The Diabetes device that could end DKA? - Dr. David Ahn

We know DKA kills. And is often the first thing that occurs when people are newly diagnosed with diabetes. But now there’s a continuous dual glucose ketone monitor, manufactured by Abbott, that could change it all. In this episode of The Diabetes Diaries, Rachael Sood sits down with Dr. David Ahn, Endocrinologist of Orange County, California. Dr. Ahn explains that CKM technology is not far from US approval, and could be an early indicator of DKA, even earlier than hyperglycemia and the alarms we get from CGM. We discuss the pros and cons of CKM, and if this will solve problems or create new ones? We discuss certain populations, specifically children and wonder if parents can use this technology, especially in conjunction with follow apps. Using CKM may increase awareness for not just people with diabetes, but also for doctors. It is known that certain medication’s can increase risk for DKA so could the evolution of CKM differentiate a new generation of clinicians more ready to prescribe drug classes like Glp1 and SGLT2 inhibitors, that maybe they were scared to do prior? Learn about the brands by Abbot and Dexcom entering the market, which could connect to other systems such as pumps. 

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Transcript

SPEAKER_00 0:02

Welcome to the Diabetes Diaries. I am your host, Rachel Seude. Joining me today is Dr. David Ahn, endocrinologist and chief of the Mary and Dick Allen Diabetes Center at Hogue Hospital in Orange County, California. Dr. Ahn is one of the leading voices in diabetes technology. And today he is here to talk about a brand new device that could change everything for people living with diabetes. Something that monitors both glucose and ketones in real time and just became available. If you or someone you love has diabetes, you need to hear this. Dr. Ahn, welcome to the show.

SPEAKER_01 0:38

Thanks for having me. This is so exciting.

SPEAKER_00 0:40

So, Dr. Ahn, every year, people living with diabetes they end up in the emergency room from something that maybe could have been caught earlier. There is now a device that is coming onto the market that could change that completely. And did it just become available? Tell me everything.

SPEAKER_01 0:58

Great news. Yeah. So what you're referring to is called diabetic ketoacidosis. And I often refer to it as kind of like the big bad guy when it comes to diabetes, especially in type 1 diabetes, but it can happen to anybody with diabetes. And um, typically, or in in a worst case scenario, like you said, you can end up in the hospital and it can be in severe cases associated with death as well. So this is why it's kind of the big bad guy, the final boss when it comes to uh diabetes. Um the sensor that came out that you're referring to is the Libre Duo made by Abbott. So they also make the freestyle Libre continuous glucose monitor. And it just got FDA approved. So, or sorry, it just got approved, the CE marking approved in Europe. So it's not yet FDA approved in the United States.

SPEAKER_00 1:40

Do you think that's coming soon, or do we know anything about that?

SPEAKER_01 1:44

Yeah, I think very I I guess we don't know the exact dates, but uh, but I think as an industry, we are all eagerly awaiting the approval. I think many of us are hoping it's uh it's gonna be approved and available before the end of this year. But until we get the official news from the FDA and the official statements from the companies, we don't know for sure.

SPEAKER_00 2:01

Yeah. So I know you were talking about diabetic ketoacidosis. Is this how most people are diagnosed with diabetes, just in your opinion and your experience as an endocrinologist?

SPEAKER_01 2:11

100%. So um many people uh are their initial presentation with with type one diabetes, especially, is going to be in the form of DKA or diabetic ketoacidosis. And that's why people often present by first going into the hospital, um, you know, the the symptoms associated with it or abdominal pain, nausea, vomiting. Um, and so it's a very serious condition.

SPEAKER_00 2:32

And they don't even know they have diabetes until they go to the hospital with symptoms, and that's when they're diagnosed. Like how tragic and depressing. Like I wish we had a way to know ahead of time. Correct. So, how does catching ketones in real time change the outcome for someone living with diabetes?

SPEAKER_01 2:51

There are many ways that um having a continuous ketone monitor could potentially impact the trajectory of their condition. Um, so I think preventing and being aware of DKA is one of the big ones because, as we talked about, the potential downsides are so severe. Um, and so having a continuous ketone monitor can kind of alert you to certain situations where you could be at risk of progressing to DKA. It's like an early warning sign that DKA could be coming. Okay. And there are a few use cases I think of. So um uh there are certain medications that we use to treat in type 2 diabetes and off-label and type 1 diabetes that can make you more prone.

SPEAKER_00 3:29

What are those medications? What do people need to know?

SPEAKER_01 3:31

Yeah, so the most common class of medications are gonna be the SGLT2 inhibitors. These are pills. Um, and examples, uh, brand name examples are gonna be like Farsega, Jardiance, Inbocana. Um, and those can increase your risk for DKA, but kind of a special form of DKA where it's not as obvious. Um, maybe I won't go into the too many details for time, but um, basically it can be a more subtle, hidden type of DKA. Yeah. And so wearing a continuous ketone monitor could be a really good safety net for people that are taking those medications.

SPEAKER_00 4:02

I think you bring up a really good point. This drug class of medications, SGLT2 inhibitors, they have a huge effect on diabetes, but also we're seeing lots of kidney protection and they offer a lot of protection for the heart. They even have some subtle weight loss changes, which is I think a lot of people don't know about this. I've heard about something called euglycemic or normal glycemic diabetic ketoacidosis. Is that a thing?

SPEAKER_01 4:29

Yes, that's definitely a thing. And that's kind of what I that's what I was alluding to. So the reason why it's tricky uh in a more subtle form is that typically we kind of associate DKA with high glucose levels. So in addition to rising ketones, you would have elevated glucose levels. And that used to be kind of the telltale sign. But when you're taking a medication like an SGLT2 inhibitor, you might have normoglycemic or you know, a fancy name for normal glucose levels, or just mildly elevated glucose levels, and still develop DKA. So in those situations, having that CGM isn't going to be enough to let you realize that, oh, I might be going into DKA. So that's why, you know, just as you stated, there's so many secondary benefits to these medications, the heart protection, the kidney protection, the mild weight loss, blood pressure reduction. So as a as a whole, we're often scared to use these medications. The reason why they're off label in type 1 diabetes is largely because of the risk of DKA. So if we have a tool to mitigate that risk, then perhaps we can unlock and give that those secondary benefits to more people with type 1 diabetes without having to use it off label.

SPEAKER_00 5:32

That's a great explanation. And actually leads me to my next question. Do you think coming onto the market, the continuous ketone monitor, is that gonna open up the door for people that maybe wouldn't have used certain medications or therapies or they were scared of it? And even providers, do you think we're gonna see more people adapting to therapies like SGT2 inhibitors or GLP1s that maybe wouldn't have before because they didn't have this monitoring?

SPEAKER_01 5:56

Yes, I I think that's that's perhaps one of the biggest use cases because so many people are taking these medications. And I'm glad you mentioned GLP1s as well, because there is a slightly risked increased risk of euglycemic DKA with GLP1s, not as much as the SGLT2 inhibitors, but um a small percentage of GLP1 users. But as you know, so many people now are using GLP1s that you know, even that small percentage will present at, you know, when the denominator's a large number. So um, so yeah, I think being able to prescribe these medications that have other benefits for our patients more confidently, knowing that we have a tool to help detect the one thing that we're most scared about in those rare cases will help us.

SPEAKER_00 6:36

Yeah, and it'll prevent hospitalization. And I think this monitor is going to bring a little bit more awareness of what is DKA. And the normal average Joe thinks DKA means high blood sugar, but it actually may mean a location problem. I always say it's a glucose location problem or a lack of insulin problem. So it's not necessarily always really, really high blood sugar over 250, 300, 400. There's a there's another issue that's going on, a lack of insulin. And so the body is pulling other forms of energy, and that's what ketones are, right?

SPEAKER_01 7:12

For sure. And I'm glad that you know you you mentioned it that way because um, yeah, it's the way unfortunately, for better or worse, uh, the way that both physicians and lay people get educated is often when there's a marketing reason, right? And so I think the fact that there's gonna be, you know, a product that detects DKA is gonna really put a lot of money into advertising, into educating the public, into educating physicians, because there's a lot of nuances to TKA, like you just mentioned. For the longest time, most people thought, oh, it's a high glucose problem. It's not um when it's actually an under-insulin problem. Um, and so, you know, the more education, the better.

SPEAKER_00 7:49

Yeah. So continuous glucose ketone monitors or continuous ketone monitors, are we gonna see, like, are people just gonna be able to buy this or do they need a prescription for it? How's it gonna work?

SPEAKER_01 8:00

Very much um similar, I think, to continue current continuous glucose monitors that are prescribed by physicians. So I think this is gonna be much more like a Libre product or a DEXCOM product, uh like a G7 product when whenever Dexcom has an option like this available. I do not think it's gonna be an over-the-counter option like the Lingo or the um Stello.

SPEAKER_00 8:20

Yeah. A lot of consumers do have access to ketone monitoring. What are some ways that somebody can monitor for ketones if they don't have access to the new prescription continuous ketone monitor?

SPEAKER_01 8:32

Yeah, great point. So, like a continuous glucose monitor, you know, there are manual equivalents to it, right? So there you can do finger finger stick testing for blood glucose. Same thing with ketones. So there are ketone meters that you can purchase where you can actually do a finger stick and get a numerical ketone value.

SPEAKER_00 8:48

And you can just buy that off of Amazon, right? A ketone blood monitor. A lot of people don't know about that.

SPEAKER_01 8:54

For sure. And some, you know, hardcore ketogenic diet people will kind of monitor their levels. Um, similarly, um, what's more common, especially in the pediatric population, is um what people often refer to as keto sticks, but they're acetone urine test strips. Um, and you basically, and it basically is like a dipstick, and and it will give you a readout to a color comparison chart to kind of determine how many ketones you have or how, yeah, how much, how severe the ketones that are present in your urine are.

SPEAKER_00 9:20

So at least if somebody doesn't have access, they have other ways to look for ketones. But the continuous ketone monitors, I wonder if they're going to be more expensive than the regular CGM, the glucose. You know, CGM still, we've both been prescribing CGM for a long time, right? And it is standard of care. We offer it to diabetes people with diabetes early, but there are some financial like barriers. Some people can't afford them if they're not covered by insurance. Do you see that happening with ketone monitors?

SPEAKER_01 9:49

I think that's what a lot of people, especially you and I, people that are really passionate about getting these sensors into the hands of the most people possible. I think those are the types of questions that we all have. Um, I don't know. I don't think they've given any indication yet whether it's gonna be like a higher price point than the Libre, whether it's gonna just kind of replace the Libre. Um, other questions I think that abound are like how will the integration with automated insulin delivery work?

SPEAKER_00 10:12

Right. Like, will these monitors connect to all of the insulin pumps? Because wouldn't that be helpful? Are you gonna have to wear two Right?

SPEAKER_01 10:20

Like a CGM and a CKM. Yeah.

SPEAKER_00 10:22

I mean, people have enough to worry about with pumps and CGM. A lot of my patients, I'm sure you can you know attest to this. I don't want to wear more stuff. You know what I mean? So I hope it's going to connect to pumps.

SPEAKER_01 10:32

Yeah, the early indications I've gotten is that um I think what I've been kind of hinted at is that it's probably gonna integrate with your system. So you're you're gonna be able to not have to wear two sensors, but that the C the CKM data is not gonna be incorporated into the algorithm off the bat. So uh the CKM data is gonna be like a separate data channel through the same sensor. Right. Um, yeah.

SPEAKER_00 10:54

People with diabetes hate more alarms. I just have to say that out loud. And so one of my big concerns about the continuous ketone monitor is is this going to wake people up all night? Is this going to give false alarms? Because we know with CGM, oh, my my CGM is lying to me. My CGM isn't reading right. Oh, do a finger stick and let's see it's right. Do you think ketone monitors are going to be the same way? Are they going to be giving false like information?

SPEAKER_01 11:23

I I think it's a real concern. And um, and this is kind of where we can maybe shift the discussion to be a little bit more um open-minded, I guess, for lack of a better phrase. Like, I think ketones are something that we don't fully understand in the sense that people don't test their ketones very often, right? Now in a presentation earlier at this conference that we're at the ADA, um, there was kind of a debate, a back and forth on how valid or how necessary is continuous ketone monitoring. So it's still a question that we have for debate. And the reality is, is most people are not buying, especially in the adult population, are not buying or at least not regularly using ketone monitoring. Um, and so we you we don't know what data is gonna look like when you have it being measured every minute. And to your point, I think the concern is that there might be false positives because there are a lot of, unlike glucose, there are a lot of scenarios where your ketones can rise. Um, there are a lot of different things that can raise your uh ketones. So for example, if you haven't eaten in a long time, um, you can your ketones can rise. That's why people uh, you know, the ketogenic diet exists because your ketone levels rise.

SPEAKER_00 12:27

People maybe like endurance training, athletes, maybe women that are breastfeeding, lactation, these are different scenarios where you may be malnourished and it's not because you wanted to be, it's just the state that you're in, right?

SPEAKER_01 12:39

Right, right. And and those are system, those are situations where your levels are actually rising, like their ketone levels are actually rising. But we also don't know what the what the kind of artifactual errors are gonna be. Like, is there something equivalent to a pressure low that's gonna happen with ketogenic or with uh ketone sensors? So I I think the first year or two is gonna be very much a learning experience for all of us. Um, and I think yeah, it it will be very I'm very excited for the data to be available, but to be perfectly transparent, I don't know exactly how it's gonna translate to clinical practice right off the bat.

SPEAKER_00 13:11

Yeah. I am worried about, I mean, I'm excited about this technology, but I'm worried about many people, even in primary care, not knowing what to do with this information. And I'm also worried about the people that go into DKA, the people that have uh ketosis are usually the ones that lack access to a lot of things anyway. So are we even gonna get the continuous ketone monitor to the people that even need it, the high-risk people? That's another question I have.

SPEAKER_01 13:41

It's a really good question because you know, it's it's both a um, it's like acts it's access both financially and um, you know, like what your desires are, right? Because a lot of the people that struggle with these DKA episodes are often the ones that might have a hard time remembering to inject insulin or might not want to have anything attached to their body. So to your point, yeah, maybe this is a tool for like the worried well, unfortunately, in diabetes.

SPEAKER_00 14:05

Yeah. What do you want every single person living with diabetes to walk away from today's conversation, knowing after hearing about all of this?

SPEAKER_01 14:15

I think you and I both did a great job of talking about this, but I think it's just highlighting the concepts that are the most important. Like you said, not everybody will be able to afford it. Maybe these sensors don't even take the market by storm. But the most valuable thing we can all benefit from is the awareness of DKA and what the value of ketones are. Um, because even though I alluded to the fact that we're not monitoring ketones that often, I think you and I would both agree like we should probably be keep monitoring them more than like next time. We totally, yeah. And so um, and so I think just if the general population understands what DKA is, they understand that you can have a normal glucose or a mildly elevated glucose and still have DKA. And they can know what types of things to look out for, like abdominal pain, nausea, vomiting, the things to the red flags for that when your DKA can be kind of tipping over into a place that you really need to get urgent medical attention. Um, if people can learn those things as clinicians, like that's what I care about because knowledge is free.

SPEAKER_00 15:13

Yeah, no, thank you for all of those insights. I do wonder that this is going to be new information. And the American Diabetes Association has put out some guidelines about continuous ketone monitoring. And then also at the ADA conference, um, several physicians did a presentation, I think just yesterday, about a consensus statement really to kind of help guide clinicians on, hey, when we get the continuous ketone monitors on, what are we gonna do with that information? Because it's gonna be detecting different analytes and it's gonna be detecting different levels of analytes. And so we, I think as clinicians, are gonna need guidance because we don't want patients to like overact or over get excited or nervous. Um, any feedback or you know, thoughts on that?

SPEAKER_01 15:59

I think it's really important. I'm glad that there they had that statement exists. There, it's actually the second statement released in the past year. I think Breakthrough T1D wasn't the other organization that helped um organize another position statement. And I think they're pretty, pretty closely aligned. So um hopefully they can put like an overlayer graphic kind of with a link to it or maybe a table of the most important number metrics. Yeah, because as clinicians, we are not familiar with number cutoffs, right? It's kind of a weird territory to be in because so many of like I would say 90% of our users, our patients are just using keto six, which are you know mild, moderate.

SPEAKER_00 16:32

So we don't know what number or you know, millimole ketone or level.

SPEAKER_01 16:37

Right, basically you know, the table that we'll show will basically at least be an initial guidance. But I think, you know, as scientists, we are very transparent, and the authors of the paper were very transparent that we're still in the early innings of this. These number cutoffs might evolve over time, but it's a great starting point for us to use as we handle our first patients coming in with the um Libre Duel.

SPEAKER_00 16:56

Yeah. So as a doctor, thinking back in your years when you were trained in residency and like here we are now, you're a very like seasoned endocrinologist. We were here talking about continuous glucose monitors and continuous ketone monitors. What are you the most excited about? Did you imagine this even happening?

SPEAKER_01 17:15

No, it's I mean, it's funny. So this is actually, I mean, you and I love diabetes technology, right? Yeah, the the roles could be reversed easily. And um that this is why I went into diabetes. Um, literally, I was in residency and I was I was writing for a medical blog. Um, and I was I reviewed the IBG star. I don't even know if you remember that. It was like the first blood glucose meter that connected to the iPhone.

SPEAKER_00 17:38

Wow.

SPEAKER_01 17:38

Um, and it used um the 30-pin connector. So it was before the lightning port. And I was like, that blew my mind. I was like, wow, like you could buy this thing that you attach to. And now we don't even do that. Yeah, now it's like people are like, what? Why would you want to check your glucose, your blood glucose, and connect a peripheral to your phone? Um, so the fact that we have like wireless streaming, two analytes, um in just 10 or 15 years. Yeah, it's it's crazy. And so um, yeah, I think when when you think about how much we've evolved over the past 15, 20 years, it's exciting and it makes us really excited for the future. Uh, you know, you you probably have heard in the news, like Dexcom announced that they might be looking into doing like a potassium sensor. Yeah, and so there's so many different more analytes.

SPEAKER_00 18:20

That new sensor is that the Dexcom G8 that's gonna be potentially beneficial for people like we could use this in people that have like dialysis or kidney issues that could detect problems before they end up having to have emergency dialysis. So the fact that a continuous monitor is looking at more than just glucose is like phenomenal.

SPEAKER_01 18:40

A couple additional use cases for a ketone sensor would be for pediatrics, because I think kids um may not be the best at communicating their uh feelings or, you know, they may be at school and not want to get pulled out. So if a if a parent is able to monitor their ketone levels remotely and say, oh, this child, you know, might be in an unsafe situation, we might need to pull them out of school or get medical attention um remotely. And the Libre Duo 10 day will be approved for ages two and up, which is exciting.

SPEAKER_00 19:06

Wow. So that's gonna be a big deal for parents. I mean, I hope it's not gonna be the school nurse like stressing out every time it alarms. But I think, I mean, Libre does have an app right now that a parent can follow. Exactly. So I'm hoping that a parent that's away and their child is at school can have access to this and see. I'm hoping the glucose and the ketones. Has Libre announced or has Abbott announced anything that we know of about that?

SPEAKER_01 19:31

Yeah. So I mean, just that follow feature and the Libre duo being approved for two and up. And it can also be a point of reassurance, right? Maybe the the mom is watching and the glucose is our little glucose levels a little higher than they'd like it to be. But if the ketone levels are fine, maybe they're like, this is the time, I'll chill back and kind of wait and see what happens. So I think that data point will be very helpful for caregivers. Um, another use case, I think, is detecting um interruptions and uh disruptions in pump supply, pump insulin supply. So um there's been some data presented that shows that ketone levels might rise before glucose levels. So it could be like an early warning sign. Yeah, so it could be like an early warning sign that your pump site might be failing. Um, so that additional data point could also be really helpful. So there's a lot of different use cases, but I think overall that we're still very excited to see and what we don't know. Because oftentimes what we don't, you know, we don't know what we don't know.

SPEAKER_00 20:24

Right. Well, thank you for all of this information. I'll be excited to revisit this topic in even a year from now at the next ADA conference. I wonder what this whole ketone, you know, discussion is gonna look like at that point. So really exciting stuff.

SPEAKER_01 20:38

Yeah. Love talking diabetes technology with you.