Video Fundamentals of Sensor-Based CGM: The Nurse Practitioner’s Perspective Play Pause Volume Quality 1080P 720P 576P Fullscreen Captions Transcript Chapters Slides Fundamentals of Sensor-Based CGM: The Nurse Practitioner’s Perspective Overview Continue To Test Back to Symposium Hello. My name is Lucia Novak. I'm a nurse practitioner board certified in both adult health and advanced diabetes management. And I am excited to have you join me in the webinar looking at critical fundament fundamentals of continuous glucose monitoring a nurse practitioners perspective. So let's get started. I'm going to be the chair and moderator of this program and hopefully you will learn some good nuggets so that you can see how to impart continuous glucose monitoring with your patients and implement it in your practice. So let's start by taking a look at the status of diabetes here in the United States. And so this slide is showing you that a little over 37 million people have diabetes in the United States and that includes both type one, type two and all of the shades in between of those other atypical types of diabetes. Why we need to be so assertive and aggressive in managing this disease is because the micro vascular complications. The ones that our patients are probably more in tuned with and are afraid of are relatively Um unavoidable, voidable and preventable if we can get ahold of this pretty quickly. So as you can see we have preventable amputations. It is the leading cause of blindness but 85% of those cases are also preventable by just having annual eye exams. Um of course the issue with the kidneys and thankfully we've got not just glucose management that can address some of these but we also have drugs that specifically address these kind of complications. And the number one killer in the United States is cardiovascular disease, whether you have diabetes or not. However, in the population that has diabetes as their co morbid, they are 4-6 times more likely to have an event a cardiac event in their life. So they are much higher at risk from having a fatal heart attack or a stroke. If not fatal, can make them have a very significant morbidity in their life, not just for them, but those around them. So when we look at what exactly the risk of all cause mortality is. When we're looking at the relationship with hyperglycemia and cardiovascular death, What we see here is that the worst the glucose is are the higher the greater they are above that upper limit of 100 and 80 mg per deciliter after someone eats the risk for cardiovascular disease goes up. And what we have known all along is that when we improve glucose, that has a direct impact on reducing the micro vascular risks that are associated. So on that earlier slide when I was discussing the microvascular complications that affect the nerves and the blood vessels that lead to amputations, um the blood vessels of the eye that can lead to blindness and of course, the same micro vascular structure in the kidney that could lead to end stage kidney disease. We know that glucose improvement will target that. And what we've known for a really long time is that unfortunately, improving glucose control doesn't seem to impact cardiovascular risk. But what this slide is showing you is that while we know that glucose management doesn't directly improve the outcomes for cardiovascular death. Not addressing cardiovascular risk and not addressing glucose management in someone who is at high risk makes their risk for cardiovascular death that much higher. And you're seeing two fold increase. I'm sorry, an 8 to 10 fold increase when the A. One C. Is just about 6.9. Unfortunately a lot of our patients are much higher than 6.9. So we had for the longest time, the A. D. A. And the American Association of Clinical endocrinologists and several other expert groups out there recommending where A one C. Levels needed to be for people that had diabetes. And for a while at least since the mid 19 nineties. Uh An A one C. Of 7% Was pretty much the area that we wanted all of our patients at least all of our adult patients to be. We really wanted to try to get that glucose to at least seven if not less than 7%. But the data that gave us that recommendation was from studies that were done in the 1980s and published in the 1990s, where we got that a one c. 7%. And in particular the study I'm discussing for type two is known as the United Kingdom prospective diabetes study the U. K. P. D. S. That was our landmark trial, we were looking at relatively new onset type two diabetes in patients that did not have heavy burden of disease didn't have a lot of microvascular and maybe not even a heavy burden of cardiovascular disease. And what we learned from the U. K. P. D. S is that if you can reduce glucose and reduce a one c, we did see a reduction in microvascular complications. Just with a 1% reduction was translating to a 25-30% reduction in those microvascular um components. What we did start to notice in the U. K. P. D. S was there was a group that was also put on Metformin. So the medications we had at the time were cell phone areas insulin. And because the study was done in the U. K. They also had Metformin available. And so there was a subgroup the Oboe, the patients that also had obesity were put on the Metformin to see if that made a difference. And what was interesting in that initial study was that it wasn't statistically significant, but there was a trend toward a 16% lower risk of a heart attack in the group that was on metformin as compared to the other arms of the study, cellphone areas, an insulin. Again, it was not statistically significant. It was empowered. This was a relatively healthy population, so we probably would have needed to follow them a little longer. And then lo and behold, we got the U. K. P. D. S. Follow up study that actually showed a reduction um in people who were on Metformin. So we got our first drug trial that was actually showing some kind of a benefit. So fast forward. We are you know still recommending this a one c. 7%. So these three studies that you're seeing on the screen the accord or the action to control cardiovascular risk. And the diabetes study group. The advance which was the intensive blood glucose control and vascular outcomes. In patients with Type two diabetes study and the V. A. D. T. Which was the veteran's affairs diabetes trial were very different studies. These were actually looking at people who had diabetes for a much longer period of time and either had enough risk factors for a heart event that it was a matter of when and not if or they already had established cardiovascular disease. And we were looking to see if we can really push that a one C. Down if that made a difference in their lives whether it being micro vascular or cardiovascular and so this particular trial actually um gave us some very important information about how we address glucose management in different populations. So basically the accord study was actually stopped early and the reason it was stopped early was they actually saw an increased risk of cardiovascular deaths and all cause mortality in the group who was in the intensive treatment trial um arm of the study the advance and the V. A. T. T. We're not stopped early. But something else that was seen across the board is that while there were improvements in microvascular complications in these patients and many of them did already have established chronic kidney disease, there was an improvement. What they did not see was any improvement in the cardiovascular disease. And in fact we were seeing increase morbidity the harder we try to drive down the blood sugars. And so the the end result that we got from this. The take home point was when your patients are long into their disease, heavy burden of complications, lots of co morbidity is to include cardiovascular disease if they're not optimally controlled. That's not the time to really be aggressive with their management. Especially again because when these trials were done um we didn't have some of the newer drugs that we currently have available the GLP one receptor agonists, the S. G. L. T. Two inhibitors. And we also didn't even have some of the uh more analog, more physiologic type of insulin available. So again this was showing you know what we want to try to get to an A. One C. Of less than seven. But we want to individualize that treatment And that's where that individualization of where we wanted the A one C to go actually came from. But what we know is that an A. One C. Of seven and an A one C. Of eight or an A one C of nine doesn't necessarily reduce the risk of hypoglycemia. So um saying that, well, okay, this patient has this kind of risk factors and aggressive treatment could actually cause hypoglycemia. So rather than aim for an A. One C. Of less than seven, we're gonna aim for an A. One C. Of eight. But we have data from Lipscomb and her colleagues that actually showed a U shaped curve or a J shaped curve that the higher the A. One C. And someone with type two diabetes, they are at just as high of a risk of a severe hypoglycemic episode as someone with lower blood sugars closer to that target range, where you would expect a low blood sugar to occur. And so we're at this crossroads of where we actually need to be thinking about that balance. How do we balance timely and effective glucose management, Getting patients inappropriate A one C levels, um making it so that they are living healthier lives not over utilizing the health care system as a result without that risk of hypoglycemia that is unfortunately inherent with some of the drugs that we do need to use in our patients that have advanced disease. So, and then how do we monitor it? So what you're seeing at the bottom of the slide on the seesaw in red, it says only six of the top 18 glucose meters Actually made the accuracy standards of the 2016 FDA guidance of where glucose is needed to fall when using a glucose meter, what they considered accurate and we only have six of them that actually met that requirement. So we have patients that are using technology to make treatment decisions and we are using that same data to make treatment decisions and what we're learning is that it's not accurate. So again, how do we get to those goals that we need to help our patients reach without that risk of hypoglycemia. So not only are the meters not necessarily accurate, a good number of them not being. What does the data that we get from finger stick blood glucose management tell us. Well on the left of the slide, you are seeing points in time. So this is a particular patient that actually was testing several times in the course of a day. I think if I actually had a patient that brought in a log that looked like this, I would be so excited because I've come to appreciate that some people with diabetes in order to properly manage this disease, it has to be pretty public. You have to be willing to do blood glucose testing when you're not in the comfort or privacy of your home. Um, it requires poking a finger drawing blood. Not everyone wants to be around that. We've Just coming through the tail end. I hope of this pandemic where everyone was masking up and we were afraid to share air let alone to your blood. So the blood glucose is on this particular patient look perfect because that gray bar is um it looks like it's a range of at least 80 To about 180. And the majority of the blood sugars of this particular patient are well within that gray bar and there only seems to be one outlier. So you know, maybe after dinner they had some dessert and that blood sugar when they checked was a little higher. Who knows? Well let's find out what actually that would look like if a patient were on a continuous glucose monitor. And what we're seeing here are the rest of the story. What connects all of those dots to actually give you a much more robust history of what the patient is experiencing. So if all you got were those blood sugars and it was the end of your day. And you're thinking finally I've got a patient that's got it all together, this is gonna be an easy one. We're gonna send them out the door and now you're seeing the continuous glucose monitor that is showing not just that one elevated. In fact the patient missed a couple of elevated blood sugars. But even more importantly were the lows the lows the bloods the blood sugar patient was experiencing and they were occurring most of the time in the middle of the night when they're more likely to suffer um an adverse event from that low blood sugar. So again blood glucose testing only gives us a point in time. So when we're talking about, okay, well the A. One C. And I just mentioned you know, just raising an A. One C. Value does not safeguard a patient from hypoglycemia. And what this slide is showing you are three different patients, all of them with an a. one c. of about 7%. But what the composition of that A one C. Actually is. And so for patient a all of their blood sugars are within that target range. So when we talk about time and range, target range, we're looking at no less than 70 mg per deciliter when they're not eating and not greater than 100 and 80 mg per deciliter two hours after they have eaten. That is what we are considering the target range. And those are the times that we expect to see the higher and the lower readings of that target range. So patient A. Has all of those readings within that 70 to 1 80 great patient B and C. Both also have an A one C. Of seven or an A. C. One as my patients like to call it. But what you're seeing here, especially with patients see is despite the fact that 58% of their blood sugars are over 100 and 80 mg per deciliter they're having enough blood glucose is below the 70 mg per deciliter range that it is. Pulling down those elevated readings and giving them that average a one c of 7%. So an a one c of 7% is not an a one c of 7% is not an a one c of 7%. The other thing that we have learned over time when we're looking at complications and diabetes management is this term of glucose variability and that is the up and down of the blood sugar over the course of the day, over the course of time and it's that up and down of the blood sugars, that variability of the glucose that has actually been linked to some of these micro vascular complications and macro vascular complications that are that are patients experience. And the more variable. The more movement we see in that blood sugar, I want to see blood sugars when we're talking about that time and range. If I were to draw that out, it should look very narrow and flat, meaning that their blood sugars are rising just high enough and they're not going too low. Um and so when we see a lot more movement of the blood sugars, that actually increases the risk of hypoglycemia and it contributes to patients not really wanting to monitor, not really wanting to take their medications appropriately because they're seeing and feeling really badly when their blood sugars are moving like this. And it also interferes with our ability to better manage the patient's diabetes treatment plan. And it prolongs what we call clinical inertia. We're all kind of stuck because we're seeing highs and lows and we're not really sure what to do. So the coefficient of variation is a percent number that we look for. And it's something that's going to be discussed as we move through today's presentations um when we're looking at continuous glucose monitoring. And so we have um the experts have agreed that a coefficient variation or CB of less than 36 Is actually ideal and suggests that the patient is not really having a lot of swings and that that CV of less than 36% is actually associated more often and more consistently than just in 81 C in being able to predict metabolic outcomes and complications that our patients could experience. So what have we learned about continuous glucose monitoring and improved A one C. And we're gonna be talking still a lot about A one C. Because it is still a very much recognized metric when we're looking at diabetes management and it is still used in um randomized clinical trials when we're looking at efficacy and safety. So in these two studies that I'm showing you, one is by Eden Miller who is going to be speaking with you soon and the other by jean right, who is also on this panel that you'll be hearing from. They looked at um just the one on the left which is Eden Miller's study is real world effectiveness. Um In patients with type two meaning what they saw in studies that if all you did was take a patient from checking blood sugars and moving them to a C. G. M. That's the only change you did. That just making that change in how they were monitoring and what they were able to do with the data that was then provided. We saw a nearly 1% reduction in A one C. And jean also saw the same benefit in his group. Again, these were patients that were you know, type two diabetes A one C of over eight. And all we did was switch how they were monitoring and we saw over a 1.5% reduction. Did you know that for a drug to be F. D. A. Approved for the indication of treatment of diabetes? It needs to show an A one c reduction of no less than 0.4%. This is way above that And it's not a medication, it's actually behavioral modification based on data that's actionable. And what's really interesting is that while these were the average reductions in a one C. S when they looked at the populations that participated in the study as a whole, when they sub when they subdivided out and looked at, well, what's the difference with people who were on insulin and those that were not on insulin? Was there a more significant drop. And in both studies they actually saw that those who were not on insulin had the more significant reduction in their A one c Above the .8 and above the 1.5 reduction that you're seeing here. So again, it's it's that behavior modification, giving them information that helps them to act and act appropriately and not just guess what they think that blood sugar of 98 means in about an hour or two from now, what we also saw. And so these two trials were done looking at people that had um type one and then another trial. The replaced trial was looking at people with type two. But these were specifically patients that were on insulin. So of course your type ones require insulin. So they were on multiple injections of insulin a day and or pump. And we're checking blood sugars with blood glucose and the other were the type two that were again on multiple doses of insulin a day. And both of these groups were relatively well controlled and taking their insulin correctly and testing blood sugar is a minimum of three times a day. And so again, all we did in these studies was say, okay, instead of poking fingers, let's switch you to a continuous glucose monitor and see what happens. And what happened was really significant. What happened was a reduction in significant hypoglycemia in both groups, Going from 196 minutes a day down to 122 or 38% reduction in people with Type one diabetes and an even greater reduction 41% going from almost an hour every day down to 35 minutes in people with Type two. And there are still a lot of health care providers out there that don't think people with type two diabetes. And even those on multiple doses of insulin will experience severe hypoglycemia. And we are now seeing of course that we have the C. G. M. That's not true. So late break information that came from the A. D. A. Scientific sessions very recently is the Flash UK randomized control trial. Um that was presented at diabetes UK and I believe was also discussed at the A. D. A. And the top line studies that were um the top line results that were reported out again this is looking at people with Type one diabetes, they saw again over two hours um of their day spent more in that safe appropriate range of no less than 70 and no greater than um 180 after meals. And that was just using a continuous glucose monitoring. And this particular one still requires patients to actually scan to get their data. So it involves the patient to be involved a little bit more. Um Again we're seeing that reduction in a one C. A meaningful reduction 10.5% and again the less time spent in blood sugars less than 70 mg per deciliter. Then compared to those that were using the traditional blood glucose testing and just nearly five times more likely to achieve that A one c. Of 10.5% reduction or over four times as likely to see an A. One C reduction of 1%. But let me go back up because these reductions in A one CS the bullet right above you Show that they were actually spending more time in the safe range. So that improved a one C. Did not come at the expense of increased hypoglycemia. That would have pulled that a one C. Down. So what this is showing you here is a different way of looking at the data. These are on the on the left are called violin fox. And I guess if you wanna debate whether it's a violin or a cello that they actually look like okay what this is doing is it's taking the data and it's giving you where all of the data points actually fell of the population in the study. So it's not just giving you an average, it's not just giving you the standard deviation. It's actually showing you where all of those folks fell in the distribution. When we're looking at people that we're testing with blood glucose testing or if they were using the I. S. C. G. M. Which stands for the intermittently scanned C. G. M. Um And as you can see in this study we're looking at time and range and it's showing here in millennials but that 3.9 to 10 mil. Um als is equal to the 70 to 1 80 mg per deciliter that I had just mentioned. And you're seeing again that there are more people that are ending up in that safe and appropriate range. And so the dark dotted line that you see in all four of those, that's the average. And yet you're seeing many more people around that average in the blue that have been using the intermittently scanned C. G. M. And again more time in that range when we compare before and after and the other slide is showing you a thermometer summary. So these are basically what we see on our continuous glucose monitoring reports. Um The green yellow red and it's kind of helping our patients to see green, meaning that's the safe range. That's where we want those blood glucose is to be that 70 to 1 80. And then the yellow and orange are those higher and then the red below are those low blood glucose is and the more that we want to reduce that. So what this here is showing you and it may not look too different or that significant. But again at six months if you compare the reduction in hyperglycemia Um where you're seeing the orange at the top going from 11.6 down to 6.1 and more time in the green. So they're spending less time high more time in the green but not because they're passing through the green and experiencing low. The most significant thing on this slide is showing you that they're actually having far less hypoglycemia. Specifically that level to hypoglycemia where the blood sugars would fall below 54 mg per deciliter. So um if you want more information about the flash UK randomized control trial, there's a link for um close concerns um that from kelly close. She does a lot of information gathering and reporting for people with diabetes. And so that's her website and you can go there and get a lot more of this information if you're interested. So what did all of this information that I just present to you actually translate to? Well our experts out there that are making the recommendations as to what clinicians need to be doing when we are helping to assist the management of diabetes in those patients. The two that we refer to most often here in the United States is the american diabetes association and the american Association of Clinical Endocrinologists. And for the longest time they didn't really agree on too much. But lately they have really come to a consensus and when it comes to continuous glucose monitoring for all people with diabetes, they definitely say that anyone who is using insulin to manage their diabetes and it doesn't matter if they're type one or type two. They should have access to C. G. M. Anyone who is at risk for or experiencing hypoglycemia should have access to a C. G. M. And any patient who chooses to monitor their glucose using a C. G. M as opposed to a finger stick glucose meter. Should also have that option. Of course the real world says what does their insurance cover because a lot of this is cost prohibitive. But when we're looking at well what should the experts be recommending and where should our health care be moving towards? We should have that option available for our patients. And ideally not not only do they want to use the technology but are they capable of incorporating and using the devices and the information that is gathered from these devices safely. So that's really where your certified diabetes care and education specialists for your advanced providers that have the B. C. The board certification for advanced diabetes management can really come in to help educate and fully utilize this treatment in therapy with patients and as a result of that um U. K. Study that we just talked about the nice guidelines which is the guidelines that are used in europe or at least one of them. They actually recommend that all adults with Type one should have access. All Children with Type one should have access and people again that are on insulin intensive therapy that have either Type one or type two should. And again just coming into line with what we have been recommending here in the United States and this is just showing um again multiple daily injections of insulin or pump should be having the option to use a continuous glucose monitoring. Otherwise the last bullet there they would be advised to self measure at least eight times a day. That's just not happening. It's just not a realistic um recommendation to have people performing blood sugars that often. And if that earlier slide that I showed you in someone who did have eight blood sugar points in the day, it still was not enough information to help us to understand what was really happening during the day of that patient that had diabetes. So what's currently available as far as continuous glucose monitoring. And we have four that are currently available here in the United States that are FDA approved. We have a duck's com products. So currently we have the G. Six and the G seven is before the FDA. So every time you turn around the technology is getting a little bit better and there are improvements coming the ever since E three, that's the newest ever since model. That's the implantable C. G. M. And um it's the ever since E three because it's the one that is now good under the skin for six months as opposed to three months when it initially came out. And um what we're also finding is the amount of times that patients have to interact with their C. G. M. As far as finger stick calibrations is starting to become less and less as well. And when we're talking about non productive therapy we're talking about is the accuracy of this continuous glucose monitor enough for a patient to make a treatment decision dose insulin without needing to confirm that reading with a blood sugar. And again as these technologies become more and more accurate the less our patients have to interact with blood testing and things like that. So what you're seeing here for the freestyle so the freestyle libre three is showing that is way cool. So that was one of the more recent things that just got FDA approved. And the difference between the library three and the freestyle libre two which is still available as is currently the the original freestyle libre one that's also still available so they just get slightly better each time. They get slightly smaller each time more accurate each time and again non objective therapy meaning they don't have to confirm. And then we have of course Medtronic's guardian sensor. Um And it's also available and unfortunately right now it's the only one that is non objective meaning that the patients do still need to interact by performing a blood glucose to help confirm what the sensor is. Um seeing because this particular sensor does communicate with a pump. Um So does the ducks com G. Six that actually communicates right now with two pumps and hopefully we're gonna start seeing um that expand as this technology continues to grow so which one your patients going to have access to again is going to be limited by cost. Um And what their insurance or their payer is going to cover because this can be expensive, even the least expensive of them all, which tends to be the freestyle brand um is still not free and can cost some money. And usually our patients that have diabetes have buy one get three free disease. And so it's not just diabetes medications and management that we need to be concerned about. There are other medications that have copays and so on and so forth. So we do want to be mindful of what they have access to and what's going to be affordable to them. Sometimes you actually are granted a choice. Um The insurer may provide and then that's when you can talk to the patient about which they would prefer to use. But any one of these would be great alternative. So the freestyle libre three. Again, this has been the most recent one that has just got approved. It made big headlines at the A. D. A. And so when we compare this with the freestyle libre too, the freestyle libre two. And the library one. When we described the size of the sensor, we said it was about the size of a quarter and the height of the sensor, so how much it stuck out on on the skin was about two quarters stacked. So the circumference of a quarter to quarter stacked. Now, if you look at the bottom right hand of the screen, you are now seeing that it is the size of a penny And the the depth of the sensor, the height is two penny stacks, so definitely smaller than what we had with the freestyle libre two. And that is what we're also going to be seeing soon with the mexican G seven when it comes out, a smaller device more user friendly, the center and the transmitter should be all in one kind of like what the library two and three have been. Um, and now what you're also seeing is just more and more accuracy as these technologies get better. So not only are we able to get away with smaller, but we're getting away with more accurate and you know, we see that with technology all the time. The first very first computers used to be something that took up a whole room in a basement somewhere. They were not portable. And even the ones that were initially portable were really clunky. And even if you think of the how the cell phones kind of have moved forward, these are like mini computers that we have now. So again and more people have them and they're more accessible and that's because as the technology gets better and better it becomes more affordable. So that is my prayer is that as we continue to advance, that the devices become less expensive, more affordable, more accessible because we already see the difference that it causes as far as diabetes management and reduction of harm for our patients. So in conclusion, we have come to really appreciate that the continuous glucose monitoring represents a foundational approach to diabetes care. Um continues diabetes continues to have significant clinical and economic consequences, both in an individual patient as well as you know, and what we pay as a country for the costs that are associated with the morbidity and the mortality associated with having this type of chronic disease. And the continuous glucose monitoring offers an opportunity in appropriately selected or, I should say, in patients who have been appropriately educated on how to use the device, both Type one and Type two to improve not only glucose control but outcomes as well as reduced cost. And as I said before, it is becoming, it actually is a foundational strategy across the spectrum of diabetes care. Published June 21, 2022 Created by Related Presenters Lucia Novak, MSN, ANP-BC, BC-ADM, CDTC Certified Nurse Practitioner Diabetes Expert Capital Diabetes & Endocrine Associates Silver Spring, MD
