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Diabetes Connections | Type 1 Diabetes
Do We Need an At-Home A1C Test in the Age of CGM? Orange Biomed Says Yes
00:22:45
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Stacey Sims
Foreign.
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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 showing research that four A1C tests a year can lead to a nearly 4% reduction in A1C levels and 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 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 with 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 seem 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 Yesel park and co President Eun Yong Ko. We are also joined by Janice Drew Bennett. She is a senior advisor at the company. Now, English is not the first language of two of these three speakers. Uh, 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, they're getting better at it. But I am also going to put a transcript of the interview in the show notes, which I I don't normally do because the. 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 OrangeBioMed, Yesil Park, Janice, Drew Bennett and Dr. Koh. 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 me.
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Yes, thank you. We're excited to be here.
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Dr. Koh
Thank you for inviting us.
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Stacey Sims
Oh, my goodness. Can I ask first, how was the trip?
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Janice Drew Bennett
I mean.
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Stacey Sims
Yes, let me ask you, you guys came a long way.
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Yesel Park
Yeah, it was 13 hours from Korea. But I'm so excited because this event is really one of the times and this is actually our third time attending ada.
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Stacey Sims
That's great. 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, you know, aren't familiar with ada?
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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. Koh 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.
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And there's a lot to get to. Dr. Ko, I know you're presenting, but Yeza, 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?
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Yesel Park
For us, ADA is for a learning experience as well as a platform to share. We come to see how others around the world are fighting against diabetes, whether through clinical research, digital tools or technologies, or community programs. And at the same time, we are so proud to share what Orange Biomedical is building. A new kind of A1C testing that makes diabetes monitoring more accessible, more obvious. And this year is especially exciting because Dr. Co, our CO founder of Orange Magnetic Lab is speaking at ADA's brand new program, the Innovation Hub.
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Stacey Sims
That's awesome. So, Dr. Koh, tell me a little bit about this. The Innovation Hub is pretty cool, but what are you going to be talking about?
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Dr. Koh
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 serious problems about the A1C accessibility. So to increase the A1C accessibility. So we are developing at home device to measure the A1C level. So I'm talking about how difficult to increase the accessibility of A1C but our technology is handled that difficult problem so we now we solve it. So I'm going to introduce our technology and emphasize the importance of the A1C measurement at home. Yeah.
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Stacey Sims
So A1C. It's interesting. My son was diagnosed at 2 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 2 and he gets his labs drawn and then it takes forever. So tell me a little bit before we go further about what you are hoping to do in making this easier for the patient.
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Dr. Koh
The frequent monitoring of A1C is so important to prevent the diabetic complications. So the moni. So if you. There is some. So I can say that there is a research that if you measure the A1C four times a year, the people's A1C level is decreased like 3.8%. But if you measure the A1C at once 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 at clinical site at this moment. So Most of the A1C monitoring is done by the clinical site. So that's why people are difficult to monitor A1C because they have to visit the clinics forever. So it's so like four times or even eight times visit 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.
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Stacey Sims
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?
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Dr. Koh
Oh yes, it is actually like from there is the research, like the famous research about the A1C level, like the research name DSI Shi 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 complications. So like keeping a 1C on the 7% dramatically lowered the risk of diabetes complications. And also there is another research in UK, the UK PDS study. And that study said the A1C lowering A1C by just 1% can reduce overall mortality by 15% and microvascular complication by 37%. So the lowering A1C is the goal of the treatment of the diabetes.
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Stacey Sims
So 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?
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Yesel Park
Sure. Actually, when I was in this pandemic, I tried email the ad form Snaskit for a 16 system. So it's a. You can get a bottle with five or six needles inside. You need to collect this blood to sound the left. So you're in needles. But then I really tried to collect the required amount of blood. It was like bleeding.
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Dr. Koh
Oh.
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Yesel Park
It's not just requiring one blood, one drop of block, but it's like you need to try. Yeah, many times. Not just in one spot to blast enough block.
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Dr. Koh
No.
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Yesel Park
And the other way is you built, you know, you built the lab or flat lab to build Venice. Blob and discomfort.
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Stacey Sims
Would you mind taking us through your experience with the A1C testing? You were talking about how much blood it took.
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Janice Drew Bennett
Yeah. 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 was a 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 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 more simpler and more comfortable.
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Stacey Sims
Can you share a little bit about what the device looks like, what the patient experiences when they use it? Dr. Ko.
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Dr. Koh
So our device, it's a palm size, it looks like cell phone, 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, the device is turned on. And you can insert the cartridge. And that 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 test kit. So the COVID test kit collect the sample in your nose and mix with the ricket and drive it. Right. And it's quite similar.
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Stacey Sims
So do you do a finger stick to put on the cartridge? How much blood to Yezel's point, you know, how much blood do you need?
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Dr. Koh
Our device is for home use device. So it's quite. We use a very different technology because our device analyzed the red blood cell one by one. So actually we don't need exact like 5 micro or 10 micro, we don't need the exact sample problem. So we just need one drop of blood. So if the one drop is big or if the one drop is small, it's fine for us. So one drop of blood mixed with the 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 DNA, the rest yesterday pointed out that the squeezing the finger of blood is problem for other device because. Because in our body there is a body ricket inside your, on, under, under your skin. So if the body ricket 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 blood cell itself. So if we style it, 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 one of the good points of our device.
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Stacey Sims
How long does it take to get the results?
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Dr. Koh
It takes like five minutes. Okay.
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Stacey Sims
Yeah. And that's all at home.
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Dr. Koh
Yeah.
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Stacey Sims
Yezel, who do you see using this? Who is this for?
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Janice Drew Bennett
Basically it's for everyone. I think whoever has prediabetes, diabetes, type 1, type 2, 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. And especially some people who have limited mobility, if they are older or if they have experienced 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 imparts patients who has that limitation still can take control of their health by using this kind of home use device.
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Stacey Sims
How accurate is it? I assume you have studies and you've done some trials on how on the accuracy.
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Janice Drew Bennett
Dr. Koh, do you want to add on that?
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Dr. Koh
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 tested our device already using the in last year. So last year feasibility studies showed that our device is quite similar with other point of care devices. And hopefully because at that time our device especially our cartridge sensor, we just manufacturing our own like our in in our lab. So this time the official clinical trial in in this year we are going to manufacturing the factories so it might be more precise. So we hopefully we trying to chase the hospital accurate.
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Stacey Sims
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 a 1C anymore, we have time and range. Dr. Cody, I see you nodding.
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Dr. Koh
Go ahead. Yeah, yeah. 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 CGM target different like the CGM target the hypothermia but. 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 hypothermias. But if you want to assess your diabetes management, you might be measured a 1C. So if you measure timing range, but you also have to measure the A1C. So A1C is for everyone. And, and so and also the point is if you don't treat the insulin or if you don't treat any medications, then you don't need to actually using the CGM. That's the ADA's 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?
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Stacey Sims
And then 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?
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Janice Drew Bennett
Every time we come to ada, we can feel what's going on here? In diabetics industry it's a big huge maybe first year the most frequently taught keyword was aid system but after that we now have GLP1 and now we hear more keyword around obesity. So it'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 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 diagnostics, 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, the greatest thing that I can take when I come back to home after the ada. And for sure we want to have opportunity to make voice what we are doing at Odorange 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.
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Stacey Sims
That's great. And 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 bit about that?
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Janice Drew Bennett
Yes.
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Stacey Sims
We're really excited for Orange Biomet to be hosting the first Map youp Health event. A local event here in Chicago. We have done a Solving Healthcare Intelligence 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 16th from 10am to 3pm in Chicago at their Humboldt Park Health Wellness center. The first local event inviting all local partners. We'll have some virtual sessions showcased 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 healthier.
- [21:35]
Wow. Okay, fantastic. Well, Yesel Park Dr. Ko Janice, thank you so much for joining me. Have a terrific show. I know this is an audio podcast but especially behind you Yesel, it has been wild to watch the construction guys are going by in 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 Buchenis 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. All wrongs avenged.