Hello and welcome to this presentation titled recent Trial Pharmaco Econom and Real World Data supporting CGM is a Best Pharmacy Practice strategy for managing persons with diabetes, a practical pharmacist based roadmap for deploying CGM in the managed care setting and we will go ahead and dive right into it. So there is a need for efficient type two diabetes management in managed care. And 90% of type two diabetes is actually treated by primary care physicians versus being treated within endocrinology and specialized C centers. 10% of people with type two diabetes are actually on intensive insulin therapy regimens and PC P visits are about 10 to 12 minutes of face time. So that's not very much time to assess insulin regimens and figure out how to intensify things. And on top of that PC PS are seeing a lot of patients. Uh this statistic is showing up to 40. Um but even many are seeing 30 that's still quite a lot of patients per day. So it's just it, it's a really a challenge to keep up with all of that. So the problem is that when people are using insulin and especially anyone who's using real time insulin. That hypoglycemia can be a great concern. And hypoglycemia is something that can occur both in type one and type two diabetes. And it's really because insulin has such a narrow therapeutic window that it's very hard to dose without ever experiencing hypoglycemia. And so in type one, pretty much everyone has hypoglycemia. I mean, when you look at our time and range, we even say up to less than 4% of the time is acceptable. That's almost an hour a day because we accept the fact that these are difficult drugs to dose and that people can experience hypoglycemia. But what's especially alarming is that 30 to 40% of people with type one diabetes experience at least one severe hypoglycemic event per year and severe indicates that they need assistance from someone else. They're not able to treat it on their own. In type two diabetes, 50% of people on insulin experience hypoglycemia and 20% experience one severe hypoglycemic episode per year. So it's not just for type one diabetes. Those that are with type two that are taking insulin are also really at this risk as well. So, hypoglycemia in addition to just being really unpleasant and having horrible effects and often it can take several hours to really feel better from the effects of hypoglycemia. It's also associated with increased risk of mortality in people with diabetes. And in clinical trials, uh, those that had a history of severe hypoglycemia nearly doubled the risk of mortality. And this was seen in two of our landmark trials, the Accord and advanced trials. And then in observational studies, retrospective clinical based study of over 1000 people showed that those with a history of severe hypoglycemia baseline had odds for mortality of 3.5 at five years. So a 3.4 times greater risk of mortality. And this was considered statistically significant and also people that experience severe hypoglycemia are more likely to reduce or stop their medications. And well, yeah, they probably need a reduction just completely stopping the medication also can have its own issues with then having hyperglycemia and having other complications. So anyone with taking insulin is at risk of hypoglycemia. And we know that time and range can help provide valuable information about whether the frequency and duration of hypoglycemia or hyperglycemia improves over time. And in a large meta analysis of patients with type two diabetes on insulin, 52% experience episodes of mild to moderate hypoglycemia. 20 per 1% experienced severe hypoglycemia in a study of patients with type two on insulin, fewer than half actually reported their severe hypoglycemic episodes. So likely this is going under reported all the hypoglycemia that's occurring. And among patients without severe hypoglycemia in the last six months, only 28% consulted their health care team following a non severe hypoglycemic event. And among patients with severe hypoglycemia in the last six months, only 48% consulted their health care team following the event. So, uh many times it's just that, that how can an intervention be done if the health care team doesn't even know that it's occurring? CGM, fortunately has increased use in type two diabetes. And we'll talk about how this can really be that tool to help address this hypoglycemia. So there's 37 million people with diabetes in the United States, About 90 to 95% of those are living with type two diabetes. And the latest estimate is 30 or 30% of people with type two in the US are wearing CGM technology. So that's that has definitely grown. There are estimates that in 2024 that it could be up to 50% of people with type two diabetes in the US utilizing CGM. And I guess my question to you is what would it take to make CGM the standard of care to approach 100%? I think if we asked, well, what percentage of people with type two diabetes have a glucose meter and have been asked to check their glucose using the glucose meter. I bet that would be pretty close to 100% maybe not 100 100 maybe like 95 but it, it would be pretty close to 100%. So what will it take for CGM to replace BGM? Like BGM has replaced urine glucose testing, which we would never suggest anyone do anymore. So let's talk about the data that really supports the use of CGM. So before I get into some of the specific studies, just high level, what do we see from CGM? We see that it has a positive impact on diabetes burden. It makes it easier to monitor. Simply people don't have to poke their fingers, whatever number of times we ask them to do and get blood and figure out where to put their lancets and just all of that type of stuff, it increases their time in that target range. It's been shown to reduce A one C. It's been shown to actually reduce some of those more um really those very important outcomes like hospitalizations and acute diabetes events. The ones that contribute to the high cost of diabetes care, also reducing time spent in hypoglycemia and even reducing work absenteeism because we know when someone is on that glucose roller coaster high, low, high low that, that can cause them to miss more work because they're not feeling good. All right. So let me start by showing an overview of the randomized control trials with flash CGM. And the impact trial was done in people with type one diabetes. The replaced BG trial was done in people with type two diabetes. In both of these studies, people were randomized either to the freestyle libre or to BGM the control group. And keep in mind when this study, when these studies were done. This was the original Libre. So it's not like the Libre two or the Libre three where we have alerts for highs and lows. The original Libre did not have alerts for highs and lows. However, it made it much easier to check glucose because you just scan the glucose and you know the number and you can see the arrow and you could see the trend. So this showed, despite having no alarms that in the type one diabetes, there was a 38% reduction in hypoglycemia and time spent in hypoglycemia per day. And in those with type two, there was a 41% decrease in time spent in hypoglycemia. And this was done without increases in a one C because you could argue. Well, yeah, if their A one C went up like 2% points, then that would get rid of hypoglycemia. But that is not what happened. They were able to reduce hypoglycemia with corresponding reductions in A one C or similar or same A one CS. Now, I want to talk about some of the real world outcomes. This is the Kaiser study and in this study, real time CGM initiation was associated with a significant reduction in a one c of 0.4% in type one diabetes and in insulin treated type two diabetes. And there were even actually greater improvements than those with type two. And what they did was this was Real World Day. So this was retrospective, but they compared people in a matched cohorts that had initiated CGM versus those that had not and shown that there was a greater improvement in A ONE C in the CGM group. There was also a 51% reduction in hypoglycemia related emergency department visits or hospitalizations. And there was an 18% increase in members meeting. They, this measure of a one C less than 8%. And we have this quote from one of the researchers, the improvement in blood sugar control was comparable to what a patient might experience after starting a new diabetes medication indicating that perhaps adding another medication is not always the answer that actually starting CGM can have a similar or sometimes even greater effect. Now, the next study I want to show you is called the flare and L four. And this was a prospective observational study and this was interesting, they compared patients that were, this was actually done in the Netherlands, but they looked at patients 12 months before utilizing CGM and then compared 12 months after. And some of the things they found were that 95% users reported having a better understanding of their glucose fluctuations. 77% reported less hypoglycemic episodes. 92% found it easier to manage mealtime glucose and 37% reported engaging in physical activity more frequently. And I love to see that because it's reinforcing positive lifestyle behaviors. But what some of um probably what our payers may be excited about is in addition to all those really wonderful things and improving quality of life and everything, there was also a 66% reduction in hospital admissions going from 13.7% the year prior to 4.7%. And yes, that was statistically significant. And then also the productivity was increased. So 58% reduction in work absenteeism going from 18.5% the year before to 7.7% also statistically significant. Ok. Next one of my favorite studies, the Mobile study, because this is really, this is the landmark study that I believe got CGM approved for use by Medicare for any insulin user not needing to be on real time insulin. And so what they did in this study is they took people with type two diabetes that were on basal insulin plus or minus other noninsulin medications and they randomized them. This was a randomized controlled trial either to CGM or to BGM. And so they compared their A one CS along with their time in range before or between the two, the two groups. So baseline A one C started around 9% and follow up, this was an eight month follow up 8% versus 8.4%. So there was a 0.4% difference between the groups. And we can also see how that time range was 59% in the CGM group compared to 43% in the BGM group. And then especially that time spent very high, over 2 50 was reduced only 11% in the CGM group compared to 27% in that BGM group. And so, and what, what's particularly really remarkable about this study is that so this was done in primary care. It's not like this was done in like endocrinology. They actually had endocrinologists available. If the primary care clinicians wanted to consult with them, I don't think any of them really wanted to consult with the endo they, they were able to manage it on their own. But what's really interesting about this is that this was not because they intensified medication. Actually, when they compared the two cohorts, the medications were basically the same. So what was the difference? Why is it that the time and range is so much higher? And the A one C is so much lower when it's not because they were intensifying insulin or they were saying, oh, this is high, I'm gonna add a new medication. It was likely because the patients were looking the data, they were engaged and they were making lifestyle changes. And so this really shows us that sometimes it's not about needing to add another medication. Sometimes this may be the next best prescription actually adding AC GM. And so in this study, it really highlighted diabetes self management that um use of CGM in people with type two on basal insulin showed a much greater a one C reduction. There was a lot more patient engagement and just very activated patients in it. All right. So there's another component to this mobile study that I think is also really fascinating. And this was an extension where they basically said, OK, so you've been using this for eight months? Great. We're gonna go ahead and we're going to discontinue it in some of you and then in others, we're gonna let you continue it and they looked at time and range and they looked at A one C. So what do you think happens when you take away someone's magical tool? Well, unfortunately, their time and range and their A one C both deteriorate. And so this is showing that there was a 12% decrease in time and range in the group that basically had their CGM discontinued. And, and we also see that A one c worsened, it actually uh increased in the group that just continued their CGM. And so I think this just teaches the important lesson that people deserve to have continued access across payers. It's really unfortunate when someone is able to get CGM covered and then maybe switches their work employer or maybe is on one plan and, and goes to another for whatever reason and then they no longer have coverage. This is what can happen, this worsened control. All right. And then, oh, I this is another, this is just a kind of a shorter study, but I thought this was really interesting, this is showing improved glycemic outcomes in patients with type two diabetes, treated with basal insulin or noninsulin therapies. And so this was a six month prospective interventional single arm study, assessing CGM use in people with type two diabetes. And at three, you can see their starting A one CS were, were definitely high if they were on over two meds, their A one CS were actually, that group was 10.4% to start the group with um less than one med was at 9.5% to start. But they implemented the CGM. And by six months, a one CS really came down a ton uh 7.2% in the than two med group and 6.7% in the less than one med group. And so this is just providing some additional data, especially in those treated with less intensive regimens with type two diabetes showcasing how this can be such a valuable tool to get people to go. Even people that are not on medications or only on one that implementing this early can have quite profound outcomes. What about older adults or people with limited health literacy? So there's a lot of unconscious bias and there's a lot of health disparities that occur in health care. And sometimes we make these generalizations like, oh well older people, this is a complicated technology. Older people aren't gonna wanna use this or it's gonna really just be too hard for them to understand it's better for them to just stick to what they're doing. They're doing good enough. Well, this was a study showing that older adults reported high usability of CGM. And so in terms of a usability score, 92.8 out of 100 some of the survey results, I believe I can set up the CGM system on my own 4.9 out of five, the CGM system showed information clearly and effectively 4.9 out of five and 12.6 minutes, six minutes average total set up time for initiating AC GM. So I think the preconceived notions are really we have to be careful about them. Also, these devices have gotten so much easier to use over time in terms of one button presses or just quick pushes onto the skin. Not many, not even having separate transmitters anymore, having longer wear times after 14 days. And so a lot of these preconceived notions that we have with technology, we gotta be careful because it's really usability. It is very easy. And even with the ones, many of them work with the smartphone apps, many people have smartphones. Now I realize still not everyone does. But many, many of my older adult patients have a smartphone, someone in their family made them get it and they have it. They may not totally know how to work it, but like with a, a couple instructions they figure it out, they, they get it. So um in studies support CGM data for education and behavior modifications. So uh perceptions of how CGM data affect nutrition and physical activity, participants reported that CGM contributed to healthy lifestyle. 90% they modified their nutrition choices based on CGM data, 87% and they were more likely to walk or exercise in response to a rise of glucose values 47%. So we see it, we, we see this and the data support this that people get that real time feedback and make healthier choices in real time. Well, what about the cost effectiveness of CGM? Because you could say, well, this is nice and everything, but is it going to be cost effective? Well, one thing for sure is that the cost of these devices have come down quite a bit. And so that's something really important to keep in mind. In fact, I'm gonna share a couple cost effective analysis. But keep in mind that the these devices continue to really come down in price where we see full retail prices really ranging from um from like 1 30 to 1 85 for two of our more common CG MS. And we know a lot of times there there could be manufacturer coupons and discounts where people can actually get it for less than that. But this here is a cost effective analysis of CGM versus BGM based on a US retrospective cohort study. And insulin treated people with type two diabetes. But this was actually adapted to the UK long term costs and clinical outcomes were estimated using the core diabetes model based on a one C lowering and reduced finger stick testing and associated quality of life benefit. And the results show that the projection showed real time CGM was associated with increased quality adjusted life expectancy of 0.731 quality adjusted life years and increased mean total lifetime costs of 2694 pounds. And an incremental cost effectiveness ratio of 3684 per quality compared with BGM. So what does this actually mean? It means that over patients lifetimes CGM was associated with improved clinical outcomes. It is highly likely to be cost effective versus blood glucose monitoring in people with type two diabetes on insulin therapy. Now that it was technically it was real time CGM. This was a cost effectiveness of flash CGM in type two diabetes and this was people that were using intensive insulin also in the UK. And um this was an I A core diabetes model used to analyze the data. The model inputs included things like baseline characteristics, intervention effects and the results were that flash CGM resulted in an incremental cost effectiveness. And it provided an incremental cost effectiveness ratio of 12 1003 £190 per quality adjusted life gear and A ONE C and intervention related health utility were the key drivers of differentiation. And the conclusions were that the consistent results across base case and a range of scenario analyses indicate that long term flash CGM is cost effective compared with BGM. And we've certainly seen in other countries, the expanded use in uh diabetes populations. And then there's several other economic analyses. So this was taken from uh a nice systematic literature review of different analyses that have been done over different countries, several from the US, some from Israel, Belgium, Sweden. And what the authors conclude here, there's a nice summary in the article that really kind of summarizes each each one. But they conclude that um CG MS use is safe and effective in improving glucose management and significant reduction in resource utilization is associated with its use. So really showcasing that it in terms of economically that the benefits are really worth the increased cost. And if you think about it like on a logical level, if you are preventing hospitalizations, even one hospitalization over the years or emergency department visits from severe hypoglycemia, it is definitely going to be worth it. And certainly people treated with insulin are going to have those higher risk events occurring. So the data is very strong in those taking insulin or those experiencing hypoglycemia from other medications. So next, I wanna switch gears just a little bit and talk about the important role of the managed care pharmacists. And one of the great things is that CGM availability in pharmacies is really expanded and I'm a big fan of it being available in pharmacies because often it's going to be easier for patients to be able to access pharmacists are widely trusted and accessible for people with diabetes. 61% of adults say they would like to get a greater range of health services from their local pharmacy. 74% of adults trust their local pharmacists to step in when primary care is not an option. And there's actually a pharmacy within five miles of 90% of Americans and they're in local neighborhoods. And there's just, there's more touch points available for people with diabetes. And this map is just showcasing that there's a lot of pharmacists availability throughout the US. So I wanted to share, I thought this was kind of an interesting case study that I came across in the literature. And this is Vermont Medicaid, how they chose to go from DME, the durable medical equipment to pharmacy. And so their Vermont Medicaid program operates under 100% fee for service model and covers 100 and 80,000 members in Vermont, over 25% of the state's population. And one of the challenges they were facing with DME is that it was just, even though patients technically had Crite met criteria, there was limited access due to some of the clinical burden and this includes extensive documentation. So typically it it's required to have the patient's demographics to have chart notes when you're submitting this also, when supplies need to be renewed, having that documentation and that can lead to delays obtaining the device and also delays in getting ongoing supplies. So what they chose to do is they actually transitioned CGM coverage from DME to pharmacy to just ensure easier and quicker access. Also, it reduced staff and clinician burden as well. And so there was actually a doubling 100% increase in utilization of CGM. And that's really going along with corresponding improved diabetes outcomes. And I can tell you in Ohio, we, we fortunately have the same approach where we, we are able to get CGM through pharmacy. And on the end of I'm a pharmacist that can also prescribe and it really just makes it so much easier because in the visit, I can escribe to that pharmacy. I know the patient can pick it up the same day or I can send to a mail order, get mailed to them if they want. But I know it's, they're going to get it right away. There's not gonna be that delay of oh, what chart notes do they need? Or we sent the chart notes, we faxed them but they didn't get them and they fax us again and we didn't get their fax and we, we play fax tag or we send the notes, but it's missing like one sentence that they wanted to see and like we need to attend it and it is, it, it's a lot, it's just a lot. And so pharmacy, not only is it accessible for patients, but it can really reduce all of those burdens. Now, one thing pharmacists can do is they also can identify patients who just may benefit more from having CGM. And one thing I like to say is well, yes, CGM can be provided to any of your patients with diabetes. But in the beginning, if you are barely utilizing CGM in any of your patients, it may be helpful to at first prioritize and keep a few considerations in mind. So for one who's taking insulin, because anyone taking insulin is taking a narrow therapeutic drug that can cause hypoglycemia. And even if the person has never experienced hypoglycemia, they are always at risk for it. And those are great people to take it. Maybe looking at well, who's not taking their medications, who's not refilling their diabetes meds or taking their meds as prescribed. Maybe that's someone that would really benefit from seeing their glucose and it may inspire them to be more proactive about medication taking behavior versus it's really easy to just check your glucose once in the morning with a finger stick and then just eat whatever you want all day and like not exercise and not really know that if there's ever a problem because you only check it in the morning. And if you're fortunate enough, it might come into range the next morning. And so that can be a problem. Certainly anyone with hypoglycemia, those not at their goal would definitely be good to first prioritize if they're really struggling to meet their glycemic targets. And then also those where you prescribe BGM and it's just the person's like, yeah, my fingers hurt. I'm not doing it or they're like, yeah. Yeah, I'll do it next time. I'll be better. I'll check three times a day, next time, but they like never do or they don't bring their log and you have no information right now. CGM is also a great tool for medication management. So it can take the place potentially if you can using another medication as we saw with like the mobile study. But also it can help really to determine. Ok. Well, where's the issue? Is there? Hypoglycemia? Is there postprandial increase in on me? And maybe we need to add mealtime insulin with that meal or maybe we need to decrease this dose here. So it can be super helpful for all of those things and then virtual care. So with our data platforms like the Dexcom clarity, the Libre view Metronic carelink ever since data management system, it's so easy to view data remotely. And so you can actually you can have virtual visits or telephonic visits and you can save people a lot of time by not having to come into clinic or come into the pharmacy all the time to make medication optimization. It's really been wonderful with all of the virtual care and just some talking points in reviewing CGM data with patients, you can identify well what activity or food choices were helpful to stay in that target range. Explore physical activity patterns, encourage appropriate portion sizes to evaluate postprandial glucose, seeing the what happened from missed doses and just overall understanding the impact of food activity and medication taking behaviors. All right. So to put this all into practice, I wanted to share a patient case which I think really just demonstrates the utility of this. And so this was a patient. I had 57 year old woman with obesity, a one C 9.1% and she needs a total knee replacement. But her A one C is currently too high for surgery. So her diabetes medications include insulin, glargine, 40 units daily and dulaglutide, the G LP one agonist, 4.5 mg weekly. Now I want you to see what happened here. She was given AC GM and she already made so many positive changes. And in fact, when you look at this here, she is 80% in range. Her GM I her estimated A one C is 6.8% and you look at that curve, it looks for the most part, it looks in range, right? And so it would be easy to look at this and a think, ok, well, she's meeting her goals and this is wonderful or B what if you didn't have this data and all you had was the A one C. Then it's like, well, what do you do now? Because we, we need to get her A one C at goal. But this is showing that she is that goal. Well, let's dig a little bit deeper. So one of the other things we can do with CGM is you can blow up the dailies and make them bigger. And if someone's, in fact writing notes as this patient was, you're able to see them. So she did a couple of days, I took a snapshot of a couple of days here where look, she actually had some lows overnight. So 68 69 and she said how, you know, she like ate chocolate and drink some lunch just to treat that low, which we could have a conversation about uh she, she wrote some other foods in there. So she went a little higher when she had barbecue potato chips and uh we can see the the impacts of that. So hop back to here, I do notice, even though there's 0% hypoglycemia, it'd be easy to say, oh, well, like she's doing fine, she doesn't have any lows. But actually, if you look at that curve, it is dropping a little bit. And in fact, we see she is having some lows. And so why didn't that come up in the time and range? It's because it's not that often it's less than 1% of the time. But for her, she's having lows because she's been so proactive about modifying her diet increasing activity because she really wants this total knee replacement. So, what did I do? What was my plan? I actually decreased her insulin glargine because I wanna promote further weight loss and I wanna reinforce her positive health behavior changes and I don't want her to have hypoglycemia. So I continued the G LP one agonist, but we went down and I think this is just such a good case because if I didn't have this data, first of all, she probably wouldn't have been as so inspired to make these lifestyle changes. But also if I didn't have this data, I mean, I might have just increased the insulin if I saw that 9.1%. A one C, I'd say. All right, we gotta go up to 50 units of insulin, right? But that wasn't the right answer here. And I think CGM really helped us to decrease the insulin. And I've had several cases where C GMC GM and A G LP one were able to get patients off of, off of insulin. So with that, just some concluding remarks I want to make is diabetes continues to have significant clinical and economic consequences, particularly in the managed care environment costs along with morbidity and mortality are increasing in patients with uncontrolled glucose levels. Sensor based CGM offers an opportunity in the managed care environment to prove glucose improve outcomes and reduce costs. And CGM is becoming a foundational strategy across the spectrum of diabetes care and managed care plans. In particular, stand to benefit from its incorporation into the standards of care. And with that, I thank you so much for attending today.
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