Well, thank you DR Isaacs and welcome everyone. My name is Susan Cornell and I'm going to talk to you about the clinical evidence rationale. And the American diabetes Association guidelines incorporating sensor based continuous glucose monitoring. Um so I think this is really important because You know, I get I'm the old person in this group and I'm happy to admit it. I've made it this long but you know, I remember graduating from pharmacy school and finger sticks were the hottest thing there was in order to manage and monitor glucose and it was great because people can now do this at home. But we've come a long way since the 1980s. Yes, I'm dating myself there. We've come a long way since the 1980s and now we can even improve more with technology on how people with diabetes can have better management and better control. So with that let's jump right in um the obligatory faculty disclosure slide for folks to see. And with that, what I want to do is kind of just put you know, put this into content for you. Um You know, this just changed. So these are the new standards that came out just in February of this year. Previously we were at 34 million people with diabetes were now up to 37 million. Excuse me. And this is post pandemic. Now this is people with diabetes And we went from 88 million to 96 with prediabetes. We haven't gotten the obesity numbers yet, but I'm curious to see what that will be because prior to the pandemic this country. The United States was at 42% obesity, 42% obesity in adults. Which is pretty pretty high. So I'm curious to see what it's going to be coming down the pipeline. And we know that obesity and diabetes tend to go hand in hand. So again when one goes up usually the other goes up. The other thing to recognize. And I think this is important for pharmacists to realize is that It is not obesity is not exclusive to people with Type two. Nearly 40% or more of people with Type one are overweight or obese. So we need to also look at that obesity factor and you're wondering why I'm talking about this and I'll share as we move on because this is where C. G. M really plays a big role. Now when we look again at the statistics out of all these people with diabetes only about 50% are meeting their goal of you know an A one C. Of less than seven. That means 50% have an A one c greater than seven. And then we look at the blood pressure and cholesterol and we're looking at those in individual silos. When we put this all together. Under 20% of people with diabetes also have their blood pressure and cholesterol controlled. So obviously there's room for improvement and that improvement needs to come from the entire diabetes care team with the patient driving that. So let's jump in and let's look at what do the 2022 standards of medical care and diabetes say. And section six is glycemic targets. Section seven is technology and both talk about continuous glucose monitoring. But specifically in section six it talks about something called time and range and that's what needs to be incorporated into diabetes management. So let's talk about that for a second. So how are we currently monitoring diabetes? Well of course we have a one C. But if you think about it, the A. One C. Is an average of three months. And really I'll be honest with you, 50% of that value, 50% of the A. One C. Value comes from the past 30 days and then 25% from days, 31 to 60 Than 12.5% from days, 61- 90. So you could see a lot of this is really the last month. And so I actually tell my patients you can study for this test. The way to study for an a. one c. is 30 days before you know you have to get it done behave yourself, eat healthy exercise, get good sleep, take your medicine, do everything you can to keep your glucose in control. And usually you can skew the number of the a. one c. That way. But the bottom line is With the a. one c. We don't know how many times the patient was very high or very low and we don't know what that variability looks like. And glycemic variability is really how we manage diabetes. So of course to we have finger sticks. That's one point in time. You know? So if I tested my sugar now let's just say I was 150. AM I going up? AM I going down? We have no idea unless I test myself an hour from now and an hour after that and people don't want to be sticking themselves 10-12-14 times a day. Some people do but really it's not practical, especially when we have continuous glucose monitoring which allows us to see what the sugar looks like. You know, for 24 hours a day for two weeks. You know, we can get trends and we can look at a lot of different data analysis from this. So just put this again into perspective for you Here are seven people That have an a one c. of 6.5. What do you think? Do you think they're doing? Well? Again their a one c. 6.5. So if we're only looking at that we would not make any changes. But I'm noticing here, you know, quite a few of these people breakfast and lunch, they're going up and even sometimes after dinner it's really not until the evening that they start going down. So what's going on and how would we find this out if we were solely relying on a one C. Now that leads me to time and range. And so again the A. D. A. Has guidelines on what is time in range. And they say that for people with Type one and Type two. So these are again adults or they should just say people with Type one and type two. Um For the most part they should be between 70 and 1 80 mg per desolate. Er um So I apologize that little red box should actually be down one bottom line. The range is 70 to 1 80 mg per deciliter. and within a 24 hour period It should be 70% of the time. So we're looking at for most people at least at least 16 plus hours out of the day. We would like to see them in range. Now older adults 70-1 80 is still the range. But now we're looking at 50% of the time because again for older adults especially those in assisted living or long term care maybe a little bit more challenging. And in those cases hypoglycemia is definitely a big problem for them. So we want to minimize hypoglycemia but at the same time if we write them a little higher keep them a little more sweet. Um You know it's easier to, unfortunately it's easier to deal with some of the micro vascular complications than it is to deal with the cardiovascular that comes with hypoglycemia. And then pregnancy just take a look for people for pregnant women, 63-1 40. And that's what we call tight time in range. And the reason is baby. We're concerned about mom and we're concerned about baby because if mom is high, baby is going to be high. And that's just a setup for baby having diabetes, you know, sooner rather than later. And again, when we're looking at pregnancy, especially gestational, You know, so women in their third trimester, we're looking at that 61, 40 90% of the day. So again, tighter control for pregnancy. And so you're going to hear a lot of talk about time in range. And I just want to share with you that there have been some studies out recently looking at certain drugs and I'll be um specifically the once weekly insulin. And there was a study that looked at one of the once weekly insulin's that showed that people using once weekly versus once daily had better time in range. In addition, They also had a subset that were tight time in range, which was 70- 140. So when we're talking time and range here and now, Because it's still a novel concept, the range is a little bit looser, you know, 70-1 80, that's pretty big range. I expect that to actually become tighter as this becomes more commonplace because the tighter the control, the better glycemic management. And we'll talk about the importance of that in just a second. Now. in addition, when we're looking at the metrics, we want to look at that time and range. But then we also want to look at, well what if they're above the range? How high are they above? You know, is a level one hypoglycemia, hyperglycemia or is it a level to hyperglycemia? You know? Where are they? So are they above to 50? Are they between 1 82 50? And then what if they're low? And you know, that's a big problem too and we'll go more into this in this session. But if they're low, how low are they? Is it a mild low? And you know, I say mild cautiously here. A level 1 54 to 69 or is it less than 50 for a level too low. So we're starting to look at where are the metrics? And what are the percentages Of range? Is these people are in within a day, within 24 hours. But to get this data, I do need to say the person needs to wear their device At least 70% of 14 days. It needs to be active. So in a perfect world, we want this person When we're getting the data to wear their device for 14 days. You know, if you get 13 out of it. Okay, it's not too bad, but seven is not going to cut it. Or if people try to take it off, put it back on doesn't work and again that will be covered later in a different session. But bottom line is we need to look at you know the time the device is worn in order to make sure the data we're getting is accurate. So let me just share with you. Kind of what an ambulatory glucose report looks like in all of the information. So we get the statistics, which I'm going to go into a little bit more detail in a second. Then we kind of get that profile, the median, the wave etcetera. And then of course the daily reports. So we can see within a day where people have, you know places or trends that we need to investigate or you know, find out what's going on. So as I mentioned the statistics and time in range. This is what it looks like. So again we're getting how many days the person is wearing the device, how how active is it. And then we're getting statistics again in this case the person 47 a little room for improvement. The good news. They really don't go low that often. So that's good because we always target the hypo first. We always fix hypo first and then we go after high here we don't have to fix hypo. So we can go right away and find out what is hyperglycemia, what's causing it and kind of look at daily reports and then of course the the ambulatory glucose profile. But here we can see that the average glucose is about 173 It's estimated the glucose management indicator which correlates somewhat somewhat to the a. one c. Is about 7.6. And then variability 49 nearing 50%. And I will tell you anytime variability is greater Than 36% and intervention is needed. So you know, we need to look at this, there's a lot of room for improvement and we need to make an intervention here. And as I mentioned that correlation of time and ranged a one c. Um you know, this is what we're starting to look at and we're finding that the higher time and range The lower the a. one c. So look here, if you have a person like the person we just had 47% we would estimate their A one C. Into the high sevens or the low eights. But if we're in time and range at least 70% of the time most likely the A one C. Will be less than seven. And if we can get time and ranged 80% that a one C. Is even lower at 6.5. So again, we're meeting the A one C with a higher time in range. And how are we doing that? The bottom line is it's actually patient driven patient information, patients learn a lot when they wear these continuous glucose monitors. Now, I would be remiss if I didn't remind folks what the classification of hypoglycemia is. You know there's different levels And obviously hypoglycemia is anything less than 70 but a level one. And obviously that correlates to the metrics that we were just talking about Is between 70 and 54 When it's less than 54. That's a level two hypo and then any time that there's altered mental status or physical status requiring assistance That's called Level three. So again, just remember hypoglycemia. We always fix that first because it is very very dangerous and causes a lot of problems. So now let's take a brief look And what do the guidelines say this year? So this is right out of the A. D. A. 2022 standards of care. So bottom line they're recognizing that see GM is improving, diabetes management is really making a difference. So a 14 day assessment looking at that time and range can actually work hand in hand with the, you know so we can kind of compare what does this look like. But here's the biggest thing is rather than waiting three months to make changes if we have time and range trends within two weeks we can take a look interpret the data and make assessments and this can be done through telemedicine. This can obviously pharmacists are doing this. Um So this is where again the treatment is being More right on time than waiting three months for for an a. one c. And here's the thing to more and more studies are showing the value of C. G. M. So we have now studies looking that show an improvement in time and range using C. G. M. Has actually reduced the number of hypoglycemic episodes. Of course that's as long as the patients wearing the device. We kind of talked about that if they take it off the data is not right. But in addition we've also seen that there's reduced or reduction in acute diabetes related events and hospitalizations. So again the data we're getting from C. G. M. Is is a win win not only for the health system but also for the patients. The patients tend to know what's going on there more actively involved in their care and they're kind of getting it bottom line they're getting it. And so that that report actually helps the person understand, hey you know what, maybe I can't have three pieces of pizza. I can only have two. I noticed when I exercise that my C. G. M. Maybe the sugar goes up while I'm exercising but it comes down and I have better time and range with activity. Uh It alerts me when I go low, I know when I missed a snack, especially if I'm on a, you know a security dog or an insulin or something that causes or has a high risk of hypoglycemia. The bottom line patients learn a lot from this and if I could just kind of wrap this up with the story, I had a patient who was in um this is gosh, beginning of february. So a couple of weeks ago came in brought in his C. G. M. Device. We were looking at the data and we noticed like between four and five in the morning that then you know his his C. G. M. Show to spike and this guy is a farmer so he's oh gosh I want to say he's in his mid seventies still working on the farm. He gets up between four and five in the morning and as we're talking and I'm saying you know so tell me more about what's going on, what happens? Do you have an alarm that wakes you up? He says well the alarm is his cat and when his cat jumps on the bed and he is not a sound sleeper that startles him and boom he jumps up out of bed and that that jumping out of bed actually spikes his sugar because it's it's kind of like an alarm going off but then it comes down and and life is good. The other thing he notices is when he has his shot of whiskey, yep that's what he said when he has shot of whiskey at night, he noticed his sugar goes up compared to if he doesn't have the shot of whiskey. So again this is just things that people realize when they're seeing the data coming from these reports. He also noticed that when he walks more that the sugar comes down when he doesn't walk and he uses the tractor or you know the obviously the farming equipment where he rides and he doesn't get off of it as often the sugar stays up. So again he's putting the dots together and actually seeing the value. So this is the benefit that people can see the value of C. G. M. When they wear it and they understand what's happening to their body. So with that you know bottom line as a pharmacist our role continues to evolve. Going back to where I started when I graduated I remember training people on how to use their home glucose monitor and back then we kind of had to sell it to the person, why should they have this? Why, you know this was before it was covered by insurance and why should they have this device and you know how it would help them? You know, here we are decades later. And bottom line we're once again going back to trying to educate the patient on the value of managing their sugar and here's a device that can help you do that better. The other thing too is we have to look beyond a one c. You know managing diabetes and monitoring it. A one C is just an average of three months and it really doesn't give us details. We have technology, we can use it And that time and range hand in hand with the a. one c. We can improve that glycemic variability and overall improved management of diabetes which is our ultimate goal. So our job is a pharmacist is to help the patient one get the C. G. M. And understand the value. But to help them understand the data and understand and interpret what's happening so they can make wise decisions in between their medical visits or their pharmacy visits and again lead a good healthy life with diabetes. So with that I'd like to thank everyone for their time and right now I'm going to kick it back to DR Diana Isaacs.
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