Hello and welcome to A P A 2023. My name is Ashlyn Smith and I'm an endocrine physician assistant in Phoenix Arizona and I work with adult patients with endocrinopathies. I'm the president of the American Society of Endocrine Physician Assistants and adjunct assistant professor at Midwestern University here in Glendale, Arizona. And I'm excited to bring to you today a topic that is ever evolving and really, uh you know, state of the art. It's a hot topic in medicine and dealing with uh C G M and diabetes technology. And it's definitely a uh a sign of what's to come in the future for diabetes management. So without further ado, let's jump right on in here are my disclosures. The whole reason that we're talking to you today about C G M technology is because we really can be doing better for our patients living with diabetes. You know, with all the advancements that we have in this field we are still dealing with and in the thirties, millions of people that are, that are living with diabetes on a day to day basis. And I fortunately, even with the advancements, the the cardiovascular outcomes, the renal outcomes that we have. We are still dealing with uh diabetes as the leading cause of blindness in the US, the leading cause of end stage renal disease in the US. And we do still see a large predominance of, of cardiovascular disease in this population as well. The risk obviously varies depending on a variety of risk factors. You can see from 2 to 8 fold increased risk of cardiovascular disease when somebody's living with diabetes and we'll talk a little bit about what makes people on the lower risk versus the higher risk and why that number doesn't ever go to zero. It doesn't ever go to equivalent risk when we're dealing with diabetes. So we'll, we'll start right here with that, that discrepancy there. So we, uh, we know that the folks who are not reaching their glycaemic targets, their A one C is over, um, over 6.9%. So they're 7%. And above, that's where we get that 8 to 10 fold increased risk of developing uh, cardiovascular death or all cause mortality. But you can see here on the right in the kind of pink red color that even folks who are meeting those glycaemic targets, even those folks that are having an A one C at 6.9% and below, they are still at a two fold, increased risk of all causes mortality and cardiovascular death. And this really underscores the importance that it's not just about glycaemic control. It's not just about that, a one c reduction that there's something else or maybe multiple, something else that we were missing. So you might be thinking, well, if a one c of 6.9% makes that, that risk go down, could we just go even lower? And that's a great question that was investigated quite thoroughly with the several landmark trials. So we have the Accord, the advance and the V AD T trial that all looked at this very question. So they compared the standard of care versus intensive intervention in diabetes management. And unfortunately, they not only did not see a significant reduction in those outcomes. The micro and macrovascular complications I've highlighted in red here, we actually saw an an a worsening of their overall health. The Accord trial uh saw an increased risk of cardiovascular death and all cause mortality in the intensive intervention group that was worse than the current standard of care. And unfortunately, that that trial had to be stopped prematurely because of that extra risk that was involved. Similarly with advanced, we really didn't see much in terms of the reduction in outcomes. We did see some reduction in nephropathy but really no difference in any of the other uh ma micro or macrovascular complications that we are looking to prevent. And unfortunately, again, we saw increased safety signals. So increased severe hypoglycemia and hospitalizations in that intensive intervention arm. And finally, with the V AD T again, no change in need for adverse cardiovascular events. We did not reduce that, that risk in the population, but we saw an increased risk of overall hypoglycemia, symptomatic asymptomatic nocturnal hypoglycemia, some of the most dangerous glycemia and again, increased cardiovascular death. So, if low under seven is the answer lower is not where we need to go. We don't need to get that A one c even lower than our current standard of care. So what are we missing that keeps that cardiovascular risk elevated? These are some pretty staggering numbers if we, we look at so we look at the residual risk of developing either major adverse cardiovascular event of an M I stroke, heart failure, nephropathy, retinopathy or neuropathy, even with our A one C reaching its target. And we can see significant residual relative risk in, in these folks, even when we're getting to their, their glycemic target. So we really need to think beyond that. A one C. We have a uh we've come a long way when it comes to glucose monitoring, which is really great. We can think back when we first were looking at uh at monitoring glucose, we really just had urine glucose testing. And then we saw the development of a first blood glucose test strip that actually had to be washed off. And then you had to kind of compare that color to determine what that glucose uh number actually was. And that was kind of an approximation. And then a big change in diabetes was when we had the glucose meter, the blood glucose meter, where we actually had a number that, that your glucose was and that helped quite a bit. But as we've all experienced, the, the not all glucometer are created equally and there are some variations and some factors that will influence how correct and how accurate it those meters can be. And then we have the advent of, of what we're talking about today, the continuous glucose monitors, we, we have the intermittent scanning and the continuous um the real time C G MS. And what we, what we're gonna be looking at today is how this has changed some of the ways that we think about diabetes and what is considered in good control versus not good control. Some folks might be surprised to know that that first continuous glucose monitor was available back as, as late as um as early as 1999. So this is not necessarily a new paradigm, but our technology is getting better. We have uh outcomes. We have really meaningfully meaningful data that we can use to assess how our glycaemic control is using continuous glucose monitors. When we're talking about getting that A one C down, lowering that risk, we have a delicate balance to strike and so do our patients who are living with diabetes who are actually having to take home our recommendations and live them out on their day to day basis. So we want effective strategies that are, are going to be effective, that are gonna provide stable glycemic control and that are gonna get us to goal uh quite quickly and effectively. So we wanna get to our A one C targets. We know that that is important to get that A one C down under seven in the majority of your patients. But uh we of course, need to individualize A one C targets. We know that that leads to the prevention of complications. We want to reduce the overall cost to the individual themselves, but also the health care system. And really, ideally, we would have a less restrictive regimen that helps with that person living with diabetes, be more consistent with their therapy and it helps reduce that overall burden of living with diabetes. I'll pause here for just a moment and encourage you if you aren't already to be assessing your patients for diabetes distress. Because of this sheer number of things that we ask these folks to do on a day to day basis and diabetes distress is not a mental health disorder. It is a very normal, acceptable, reasonable response to somebody dealing with the amount of things we ask folks to do on a day to day basis. So we want to get to our glycemic control. We want to get there quickly and effectively and make it stable. But we also have this other side that we're balancing. We don't want to have it drive, get, get um drop too low and see uh a risk of hypoglycemia start develop by utilizing agents or technologies or regimens that are lowering a risk of hypoglycemia that helps reduce the fear of hypoglycemia. It helps us advance therapy a little bit faster and it helps with the the patient being more receptive to advancing therapy if they aren't as worried about going low. I, I don't know if you've ever experienced this, but you can imagine how if somebody is worried that they might be going low on, on their blood sugar, that that might lead them to either skip medication or reduce the dose of medication to help mitigate some of that risk. So by by utilizing agents and technologies that lower our risk of hypoglycemia that tends to improve adherence to the diabetes regimen. And of course, we saw in those trials very clearly in those landmark trials that those increased risk of hypoglycemia, we saw increased all cause mortality and increased cardiovascular death. And one of the running theories about why that was is because of hypoglycemia. So if we're not dealing with that as much risk, we see lower morbidity and mortality and lower health care utilization. Unfortunately, to date, we, we've had, we have now the uh glucometer and we have continuous glucose monitors. So if we're just using Glucometer, we may be thinking, ok, great. We know what our numbers are. We know what kind of uh what kind of blood sugar we're dealing with. Uh what uh that that overall risk is. But there was a pretty remarkable study that was done that actually looked at that at six of the top 18 Glucometer that actually met the 2016 FDA guide uh FDA guidance. And out of those 18 that they looked at only six of them actually met that that criteria. So if your patients are using Glucometer to make treatment decisions, or if you are looking through that meter or that blood glucose log to make treatment decisions, we may not be dealing with a accurate numbers. And actually, in 2000 2019, the FDA tightened that guidance even further. So we don't know quite yet, but I can imagine that fewer of the glucometer will meet those effects if already the 2016 guidance meant that only six of those 18 glucometer uh met that requirement. So what are some of those barriers that can be present to that prevent our patients and prevent us from getting to the treatment goals that we set up? One of those? That's so key. We'll talk about this here in a minute is that not all A one CS are created equal? So having an A one C at seven does not necessarily mean that we have good glycaemic control. The way that I explain this to my patients is you can average a 335 get a pretty decent A one C but that's not considered good diabetes control. So the A one C alone is not enough. We have great data behind an A one C. But that's not the end of the story. We are shifting to a, a paradigm of kind of a validated A one C or pairing that A one C with glucose data to ensure that we are seeing more stable numbers, not those high highs and not those low lows. Unfortunately, with fingerstick blood glucose monitoring, that's kind of a snapshot in time. It tells you exactly at that moment, assuming it's accurate and that exactly at that moment, but that reading is, it does not tell you what it was five minutes ago or the trajectory for the future. And this introduces a, a particularly troublesome uh problem within diabetes management. Is this idea of glucose variability that glycemic variability. That's when your patients may describe that roller coaster that up and down and up and down. It's frustrating to see as a patient. It's frustrating to try to manage as a provider. And we know that glucose variability drives complications. We'll talk about that here in just a moment. The more ups and downs we have that increases the hypoglycemia risk. As you can imagine if we're not sure what our blood sugar is gonna do, we may not take our medication consistently because it's unpredictable. If you're seeing that pattern on a, a blood glucose log, you might be hesitant to start more treatment yourself as the provider. And overall, it de definitely increases the disease burden because we're dealing with that, that frustration, that fear of what does this mean? We may see higher health care utilization because of those high highs and low lows. So we want to pair that a one C with trying to lower our variability because we know here on your right side that this is some of that, that data that we're talking about a higher coefficient of variation, which is the more roller coaster we're seeing, we have a a more unfavorable metabolic profile. We have higher rates of micro and macrovascular complications and higher rates of mortality. And what's so key here if, if you want to focus on one thing on this slide, it's that bottom right that we see in red, the association of the coefficient of variation, the the variability of glucose was more consistent than an A one C in predicting metabolic outcomes and complications. So this is powerful information that can really help drive outcomes when we're managing diabetes. Here is a visualization for all of our visual learners out there myself included. And this is a visual depiction of what we were just talking about about how not all A one CS are created equally. So if you were able to see this kind of information, uh these are all a One CS at 7% they're, they're examples of glycaemic patterns that are possible with an A one C of 7%. So, as you can see, I would be much more reassured by that the patient on the left who is 100% time in range versus somebody in the middle. I'm maybe a little bit concerned about that hypoglycemia, but we're hitting our 70% in range versus the person on the right. I'm very concerned about the, this glycaemic pattern and even though their A one C is at 7% I would not consider this good control. And if that's all the information we're looking at, we're just looking at an A one C or we're just looking at snapshots in time, we might be missing this variability and therefore our reassurance that we're getting to our goals is not really based in fact. So we need to think about that glycaemic variability. So what we pair together is an A one C plus time in range and we'll talk in great detail about what that means. We have a variety of continuous glucose monitors that are available and we have a couple newer ones as well. If you haven't heard about them yet, I'm sure you will in the, the near future, many of us are already familiar with Dexcom G six and the Freestyle Libre too. And of course, our, our Medtronic uh C G M, we do also have an implantable C G M which is the Everen C G M and then both Dexcom and Freestyle Libre have relative, the uh new versions that have launched within the last uh about a year or so. And so we have a lot of options that are available and we can kind of talk a bit about what uh how we would choose between all of them. But the great thing is that we do now have a variety of options that may or may not interface with different apps or different pumps depending on what your, your patient's needs or their desires are for, for diabetes management. But it's important to know that there are a few key differences uh with all of these V C G M options that we have available. The first, I'll, I'll call you to is the, the which is essentially the standard deviation. So every time that it's showing you a glucose reading, how accurate is that? What kind of percentage up and down do we have on, on each of those readings? So we have a kind of a rough 9% for most of them if you, if you want to put that number in. So when you're talking to your patients, and they're saying, well, how accurate is this? Really? We can kind of have that rough 9% in, in our mind, but some of them are a bit more accurate than others. So we have, uh we have the mars listed out here. I do want to emphasize here with uh with ever sense. And with medtronic that these mars, these standard deviations are with appropriate calibration. So it's very important that when we're using those two agents, those two, those two sensors that we have our patients calibrate uh as they need to, to keep that accuracy. So for, for ever since uh for that 1st 21 days, we need uh 22 calibrations per day. And then after that, we can move to just one calibration a day. And then this uh this mard, this 9.6 mard with uh with the Metronic C G M is based off of four calibrations per day. Uh We can get by with 2 to 4 anywhere within there. But if we want to get to that 9.6 accuracy, we do need those four calibrations a day, which can be tricky sometimes that other folks who've been doing it for a while or who are really um open to that, that might not be such a hardship. So we always have to make sure we're tailoring our, our technology to our patients. And then importantly here, um it can it be used for non injective therapy, meaning we can use this data to make treatment decisions and almost all of them would save the Metronic have that have that indication from the FDA. So all of this sounds great, this, these theories that we're talking about these options that we have available in principle. This sounds great, but we wanna look a bit now at some outcomes and we'll, we'll dive deeper into this in, in a bit too, but just kind of some baseline, uh, outcomes there. Uh, this study was a hypo D study which actually looked at, uh, folks with type one diabetes who were at our highest risk. So you can see here, we want to see, um, we wanted to look at the avoidance of hypoglycemia in those folks with the highest risk. So type one diabetes who were on MD, I, who either had impaired hypoglycemia awareness or a history of severe hypoglycemia. And what you're wanting to see the, the um the X axis is the number of hypoglycemic events. So we want to get as close to the Y axis as possible. That's a good outcome. So of course, uh we, we saw with the control group, there was really no difference between the baseline and the follow up versus the C G M group. This, these circles were the baseline and then we saw improvement in the correct direction uh on follow up. So this is the those folks at the highest risk, the the people that are living with type one diabetes on intensive insulin management. And they have major risk factors like hypoglycemia, unawareness or history of severe hypoglycemia. So this is powerful data that, that we saw there are a couple of other um of other studies that actually looked at type two diabetes. This is by no means exhaustive. There are so many studies that have been done with uh C G M depending on whether it is real time or continuous and combination, sometimes of type two versus type one. But these, these are two really powerful studies that I wanted to, to highlight. So you're first on your left. Uh uh We had a randomized controlled trial for folks with type two diabetes that were anywhere from on lifestyle intervention alone all the way through all modalities except for Brandl insulin. So really of the big spectrum of people living with type two diabetes and we saw that the control arm versus the, the intervention arm. So that intervention arm that, that uses C G M that use C G M saw a significant reduction in a one C without medication intensification. And that's huge. So we're talking about our, our folks that are wanting to deploy just one more pill, one more shot more units of insulin. This is a way that we actually saw a reduction in a one C without adding an extra pill. And what's so great to see is that there was sustained improvement over the next 40 weeks, even after that C G M was removed, which leads me to believe that those insights that that person gained by wearing the C G M, what causes their blood sugar to go out, what causes their blood sugar to come down then that those tools that they were able to glean from using the C G M, they were able to apply later on. So this is meaningful reduction and sustained reduction in a one C without the addition of another medication. Again. Similarly, on that right hand side, we have another randomized control trial on type two with type two diabetes on insulin therapy. And we saw those, those problematic things that we've talked about the, the hypoglycemia which can lead to worsening of clinical inner show fear of hypoglycemia, missed doses of medication. But we did see in that C G M are significant reductions in the risk of all levels of hypoglycemia and overall improvement in treatment satisfaction, which is key to getting buy-in to the therapy that you're recommending. We are in this paradigm of shared decision making. We have to make sure that what we're recommending is safe, but it also is realistic and acceptable to the person that you're talking to who actually has to go home and do what you've recommended. So if we can improve treatment satisfaction, then we typically will see a reduction in overall diabetes distress and disease burden, which improves their adherence, improves their satisfaction. And it does help to reduce the risk of complications. You do not have to memorize all of these studies and you certainly don't even have to read all of these studies. Uh But this is a great, uh a combination of all the world, world, world evidence that we saw for that we have for C G M use in type two diabetes. And I wanted to highlight a couple of things because we, we start to think about C G M sometimes is the kind of worst of the worst. So that first study I talked about people with type one on intensive intervention who are at high risk risk of hypoglycemia. But we're really seeing the benefit across a wide range of people living with diabetes. And I'll, I'll call your attention first here. The, the this is one real world study that was looking at both basal insulin and noninsulin therapy. And we did see overall reduction in the, the risk, uh the rates of uh acute diabetes related adverse events in that in both populations, which was uh was a great intervention to see. And I want to highlight a couple of things down here. So we have, uh we can start to think, well, maybe we just see the the outcomes in people who are at the highest E one C. So of course, they have more uh room for improvement. So we're gonna see better outcomes with an intervention in those folks. But we actually can see that uh in several of these, we saw whether the A ONE C was under 9% or over 9%. We saw significant reduction in both groups. Similarly here, this, in this study, we saw that, that reduction in A one C, whether that, that A one C started under nine or it started over 9%. And in this study was across many different countries and across all subgroups within each of the countries. We saw a significant reduction in A one C and this is for folks with type two diabetes and this is real world evidence versus randomized controlled trials. And I think both sets of evidence are so important. We want that structured randomized control trial to, to practice evidence based medicine. But we want that real world data to be able to see. How does this actually play out in the clinic? How does this actually work in the real world if you will? So both of those are so important. We have guideline directed therapy about when to when to be talking about C G M when it should be offered. And this is the the 2022 update from ace and the American Association of Clinical Endocrinology. And this is their, their practice guideline that they recommend real-time glucose monitoring or scan continuous glucose monitoring. That's recommended for people that have type two who are either treated with insulin therapy or have a high risk of hypoglycemia plus or minus hypoglycemia unawareness. So we don't have as stringent rules about who might qualify for AC G M anymore. We have, you know, obviously somebody who's on insulin therapy already, that doesn't specify how many shots per day or what type of insulin or what dose of insulin just on insulin therapy. But this can also just be somebody who's at high risk for hypoglycemia or is has another identifiable risk factor like hypoglycemia and awareness. So you might be thinking, well, how do I determine if somebody's at high risk for hypoglycemia? And they actually have this great graph that can kind of help you see where on the spectrum this person is and where their hypoglycemia risk is. So again, you don't have to memorize this but just know that this is in um this is in the guidelines to be able to show us uh where we are in terms of overall risk. So to the left and this kind of more purple color of these are, are, are people that are going to have less risk of hypoglycemia versus the right hand side, this, this is the highest risk of hypoglycemia. And it goes from our antihyperglycemic agents that are not likely to cause hypoglycemia. But then we start to see increased risk for folks on Sophon aas or Glens. Uh basal insulin increases that risk further MD. I certainly does increase that too. And then we start to see with our pump therapy a higher and higher complexity and a higher and higher risk of hypoglycemia. So if your, if your patients are on um even starting from the those secreted gos and up, we might be thinking about is this an appropriate patient to be talking about AC G M? So shifting now to our ad a standards of care. This is uh this was just updated in 2023. So hot off the presses and we see kind of a, a similar recommendation from the ad a that real time glucose monitoring or intimately scanned should be offered for diabetes management. This does not specify type one or type two for diabetes management in adults with diabetes who are either on MD I or on some sort of infusion of insulin like an insulin pump who are or on basal insulin alone. And that are uh uh capable of using the the device safely, either themselves or a caregiver or loved one that can use the device appropriately. So this is very similar but not quite the same in that there. The specification is not just those at highest risk, but it's focusing more on the type of intervention that the individual is on.
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