Hello everybody and welcome to this session, the emerging foundational role of sensor based CGM for managing diabetes, new trends in Medicare and Medicaid reimbursement for continuous glucose monitoring in insulin dependent patients. My name is Diana Isaacs. I'm an endocrine Clinical pharmacy specialist. I'm also the Director of Education and training and diabetes Technology at the Cleveland Clinic in Cleveland Ohio. In terms of the learning objectives for this program, we are going to outline and discuss the basis for sensor and patch based CGM technologies and how to best implement CGM based technologies into their overall diabetes care plans for people with diabetes within the managed care environment. We are also gonna discuss new developments in C MS, both Medicare and Medicaid reimbursement for people on insulin therapy. And we're going to gain a better understanding of new technological advances in CGM devices with a focus on the A GP or the ambulatory glucose profile and the glucose pattern insights reports. And then finally, we're also gonna analyze the rationale and evidence for pharmacists recommending and facilitating adoption of technology centric CGM monitoring and treatment plans using patch and reader based technologies in the managed care setting. So let's go ahead and get started. And before we dive into the CGM specifics, I just wanna talk a little bit about the current state of diabetes. So as it turns out, we are not doing a fantastic job in managing people with diabetes. And the problem is that the number of people with diabetes is really growing and growing. The latest estimate from the CDC show that 11.3% of the US population lives with diabetes, another 38% live with prediabetes. And if you think about it, that is almost half the population affected with prediabetes or diabetes. And we know that people with prediabetes are really have a high risk of developing type two diabetes in the near future. Now, most of these cases are type two diabetes, although interestingly cases of type one diabetes are on the rise as well. But what is particularly concerning is that when you look at the percentage of people meeting their goals, which we often say gold standard is having a hemo and a one c of less than 7% only about half of people are actually meeting that mark. And it's actually gone down when you compare the data from 2010 to the most current data, it actually went down from 57% to 50%. And you could argue, well, don't some people have a higher target of less than 8% if they have more comorbidities. And well, yeah, that's certainly true. Even when you look at this data for less than a one c eight, less than 8%. A one C, only 75% of people are meeting that mark. So still another 25% are not meeting that goal. And then just in terms of thinking about the barriers, there's certainly many, many barriers. But we do know that for those that are taking insulin injections, missing even two or more insulin injections per week can dramatically increase A one C. For those on mealtime insulin, it can increase A one C by up to 0.4%. There is also a lot of therapeutic inertia, especially with type two diabetes and therapeutic inertia is the failure to initiate or intensify therapy when therapy goals are not reached. And so for example, for a one c, only half those people are achieving the A one C of less than 7%. Well, what happens in practice, we say, oh, well, maybe just work on diet and exercise for another few months, come back in three or six months. And that cycle just kind of continues for years and years where we're not doing anything in terms of targets. Research indicates that people with diabetes remain at suboptimal glucose management for almost three years from patient and clinician therapeutic inertia limiting treatment intensification. And when you think about the economics of this delaying intensification by even one year with type two diabetes has been associated with substantial clinical and economic burden. So that brings us now to CGM, which can definitely be a tool to overcome therapeutic inertia and help people with diabetes achieve their glucose goals. So what is CGM? Well, it's measured glucose levels every 1 to 5 minutes and recording those glucose levels every 5 to 15 minutes, depending on the device. If you do the math, that every five minutes is actually 288 readings per day. So providing a lot of information, there are three components. So there is that sensor which is in that interstitial fluid, sensing, the glucose concentration and then communicating through a transmitter, which is just above that sensor to some type of eater or receiver. In many cases, the transmitter and the sensor are all in one piece. They're not necessarily separate pieces with some of the CG MS. It is a separate piece and some of them even require charging in between uses. And then many times for the receiver, people are able to use a smartphone. Some people are using insulin pumps or some people have dedicated readers or receivers. And one thing to note is this is measuring interstitial fluid and this is different from the capillary glucose, which is what finger sticks measure. So there is something called the lag time where if glucose is rising or falling really quickly, you expect there's going to be a greater difference between the two. But eventually the CGM will catch up and because these are mentoring different areas, often the readings are going to be a little bit different. They're not going to be identical. And that's really totally OK. So to put this into illustration, this, what you're looking at here represents a 24 hour time period going from zero, which would be considered like 12 am to 24 which would be considered midnight. The green represents the target glucose range, which we say is 70 to 100 and 80 milligrams per deciliter. And these four black dots represent glucose meter readings. And if you had someone measuring like this and you had a series of maybe uh glucose logs in with numbers like this, we'd all probably say, OK, these look to be a goal, they're all in the range and we'd continue present management. But what happens when you put CGM on the person? Well, suddenly you're able to see everything that's happening in between the dots. And in this case, we notice that there's actually some undetected hyperglycemia. What looks like is occurring between eight and 12. So likely after breakfast, it may be after dinner after four P M-16 100. And then what's really alarming though is these undetected hypoglycemia that appears to be happening between four and 8 a.m. And these are the kind of things that you discover through the use of CGM that you don't see with BGM or blood glucose monitoring. Well, you might be saying, well, that's all great. But don't we rely on A one C? Well, yeah, we utilize a ONE C, it could be helpful to assess someone's overall progress. But the problem with A ONE C is that it is based on an average. And so it really only tells us a very small part of the story. And I think of it like a ONE C is a destination, but you don't have the map to get there. So it's nice to look pictures of it, look at pictures of it, but like how are you physically going to get there? And so really the problem with A one C is that you can have an A NC of the goal is under 7% for most people, but that could be very many different things. So on one hand, it could be, you're spending 100% time in range, which would really be ideal if you could do that. Um or on the other extreme, like on the left on here, you could be spending a lot of time low and a lot of time high. And that's really the issue is someone's a one C could be at goal, but they could be having a lot of this glucose variability. Now, what we know about diabetes is there are so many different factors that can impact glucose levels. It really is a lot more complicated than oh we'll just reduce the number of carbohydrates you eat and just take your medications as directed and try to exercise more. It turns out that it's been described that there's 42 factors that impact glucose levels and it's really, it's so much more nuanced, like the effects of caffeine can really spike some people up. Some people are affected by the outside temperature. We know stress comes in a lot of different forms. It can come as family pressures, social pressures work, all of that can impact glucose levels, sleep quality. And so all this to say is that people are unique and they're individually impacted by these 42 factors. And so the best way to learn how someone is impacted is really to have more data, to be able to see in real time how they respond to these different factors and then they can develop an action plan to stay in range. And so that is really where this power is of this real time data with CGM. So in addition to it's nice as part of being part of the health care team to look back on the data retrospectively and and see the patterns, but for the person living with diabetes in real time, they can see their number, they can also see the direction their glucose is going and they also can set individualized alerts so that they know if they're getting, if they are going too high or they're going too low or they're expected to go too low soon. And it's been shown that these types of alerts and real time data can reduce episodes of severe hypoglycemia and hyperglycemia associated with emergency department visits and hospital visits. It also increases that time and range and reduces A one C levels. And a lot of this is related to the fact that you can, a person could just map out these 42 factors. I mean, CG MS will allow you to track things like insulin doses, carbohydrates, uh just keeping other notes of logs of what types of food has been eaten when exercise or physical activities occurring. And so someone can look back or you, they can look back with their health care team and really see, OK, what, how did I respond to this walk or maybe next time when I'm gonna have this activity, I need to eat an extra snack or maybe I should eat a little bit uh smaller portion of dessert after the meal instead of the big dessert. And so this can just really provide a lot of real, the good feedback for lifestyle modifications. So some key things really to remember with all of this is that diabetes is continuous. So the majority of diabetes actually care actually transpires in between visits outside of clinical encounters. So having a tool that someone can utilize and get this real time feedback in between visits is really, really valuable. Also that A one C alone really is just not enough. And while we often will still routinely get it. We actually don't have to. The ad a the American Diabetes Association standards of care. Say that while, yes, you should be assessing glycemia every three months for someone, not a goal or every six months for someone at their goals. It doesn't even have to be an A one C. It could actually be based on CGM like a glucose management indicator, which is actually an estimate of A one C based on someone's CGM data or it could be based on their time and range. That being said, we often will still get it when we're ordering labs. But we can't rely only on A one C and then blood glucose monitoring, even though it really was the standard of care for so many years. And certainly when blood glucose monitors came out, it was a big upgrade from urine testing. But now we have CGM. And so when we have a tool that allows us to see between all of those dots, that's going to be much more informative and valuable compared to just those single dots, it's going to tell us the whole story instead of just one part of it. Now, I wanna talk briefly about the different types of continuous glucose monitors and there is professional and there's personal, so professional is owned by the clinic and it's used on a short term basis. So often it it needs to be for a minimum of three days for the purpose of for it depending on the device used, it can be used up to 14 days and coverage tends to be very good for both type one or type two diabetes or even prediabetes. This type of CGM is not compatible with insulin pumps or connected pens or anything. Now, personal CGM is meant for long term use. It's owned by the person with diabetes and the insurance coverage sometimes can be a little bit more limited. Although we are seeing now that insurance coverage has really expanded to allow for more people, pretty much anyone using insulin. And in many cases, other types of therapies are being covered now and this types of CGM is compatible with smartphones with connected pens and insulin pumps with selected devices. So in terms of the different options for professional CGM, there's the Libre Pro and the Dexcom G Six Pro G Six Pro offers a blinded or unblinded and most CG MS are unblinded. All the personals are gonna be unblinded, meaning a person can see their data while they wear it blinded. Simply means that they're not seeing their data while they wear it, but then it can be downloaded to get that full picture. The Libre Pro is only blinded while the G Six Pro offers both. Now, when it comes to personal CGM options, we have several available now and the we have really two categories we call it real time CGM where there's no action required to be able to see their glucose readings and then we have intermittently scanned CGM or flash CGM. And that's where a person would go ahead and scan their sensor, either with a dedicated reader or with their smartphone to be able to see their co readings. And of the options that are listed here, Libre two is considered to be a flash CGM. All of the rest of them are considered to be real time CGM. And um, you can, we've got one implantable option, which is the Everen E three. That's the 180 day implanted version. And then there is an outer transmitter that goes outside of the body. Now, we also have this category called integrated CGM. And this is allows basically these different devices to work with compatible insulin pumps as well as even compatible automated insulin delivery algorithms to meet this category of IC GM. You have to have even higher accuracy standard than just the minimum to get AC GM approve. And so in terms of the devices that meet this criteria, it is the Dexcom G six and G7 as well as the Libre two and the Libre three. At this time, only the Dexcom G six is directly compatible with certain insulin pumps like the tandem, the T slim X two, the Omni pod five, the Beta bionics we do expect in the very near future that we are gonna see. Libre 2 G7 amongst others integrating. And what I've done is I've taken a snapshot here of what we expect that integration is gonna look like this is with a tandem insulin pump where someone could essentially choose what sensor they wanna wear and utilize this technology. Now, when it comes to CGM, we get a lot of information that we're not used to. And in some ways one could say, well, it was easier when all I had was an A one C, you just have one number and so you just, if it's too high, you try to increase therapy. If it's too low, you decrease therapy, right? But often that may not be the best approach because as that example showed in the beginning with the CGM tracing, what if that person's A one C was above and we went and we increase their therapy, we could drive even more loads. So that's where all these CGM key metrics are really helpful and time and range is our go to. That is the time spent between 70 100 and 80. And the good news here is that we are not even aiming for perfection. What we have learned is that if someone can achieve 70 or more in that target range, they're likely going to meet their other metrics. And in fact, 70% time in range correlates very well with an A one C of around 7%. There are also other goals which include less than 4% of the time below 70 as well. As less than 25% of the time over 1 80. So we call them the time and ranges. They really all go together. Yes, that 70% between 71 80 is important. But we also want to look at the lows and the highs and when you're explaining this to patients, a good rule of thumb await to think about it is that 1% of the day is 15 minutes. So that kind of helps to put it in perspective. And then we have a few other metrics. So one, the big one I wanna showcase is that GM I that glucose management indicator, which is an estimated A one C based off of this data. And this is the ambulatory glucose profile report or a GP report. This is the one pager that is like the EKG of diabetes. So in one page, you get the whole story at the top, you have your CGM key metrics, you get those time in range, you get your average glucose, the glucose management indicator and also the marker of glucose variability. If that's over 36% it just means there's more ups and downs the person is more on that roller coaster in the middle. You have the visualization where you can hone in on any obvious patterns. And so for example, this red here between three and 6 a.m. or three and 8 a.m. that indicates that is a time where there is a lot more hypoglycemia occurring. And that may be an area of focus with adjustments and then the bottom will show the last 14 days of CGM data, all of those individual tracings. And the nice thing about that is the middle part that A GP is designed to show the obvious trends, but it excludes the outer 5% of data. And that's where you can go to the daily profiles and really see the full picture if there were maybe any additional episodes of hypoglycemia or hyperglycemia that did not show up in the middle component of this A GP report. Now, what are the recommendations for using CGM? Well, the American Diabetes Association updates their guidelines every year and I feel like these have really continued to expand. And so our 2023 guidelines say that CGM should be offered for diabetes management in adults with diabetes on multiple daily injections or C si double I stands for a continuous sub QE insulin infusion. So that represents an insulin pump, they also go. So basically just to recap anyone on intensive insulin therapy, whether type one or type two should be offered CGM. Now, the second component of this says that real time that CGM should be offered for diabetes management in adults with diabetes on basal insulin. So that means anyone on a basal insulin. So once a day, insulin, maybe in the future or once a week in, they also should be offered and then it also says the third component is initiation of CGM early in the treatment of diabetes can be beneficial. So just keep that in mind that the evidence is really strong. We're gonna learn more about that today. But the evidence is really strong and that is why the ad a put a level, a recommendation for basal insulin users and mealtime insulin users. So C MS expanded their coverage in 2023. It's been quite remarkable and the new guidance is that people need to meet at least one of the following criteria that they're treated with insulin. And you'll notice it doesn't say, oh, they're treated with three times a day insulin or four times a day insulin. It just says insulin because it's just insulin even if they're on once a day insulin uh that meets the criteria or they might not even be on insulin, they could just have a documented history of problematic hypoglycemia, which would be recurrent level two hypoglycemia. So that would be events with glucose less than 54 despite two or more attempts to adjust medication or modify treatment or a history of one level three hypoglycemic event which requires third party assistance. So this potentially can open the door for people on sulfa urea or other therapies that could cause hypoglycemia. And so this is quite significant because in the past, people needed to be on mealtime insulin. And in the further past people needed to do four times a day, finger sticks and all of that is gone. Just this criteria allows people to be eligible through C MS. Now, that's Medicare. What does Medicaid say? And I Medicaid is a little bit more variable. So while Medicare now it's across the board, anyone with Medicare on an insulin will have coverage. We see why different things with Medicaid, there are still some states that require a type one diabetes diagnosis. There are still some states that require someone to be on mealtime insulin, but we are seeing it get a lot more progressive and I can tell you in my state in Ohio, I think it's one of the, I'm very fortunate to live in a more progressive state where the only criteria is that a person has diabetes. And in fact, the CG MS are available through the pharmacy. And so all they need is a diagnosis code of diabetes. It does not matter what medications they're on, they don't need to take insulin, they don't even need to take Metformin. They don't need to be on a medication and it is covered. And this has been amazing to really expand access, especially to underserved communities because um there are more a greater number of underserved people that are utilizing Medicaid. Now, I also just wanted to highlight some cool things about how CGM yet helps the individual. It helps the health care team adjust things for the individual, but there's also some implications for remote monitoring and population health as well. And this is just showing a dashboard from le brave view of how you can organize your panel. You can look at things like average glucose levels, the percentage of time different people spend in their glucose target. You could look at hypoglycemia time below target glucose variability. And so you could actually proactively reach out to people based on what you're seeing and, and people that are really outside of the desired metrics. And in terms of billing and reimbursement, there's several codes that the the health care systems can utilize in terms of start up and training, as well as there's a professional CGM and personal CGM start up and training. And then the CGM interpretation code can be utilized as well, which many clinics are taking advantage of because they are performing these services and reviewing and interpreting these data. And so they can take advantage of these codes and you can see kind of approximate reimbursement here based on that. So really to sum it all up CGM can support timely treatment optimization. A one C, it can help to achieve A ONE C goals and to really help to counteract therapeutic inertia by being another tool in the toolbox and really reinforcing lifestyle modification and making it easier for the health care team to make medication adjustments. We know that managing glucose levels early in the diagnosis has long term benefits. There's actually something called the legacy effect. That's been shown that if people are well managed early on, even if their management deteriorates a little bit in the years down the road, it's like there's muscle memory, they still have better outcomes than people when they were first diagnosed did not have as quality of glycemic management. And so here we've got a tool that can really help us to achieve those goals earlier on. And with that, I wanna thank you for attending um this first part of the presentation and welcome you to attend all of the others.
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