park, Janice Drew Bennett and Dr Ko, Welcome to diabetes connections. I can't say live from ADA, because we're taping this to air later, but you're all there. Thank you so much for joining   Yeaseul Park  03:08 me. Yes, thank you. We're   03:10 excited to be here. Oh   Stacey Simms  03:11 my goodness. Can I ask first, how is the trip? I mean, yes, let me ask you. You guys came a long way.   Yeaseul Park  03:17 Yeah, it was 13 hours from Korea. But it's I'm so excited, because this event is really one of the times, and this is actually our third time attending ADA.   Stacey Simms  03:31 That's great. And we have so many questions for you, but Janice, let me ask you, you're there as everybody's setting up at the kind of beginnings of the show. What is it like right now for people who aren't familiar with ADA,   Janice Dru-Bennett  03:42 yes, you can hear the hammers in the background, although, but not on this podcast, but there's a lot of noise and people walking by. We're just setting up this the day before the exhibit hall opens and Dr Cole will be presenting at the Innovation Hub tomorrow, which is where we're sitting right now, with tables of innovators will be showcasing their diabetes innovations, and   Stacey Simms  04:04 there's a lot to get to. Dr Koh, I know you're presenting, but yes, let me ask you, like, what why? I know you said it's your third year, but why is orange biomed at ADA, what is your goal   Yeaseul Park  04:16 for us? ADA, is for a learning experience. As well as a platform to share. We come to see how all those around the world are fighting against diabetes, whether through clinical research, digital tools or technologies or community programs. At the same time, you're so proud to hear what orange biomat is building anytime, and eight months exhausting. That makes diabetes monitoring not accessible, not so many. And this year is especially exciting because Dr ko our co founder of orange buying at the group of speaking at ADA brand new program the innovation Hall.   Stacey Simms  04:58 That's awesome. So Dr Koh, tell me. Little bit about this, the Innovation Hub is pretty cool, but what are you going to be talking about?   Unghyeon Ko  05:05 Yeah, actually, I'm talking about the engineering part. I mean our technology, so our orange biomed, we are trying to solve a simple but a serious problem about the A1C accessibility. So to increase the A1C accessibility. So we are, we are developing at home device to measure the A1C level. So I'm, I'm talking about how difficult to increase the accessibility of A1C, but our technology is handled that difficult problem. So we now he's so agreed. So I'm going to introduce our technology and emphasize the importance of the A1C measurement at home.   Stacey Simms  05:49 Yeah, so A1C, it's interesting. My son was diagnosed at two, and in the pediatric world, you know, they'll just prick a finger generally and have that A1C right away. But my husband lives with type two, and he gets his labs drawn. And then it takes forever. So tell me a little bit before we go further about what you're hoping to do and making this easier for the patient,   Speaker 1  06:10 the frequent monitoring of A1C is so important to prevent the diabetic complications. So the money, so if you there is some so I can say that there is a research that if you measure the A 1d the four times a year, the People's A1C level is decreased like 3.8% but if you measure the A 1d at one per year, Then the A1C level is increased 1.5% so the frequent A1C monitoring is so important to prevent the diabetes complications. But problem is A1C measurement is only available at clinical site at this moment, so most of the A1C monitoring is done by the clinical side. So that's why people are difficult to monitoring A1C, because they have to visit the clinics forever. So is so like four times, or even eight times visit the clinics or hospital is quite difficult, especially in the people living in the far area from the hospital. So that's why the home A1C test is required. So I think that's why the accessibility of the A1C is one of the important things in managing the diabetes complications.   Stacey Simms  07:39 Dr Koh, is there evidence that, I mean more frequent A1C testing, I think would give many people peace of mind, perhaps. But is there evidence that it really does help in your health?   Speaker 1  07:51 Oh, yes, it is actually like from there is the research, like the famous research about the A1C level, like the research name this t and this research proved that the A1C is the one of the strongest predictor of diabetes complication. So A1C is completely related with the risk of diabetes complication. So like keeping A1C on the 7% dramatically lower the risk of diabetes complications. And also, there is another research in UK, the UK PDS study, and that study said they are A1C. Lowering A1C by just 1% can reduce overall mortality by 15% and microvascular complication by 37% so the roaring A1C is the goal of the treatment of the   Yeaseul Park  08:47 diabetes. So   Stacey Simms  08:48 when I think of at home diabetes tests, blood tests, seem like they're they're really sensitive, right? You have to be very careful with things like that, although we do, we did finger sticks at home for years and years. Are there challenges with at home A1C testing that that people like me could mess up,   Yeaseul Park  09:06 sure actually when I was doing pandemic outside system? So it's a new   Yeaseul Park  09:19 box of mustard with five or six needles inside, and we need to collect this blood to sound the left result. But then I really tried to collect the requirement matter blood, which is like it was like bleeding. Oh, it's not just retiring in one block, one drop of block, but it's like you need to try, yeah, many times, not just in one spot, to collapse in the block. And the other way you. Built female in, built a lot more broadly, to store your venous blood, and that's features like discomfort.   Stacey Simms  10:10 Would you mind taking us through your experience with the A1C testing? You were talking about how much blood it took? Yeah.   Yeaseul Park  10:17 So it, it requires many, many drops of blood. So I felt like it's like bleeding, and you make a lot of mess around the table. And so I felt, even though it's it was a topic time it was pandemic. So that's the only option I had at that time, but I wanted to make it simple and easier. And the other types of point of care devices only use a drop of blood still have some limitations, because we all don't want to bleed too much, so sometimes we try to finger stick very small and just squeeze to get enough blood. But if you squeeze to get enough sample volume, that's make your other liquid, like sweats, can also mix with your blood, and that actually affects the accuracy of the testing usually so many point of care devices also not recommend you to squeeze to get enough blood, so that means you need to treat a little too deep to get enough. So we really wanted to make this whole process or simpler and more problem.   Stacey Simms  11:43 Can you share a little bit about what the device looks like, what the patient experience is when they use it?   Speaker 1  11:48 Dr, CO, so our device is a palm size. Is in most like, like self, self poem, so it's a palm size device. So our device has no switch, but there is only a slider in the front of the device. So if you slide that, you can the device is turned on and you can insert the cartridge, and the cartridge is disposable cartridge. So after that, you just collect your blood and dilute it in the collecting tube and drop the sample into the cartridge, then analyze the A1C like automatically. So it's quite similar with the covid by covid test kit. So the covid test kit collect the sample in your nose and mix with the Rickett and drop it right? And it's quite similar.   Stacey Simms  12:45 So do you do a finger stick to put on the cartridge? How much blood to yells? Point, you know? How much blood do you need?   Speaker 1  12:52 Our devices for home use device, so it's quite we use a very different technology, because our device analyze the red blood cell one by one. So actually, we don't need exact unlike like five micro or 10 micro, we don't need the exact sample block. So we just need one drop of blood. So if the one drop is big, or if the one drop is right or small, it's fine for us. So one drop of blood, mix with their sample and drop one drop onto the cartridge. So maybe you can, you can drop one more than one drop, but we recommend one drop. So one drop of blood sample my dinner the rest yesterday pointed out that the skeezing the finger of blood is a problem for other device because, because in our body, there is a body wicked inside your under, under your skin. So if the body wicked is mixed with the blood samples, so it might be a problem because it dilute the blood sample. But our device, we analyze the Red Cross itself. So if it is diabetes, I think so we will find so you just puncture very best, and if you scale it, and it's totally fine for us. So it's, it's one of the good point of our device.   Yeaseul Park  14:20 How long does it take to get the results? It takes like, five minutes. Okay, yeah, and that's all at home. Yeah. Yezel, who do you see using this? Who is this for? Basically, it's for everyone. I think whoever has pre diabetes, diabetes type one, type two, and especially, I think who has limited access to primary care or lab testings. You know, many people who are older, tends to have more, especially the people who has limited access to primary care or lab testings. We believe this device can give more value to them. Yeah, and especially some people who have limited mobility, if they are older, or if they have experienced that amputation or something like that, they cannot go to the hospital by themselves. They need a caregivers to drive them to the hospital for the simple lab testing. But now I think it empowers patients who has that limitation still can take control their health by using this kind of home use device. How accurate   Stacey Simms  15:33 is it? I assume you have studies, and you've done some trials on how on the accuracy?   Yeaseul Park  15:37 Dr, CO, do you want to add that?   Speaker 1  15:40 Oh, yeah. So we are preparing the clinical trial. So the official clinical trials will be done within this year, but so that's our plan. But we we tested our device already using the in in last year. So last year, feasibility studies show that our device is quite similar with other point of care devices, and hopefully because at that time, our device, our especially our cartridge sensor, we just manufacturing our own like our in our lab. So this time, the official clinical trial in in this year, we are going to manufacturing in the factories so it might be more precise. So we hopefully we trying to chase the hospital accurate.   Stacey Simms  16:30 And I have to ask, where more and more people with diabetes are wearing a CGM and looking at time and range. What would you say to people who would tell you, well, we don't really need A1C anymore. We have time and range. Dr Cody, I see you nodding. Go ahead, yeah, yeah.   Speaker 1  16:47 So that's a very important point, but because the timing range is also important, and the CGM is very great technology for diabetes people. But problem is, like the A1C and C GM target different, like the CGM target the hypothesemia, but the A1C targeting the diabetes complications. So like, if you measure the timing range and you can manage your average glucose more nicely, but it might be prevent your hypothenia. But if you want to assess your diabetes management, you might be measure A1C. So if you measure timing range, but you also have to measure the A1C. So A1C is for everyone's and so. And also, the point is, if you don't treat the insulin, or if you don't treat the any medications, then you don't need to actually using the CGM, that's the ADH recommendation. So, but in in that case, you need the A1C as well. So A1C for everyone, and the CGM is for the people who treated the insulin. That's the ADA guide, right? And then,   Stacey Simms  18:12 yes, let me just ask you. You know, you came all this way. As you say, this is your third time at ADA. Trials are starting soon. What's your hope here? Is this something you see in homes of everyone who has any kind of diabetes? What's the big goal for Orange biomed?   Yeaseul Park  18:28 Every time we talk to a day, we can feel what's going on here in diabetes industry. It's a huge maybe first year, I the most frequently hard keyword was aid system. But after that, we now have GLP one, and now we hear more keyword around obesity. So that's a little slightly different trend I can feel. And once you come and join this full sessions, then I can see there's make everyone is making a progress, and we are all together. Want to fight against diabetes in their own way or with their own expertise, whether it's pharmaceutical, whether it's medical device or diabetes, sex, sometimes any other community programs that really support this patient and families, the community, and it's Really this whole atmosphere actually really motivates our team and myself, and we can feel the value. I can really feel this we are doing something valuable to patients and our community, and that's the most great thing, like the greatest thing that I can take when I come back to home with a. After the ADA. And for sure, we want to have opportunity to make voice what we are doing at Orange biomed, and want to deliver this value to the patient and other healthcare professionals. Otherwise, even though we are working hard to make this progress, no one knows, and that makes any changes the world. So that's the important purpose we are coming here. That's great.   Stacey Simms  20:30 Janice, before I let you all go, I know you wanted to talk about an event you've got coming up in Chicago. Can you tell me a little   Janice Dru-Bennett  20:37 bit about that? Yes, we're really excited for Orange biomed to be hosting the first map your health event, a local event here in Chicago, we have done a solving healthcare challenges webinar to announce our map your health campaign, which is, monitor your A1C, monitor your health and then adapt your treatment and prevent chronic disease. And we're actually going to be hosting on August 16, from 10am to 3pm in Chicago at their humble Park, Health Wellness Center, the first local event, inviting all local partners. We'll have some virtual sessions, showcase with yoga or ask the endocrinologist. So we'll have a very exciting agenda that both virtual and on site participants can join in, eat healthy foods. See, see what's in Chicago from a screenings perspective, and really get people motivated to map your health. So hashtag, map your health. Tell your your your health story, and let's get everyone, um, healthier. Wow.   Stacey Simms  21:35 Okay, fantastic. Well, yes, I'll park Dr co Janice, thank you so much for joining me. Have a terrific show. I know this is an audio podcast, but especially behind you. Yassil, it has been wild to watch the construction guys are going by and motorized carts and things are going up behind you. So have a wonderful ADA. Keep us posted, and we'll get the word out about your event in August and going forward. Thanks so much for joining me.   more information in the show notes about the studies and about orange biomed. You can sign up for alerts and emails from them as their product moves forward. So if you're interested, definitely check that out. Thank you to my editor, John Bukenis from audio editing solutions, thank you so much for listening. I'm Stacey Simms. I'll see you back here soon. Until then, be kind to yourself.   Benny  22:30 Diabetes Connections is a production of Stacey Simms media. All Rights Reserved, all wrongs avenged.    

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