The Case for Prescription-free Glucose Biosensors for Patients with Prediabetes
The approval of new prescription-free glucose biosensors has significantly broadened access to continuous glucose monitoring (CGM) technology for a number of populations, including those with prediabetes and individuals interested in tracking their glucose for health insights. In this video, Diana Isaacs, PharmD, CDCES moderates a roundtable discussion with Rachel Stahl Salzman, MS, RDN, CDN, CDCES, Rachel Sood RN, MSN, APRN, NP-C, CDCES, and David Doriguzzi, PA-C on the benefits of these biosensors, how they have broadened access to CGM to larger population, the data gained from these biosensors, and more.
Transcription:
Diana Isaacs, PharmD, CDCES: Hello everyone, and welcome to this roundtable called the Case For Prescription Free Glucose Biosensors For Patients With Pre-Diabetes. My name is Diana Isaacs. I am an endocrine pharmacist and the director of education and training in Diabetes Technology at the Cleveland Clinic in Cleveland, Ohio. And I am very excited to be joined by an amazing panel today that includes Rachel Stahl Salzman, who is a registered dietician and diabetes care and education specialist in the division of endocrinology, diabetes and Metabolism at well Cornell Medicine in New York City. We also have another Rachel, Rachael Sood, who is a board certified diabetes nurse practitioner and the owner of the Diabetes Collective from Mandeville, which is near New Orleans, Louisiana. And because we have two Rachels, we're going to refer to Rachel Salzman as New York Rachel. Then, we also have David Doriguzzi, who is a physician associate specializing in diabetes and thyroid care at First Valley Medical Group in Lancaster, California.
So, thank you all so much for joining today and this should be a really exciting discussion. So to start us off, we know that we have had the approval of new glucose biosensors, and that has really broadened access to continuous glucose monitoring to more adults. And this includes people with type two diabetes who are not on insulin who maybe did not have coverage for CGM. Also people with free diabetes and then also just anyone, any adult that has an interest in tracking their glucose for health insights. So I'm going to turn the first question to New York Rachel, and I want to ask you, how has the approval for these glucose biosensors really broaden access to CGM for these various populations like pre-diabetes and maybe people that just want to gain health insights?
Rachel Stahl Salzman, MS, RDN, CDN, CDCES: This has been such an exciting evolution in the glucose biosensor world. The biggest change now is that it's prescription free, in essence direct to consumer, and this really opens up the door to allow more people to access this amazing technology and learn exactly how their lifestyle impacts their metabolic health. People can go directly on the company's websites and purchase the devices. They don't have to wait for an appointment with a medical healthcare professional, which we know could be months and months wait. So it's getting people access faster, more timely, and ultimately helping them understanding their health.
Dr. Issacs: Awesome. And David, anything to add to that?
David Doriguzzi, PA-C: Yeah, it is a really incredible time, where the most advanced technology available is now being put in the hands of any patient who could possibly benefit from it, which frankly, as I think we're going to talk about in a little bit is probably most people with diabetes, there is a time where the best tools available were only put in the hands and on the abdomens of the people who were really kind of considered what we might call trainwrecks, people who are more advanced in the disease state. And while it's absolutely beneficial for them, we've learned over the past several years that the earlier we adopt this advanced technology, the greater we can impact the trajectory of that patient's metabolic status and disease, excuse me, disease course.
Dr. Issacs: Definitely. And then Rachel Sood, anything to add to that?
Rachel Sood RN, MSN, APRN, NP-C, CDCES: I think it's just nice that we're giving people just the capability to take their healthcare into their own hands, and this is something that is a step in the right direction as far as people being proactive instead of this reactive healthcare. I think we're just seeing a lot of changes in healthcare where people are limited, like Rachel from New York said, that people can't get in to see office visits, they can't even get in to see a dietician ahead of time, and at least now they have increased access to a biosensor, they can start to see their glucose live and start to learn and get insights ahead of time before even meeting the provider. So, it just provides that additional layer ahead of time so that people can kind of get ahead and know what they're bringing into the appointment before it even starts. So I think that's really neat.
Dr Issacs: Yeah, I mean I think just right, the ease of availability and now people are hearing about it, and they don't have to get a prescription, they don't have to ask their healthcare provider, which depending how familiar, they might readily give them a prescription or it might be more hesitant and now they can just get it. And a lot of them are coming now to their healthcare visits and they already have this sensor on and they're already learning from their data. And just like you said David, in the past it used to be sensors were only for people with Type 1 diabetes or people that had a lot of hypoglycemia. And I've been fortunate to see this explosion really since the beginning when CGM was only accessible to the small group of people. And when people could gain access, whether that was someone that was on insulin or even on no medications, people find value in that data and that's just been awesome to see that explosion happen.
Alright, well another question for you all. So we know the ease of use of eliminating finger sticks definitely is a huge selling point. A lot of times we ask our patients, do finger sticks check at least twice a day or check before every meal or go ahead and check before meals and after meal and see what happens. But that is a huge burden and who really wants to be poking their fingers and drawing blood from them? So that already huge, huge selling point. But we also know with the CGM, it is measuring glucose continuously. So we are getting so much data. So how does all of this data, what are the benefits of that? And David, I'll turn it to you first this time.
David Doriguzzi: So what I've found in my practice is that most patients want to succeed. We've got the stereotypical patient who kind of engages in the struggle of provider versus patient, do what I say, and then the patient we write in the chart. I believe that most patients would like to do well, but the problem is that most patients unfortunately lack the tools. And if we can put the tools in the hands of the patients who would actually benefit from them, it empowers them to succeed. And unfortunately you mentioned finger sticks and a lot of patients in the most influenceable phases of their diabetes progress, IE pre-diabetes, oftentimes they don't even get that. And so we give them the advice to, okay, your A1C is a little bit high, you don't have type two diabetes yet you should diet and lose weight and then let's check back in three to six months.
And that's about all they get. And that's kind of the equivalent of a patient's falling out of a plane and we tell them, you really should think about learning how to use a parachute and if you hit the ground then we'll intervene. But we have this golden opportunity earlier on in the phases of diabetes where a patient's A1C is still relatively low, newer after the time of diagnosis where they can make a huge, huge impact on their own futures and allowing them to see that glucose throughout the day has this tremendous impact on the development of their own understanding of the cause and effect relationship between different types of foods and what it does to their glucose in the background, something that they previously would've had no idea was even going on.
Dr Issacs: Those are all really great, great, great points. non-New York. Rachel, what do you think?
Rachel Sood: I think that this is giving people the capability to David's point to see things that they weren't able to see before. We know that with pre-diabetes, even leading up to type two, you will see more elevations in mealtime glucose levels, but yet if you just do a finger stick once or twice or two seconds a day, you're not capturing all of that data so you're not seeing the real picture. So I think the use of the biosensor early on, even in pre-diabetes or early onset type two, we're actually able to diagnose and intervene earlier and we're getting to see the mealtime and how exercise, how stress and how all of these activities affect glucose. And I really don't think people know that's what I've gotten in my patient population when they have used biosensors, they had no idea that they were so, so high maybe after a particular meal or after they go to a certain coffee shop and get their favorite snack and coffee there. And they've been able to kind of change their routine, but they did it on their own because they can see everything without me telling them, Hey, do this, this and this. People don't typically respond to that. If they can really do things on their own and take accountability for their actions, it just works out better. So I definitely am seeing that and that's what we want to see in our patients. We don't want to have to jump straight into medicine if we don't have to, but of course we use it to support patients and using biosensors even with other medications, we see a large GLP one GIP one use right now and using biosensors along with those really compliment each other I find. So patients are able to see that these medications are working and they are helping them make better decisions about their meals and activities.
Dr Issacs: Yeah, I totally agree with that. And especially with the Dexcom stello, it has that spike detection feature and so it can alert someone that they've had a spike with a certain food and then it really prompts them then to reflect on possible causes of that. And that can really lead to behavior change. And I also, as a pharmacist, I mean I love medications, but a lot of my patients don't love medications. And so when they can use a device like this to get this real time feedback and then they can make lifestyle changes, many times they may not need a medication and so that really makes them happy too. Rachel from New York, what do you think about all of the data from these devices?
Rachel Stahl Salzman: Yeah, I agree with what everyone said. I think these biosensors have the added benefit that we're all talked about, the ease of use, how easy it is to put on the device lasting for 15 days or more to be able to make it easy, but really the power lies in the volume and the quality of that data. Being able to see their glucose levels 24/7 from their smartphone app, it just makes it so easy. And just to share a couple examples, people come back to me in the office and say, I've noticed whenever I took a walk after a meal that helped to lower my blood sugar or when I added more vegetables to my pasta and not just pasta alone. So I love these examples that people come back telling me of things that they've noticed about their glucose values and the changes as opposed to what Rachel was saying, how we talk all the time about strategies for healthy eating strategies for activity, but when they see it in real time and could watch the arrows of the glucose sensor telling them is it going up, going down? They're having those in the moment changes that they can make. And the last point I want to make with all this data is how it helps us. So we're giving it to the people in their hands, but when we could go back and review the data, for example with stello, we could take from Dexcom Clarity, we could look at their glucose data over the past two weeks, three weeks, four weeks and more and have more enriched conversations with them, more specific examples, more ultimately personalized care that I think ultimately helps improve their outcomes.
Dr Issacs: Yeah, that's a really great point about being able to look back because like with ello, that connects with Dexcom clarity, which we're already used to using with the Dexcom G six and the J seven. And so yeah, we can go ahead and look back on that and it can really drive good discussion with the healthcare team. Then also, there's a lot of insights directly in the app itself, so people can get daily insights and weekly insights, even if they're not looking at their numbers all the time, they can get these insights that really prompt this reflection on what's happening with the data. And then one of the, I would say big differences with these biosensors compared to real-time CGM, the prescription products is just that the alerts have really gone away or they've majorly been cut down. And that's because these products are designed for people that are not taking insulin, they're not taking drugs that are expected to cause hypoglycemia. And so there's really not a reason to need to have this low alert of 70, for example. And so that's kind of nice because actually people without diabetes can have glucose readings that can go lower than 70 and it is fine. They don't need to intervene. We don't want them suddenly taking in a bunch of sugary foods and drinks when that happens. So I actually, I really appreciate not having all these additional alerts.
Rachel Sood: I wanted to speak to that, Diana. I definitely think that it can be very intimidating when you get a new diagnosis of type two or someone tells you all of a sudden in clinic, Hey, you have pre-diabetes and maybe this is just very, very sudden for you it's intimidating, it can feel overwhelming. And with using Stello CGM, it does have all kinds of learning tools built in, and there's a lot of things to learn and know about diabetes. It can be very overwhelming. And I like how the app does have some tools that can teach patients like, what is glucose? How does glucose affect my activity? What can I do better? And it's nice because no one wants to prick their finger, no one likes needles. And in doing this, we're eliminating that whole burden of having to prick the finger and just being able to see insights and there's no alerts and alarms, so it's not super intrusive. And if they want to look at the data they can, and then if they don't want to look at it, they don't want to look at it, but it gives them that option and people need options for care, and this just gives them a little more independence, I think.
Rachel Sood: One thing I find that over the counter biosensors do, like Dexcom Stello is showing people something different than hemoglobin A1C. So for so many years we've been focused on just getting this one single blood test and people get it at their office visits like every three to six months. And we know that capturing just hemoglobin A1C alone doesn't show the full picture. And when we use a glucose biosensor like Stello, people are all of a sudden open to seeing glucose, which seeing this time and range and getting glucose in a range that's more particular and focused for that patient brings better outcomes longer term than just capturing hemoglobin A1C alone. And that's I think how we're going to move better into ending all of this progression to type two diabetes. There has to be something we can do other than just medications and bringing awareness to not just capturing hemoglobin A1C, we want to look at the full picture and Stello does that for us. Do y'all have anything to add? Do you feel like A1C is like, are we bringing more awareness with this than moving away from A1C alone?
Dr Issacs: I was just going to say we relied on A1C for so long because that's all that we had. Right. And there's so many limitations to A1C. I mean, it's based on the lifespan of red blood cells, so anything that impacts red blood cells can make that inaccurate. But also, like you said, it's an average and so it gives no insight into how someone is doing, how much glucose variability they have. And someone could find out, oh well they have an A1C of 6.4, so great they don't have diabetes. But there could be some real opportunities to make changes and that A1C is just not going to help them do that.
Rachel Stahl Salzman: I would just add the fact that now we have an opportunity to make more timely interventions. The person themselves, by looking at their time and range over the past week and reflecting on it, finding ways to continue to increase that time and range could be really encouraging and powerful for them to make changes before they are waiting for that two to three month A1C check. And some people are even waiting six months or longer. So it's really able to get them to make changes more timely, which are going to help in their care. Yeah,
David Doriguzzi: I would agree. There's a lot of different ways to achieve the same. A1C, again, it's an average. You can mathematically achieve the same average with a lot of different number sets. And looking at the A1C is sort of driving with your eyes on their rear view mirror. It tells us where you've been. And when a patient focuses on their time and range, they can look down to the last seven days if they choose and get an idea of what's ahead them, what's going on with the road that they're on, as opposed to where they've been in the past
Dr Issacs: Yeah, those are great points and that's something that is also unique to the stello is that there is a lot of education actually embedded in the app itself, and I really appreciate this. I actually wish all of the CGM sensors would have this as well, but it really prompts someone, for example, if their time and range is not a goal or there's glucose spikes, it prompts them that they can read articles to really learn about time and range or learn about strategies to really increase time and range or reduce those spikes. And they're in very easily readable, digestible nuggets. So it's a way of making education easy to access. And I know I appreciate that because also people that may be using these products since they're so accessible, maybe have not talked to their healthcare team or they haven't been into the doctor's office in a while. And so this is a great way to access that. And even if they have the best team in the world, being able to reinforce this education through a mobile app is really awesome. So I appreciate that.
David Doriguzzi: It's really pretty amazing that a single product has the ability to cover so many different areas of the spectrum of the knowledge base of diabetes from the basics we were talking about, what is glucose things that we sort of take for granted from our positions that a lot of the jargon that we might use that we just sort of assume that a patient's going to understand what even is a carbohydrate, what makes that different than a protein, the sort of things that we'd like them to employ when making dietary and lifestyle choices that maybe they don't really fully understand but don't feel comfortable vocalizing that. And that's put into the education in this app in a very non-confrontational, non-judgmental way, giving notifications to patients that are meant to be more of a motivator rather than a alert. But also going from the basics of education to that advanced report option that Rachel Salzman was mentioning, where we as providers have the ability to get the full A GP report, the full evaluation to where we can make our own office visits more meaningful and achieve more during the limited time that we have with these patients, and hopefully get more primary care providers comfortable with analyzing continuous glucose data, which previously in the past was a very daunting undertaking.
And thankfully now because of the advanced algorithms and the analysis and the way that it's reported is so much easier than ever before. And it's something that I think most primary care providers could benefit from and would be surprised to learn is a lot easier to use than they might've previously thought.
Dr Issacs: Yeah, definitely. So another question that I have for you all is how can glucose biosensors lead to earlier interventions and potentially lifestyle changes? And I know we've touched upon this a little bit, but I guess I'm curious to learn maybe some examples of how this could play out. So Rachel Suit, I'm going to turn this one to you first.
Rachel Sood: Sure. I'm using biosensors in my practice. I'm certainly using stello. And what's neat and unique to this app is that it is detecting patterns. So for instance, maybe there is, I have a patient, for instance, that she feels like she's eating lots of plant-based diet, lots of protein, she's going for walks, she's exercising. But at the one week point we get this report kind of halfway through using the sensor and it's about 15 days and she's getting little patterns and she's noticing that she has really high glucoses and spikes on Tuesdays and Thursdays, and what is she doing on Tuesdays and Thursdays? She's taking her son to the baseball park. And at the baseball park she's getting candy and some popcorn and drinks from the canteen because we're looking like, why are you always spiking and going really, really high on these days? And it's helped her realize, okay, these are my patterns and these are my specific times that I need to really focus on.
So I think that using products like Stello is helping people not feel so overwhelmed again because they're able to look at these are the areas that I need to work on instead of just a general statement, eat healthier. Like you were saying, David and Rachel, I'm sure you can speak to this just with all of your dietary experience. Some people respond differently to different foods, and so it's really helping people zone in and that way they can work on just those areas. And it really, as you know, it cascades down to the whole day. So if they work on just those targeted things, it's not so overwhelming for them. So I like that portion of it. So pattern detection for sure.
Dr Issacs: Thanks. Those are great examples. So yeah, Rachel Salzman, I'm curious you being a dietician, your experiences.
Rachel Stahl Salzman: Yeah, I think it's just been so amazing with these biosensors, it's like a light bulb goes off for the person I'm working with them talking to 'em about these strategies and they go home and try it. We know habit formation is changing. Habits rather is so hard when people have ingrained ways of doing things. So now to be able to give them a tool that they could experiment with, I encourage self-discovery, it's experimentation, try you love your oatmeal, let's try to find ways to fit it in. Maybe adding some protein with it, putting some nuts or mix a dollop of Greek yogurt on it, smaller portion, the type of oatmeal we can get creative and work with them to find ways to fit their favorite foods in rather than them thinking that, oh, suddenly it causes a spike, I can't eat it. So I think making sure we're providing that education and support to find ways to do it.
And people, again, like I said, I think the walking is a huge thing. Being able to see in real time with the arrows that the Stella app would show them that their glucose levels are coming back in range. I just had a patient a week ago and she's really struggled to take her medication. She really just didn't want to even look at her glucose data because she knew that it would be scared basically. And I think, so I worked with her, we put it on during the visit together, we had a telehealth visit. I said, let's just put it on. She was shocked. It took us five minutes or less. I think we're all familiar, these sensors don't take long to put on. And after that she sent me a message, she's like, wow, I'm taking my medication now. Just that moment of that insight is just amazing, right? Because we know that that is so important to help keep them in range.
Dr Issacs: Awesome. I love all of those examples. And David, what do you think?
David Doriguzzi: I think a lot of times patients will without guidance, make meal choices and lifestyle choices that are good in intentioned, but without the guidance sometimes they don't end up helping them achieve the goals that they're looking for. For example, I had a patient who I had this similar conversation with about it looks like your A1C is a little bit high, we don't need to start any medication, but let's talk a little bit about cutting back on carbs, restructuring your meals and exercising and whatnot. And the patient comes back and they didn't quite reach the improvement that they were looking for. So we had a conversation about, tell me about the efforts that you've been making. And they said, well, changing. I've been eating healthier. I put the sugary cereal away and it had cornflakes or Rachel mentioned oatmeal. I hear that a lot. The things like oatmeal or brown rice, things that are still carbohydrate in nature but are generally thought of as sort of a healthier food.
And of course, we'd rather have somebody eat whole grain bread than a candy bar, but the effect that it still has on somebody's glucose is something that oftentimes comes as a surprise to people and we can tell them and give them handouts and lists of what to eat, what to avoid, what to rebalance. But what I've found is that the conclusions that patients come to on their own, based on their own observations are always going to be much more impactful than anything we could ever tell them. And when I have given a patient something like Ello to have them monitor and see for themselves the cause and effect relationship between foods that they normally thought might've been helpful and realize that, oh gosh, maybe this isn't actually going to help me achieve my goal, they start making those changes all on their own. And again, that is always going to be more sustainable than them making a change just because I told them to.
Dr Issacs: That's such a good point. I mean these are all excellent points, but yeah, I can't count how many times I've suggested to someone, “Hey, can you try replacing your cereal with something else? Cereal causes blood sugars to spike up.” And they're like, “yeah, whatever.” I mean it's just ingrained like cereal, what's healthy? It's got a lot of nutrients on the label. But when they wear this and then they see the difference between that bowl of cereal compared to maybe a more balanced breakfast, like a hard boiled egg, it really leads to profound change. And then also, I just wanted to add it is thought that there's at least 42 factors that impact glucose levels. And a lot of these are very person specific. And one example is like coffee, how some people just from caffeine alone can see that their glucose rises. Another example is physical activity where I've had people surprised either at wow, how much a 10 minute walk can really help to lower their glucose.
But also even on the flip side, I've had people that do more intense activity and actually notice that it goes up and that's led to, oh yeah, maybe I don't need to carbo load before this workout. So it's really, the findings have been quite incredible and I'm so glad that we now just have increased availability and now we have the over the counter sensors. So alright, one last question for you all. I just kind of want to hear at this point, any take home point that you have about OTC CGM? And since you all had a chance to start, I'll take volunteers. Who wants to start us off with your take home point?
Rachel Sood: I'll start off. I think that one of the most powerful things in life, not even just talking about diabetes, just routines in general, is consistency. And we see this in all aspects. Starting a business, learning a new sport, learning a new routine, maybe eating a different way and consistency helps with this repetition. When you're doing just doing the capillary blood glucose, it's hard to be consistent, it's hard to get consistent numbers and it's hard to get a consistent, but when you introduce something like stello and you're seeing the glucose live on a consistent basis, it helps you, just like David was saying, further reinforces all these behaviors that you're doing. And it helps reinforce so that you are using repetition and you are consistent because you're seeing something consistent finally. And if you weren't seeing that before, you weren't able to be as successful. So I think that it's helping people, again, just be proactive and really, really get better at just all things in life. They are able to finally see how things are affecting them.
Dr Issacs: Great.
Rachel Stahl Salzman: Yeah, I would add, I just think in this really advancement of glucose biosensors, what we kind of alluded to in the beginning, this idea of moving from a reactive to a more proactive world in healthcare I think is so important. When we think about, I think it's like 98 million people in the US alone have pre-diabetes to now have a tool to help them to understand their glucose levels, their metabolic health speaks volumes and could really help us to ultimately help prevent or delay the onset of type two diabetes. So I think that it's this idea of giving the tool for people in their hand. It's like what do we have to lose to encourage the use to allow people to have that information to better understand their health. So it's really exciting,
David Doriguzzi: And I'll just expand on that by saying I can't think of a single development and healthcare technology that has not done good when put in the hands of more people that could benefit from it. The fact that we now can allow patients who otherwise wouldn't have had access to the technology that will give them knowledge of their own condition can only lead to wonderful things. Better understanding, better visibility of a patient's glucose has been shown in clinical trials to be beneficial and lead to greater outcomes, better improvement in A1C. And the earlier we get a handle on that, the better. There's a metabolic memory that will persist throughout the patient's diabetes career that will lead to fewer complications down the road. And in some clinical trials, just being able to use CGM to view their own glucose all throughout the day has had as much effect on A1C as certain medications have in other clinical trials. And there's not a single drug interaction out there to the knowledge of one's own glycemic control.
Dr Issacs: Thank you. These are all excellent. Take home points, and I'll just add to it for any healthcare professionals that may watching this, I encourage you to be in the know about this because your patients likely may come in on these devices. And so it's great to know about them, to be able to their use and also to advocate their use for people that may not know about them already and may not have prescription coverage, maybe because they have pre-diabetes or they have type two diabetes and they're not on medications. And then I would encourage you also to try one because anyone, they do not require a prescription. So anyone can go ahead and obtain one. And so I'd encourage you if you haven't already to go ahead, give it a try, you might be surprised by some of the things that you find out about yourself. With that, I want to thank everyone for tuning in. I want to thank all of my panelists. This was a very great engaging discussion and wishing you all the best.