Narrator - Dr. Abel 00:00 Welcome to HelixTalk, an educational podcast for healthcare students and providers, covering real life clinical pearls, professional pharmacy topics and drug therapy discussions. This podcast is Narrator - ? 00:12 provided by pharmacists and faculty members at Rosalind Franklin University, College of Pharmacy. Narrator - Dr. Abel 00:17 This podcast contains general information for educational purposes only. This is not professional advice and should not be used in lieu of obtaining advice from a qualified health care provider. Narrator - ? 00:27 And now on to the show. Dr. Sean Kane 00:31 Welcome to HelixTalk. Episode 162 I'm your co host, Dr. Kane, Dr. Khyati Patel 00:36 and I'm Dr. Patel, and today's episode is something special. It is our first ever CE episode. So basically, if you listen to it and complete a few additional steps, we'll talk about it in a few minutes, you're going to be able to get CE credit if you're a pharmacist. But nonetheless, the title of our episode is “A1C You Later,” a concise review of CGMs (continuous glucose monitors) for the practicing pharmacist. Dr. Sean Kane 01:06 and Dr. Patel, as you mentioned, this is our first ever CE; we're super excited to be able to offer one hour of CE credit for pharmacists, and we'll talk about how to get that CE credit in a little bit. But really what we're doing today is talking about the A to Z of continuous glucose monitoring for the clinician who is less familiar with CGMS, kind of the landscape of how they work, what devices are out there, what we need to know about them. Then, are they Dr. Khyati Patel 01:30 effective, right? And with it being a CE episode, we have to have learning objectives. So the learning objective for the CE are describing commonly available types of CGMs in the market and their features and capabilities. Second is summarizing evidence and guideline recommendations for the use of CGMs and management of diabetes. Third is identifying the role of pharmacist in selection of CGMS and provision of education to patients as well as providers, and last but not the least, interpret the ambulatory glucose profile, which is the CGM data output, and recommend changes in anti hyperglycemic regimen for a given patient. Dr. Sean Kane 02:14 And for the listeners that want to obtain CE credit, you can go to HelixTalk.com this is episode 162 and in the show notes, you're going to see a link to obtain CE credit. Now it is $5 the cost of the nice coffee at Starbucks or your favorite coffee place, but that helps us cover the cost of the CE which was currently generously supported by the Rosalind Franklin University College of Pharmacy. So once you pay the $5 fee, you'll be redirected to our CE partner, which is called CE impact, to complete the evaluation and then earn that CE hour. Dr. Khyati Patel 02:47 And Dr. Kane, I'm super excited that College of Pharmacy shares our excitement, and they're supporting our first CE episode adventure, and they're sponsoring the CE cost, but we hope that our audience will continue to listen obtain CE credits for the future episodes we create. Dr. Sean Kane 03:03 And then, as you mentioned, Dr. Patel, this is CE, so a little bit different. We do have to disclose that we don't have any conflicts of interest related to today's activity, and we will be talking about some brand names and things like that. We don't have a preferred device. We've kind of picked the common devices on the market that we feel the practicing pharmacist needs to know about. Dr. Khyati Patel 03:23 And most of the content that's developed, in case you want to dive more deeper into it, look up the system one by one. We have some references that would be part of the show Dr. Sean Kane 03:33 notes as well. So to kind of break into it. Dr. Patel, this is a fascinating episode for me, because I would consider you the guru of CGM, and I am the novice grasshopper. I don't know that much about CGM, so why don't we just start talking about what are some of the terms that the listener needs to know with respect to CGMS to be able to understand what what else we're covering in today's episode. Dr. Khyati Patel 03:57 My chuckle definitely did not come across, but I am still kind of swimming in the world of CGM learning, you know, little by little, every day, I appreciate what you said, though, one thing I want to mention, and we kind of did this as part of a larger episode on digital health and CGM devices falls under The variable sensor technology of that bigger umbrella. And as we mentioned in that episode too, this technology is evolving every single day. You talk about one thing today and tomorrow, that thing becomes old. So take that with a grain of salt and kind of keep up with this if you are using these technology to help your patients. But with that said, defining CGM. CGM actually is continuous glucose monitoring, and the devices we are talking today are the CGM. So, you know, if you see the s next to it, it's kind of designating that we're talking about the devices. Dr. Sean Kane 04:55 Of course, we have a sensor, and this is something that's fairly thin that can be applied over the skin, and then. Has a probe that goes into the skin and measures sugar, glucose and the interstitial fluid, wherever that probe is at. Most of the devices are going to have sensors that measure every five minutes, but some of them can even do it more often than every five minutes, which is pretty crazy to think about. And then most of these are going to be worn over the skin, except there is one device called the ever since III, that's actually surgically embedded under the skin with a minor outpatient office procedure. Dr. Khyati Patel 05:27 Yeah, that's pretty neat. You may hear a term called transmitter as well. It's basically a wireless component that connects to the sensor so that it helps sensor relay the data to whichever display device the patient choose to use. Then, of Dr. Sean Kane 05:45 course, the display the device, this is your reader or your receiver, and this is going to be the thing that obtains the data from that transmitter and then puts it somewhere. So examples could be literally a reader, like a specific device that will obtain that data could be a smartphone, a smart watch. It depends on the device in terms of where that data ends up being transmitted from the sensor to a reader or a display device. Dr. Khyati Patel 06:11 And the terminology, sensor glucose is something to get our wrap. You know, head wrapped around. We've always talked about plasma glucose, or blood glucose. So what these devices measure is called sensor glucose, and it's a little bit different there, you know, it's measured through a generation of a small electric current when the glucose kind of reacts to the enzyme glucose oxidase. And then there is an algorithm behind the scene that converts this to an estimated glucose Dr. Sean Kane 06:40 level, and we'll talk about this later. But, you know, one common question is going to be, is this as accurate as it would be if I did a glucometer check? And one of the ways that we describe the accuracy of you know, the sensor glucose versus a blood glucose from a glucometer is something called Mard. Mard is an acronym, M, a r, d, for mean, absolute relative difference, and this is the average of the absolute error between the CGM values and then a reference value, which could be from a glucometer. Obviously, the lower the mean, absolute relative difference or Mard, the better. So lower is better for Mard. Dr. Khyati Patel 07:17 And last, but not the least, there is a term called AGP, and that stands for ambulatory glucose profile. This, in a nutshell, is the data output, and has lot of different indicators that are part of it that a clinician would kind of interpret and make changes in therapy and medications as necessary, and one of the component of AGP, ambulatory glucose profile, which is like an output, is tir, and that stands for time in range. Now we have TTR for anti coagulation, so tir is a similar concept, but more for the sensor glucose. And basically is the preferred range for most of our patient is 70 to 180 milligram per deciliter. And basically the time in this preferred range is kind of tells patients where they need to be for most of the time. And this this time and range goal, we want it to be 70% or more, because that equivalents to a 1c of seven or less, Dr. Sean Kane 08:23 then we also have the GMI on our ambulatory glucose profile. This GMI stands for glucose management indicator. You can kind of think of it kind of like an estimated a 1c and that's based on the glucose values from the sensor. Dr. Khyati Patel 08:37 And last, but not the least, there is variability coefficient. And it kind of just tells you, you know, over the course of 24 hours, or over the course of 14 day, that's the output AGP is how, what kind of fluctuations are you seeing in the glucose level? And so the goal is, you know, we want the numbers to be between 70 and 180 without wide variations. And so that coefficient goal is less than 36% and Dr. Sean Kane 09:08 we'll actually discuss many of these metrics later on as we get into more of the details of interpreting that AGP, the ambulatory glucose profile. But again, we're just trying to set the scene here in terms of there's a lot of new terms that clinicians may be less familiar with, Dr. Khyati Patel 09:23 right and kind of starting from the glossary terms, diving into different types of CGM Dr. Kane, most of our patients and providers are going to come across something called Personal CGMs. These personal CGMs have two different subtypes, and you know, for the purpose of this episode. You know, these also have farther subtypes. So let's, let's kind of take it one stand at a time. We were talking about stand‑alone CGM so basically, that CGM can be given to the patient. They are not connected to any other technology. For example, like the insulin pump, there are also personal CGMs available. They're called integrated CGMs that are connected to certain other technologies, such as the insulin pump. So talking about stand‑alone CGMs, we have the intermittently scanning CGM referred to in literature as small i, small s, CGM, or real time CGM, again, referred in the literature as small r, small t, CGM. Yeah. Dr. Sean Kane 10:25 So those intermittently scanning CGMs, this is where the user has to use the reader device to kind of pull the data off of the sensor at some time frequency. So usually, at a minimum, it's going to be every eight hours. But Dr. Patel, it sounds like sometimes clinicians encourage patients to do this at regular intervals, like at breakfast, lunch, dinner or some period of time, because if they wait too long, then the CGM starts deleting the oldest data point, then they won't have that data point. Is that correct? Dr. Khyati Patel 10:55 That's right. So little sensor that they wear holds data for up to eight hours, and if it's not scanned within that eight hour, then it will start deleting all their data to make room for the new one. And so therefore, recommendation is that you must do a scan at least every eight hours, so there is no, you know, gap in data. So behind the scene, you know your device is still capturing that information. But I usually tell my patients to incorporate this act of scanning as part of their lifestyle, and usually attach it to activities that they're doing, such as getting up from the bed, eating the breakfast or lunch or dinner, or before starting an exercise. You know, if exercise is longer during after, all of these things kind of can be a points can be suggested as the time or reminders that they need to scan their device and Dr Dr. Sean Kane 11:44 Patel, I think it's important to just point out that during the scanning process, you're not necessarily checking your sugar at that moment. What you're doing is you're basically downloading the data from the sensor, so the sensor is continuously capturing your glucose throughout that eight hour period. It's just that the intermittent scanning process is what downloads the data onto the reader device. Dr. Khyati Patel 12:05 That's right. And again, as you said, it's not checking your blood glucose, your sensor you're just wearing. It's inserted already to you. So the act of scanning is really just bringing a reader device over the sensor and let it read the data. Dr. Sean Kane 12:19 So then we also have the real time CGM. Can you tell us a little bit more about that? Dr. Khyati Patel 12:24 Dr. Patel, sure, the real time CGM is great for somebody who does not want to remember that they have to do the scanning part. Okay, so once you pair the sensor to the reader device, it is going to send the data without any scanning required. So it will just communicate the data directly. Besides the, you know, the app applying the sensor transmitter, if the device has transmitter, initial pairing of it and removing, there is, you know, removing at the end of the wear time. There is no other user action required between the sensor wear. That's really neat. Dr. Sean Kane 13:00 So Dr. Patel, it sounds like we have a bunch of different kinds of different kinds of devices out there. Probably every device is a little bit different terms of their feature set and things that pharmacists need to know about them. What are some of the kind of most common CGMs that a typical pharmacist is going to see in their day to day practice? And can you give us some examples of what makes a device unique terms of characteristics or attributes that it has that other devices don't have? Sure? Dr. Khyati Patel 13:26 I mean, we could make selection based on many different criteria, but if you're looking at CGMs in general, you know it differs based on what is the length of sensor wear time, so meaning like, how often do you have to change the sensor? Where can you apply the sensor? What is the warm up time for the sensor? So, quote, unquote, like activation time. Does it require calibration with finger stick testing or not? What is the approved age for use, if there is a non adjunctive labeling or not? And what that really means is, can the data from the sensor, so sensor glucose be used to make treatment decision or treatment for hyper or hypoglycemia, and then other things, such as, you know, does it connect to my phone, or does it connect to, you know, a reader device? Or do I have the reader device available or not? And then last but not the least, you know, there are some drug and substance interactions that are specific to each device and that all would kind of factor into how you go about selecting a right sensor for your patient. Dr. Sean Kane 14:35 So Dr. Patel as an example, most sensors are going to be worn for 10 to 14 days on the skin, but there is a sensor out there, the Eversense E3; this is surgically implanted, and they even encapsulate the sensor with dexamethasone, a steroid to decrease the inflammatory response. And that one, once it's implanted, it's good for 180 days. So clearly, there's a big difference between 10 and 14 days versus a surgically implanted one. It's good for 180 days. Dr. Khyati Patel 15:02 Yeah. I mean there that's a huge range. And the Eversense is definitely a little special. And when it comes to how the sensor is kind of inserted underneath the skin, most of these sensor application sites are going to be the upper posterior arm, so kind of like that loose skin, you know, by your tricep area or abdomen, and the sites are kind of, you know, specific based on the patient's age. That's how they're studied in clinical trials. So that's part of their kind of, quote, unquote labeling. Dr. Sean Kane 15:32 And in terms of calibration, this is where you have to do a glucometer finger stick to make sure that you've calibrated your sensor appropriately. Generally, you don't have to do that, but there are two devices the ever since e3 that surgically implanted one and then the Guardian connect where you do need to do that as part of your setup process. Dr. Khyati Patel 15:49 Yeah, and the calibration, Dr. Kane is basically you're asked to check one to two finger sticks per day in addition to wearing your sensor. So that's, that's the process. So kind of doesn't completely take away the finger stick part of it, especially with the Eversense E3 and The Guardian Connect. The other thing that is a little bit different is how the alerts are communicated. The FreeStyle Libre 14 days system is kind of being phased out of the market. But except for that one, all of the other CGMs that are now available in the market do provide high and low sugar alerts. So basically, if the sensor detects that your sugar is high or low, it's going to directly send it to the display devices. In some devices, these alerts are quote, unquote, optional, so you can turn it on or turn it off. Example is the libre two system. But for other devices, the real time CGMs, you don't have the option, they're going to provide the alert directly to you. And some of the RTC, GMs, or real time CGMs can predict future highs and lows. So it's going to kind of tell you, Hey, you're going to have, if you don't do anything about the sugar, you're going to have a low sugar in the X amount of time, and that basically depends on how fast, what's the rate of decline that the sugar is going to go under that hypoglycemic range, below 70. Dr. Sean Kane 17:12 And then, of course, age is a determination here, both in terms of application side of the sensor, but also the type of device. So you know, some of these devices can be used in as young as two years of age. But as an example, the Eversense E3 you have to be at least 18 or older for that particular device. Dr. Khyati Patel 17:31 And Dr. Kane, we kind of mentioned warm up time earlier. It's basically an activation time once the sensor is inserted. So there is kind of a period of an inactive time. Once the sensor is inserted into the skin, it allows the sensor to get warmed up, to get familiar with the interstitial fluid that you're entering. So when you try to scan your device to that sensor, or when you try to see your data, there will be a reverse countdown. Then say you have X many minutes remaining in the in the warm up this warm up time can depend on the device, and it ranges anywhere between 30 minutes to 24 hours. So for example, if you have a 30 minute warm up time, I'm not going to ask my patients to, Hey, make sure you test your sugar with fingers thick unless, obviously they have an episode of hypoglycemia during that time, than they should. But devices that can take 24 hours to warm up, you might have to suggest your patients that they do finger stick during those 24 hours to get the blood glucose data. Dr. Sean Kane 18:31 And as you mentioned, Dr. Patel, another distinguishing factor is whether the device itself is approved by the FDA to allow for med changes to occur, meaning, based on the data, has the FDA approved clinicians to alter an insulin dose? For example, currently, all devices have that, except for the Guardian Connect system, and for that, again, a patient would need finger stick glucoses to be able to make those decisions. Per the FDA approval of that particular device. Dr. Khyati Patel 19:00 That's right. And we call this particularity as non adjunctive labeling. And you kind of look look out for that if you're choosing system for your patient. The other separation point is, you know, what is your display device? Is it a particular reader, like a separate device that comes with the system, or can you pair it with your phone? You know, I'm very forgetful, and I forget things here and there. And I probably will say, I want to carry less stuff, and so if my phone's compatible, hook me up with my phone. I don't want to carry or worry about another device. And there are, I have some patients in the clinic who are? They'll say, Nope, I don't want anything on my phone. I barely use my phone. Please give me a separate reader device, and that's what I would use, and it's kind of different for all the systems, too. One thing to note, though, our Medicare CMS criteria for coverage is that the patient has to have access to a reader. We don't know why that stipulation is. There, but it's there, so the only the system that provides the reader can be prescribed to the patient. So currently, FreeStyle Libre three doesn't have a reader available in United States, so we can't prescribe that to our patients who have Medicare as their insurance. Dr. Sean Kane 20:15 And then, you know, we mentioned it earlier. But another consideration is, are there substances, medications that can interfere with glucose readings, potentially providing falsely high or low sensor glucose readings, depending on the sensor, substances like Tylenol, vitamin C, hydroxyurea, tetracyclines, mannitol, some of these are more common. Some of these are definitely not very common, but most systems will have one or two of these substances that will interact with the sensor, and a patient and a clinician need to know that and either avoid those substances or manage that interaction with an alternative testing strategy. No as an example for vitamin C, depending on the sensor you look at, we're looking at a dose of 500 milligrams a day that would interfere with it. That's actually a fairly low dose the Tylenol. It's four grams a day, which is the maximum dose, and hopefully they're not exceeding that, but if they are getting the max daily dose of acetaminophen, that potentially would be enough to interact with the sensor. So it's important that we recognize that some devices may interfere depending on the medications that a patient takes chronically. Dr. Khyati Patel 21:20 Yeah, and at the start of the sensor, or the system for a patient, it kind of walks you through some steps. And one of the screens that come up, it kind of tells you, like, make sure you're not taking Airborne or Emergen‑C. These are all some examples of a really high vitamin C containing products. We're going to have a chart in the show notes comparing variety of these features that we discussed about the, you know, these commonly used six personal CGM devices that are in the market. So please feel free to check that out. Dr. Sean Kane 21:53 And you know, Dr. Patel, still, just to highlight a couple things in there, because we have kind of compared and contrasted some features here and there. I just wanted to point out that most of the devices in that table are that real time CGM, where you don't have to swipe all of the time because it is continuously providing that real time data back to the reader. There is one intermittently scanning CGM device, the libre two. And as you mentioned, there is a libre three that does not come with the reader. The libre two does come with the reader. I'm assuming that might still be on the market, probably because of that Medicare, Medicaid requirement for the reader. Is that correct? That's correct. So again, a good example where the older technology is still kind of out there because of kind of insurance reasons, but most of the newer devices seem to be going toward that real time CGM technology. Dr. Khyati Patel 22:40 And we'll talk as to why that is the case in just a little bit, when we talk about the evidence for use or these different devices. Dr. Sean Kane 22:47 So Dr. Patel, this technology is absolutely blowing my mind, that we can potentially have every five minute glucose readings sent to a device, and then you have this report generated at the end, whenever you want to see their ambulatory glucose profile. There are so many other things that these CGMs are capable of doing in terms of integrating with other technology and digital health and things like that. Could you just walk us through some of the neat things that are going on with the CGM integration with other technologies? Dr. Khyati Patel 23:18 Yeah, absolutely. You know, we talked about apps, so apps for scanning your sensors, or apps to share data with your providers or let your family members kind of follow you. And this is a perfect, perfectly good example of how parent of a type one patient who is wearing a sensor can kind of follow their numbers throughout the day. They're they don't have to be next to them. They can, you know, kids can be in school, but the parents can check their sugar remotely. So there are apps for that. There are platforms where patients can upload the data and kind of, it's a, you know, cloud based platform, so you can have this data available to you. But that's also adds to this sharing feasibility. And then when you when you say integration, Dr. Kane, you know these, these devices are, or can be paired or integrated with medication administration systems like the insulin pumps or smart pens. For example. Good example is in pen. So again, there, you know, there has to be caveats. And, you know, perfect pair has to match. And so not all of these devices are pairable with other technology, but there's, there's some pairs out there where integration is possible. Dr. Sean Kane 24:34 Then, of course, Dr. Patel, in your practice, as patients, want to share their data with you as their you know, pharmacist, I assume you have to be a little bit knowledgeable in terms of how to get that data, either from the device or the reader or from a website or something like that. So can you tell us how you get the data when they are sharing it with you? Dr. Khyati Patel 24:53 Yeah. So, you know, obviously this is personal health information, so HIPAA, regulations and law come in play. And. So really, patient has to accept that they want to share the data with the provider office. We can provide them a shareable code or practice code, and so if they're using their smart devices to scan information, that's a live share with physician office, once they approve the share, we don't have to use a cord or driver to download the data. However, if they're using a reader, we could use a cord to download the data at the office when they come in, and we have to, then providers have to create accounts on these platforms too, and these platforms a couple names, again, dropping here brand names are libre. View platform, or Dexcom clarity platform, allows you to kind of manage your staff who should have access to the data, who can print the reports, you know, all that stuff. So yeah, practice accounts and logins have to be managed in order to view data. Dr. Sean Kane 25:59 And then finally, just before we move on to our next section, something that came up in my mind Dr. Patel is, can a patient have an x ray, MRI or other procedures done when they have one of these sensors that they're wearing? What is the typical answer to that? And it may differ based on the device? Dr. Khyati Patel 26:15 Yeah, basically, you know this sensor transmitter combo is usually recommended to be removed prior to undergoing any procedures like MRI, CT, scan, any kind of X ray based tests or treatments and procedures that use heat, like concentrated heat in a body area. It's called diathermy. There's only one sensor which can sustain MRI, which is ever since e3 but it still should be removed for other type of imaging, as we mentioned, CT and X ray. So this, this kind of becomes a great counseling point for the patient. And I advise patients to schedule their procedures towards the end of their sensor time so they can kind of remove the sensor, go do their CT or X ray, come home and then put on the new one that we are not ruining a perfectly good sensor. Dr. Sean Kane 27:08 Love that, so thanks, Patel. Kind of moving on to our second objective thinking about, you know, sensor glucose chemistry. So earlier in the episode, you mentioned that there is a difference between a sensor glucose SG and a blood glucose, Bg, you know, blood glucose, we're very familiar with this. This is the finger stick where you have a glucometer sensor, glucose. That's the glucose value coming from the CGM sensor. Are these the same, or are they different? Dr. Khyati Patel 27:35 They're not the same. Good point you brought up. Dr. Kane, there is always a little bit of a lag between the sensor glucose and blood glucose, where blood glucose is always ahead of the sensor glucose. So think of this as kind of like the engine and the caboose. Your engine is your blood glucose and one of the last caboos In your train is your sensor glucose, but your sensor glucose, the last Caboose is always going to end up where the engine was, the engine's always going to be ahead of it, and that's why these sensor glucose values are not just absolute values. They come with certain arrows. And paying attention to these arrows on your display device matters. The arrows point out in certain directions. So it tells you whether your blood sugar is kind of steady, like the trains going on a flat terrain, or the trains going uphill. So you'll see kind of like a diagonal up arrow, diagonal down arrow, if it's going downhill, and then the sharp up and sharp down arrows are also there, and that just kind of signifies how fast the sensor is detecting change in sensor glucose. And one of the, you know, counseling point that I have for patients is to always pay attention to the arrows, because the arrows matter. I can kind of tell you in future where you're going to have low sugar or high sugar. Dr. Sean Kane 28:59 And of course, kind of when in doubt, or when there's a concern that that finger stick is really what the patient should be doing. You know, that's the gold standard, if you will, in terms of what is the current blood glucose value if a patient thinks that they may be hypoglycemic, for example. In addition to that, we also mentioned earlier that some CGMs do require calibration, and this is we're going to have one or two finger sticks every day kind of calibrate. So that's one thing to think about, and also certain systems like the Guardian Connect system, they don't have the non adjunctive labeling, which means that theoretically, the FDA has not approved that device to inform dosing changes, or, you know, insulin regimen changes that that has to be done from a glucose finger stick as opposed to the CGM monitor data. Dr. Khyati Patel 29:44 And certain CGMs have a specific type of indicator that comes up next to the number the sensor glucose number. If that indicator ever comes up, the sensor is telling the person that, hey, you know, I think that your sugar is changing. So rapidly I don't trust myself giving you the right information, please go ahead and do a finger stick testing instead. Example of rapidly changing sugar situations are somebody experiencing hypoglycemia or during the time of heavy exercise, for example, and so that may require a patient to do a finger stick test. So wearing a CGM doesn't take finger stick testing completely away from the user, Dr. Sean Kane 30:29 and we mentioned this earlier, but one difference between the devices is kind of the accuracy or the mean, absolute relative difference or marred and each of the different devices are going to have different Mard values that are expressed as percentages. And these Mard values come from clinical trials. Dr. Patel, can you tell us a little bit about how this is determined, and are there large differences between different devices in terms of their Mard values? Yeah. Dr. Khyati Patel 30:55 So as we mentioned earlier, lower the Mard the better it is. And so if I were to give you some numbers. Dr. Kane, the Dexcom g7 which is the newest system approved, has a mod of 8.2 the libre three, which was relatively approved late last year, has a mod of 7.9 there is sort of this mad dash for improving your Mard value. But if we look at what Mard is, and you kind of define that earlier, there is some concerns about how accurately this Mart is calculated in clinical trial. It's taking the sensor glucose and then comparing it to blood glucose that's measured by a reference system. Now that reference system could be a glucometer that uses finger stick testing. And not all clinical trials use the same reference system. Every every child had a different one. So that brings in, you know, your your comparator is not the standard of care, and it kind of brings in those variabilities, and so take these Mard values as a grain of salt. There is a lot of discussion going on that March shouldn't be really what we look at. There are some statistician weighing on behind the scene and kind of proposing, instead of Mard, you know, what other units should be used to check accuracy of these systems. Dr. Sean Kane 32:21 Love that. And I assume that when the FDA approves these devices, that they probably have some maximum Mart that is allowed. But from a marketing perspective, of course, these device manufacturers are going to have the lowest Mart that they possibly can. Maybe you could tell us a little bit more about how these devices are approved by the FDA, right? Dr. Khyati Patel 32:38 So CGMs are approved as medical devices. FDA has a subsection called centers for diagnostic and Radiological Health, CD, Rh. They're going to review applications for medical devices. And these medical devices can be approved via many different pathways. For example, our finger stick, glucose monitors. They go through 510, K class two pathway. But then, depending on what is the risk and benefit of using these devices in patient care, the classes vary. So for example, the stand‑alone CGMs, they are approved through the 510, K class three pathways. These were some of the older ones versus some of the newer, integrated CGMs are approved through 510, K, class two pathway, so class three pathway has a little bit more rigorous process of approval and scrutiny, if you were to say, by this subsection, the, you know, CDR, Rh, but really they're looking at, you know, how much control are you giving to the user who's operating the system, and whether it's going to result into safe and effective use? So basically, kind of looking at, you know, is it going to harm the patient or not? Dr. Sean Kane 33:52 So then that kind of begs the question, Dr. Patel, are these prescribed products? Where can I just walk in a pharmacy and buy one, although I'm sure it would be expensive without insurance. Or are these prescription only devices, where a prescriber has to actually grant me access to have these devices? Yeah. Dr. Khyati Patel 34:12 So actually, CGMS are prescription products. So unlike you know, you could go and grab a one touch Ultra meter from you know, shelf at your local pharmacy. You can't do that with these guys. You need a prescription from a physician, and then, you know, we're gonna roll about approval from the insurance and stuff, which we'll talk about a little bit later. But yeah, you can't buy this as OTC without scripts. Dr. Sean Kane 34:34 Then, of course, from an insurance standpoint, in terms of coverage, my brain automatically thinks, Okay, so it's convenient for the patient. But do we have data showing any clinical outcomes? So are a one sees better is time and range? Better is the variability of the blood glucose different given that there's a bunch of different outcomes that can be measured in these clinical trials, different patient populations, things like that. Can you give us to. A very broad sense of what does the evidence generally show for CGM devices across the continuum of all of these different patient populations and different endpoints? Dr. Khyati Patel 35:11 Sure, Dr. Kane and you know, the world of CGM outcome is really vast. There's tons and tons of studies done, randomized, controlled trials, as well as some observational studies and retrospective studies after, you know, it's used in the market, but they're kind of looking at the outcomes of efficacy and safety. Efficacy outcomes are, you know, difference in agency, what was their attainment of time and range, the variability safety outcomes were, you know, time in hypoglycemia. Did it cause diabetes related ER visits or hospitalizations? And kind of looking at our pregnant patients. Some studies also looked at neonatal outcomes. And then when we talk about our patients in general, these are patients with type one diabetes, patients with type two diabetes, and patients who have diabetes, either type one or type two, and they're pregnant. And you know, these patients were taking variety of medication. So, you know, they were looking at patients who are on basal-bolus insulin regimens and an MDI, you know, injectable regimen fashion. Patients who were using insulin via pump, patients were using oral medication and basal insulin only. These are our type two patients, so they were looking at all this different combination. Dr. Sean Kane 36:28 So it sounds like very likely this would be hundreds of trials that have been done in all of these different patient populations. Could you just generally summarize what are the typical findings with using CGMS, given that, you know, every trial is going to be different with different patient Dr. Khyati Patel 36:45 populations, absolutely, you know, they're heavily studied in our type one and type two patients, as opposed to, you know, pregnant patients, as we can imagine. But in general, with type one patients, the, you know, the RT CGM, the real time, CGM showed improved ABC reduction, so better glucose control and decreased hypoglycemia and related care in the ER or hospitalizations. Because of that, the is CGM trials were a little bit all over the place. You know, most studies showed ANC improvement, some did not, and that's where kind of it lies. You know, we have robust evidence coming from the RTC GM studies. Dr. Sean Kane 37:28 And then in patients with type two diabetes, is it kind of the same pattern, Dr. Khyati Patel 37:33 similar pattern, but interestingly enough, we saw a one state reduction in, you know, with the RTC GM studies. And you know, some is CGM studies, but the iscgm studies, again, were small, or were studying even C reduction as kind of like that secondary outcome instead of primary outcome. And so the data is a little bit mixed with type two patients. Even C reduction is there with RTC, GM. But then if you look at hypoglycemia reduction, you know, there was no, no reduction in hypoglycemia that was seen. So it's kind of all over the place. But if you look at the observational studies, we do see even C reduction, you know, decrease in hospitalizations due to diabetes related events, and then improvement in patient satisfaction was also seen. Dr. Sean Kane 38:20 And then finally, in pregnant women who have diabetes, what is the general gist of what that data looks like for CGM devices, Dr. Khyati Patel 38:28 for pregnant patients? You know, this did show reduced even C levels, and kind of like no difference or a little bit of improvement, depending on you're looking at randomized control trials or observational studies in our neonatal outcomes, such as, you know, babies born with heavy birth weight or neonatal hypoglycemia. Dr. Sean Kane 38:49 So then, given that we have a variety of different studied populations, kind of a mixed bag, in some cases, of different results. In cases like this, I like to go to the guidelines, because the guidelines are written by experts who have reviewed all of those hundreds of articles. I know we have the American Diabetes Association, ADA guidelines, the American Association of clinical endocrinologists, or AAC e guidelines. Do these guidelines recommend CGM devices? And if so, do they prefer the real time or RT CGMS over the intermittent scanning? Is CGMS, or do they not care and just want any CGM device Dr. Khyati Patel 39:24 coming from AAC, E, which is the American Association of clinical endocrinologists. They're not, you know, saying specifically to use one over the other, but they're saying, use the CGM to improve glucose control and decrease hypoglycemia. Ada, which is American Diabetes Association, breaks down this evidence a little bit further. And you know, because, as we discussed, the real time CGM studies are a little bit more robust. They have stronger recommendations for the use of RT CGM compared to the if CGM, the intermittently scanning CGM for both for improvement of glucose control as well as Dec. Is in hypoglycemia Dr. Sean Kane 40:01 and Dr. Patel, just for clarity, both guidelines are recommending a CGM device in all patients with diabetes, or only in specific populations of patients who have diabetes. Dr. Khyati Patel 40:11 They both are recommending use of CGM in patients with diabetes. However, when we look at pregnant patients who have diabetes, the ADA still recommends to use CGM in conjunction with your pre and post finger stick glucose monitoring. So they're saying you could use, you know, your CGM in pregnant patient, but you still need to rely on the finger stick testing for insulin dose changes and all of that during pregnancy. Now just one caveat with that, Dr. Kane, good for our audience to know as well. Up until now, FDA did not approve any CGM devices for use in pregnancy, the newest one that's come g7 is the first ever one approved for the use in pregnancy. There's a little bit of difference between FDA approved versus what are their guidelines are recommending and g7 was, you know, approved just very recently, and these guidelines are still reflecting post and pre. Finger stick glucose monitoring should be done in pregnant patients. Dr. Sean Kane 41:13 So Dr. Patel, just for clarity, if a patient is on just metformin and has type two diabetes, would these guidelines recommend the use of the CGM in those patients. Or they're more nuanced in terms of among patients with diabetes, that certain patients are more indicated for a CGM than other patients. Dr. Khyati Patel 41:30 Great question. Dr. Kane, and this requires us to kind of dive more deeper into the type of patients that were studied in trials. And most of these type two patients you give a Metformin example, were on at least a basal insulin dose. So they had at least one insulin dose going for the day in addition to the other oral medication. With that said, you know, I've in real clinical practice, if patient has private insurance, I've seen them using CGMS to manage their glucose, even if they're not on insulin. Dr. Sean Kane 42:03 So it's one of those cases where it's a difference of insurance coverage versus FDA approval versus guideline recommendations, and that's right, well, Dr. Patel, why don't we switch gears a little bit and talk about how pharmacists can play a role in selecting a CGM or providing education with respect to CGMS, what is the role of pharmacists when it comes to this topic? Dr. Khyati Patel 42:27 Dr. Kane, this is a very, again, just like the technology itself, it's a very evolving process in general, and the role of pharmacists would depend on the work setting. So you know, inpatient pharmacist may get to see patients bringing their CGMS. They may be involved in data interpretation or maybe troubleshooting, although, you know, we have finger stick testing protocols, there are stoicing protocols in place. The outpatient pharmacist I'm talking about community pharmacists are probably involved in dispensing these devices, helping overcome some of the access issue insurance coverage issues, as well as, you know, troubleshooting type questions, and you know, patient education about the substance interactions we had talked about. And then, if you if a pharmacist is someone like me who works in an ambulatory care practice under a collaborative practice agreement, the involvement could be even further robust, and that way include, you know, kind of doing the needs assessment for the patient and then kind of guiding the providers to the prescribing process, kind of learning, you know, what insurance or what DME company does this order Need to go to, helping patients through the adjudication process, and then initial placement education, kind of reteach the patients, troubleshoot both for providers and patients, and then when patient has a successful 14 day first wear of the sensor, bring them back and they could Be involved in interpreting that data, educating the patients, and then, based on the, again, the collaborative practice agreement, they could be involved in medication management, billing as well, as, you know, further monitoring support. Dr. Sean Kane 44:13 So Dr. Patel, there's a lot going on here in terms of, especially for someone like you and that Ambulatory Care Clinic, there's a lot going on here in terms of the nuts and bolts and logistics and education and things like that. Why don't we at least start with coverage in terms of how is this covered by insurance, and what are some nuances of that insurance coverage? Are you paid for your time? Do all patients qualify for a CGM? What are some of the nuances of that? Dr. Khyati Patel 44:40 You know, buck is going to stop if its device is covered or not? And so we kind of established earlier, a little bit that, and this is a known fact that glucometers are covered under CMS under Medicare Part B, and that's, this is where these devices are covered. And we also included how FD. Approves these devices as durable medical equipment, and so CMS takes this really literally, and they want them to be processed by DME companies. And every Medicare insurance have their own preferred DME that they want prescriptions coming from. There's some exception, very rare exceptions that some Medicare allow retail pharmacies to process this, but most of our patients, who are 65 and older who have Medicare, we're going to have to figure out what DME is contracted and you know, where can we send the prescriptions? Dr. Sean Kane 45:34 And just for clarity, DME is durable medical equipment, so this is where someone who needs a walker would also go or something like that, correct? Dr. Khyati Patel 45:43 Yes, that's true, and many, many different services and devices are under DME. But yeah, these, these companies, and especially if they're a type one patient, you know, they might be sending them their pump, you know, integrated technologies as well. So it's a bigger umbrella and a bigger city to navigate, I get sent a link for DME coverage. You know, once every month that's updated with the list of insurances and kind of like the pair of DME and the insurance that the patient can carry. One thing to remember is the CMS is kind of traditional. We talked about how earlier your display device could be your phone, it could be your reader, and sometimes, in some system cases, you you have options to choose either or. But the requirement for Medicare is that you can only prescribe. They will only cover systems that are available with reader. They don't they want their patients to use the reader. So libre three currently doesn't have a reader in the United States. That's that's not going to be covered by Medicare. So kind of have to know these nuances as well, and Dr. Sean Kane 46:49 then for clarity, so Medicare, Medicaid is going to go through that durable medical equipment or DME process, which would not be through a community pharmacy. What about for those that are third party pairs that just have their Blue Cross, Blue Shield or Aetna coverage. Are they going through durable medical equipment companies? Or is there a different process? Dr. Khyati Patel 47:08 Yeah, most, most of those private or commercial insurances would be processed at our retail pharmacy. And, you know, I've kind of seen a gradual improvement, kind of like slow door opening if you were to say of coverage at retail pharmacy for number of devices. And as we discussed earlier too, our Dexcom and FreeStyle Libre are kind of like the big players when it comes to commercial insurance coverage. Dr. Sean Kane 47:36 So Dr. Patel, as you mentioned, the role of the pharmacist is going to be to get it paid for First of all, but then to get everything set up right. So we talked earlier about how the patient is going to have to be set up, but also the provider terms of getting the data about the patient's glucose values. So there's going to be a setup process there in terms of how the patient's data gets to the provider to make informed decisions about medication changes. Dr. Khyati Patel 47:59 And then, in addition to that, Dr. Kane, because I was involved in doing this at my own clinic, is you kind of have to create a workflow. You know, like all your team needs to be on board, they need to know what happens when a CGM patient arrives for a visit, who's, who's going to access the report, who's going to print it? You know, how you're going to, you know, are you going to do a shared appointment? Are you going to do a tiered appointment? And then, you know, how's the billing? Any kind of troubleshooting that would happen? Dr. Sean Kane 48:27 So Dr. Patel earlier, I asked the question of the money aspect of it. So we covered getting the device covered for but what about Dr. Patel's time the pharmacist time in doing all of this stuff is the time involved in getting a CGM setup, and then using a CGM, is that time covered in terms of the clinicians time? Dr. Khyati Patel 48:46 It's a little complicated. Great question. Nothing is free in this world, but it's a little bit complicated. There are CPT codes and that are honored by Medicare as well, as you know, commercial insurances, and these codes kind of differ for professional versus personal CGM, whether this is start of the CGM or this is an interpretation of the CGM, but all in a nutshell. You know, our pharmacists are not included in the pool of clinicians who can directly bill for the services pharmacists can render the service of CGM initiation and the supervising physicians can bill for it. But when it comes to the interpretation codes, the pharmacists are not included as providers, although pharmacists are well capable of interpreting an AGP and making medication decisions. Dr. Sean Kane 49:41 So this would be another example of kind of the decade long fight of having pharmacists as having a provider status. That provider status would mean that the pharmacist could bill for this if they were recognized by CMS as providers. But until that happens, that's not the case. So what you're saying is that you do run. The service, but it's billed under your provider that you have your collaborative practice agreement through, as opposed to Dr. Patel is billing. Dr. Khyati Patel 50:07 CMS, that's right, and we hope, like you said, that you know future advocacy will change some of this. Dr. Sean Kane 50:13 Well, Dr. Patel, kind of her last learning objective for this continuing education was focused on the interpretation of an ambulatory glucose profile or an AGP. And in the show notes on our website, HelixTalk.com Again, this is episode 162 we have an image of an example AGP report, and we're going to use that in terms of how we're talking about interpreting the AGP, because it is a visual report, and that's a little hard in a podcast format, but for the listeners, you can see that in our show notes, maybe you can walk us through some of the items that are big ticket items on the AGP report, in terms of things that you would really want to focus on when you first are handed that reporter pull it up on a computer from a patient's CGM device. Dr. Khyati Patel 50:56 Yeah, absolutely. And we do have battleino article, battleino and colleagues article in the show notes too. So you can dive more deeper into different targets and parameters that are included in the AGP report. But the first thing I look at when I have this report in front of me is, what percent of time the CGM was active, you know, what is the patient's sensor use time, as we all know, you know, with those statistics, a lot larger the end, the better the data, right, the reliability of the data. And so we want to make sure that patient has at least 70% or more of the data captured by the sensor. Dr. Sean Kane 51:35 Then another endpoint is time and range, or T, I R, and generally this means that you pick up blood glucose parameter like 70 to 180 and it's just a percent of the time that the glucose values are within that 70 to 180 for most people, we want this to be about 70% or higher. For older patients, where we're a little bit more liberal with their glucose goals, it could be something like 50% or higher. And then for pregnant women, the tir the time and range is still 70% or higher, but the goal values may be slightly different, a little bit more conservative, so something like 63 to 140 so a little bit more narrow of a goal versus a non pregnant patient. Yeah. Dr. Khyati Patel 52:20 And the other thing we look at in that report, Dr. Kane is the coefficient of variability, and we want that variability to be less than 36% there is some debate that it could be less than 33% as well. But in general, for that, we're looking at that AGP glucose profile, the curve, and that the glucose curve kind of needs to stay between 70 and 180 as much as possible. If you're seeing kind of like a lot of waves up and down waves. That means your sugars are varying a lot from the range. And that's that's not good. You could have a perfect even see if you're bouncing up and down. But the idea is to kind of get you more in the range of that 70 to 180 for most patients, that picture kind of speaks a volume, because we can target many different areas, and that's what we use in clinical management, right? We look at all of these parameters, and then we say, Hmm, okay, the tir, the time and range is not at goal. Let's look at that curve and see where the peaks are happening, right. Let's say the peak is happening between seven and 9am in the morning, and that's that's when patients waking up. We can say, Oh, your fasting sugars are high. Maybe we need to work with medications or adjust medications, or kind of targeting this fasting medication. Dr. Sean Kane 53:41 And Dr. tell to be honest with you, this process is not that different than if you had someone who comes in with an A 1c of 9% and they have three glucometer readings per day in terms of how you would manage that patient. The difference is, because they have a CGM, you get a lot more data, and it can really help you identify kind of the areas of opportunity, the things that you might need to change, versus if they just have a glucometer, you have much less data to be able to identify strategies to drop that a, 1c because you just don't have as many glucose values. Dr. Khyati Patel 54:13 Absolutely and, and let's talk about the flip side, right? If the patient is having those, I had a patient who was having those around 12 or 1am in the morning, and we're like, whoa, why? Why is that happening? Well, turns out the patient was taking their short acting insulin two to three hours after they were having their dinner. Because they were having dinners outside, and they were taking their insulin bit, and they would come home and inject it, you know, you're not supposed to, and they would end up having hypoglycemia. So the graphs are able to kind of tell more of a story, because there's a lot of data points and Dr. Sean Kane 54:47 kind of related to that that could tell if that coefficient of variation is above the 33 to 36% you're probably going to be identifying where are you seeing lots of highs or lots of lows, and then kind of diagnosing what is. Is, what is the issue with that? Is it that they're eating a lot of carbs, or their correction factor is not correct for what they're eating? The timing of the food needs to be addressed. It's going to be a very patient, specific thing, but you're going to be looking at those highs and lows and try to figure out what led to those occurring. Dr. Khyati Patel 55:17 That's absolutely right, and to kind of demonstrate that, you know, again, Dr. Kane, you said it's a little bit hard to do it in terms of this podcast, but we have a patient case. Let's say you have Mary, who is a 65 year old patient with type two diabetes who is using multiple daily insulins. So we are talking traceba, 44 units daily. Humiloc, 24 units, three times a day with meals, along with metformin and trulicity, you know, three milligram once weekly. And she's been wearing the libre too for past, you know, for for easiness sake, that's her preferred device. That's what she's using for past two months. And presents to clinic today for CGM interpretation, slash medication management. Visit. We do have an AGP report for Mary that we're going to put in the show notes so you can refer to it. But you know, just kind of describing Dr. Kane briefly, when you look at that image, how would you go about interpreting her data? We're looking at tir time and range glucose variability. What's the sensor of your time, time in hypoglycemia, time in hyperglycemia. And then what is your kind of overall interpretation of the glucose curve? What are the areas that are open for improvement? And then how would you go about, kind of making those improvement? Dr. Sean Kane 56:33 So Dr, tell one thing that I would start with is, did they wear the device? So in this example, Mary's percent time active is 99.9% so this is an a plus for Mary. Basically, she's she has the libre too, so she has to scan it, because it's the intermittently scanning. She has to do it at least every eight hours, if not more frequent. So she's doing a great job. Basically, we're capturing all of the time period that we can with the device. So that's great. And that's step one, right? Dr. Khyati Patel 57:00 The other thing you can look at is average glucose as well as the variability. So her average glucose is 173 which is, you know, some by some parameters, this is also higher, and the variability is 49.5% remember that target, or variability, the ups and downs, we want it to be less than 36% Dr. Sean Kane 57:22 and then I see Dr. Patel on our on our report. Here we have the glucose management indicator, or GMI. Can you help us understand her 7.6% GMI? Dr. Khyati Patel 57:32 Basically this GMI is representing kind of like your Ave and C in this 13 day now even see, usually, is this 90 day parameter we check at the lab. But basically the GMI saying, if patient keeps up with this data in 90 days, you're you can't expect patients even see to be about 7.6% Dr. Sean Kane 57:55 so then, Dr. Patel, if I move on to the time and ranges graph that's available, I see, you know, 20% of time was spent very high, more than 250 I see 23% of time was spent high, between 180 and 250 and then roughly half the time was spent in range. And then she just had a little bit of low, or very low values, you know, roughly 10% hypoglycemia. So it seems like most of her values are on the higher side, but she does have some hypoglycemia episodes as well. Yeah. Dr. Khyati Patel 58:24 And if you look at all those parameters and match with what's normal and what's not, the high ranges, we want them to be less than 25% obviously the target 70% or more, and the low hypoglycemic range, we want it to be less than 4% and so here we are kind of exceeding some of these parameters, and that's where the interventions are going to be. And if you look at that curve, the glucose curve you're talking about, you identify that she's making up some of it. We let's say eight o'clock, and 10 o'clock there is a sharp peak that's happening if there's her wake up time, likely that her fasting sugars are very high. If this is post breakfast, maybe this is, you know, adjustment that's needed in her breakfast, humility dose. And then another example of the peak here, Dr. Kane, is somewhere between, let's just say 6pm and 9:30pm and this could very likely be her dinner time. Humolog not being sufficient, and so that intervention could be made in discussion with the patient. Dr. Sean Kane 59:32 And then Dr. Patel, on the flip side, she did have a little bit more hypoglycemia than we'd like to see, which did contribute to that higher coefficient of variability. And if we look at the graph here, I can see kind of two areas that tend to be more commonly hypoglycemic. So I'm seeing kind of the midnight to 3am time frame as well as the three to 5pm time frame. What are your thoughts on? What could drive those times for a typical patient to be hypoglycemic? Dr. Khyati Patel 59:59 Yeah, usually. Overnight hypoglycemia, you know, we caution your basal insulin, or, you know, maybe not having enough snack, like a protein filled snack before bedtime. So those, those are a couple interventions to consider, and then the 3pm to, you know that 6pm could be that they're maybe not eating enough carbs in the Lange and still injecting that 24 units of Puma log, and that's probably a little too high of a dose. So kind of balancing those two things out can alleviate the situation. Dr. Sean Kane 1:00:33 So Dr. Patel, clearly, this is a conversation with the patient where you're correlating, you know, this massive amount of awesome data with kind of what they're doing at that time and what is typical for them, and then deciding, based on their behaviors and their glucoses, what would make the most sense for medication changes to get in that time and therapeutic range Dr. Khyati Patel 1:00:53 and the CGM devices and the report, the AGP report, Dr. Kane does exactly that. It gives us a deeper picture, clearer picture, so we can individualize therapies and approaches for our patients. Dr. Sean Kane 1:01:07 So Dr. Patel, couple key concepts here that I think are worth highlighting. First, there are two main types of standalone, personal CGMS on the US market. These are real time or RT CGMS and intermittently scanning, or is CGMS, and then, of the CGMS on the market, there's a ton of different features and differences in terms of how long you can wear them for, how long they take to warm up, where you can put them on your body, whether you need a reader or not, or if you can use your phone, what age you can be to for FDA approval of use, whether you have to calibrate them with a finger stick glucometer, whether you can have non adjunctive FDA labeling, where you can make med changes based on it, whether they're interconnected with other technologies, like in some pumps, drug interactions that interact with the sensor itself. There are so many features and facets of picking the right CGM for a given patient. Dr. Khyati Patel 1:01:59 And again, this picking also depends on, you know, what level of evidence we have for them. And you know, for both type of CGMS are studied in variety of different patients with diabetes, type one, type two, pregnant patients. And they've looked at many different outcomes, such as, you know, improvement in glucose control, hypoglycemia, kind of diabetes related hospitalization, patient satisfaction, neonatal outcomes in terms of pregnant patient and, you know, there's plenty of evidence out there, but in general, the strength of recommendation is a little bit stronger for real time CGMS than the intermittently scanning CGMS. Dr. Sean Kane 1:02:38 The number three is that pharmacists play a huge role in educating providers and patients, ongoing support, interpreting the AGP report and then making recommendations in terms of medication changes based on that AGP report, let alone the billing aspect and things like that. There's a ton of opportunity here for pharmacists to play a role Dr. Khyati Patel 1:02:57 and what we do day in, day out, with using the data that's available from CGM, which is called ambulatory glucose profile, it's kind of helps us understand the glucose trends. And the recommended goal for most of the patient is to maintain this glucose range between 70 to 180 with at least 70% or more time that's spent in this range and then variability coefficient, we're going to keep it smaller as possible. So this coefficient goal is no more than 36% Dr. Sean Kane 1:03:27 Dr. Patel, I think that's a great conclusion to our first continuing education HelixTalk episode, for those pharmacists who would like to get one hour of continuing education or CE credit, you can go to our website. HelixTalk.com Again, this is episode 162 click on the episode, you'll see our show notes that will have a link to be able to pay for a $5 fee to get the CE. And then from there, you'll be redirected to our CE partner, which is CE impact. You'll have a couple of assessment questions, and as long as you pass those, you'll be able to get your one hour of CE. Dr. Khyati Patel 1:03:59 And Dr. Kane, this is, you know, our very exciting opportunity to be able to do a podcast CE, and we would like to thank our CE partner, ce impact, as well as college of pharmacy for sponsoring. Speaker 1 1:04:10 So with that, I'm Dr. Kane and I'm Dr Dr. Khyati Patel 1:04:13 Patel, and as always, study hard. Narrator - Dr. Abel 1:04:16 If you enjoyed the show, please help us climb the iTunes rankings for medical podcasts by giving us a five star review in the iTunes Store, search for HelixTalk and place your review there Narrator - ? 1:04:27 to suggest an episode or contact us. We're online at HelixTalk.com thank you for listening to this episode of HelixTalk. This is an educational production copyright Rosalind Franklin University of Medicine and Science.