Thanks so much. I'm Doctor Eden Miller. We're gonna go beyond the A one C and I'm gonna talk about the section of maximizing patient engagement as well as satisfaction with sensor based glucose monitoring. We're gonna review some real world data confirming that patients shared centric preferences for when we integrate CGM based care in the diabetes specialist and primary care setting. So, diabetes management and people with diabetes, you know, why do we want to achieve early glycemic control? It really does matter if we look at two individuals on their journey with diabetes. And let's look at person with diabetes number A though, it's that early intensive individual. In other words, we identified they had diabetes. We kept that at an A one C less than seven for that first two, first 10 years and maybe over time that their A one C drifted uh to nine. And if we contrasted that with person with diabetes, B, let's say they started out for 10 years with their A one C at nine and then finally came around and got to target 10 years later and had an A NC of seven, which individual tended to have the best outcome, they had the same glycemic exposure over 20 years. However, what we see is that individual that had early aggressive foundational A one C control, getting them to target early in their disease, had a third less of the risk of cardiovascular disease and had an over 50% reduction in the failure of the EGFR or the reduction in the EGFR yet, if you were to come late to the party. In other words, that individual that had poor glycemic control initially and then improvement, they didn't have the same outcome. So we now know that there's what's called this legacy effect. We have earlier implementation of intense therapy and it's associated with less complications. So this is why we say when somebody comes in, we want to get them to goal, we want to be assertive about their control and we wanna essentially try ultimately to put them in remission early rather than trying to get them there late. So what about complications? You're all familiar with the UK P DS. This is a ongoing trial. In fact, there was a 10 year retrospective and what we showed is that improvement of control, as I mentioned earlier, that legacy effect had both micro and macrovascular impacts. And this is why you want to have that conversation and say, hey, listen, you're early in your disease. We wanna get you to control because this study of about 4500 patients in the United Kingdom with type two diabetes. They looked at those individuals over time. This is a very longitudinal trial and they found significant reductions in amputation or peripheral vascular disease. I call that metastatic diabetes as well as those small vessels, right? The eyes, the kidney, the little vessels in the feet, as well as overall mortality and then cardiovascular of M I and all causes of cardiovascular Botta. Now, you've heard it before that lower A one C improves these overall risks. And it's true for every 1% reduction in the A one C. We see improvement with that especially in the microvascular, right? We know for sure that the eyes, the small vessels in those kidneys have a great impact with A one C control to a lesser degree with cardiovascular disease. But it really is important of what therapies you choose to get them to target to infer additional cardiovascular reduction. And so you wanna set that precedence, that foundation so you can have a legacy of living well with diabetes. So let's transition a bit to what we call that uh validated A one C and this is a phrase that I started to kind of propagate a bit because we wanted to take the A one C metric that we still very much use. We still very much like we're very fluent in that we understand what we're trying to get to target. But we also want want to take time and range. So A one C is that retrospective three month average. But time and rage, it goes beyond a one C, it really tells the entire glycaemic story. And so how are we going to bridge these two? And so I often ask individuals or I ask students, uh you know, if their patient was reported A one C I I say to them, has it been validated by time and range? Because time and range tells us all the different places that a person visits, the highs, the lows and it is not, it is more of the compilation of the average A one C because you can have the same A one C then have vastly different time. It's in range. So there are factors that have a big impact of living daily with diabetes. We understand that there is a distress with it. And in fact, in fact, those individuals would have diabetes, whether they're type one or type two on insulin or those that are type two, not on insulin. They have different kinds of how shall I say burdens or inertia and you as a health care provider need to inquire regarding these. You can't assume just because we as clinicians have our own inertia have our own opinions. I really urge you to at each appointment, address, some of these barriers, address some of these concerns that really do impact individuals. And you can see that depending on the type of person with diabetes or that I impact of their therapy. It really depends on some of the things that they are concerned with, whether they're type one and they're concerned about hypoglycemia or what we see commonly as persons with type two diabetes are really concerned about the complications related to their disease. They are, they don't want to have a heart attack, they don't want to have a stroke and all of them do share this common food issue. Food is number one, patients cannot get enough information regarding food and how it affects their time and range. And ultimately their A one C in addition, all of that burden of this information and the the this direction of where they're going, they want to know how to dose their insulin, they want to know what to do when you have unexpected glucose numbers. And so a lot of this burden or information can be illuminated by CGM and you can actually empower the individual to know many of these metrics so that they feel more in charge or directional with their own control. So what are some of the drivers of a positive mindset? So when those with type one diabetes, if they feel that their numbers are on target in range, right, the high to low because they could have a great A one C, but maybe they're having a significant amount of hypoglycemia. So it really is that seeing those numbers in range and that they feel as though that their diabetes is on track almost like there's an autopilot. Then as a result of that confidence in their numbers, they feel more likely to be able to do some exercise. It's one of the concerns that persons with type one have. I'm afraid if I exercise, I'm gonna go low and I gotta feed the beast of diabetes before I exercise. Isn't that just negating the effect of exercise? So you can see that these are some of the things, at least in the persons with type one that really gives them that positive foundation. Now, we see similar things with those with type two on insulin because it is more of a focused glycaemic disease. And so they are very aware of their numbers and they want to know that they're taking their medications uh as it's prescribed or as there's according to. And then as a result of that, they feel less diabetes distress, right? Less distress means more engagement, the highest level of diabetes distress equals the most lack of engagement. In fact, you will see individuals in your practice who are completely disengaged from their disease. And that's when I pause and I say, hey, how much distress are you having? In fact, sometimes the distress may not be that evident. They become apathetic about their disease because they feel so overwhelmed. And so we're trying to give them that positive mindset, trying to give them that information. So they know what their numbers are. So they can feel empowered to make healthy eating decisions and then adhere to whatever treatment plan that the two of us have developed for their overall health. So let's talk about particular studies that look at time and range. It really is. Number one for everybody. Yes, we say what is important to you whether you have type one, type two on insulin or not on insulin, on oral anti agents for type two diabetes, they all want time and range. They all say to you what are my numbers supposed to be? And if you don't share those numbers with them, in other words, what their target ranges and if you don't provide them something to monitor their time and range, they really feel like they're not achieving that. So time and range is important at the very top number one for all of these individuals. Then from there it varies. I think the type ones are worried about unexpected numbers, right? Hypoglycemia, y glycemic variation. And as a result of that, they're gonna dose and then their A one C comes at the bottom. Now type two persons, they wanna know what their blood sugar should be, what range. They also want to see that A one C but they got a lot of other competing health issues, right? They have hypertension, they have hyperlipidemia and then they wanna make sure they're dosing their insulin correctly, but they're less concerned about those unexpected numbers. Now, type twos, not on insulin are also concerned about time and range in A one C and those overall health conditions, but less concerned about those unexpected numbers. And so you can see that as you look at CGM, it's an implementation, it's gonna be different for each individual. That's why again, I go back to that additional question, ask the person with diabetes, what's important to them, ask what kind of goals they have for themselves and ask what some of the barriers are and so that you can make an impact on them individually. Now, let's see about those patients who could benefit from CGM. I get this question all the time. Doctor Miller who could benefit from uh a ac GM utilization. Well, first of all, it's anybody who wants to know their whole glycaemic story, right? Because an A one C is a retrospective three month average that you can't do anything about because you've already reached your destination and you can hope that you glean information about your glycemic profile from that three month metric. And so if a person is disappointed, oh, I thought I would be better, then you can say, hey, would you like to be able to view all the different glucose places you go? Right? That's that individual or let's say you have individuals with the same A One CS, but they have vastly different CGM profiles you cannot assume because they have the same in a one C that they have the same journey. I often say you're a one C is going from point A to point B in a three month period. Some people go directly there, some people get lost. They go into the land of hypoglycemia, they go into the land of hyperglycemia. And so it allows us to give them information to make sense of their glucoses, both to the prescriber and to the patient. Now, one other thing that I think CGM does is it really takes disengaged, highly distressed individuals who are not tracking or participating in their disease. And it gives them that engagement, it gives them insight and it gives them the engagement that allows them to say, hey, I've been empowered. I know what my numbers are. But you have to also understand as you communicate to these individuals not to emotionalize their disease, not to emotionalize the number. I'm gonna tell them the blindfold is off. You now see your numbers and you now could be empowered. How can you empower them by talking about the effects of food and activity, right? Stress lifestyle choices, engagement in medication. You can also provide them the comfort and the support for hypoglycemia. If you've never experienced hypoglycemia, let me share a little story with you. It feels like you're dying and when you have this hypoglycemia that occurs, you are so uh consumed by it. All of your warning symptoms in your body are going off and you want to avoid it at all costs. So oftentimes we tend to raise the glucose to avoid it, but that doesn't guarantee it. In fact, it increases that risk because it's variability that causes hypoglycemia. So you give people a tool that prevents and predicts hypoglycemia and allows others to monitor them as well to keep them safe. So really, in summary, who could benefit from CGM, anybody with diabetes, anybody who needs to know the effects of their life, of their choices of their medication and how it impacts their glycemia and their overall health. So let's talk about the association of CGM usage and that satisfaction because you know, we could have this really cool thing that gives us a lot of data. But those individuals that utilize it, how do they feel about it? So there is this really great study that looked at a prospective multi center trial for 18 and above, it looked at a six month baseline period, then six month follow up for those who utilize CGM. There's about 1000 participants. It didn't matter what kind of diabetes you had, whether you were type one or type two. And we looked at what's called the diabetes treatment satisfaction. We did see that that scanning frequency was correlated with a one C reduction. You gotta be kidding me. How is that possible? Well, because you can manage what you monitor. In other words, if you empower the patient to look at their glycemia more, they have a higher a one C reduction they also were able to predict hypoglycemia was significantly less even amongst those persons with type two diabetes, who we typically say don't experience hypoglycemia. But they do, especially if you're choosing therapies or incorporating those that have a higher hypoglycemic risk. So how did the data come out? So if we look at the freestyle libre system, the FSL system, you're familiar with that and we looked at their overall satisfaction for those with type one diabetes with a significant improvement in their overall satisfaction compared to blood glucose monitoring, even if they were testing four or six times per day. In addition, we had a similar type uh of reported satisfaction if you had type two diabetes on the bottom. So you can see that by giving them information by giving them more data, they actually felt more satisfied with their overall disease. This is that empowerment and engagement I talked about, right. It's that you give them the opportunity to manage their own diabetes and their distress actually goes down. It's because they now can see those numbers and they can actually try to impact and do something about it. It also allows you as the prescriber to be able to look at their own data because you've been blinded to their glycemia as well. And now you can make very specific pointed treatment impacts and recommendations that's going to improve their overall control. So look at how the different scores came out whether they were uh they felt more comfortable with the treatments that they were doing. They felt that CGM was more convenient. I can't tell you how many times I'm hearing clinicians say, well, this patient doesn't need CGM. It's just more trouble. No, it's not. It actually takes away some of the burden of their disease. They feel that they understand their diabetes better. They feel more engaged. They have less high and hypoglycemia because guess what you as a prescriber do not have time to do all of the management for them. Your job is to turn them into experts on their own disease. And continuous glucose monitoring allows them to carry some of that responsibility of their disease. And you get all the data to go through with them later to try and make very specific interventions. Now, if you look at elderly patients, right? People that are not as tech savvy. Oh, they're older. They're not gonna be needing those information. Yeah. And do they really need to know what their glucose numbers are over 65? Absolutely. In fact, hypoglycemia in this particular group is what caused detriment, morbidity and mortality. It wasn't the destination A one C, it was high glycemia. It was the frustration regarding their daily life and how it impacted them. They looked at about 260 people with type two diabetes greater than 65. And they looked at the improvement in the A one C as well as the daily scans again, the higher scanning frequency improved A one C. Why? Because you know your data, you know how you got there. So the use of CGM was associated with significant improvement in diabetes treatment satisfaction amongst type two persons. In addition, that that frequency of scanning, my opinion is a minimum of eight scans per day or eight views because some of those you don't have to scan, but eight views really correlated with better control and better A one C uh prediction. And they overall were satisfied very similar to what we saw in the previous trial. So this continues to be recorded and continues to show that overwhelmingly, you give AC GM to a person irrespective of the type of diabetes, they have irrespective of their age and they're more engaged and they're more empowered. So you actually take away some of the burden. I've never seen a system in diabetes that had just as much benefit to the wearer, the person, the patient as it did to the prescriber or the clinician. It has dual impact. And this is why we're so excited about incorporating continuous goose monitoring and we're here to try and educate you really get you excited and overcome some of the barriers and inertia that you have as clinicians for incorporating it. So patients express greater ease. This is a great little trial that I was familiar with. It was looking at uh continuous glucose monitoring in diabetic persons and 95% of them said I have a better understanding of my glycemia. 95% we can't get 95% of the people to agree on anything. They also felt that they were able to manage their food. Aren't you constantly telling your patients you should eat better? You should do this. What if I told you that each individual responds specifically to food? Of course, orange juice raises everybody's blood sugar. But I don't mean that when I put AC GM on an individual, I asked them to find the fab five, the five foods that do not affect their glycemia in a detrimental way. And those that they can count on things that are healthy things that you go, you know what my blood sugars are great. I also want them to find the forbidden five, those five foods that they thought didn't impact their glycemia or they realize they're really not worth it. I had this great story of an older gentleman who I put AC GM on and he was like, oh, why do I need this? And I said, I want you to learn all the different places you go. I want you to observe. I want you to write down and tell me what you found. When he came back. I asked him, what did you learn? And he said, doc I learned the oatmeal hates me. And I said, really? And he goes, yeah, I had no idea. I thought it was healthy but for me, my blood sugars were going so high. I said, what do you do different? He said I used a Greek yogurt and fruit and I did a frittata and it was much better. And so he felt more empowered to make changes. They also feel less hypo. I hear patients say it's like my little guard dog. It watches me when I don't want to think about my diabetes and it alerts me if something is out of range. And with that comfort, we get empowerment for physical activity. This is one of the hardest scores to improve. If you talk to your persons, they really say they have trouble engaging in physical activity. They, they, for those with type one, it's about safety and hypo with those with type two, it's about seeing the effects of exercise that improve their glycemia and guess what they tend to exercise more. So if you use technology from an app based system, I, I'm not saying we have to force those who don't want to use it. But when you use your app on a phone, your phone tends to be with you. Right. It's another appendage. We've all, when we lose it, we feel like our arm has been chopped off. But when we use CGM app app platforms, we actually see improvement in hyperglycemia of less time as well as lower average overall glucose and less variability. In fact, those using an app based CGM had 1.2 hours in range per day by just having it. Why? Because it is with them, it's with them all the time and it's how we're trying to integrate those metrics into daily living. And so 87% of those patients sharing the CGM really continue to use their sensor because they engage with their physicians regarding it. So here's one more plug that you've already heard uh from my cohorts, you must download these things. You must as you as a physician engage in the data, right? We're telling the patients to engage in the data. I'm telling you as a clinician to engage in the data to figure out a workflow, to download it, to discuss it with the patient. Don't forget to bill it because that's something that you are allowed and you should bill. It's your time and it's your expertise. This is one of my favorite studies. I actually worked on it. If you look at the little tiny fine print on the left lower hand corner, this was a great study looking at how the use of CGM in both patients with type two and type one diabetes improved overall hospital admissions and absenteeism. This is big dollars. So for those of you who are interested in the economics or the cost savings of medicine, the flair study showed a significant decrease in hospitalization and absenteeism, 66% reduction in a 12 month period and that was for six months after getting CGM. Those patients not on bolus insulin had a reduction in acute related events. That means low or high blood sugars because you gave the monitoring to the patient. And so they could reduce these acute related events hospitalizations, which is big bucks which will pay for CGM many times over. And if you have less acute events, less hospitalizations, you have people that have not missed work as much. Why? Because they're not sick because they're feeling good, they're able to engage in their daily activities without as much disruption from their overall health. Now, here's how the data played out after initiating the freestyle Libra system. At six months, we see those individuals had a reduction in air one C by 0.8 and it was still there at the next 12 months of 0.6. It's called legacy effect. That legacy or durability is what always looking at. It doesn't mean that that new CGM that Libre was so novel that it improved. In the first few months, we actually saw continuation and we saw the greatest reduction in those individuals who were not on insulin. So this first group are those that were on long acting insulin and all types of therapy. In other words, type two diabetes, all put together. They saw that improvement at a one c of 0.8 and 0.6 respectively. Now let's take the group that weren't on insulin. Yes. Type two persons, not on insulin, not on insulin oral anti diabetics, injectable G LP ones, look at the A one C reduction they had of 0.9 0.9 in that for six months. Why do you think that is because many of us have not emphasized the need for glucose monitoring in these individuals? Why? Because we said, well, they're not gonna go low but CGM is not just for hypoglycemia. That's safety. That means that all persons with type one, all persons with type two and insulin or sofas have to be on CGM. But these individuals were not. And it's because CGM also provides benefit that goes beyond just hypoglycemic detection and it was durable out to 12 months. I loved participating in this study. And in my opinion, this was one of the studies that really helped the Centers for Medicare and Medicaid A pro CGM and at least those individuals on long acting insulin. However, I'm here to tell you that those even individuals not utilizing insulin are still gonna benefit dramatically. So don't make the determination of CGM based on what therapy or hypoglycemia. You can see it goes well beyond just that particular thing. Now, many of us think that type ones get hypo, it's true. Type one diabetics have more variability in their glucoses high to low. So the impact trial on the left showed that when you use sensor based CGM, you went from 100 and 96 minutes to 100 and 22 minutes in hypoglycemia per day, that's per day. That's not in like months, that's on a daily level. Now, lets look at type twos with the replace trial on the right hand side. Remember many of us think type two persons don't even get hypoglycemia if we're not on insulin. But they can, we didn't see as much reduction, but we saw a statistically significant reduction in those individuals in hypo per day. This is really good stuff. This is that foundation because hypoglycemia is occurring a lot more than you realize. Now, diabetes related complications after looking at time and range, OK? Type one and type two respectively and look at the different time and range 58% 70 or 80%. Now the target as many of, you know, for time and range is 70%. We saw that. But let's look from left to right at the hazard ratio or the incident related to diabetes complications. In other words, there was an improvement in myocardial infarction, renal disease, vision loss and amputation from left to right by improving time and range in both type one and type two individuals. So this is beyond just that A one C, this is that those individuals looking at time and range. And if you were to share with patients, hey, if we improve your time and range, get to that target of 70% or above. This is what can improve. Don't you think they're going to become more engaged? Yes, especially if you give them a metric and data that they can follow in real time because they can't change things that happened in the past. They can only change things presently. And CGM provides that plus it helps predict the future. So for those of you economics out there and medicine, this is what really translates into cost savings. We talk about investing in individuals to create a cost reduction. Now, many of our payers are not interested in 10 year cost reduction. They're interested in quarterly products, uh quarterly profits and for that, that they are very, how shall I say disconnected because persons with diabetes live a legacy, they live a lifetime, they don't live by order. So if we look at 10 year cost reductions with type ones on the left and type twos on the right, we see significant improvement in cost savings in the billions after improving time and range from 80% to from, from 80% to 58%. In other words, if we have improvement in time and range, we have significantly less cost. But if the a one's time and range went to 58% we have double uh the amount of costs. And so this is what I try to talk to payers. You give them a tool that yes is going to have a fixed cost with it, but you're gonna pay for it over and over and over again by the cost savings for these individuals and those costs have to do with many different things. If we look at those with type one, it has to do with hypoglycemia. That's notwithstanding. That's why type one diabetes is standard of care to give them CGM. We, we see reduction, a 20% reduction in hypoglycemic events as we see that improvement in time and range. Right. So the more time and range, the more you save. And this is why you're telling these individuals for their own metrics, for their own satisfaction, for their own health, which you're really helping the entire health care system at large. So what are the standards of care? There are standards of care? They are really becoming embedded and foundational in the practice of medicine and that is the use of CHGM should be considered for all persons with diabetes using insulin. It doesn't matter whether you're type one or type two. That's kind of the foundation. In addition, C MS has also said for those with chronic diseases such as heart disease, kidney disease, dementia, other things should also be on CGM. Those with any acute related events, those who have trouble with mentation or cognition or ability to engage in their disease, those individuals on oral agents that cause hypoglycemia. So you can see these are all the standards of care related to CGM and technology and you can see them in section seven and review them. In addition, this is something you need to know because as you engage with payers, you need to remind them what the standards of care are. However, I think the three of us have illuminated that CGM can be beneficial for all persons with diabetes. It all depends on what you're using your CGM for. Right? And so you can see that all individuals with a glycaemic journey need to know what their numbers are for various reasons, whether it's safety, whether it's lifestyle, whether it's choices or whether it's engagement. And so you should select the device that meets the individual's needs. When you prescribe it, you should understand that they have education and training, you need to bring them back in. You need to follow through with the data. You know, just recently in my state Medicaid approved this and they said they want you to go through the data every six months. That's where it's you as a prescriber, you need to engage with the data. We're asking patients to engage and educate, but you need to as well as a prescriber to also be educated on how to impact this. And you need to know that there are broad applications for type two, not just type one, whether there's medications that cause hypoglycemia, multiple da daily injections or basal insulin. You don't, don't have to be on MD I to be a type two person, we are telling you it will be approved for Medicaid and Medicare if you're on insulin. But those individuals who need more engagement in their disease should be offered. CGM and yes, type one and youth should be on CGM. This is now standard of care, standard of care. And so if you have an individual with type one diabetes who isn't on CGM, you really need to have a conversation because this is foundational to their overall living. So let's summarize what does the person and the clinician get with CGM? The person DGM brings diabetes from the past into the present and helps predict the future. It's individually driven, individually engaged and their individual story. It provides trend arrows. And if you're familiar with it up down stable, in order to predict both hypo and hyperglycemia, it illuminates the effect of food, time of day activity, engagement and medication illness. All those things tell your patients to look for that, tell them to journal, make a note of it, learn about their own life and all the different places they go. It gives ease of mind to the person with diabetes as well as the loved ones. Now, you as a clinician, you get an opportunity for the patient to engage and to share the burden of their own disease. It allows you to not be so worried about hypoglycemia so that you can advance therapy and the patient will be protected when you download and you review these A GP, you're gonna see a pattern. It's gonna reveal the impacts of glucose management. You're gonna have an opportunity to intervene both intensify and in some cases de intensify. It gives you that principle, shareable data and I urge you to review it, share it electronically, send it, print it whatever you wanna do because this is their report, it's not their report card, it's their report. And both the person with diabetes and the clinician with diabetes need to engage in CGM. But how do you need to be effective in CGM engagement? The patient needs to feel in control. You need to tell them not to emotionalize the numbers, they need to be learned. They need to feel that they have a directive or where they should go be familiar with the target and the numbers that you want for the patient and then tell them you're gonna share, you're going to talk about the that particular CGM and what type of features they need, whether they need alarms, whether they need uh different types of metrics, whether they're scanning, whether they're viewing, whether they're streaming, I tell individuals to journal. I don't, don't want a narrative. I just want a journal. I wanna know what, what food did you eat? Give, give me a little thing. What you do? Did you work out? Did you? Oh, I forgot my medication. Now I have it and, and then when I took it, this is what happened. Download it, download it, download it. You know, it's like a terrible statistic in primary care. It's like 20% of all CG MS are downloaded. What are you guys waiting for? Well, I don't know how to download it. Well, then take a lunch time, get the representative in and figure it out. It's not rocket science. You just need to put that workflow in at once one time in order to get this streamline, get that data in, incorporate it, create a workflow in your office who's responsible for asking who's responsible for downloading. How do you complete the circle? It really is. It's essential for you as the HDP to keep that dialogue open and support CGM to not just say, well, I don't know how it's affecting you. This is your responsibility. You need to know how it works as well. But this is an opportunity because I promise you you incorporate CGM into your practice, you're gonna save a lot of time, a lot of time and you're gonna be able to bill for that time that you do spend uh discussing it with the individual in the office. So my big question is, what are you waiting for? You are giving the patient a tool to have better glycemic control early in their disease to create a legacy for the future. Both with type one and type two. CGM improves the quality of life with the patient. Even if you never did anything with it, it reduces acute related events, hospitalization, massive economic impact in proving time and range. I don't care what type you are has less complications for the patient in the both the acute and the long run with heart disease with kidney, with vision. The AD A recommends it for standard care with all persons with type one, as well as those with type two who are on insulin. But understand CGM is for all persons with diabetes. It depends on what you want to get from the CGM. You are the person, you are the person who identifies, the person starts, the prescription encourages them, enables them and brings them back around. So don't let CGM inertia be traced back to you. So I'm asking you.
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