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 Narrator - ? 00:11 is 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 110 I'm your co host, Dr. Kane. I'm Dr. Patel. Today we have Dr. Srivastava back on HelixTalk, and today we're actually talking about diabetes, which is a topic near and dear to your heart. So we thought that it would be great for you to join us today. Unknown Speaker 00:45 Thank you. I'm so very excited to be here. Speaker 1 00:48 Thank you for joining us and introducing the topic. It's the top 10 updated recommendations from the ADA standards of care 2020, as we know, the American Diabetes Association called Ada updates their guidelines, standards of care every year. So you hear from us once again on what's the latest and the greatest in the world of diabetes, and we are getting more sophisticated. There is an app for everything. So there is an app for the standards of care too, in case you want to have these recommendations on your palm and the document that is the Bible of ADA. It's actually a living document. So if you download a PDF on your computer, there's might be some updates occurring, as we speak, during the year on their linked version at the ADA website. Speaker 2 01:35 And I absolutely love that. When I first found out that it was a living document, I did a little happy dance, and it's because we know that evidence comes out throughout the year and it doesn't always align. And luckily, the standards of care come out every year, but not all the guidelines are like that. And so to get updated to be like, Okay, what are the experts going to say about this new evidence? And we don't have to wait the next year to find out. They often will go ahead and put that information in so we can start practicing it. Speaker 1 02:00 That's the evidence based medicine on steroids Dr. Sean Kane 02:03 that's great. So it sounds like today we have the top 10 items that really you two wanted to identify and talk about with the 2020, ADA guidelines, and we've kind of split it up into these 10 different sections that are notable. And you know, these are just our sections, but you know, this is a large document, so for any listeners that want to know more about it, clearly they need to go to the actual physical guidelines or in the app, right? And we'll have links to that in our show notes at HelixTalk.com Again, this is episode 110 so why don't we go ahead and get started with number one in terms of what was something notable about the new 2020, guidelines? Speaker 1 02:39 Okay, I'm following the theme of the document and the different sections that are in there. So let's just get started with screening and diagnostics and probably terminology. And so what they have done for patients, female patients who are considering pregnancy, they've kind of intensified their screening recommendations for pre pregnancy, so testing for the pre diabetes, or even type two diabetes, if the patient has any risk factor, at least one risk factor, and they're obese or overweight, so we're going to make sure that we're screening them early on to provide them support before they conceive, and going along the lines of pregnancy, moving on to the gestational diabetes, which is the diabetes that they're diagnosed with while they are pregnant, We used to have a couple different strategies to test for this GDM presence, one step or two step approach. The two step approach to use couple different criteria to pitch your blood sugar against and say, Yes, you have it. Yes, you don't it was the National Diabetes Data Group, as well as the Carpenter and Coustan. The carpenter crouston criteria is a little bit lower diagnostic threshold versus the NDDG, which is the National Diabetes Data Group, and in hope to identify patients and prevent the pregnancy related morbidity and mortality issues, they're going with the the lower diagnostic threshold criteria, which is the Carpenter and Coustan, and leaving the nddg criteria out so we don't have to pitch against two different thresholds. We just look at one now, which will make it so much easier. Dr. Sean Kane 04:09 So Dr. Patel, that means that more pregnant women will potentially be diagnosed with gestational diabetes as a result of focusing on the lower criteria. Then I Speaker 1 04:17 think that's what it translates to, right and when it comes to diagnosis of and treatment of gestational diabetes, we kind of look from recommendations from the ACOG too, and not just the ADA. So it's very likely that ACOG is still adhering to the both the you know, criteria, and ADA has decided to drop the other Speaker 2 04:35 one, and I remember having to drink that solution. Awful. Yes, starts off tasting great and then, but I do think that's great that they've at least streamlined our recommendations now and then, also, we are learning more and more about the different types of diabetes, and so often we just kind of box it into two, type one diabetes and type two diabetes. But now, as we're learning more about the past. Pathophysiology and the different factors that are contributing to hyperglycemia, we're learning that it's not just either type one or type two. So while the guidelines don't go too too much into detail about this, you will be hearing about the different types of diabetes more so as we learn more about them and how to go about treating patients with those different types. What are some of the examples? So we have type 1.5 it might also be known as, to some of you, LADA, latent autoimmune diabetes in adults. And then we also have type 3c which is pancreatogenic diabetes, Dr. Sean Kane 05:38 and that would be where a patient has probably acute pancreatitis to kill off some of those beta cells in their pancreas, and now, not from an autoimmune related reason per se, but now they have diabetes and they're not producing enough insulin because of that pancreatitis that they had. Speaker 2 05:53 And of course, understanding the exact diagnosis really helps us determine the best options for their treatment. Dr. Sean Kane 06:00 So number two is pre diabetes. What do we know about pre diabetes, and how has that changed with the 2020? Update? You know, Speaker 1 06:07 there is a lot of emphasis put on the prevention programs that are identified. We have the Diabetes Prevention Program DPP. They call it shortly. We have it that tool kit from the CDC. There are a lot of different payers that are now paying for the services if a provider decides to implement this program and provide the services. So they're really pushing these diabetes prevention programs, because it's outcome driven, payment driven, strategy that can help patients not develop diabetes or delay the progression. Speaker 2 06:38 Absolutely, I attended one of the DPP program trainings. It was a two day training session. It is amazing. All the material is available. It's available free of charge to us. You go through the training to best be able to use that material, and through the DPP you can actually bill for those services if you choose to do it. It's a year long program that first year you have to collect very, very minimal information for this program, and then the next year, you can start billing to provide these services for our patients. And also, what's amazing about this the reason that these programs are promoted is because, while we know Metformin can be utilized in some patients, really the best, best outcomes are with diet and exercise. Dr. Sean Kane 07:21 That was actually going to be my next question is, you know, of course, you know these lifestyle modifications should be done. Does Metformin still have a role in these patients as well? Speaker 1 07:30 Yeah, in certain patient population, definitely there is a role. We're looking at those with higher BMI, so above 35 or above patients with younger age, less than 60, and if a woman had a history of gestational diabetes, all these patients would benefit from Metformin, like therapy in their pre diabetes stage. Dr. Sean Kane 07:51 Dr. Srivastava, I'm going to have you kick off number three, which is lifestyle management, which I assume has some implications with also with lifestyle medicine, which is a recent HelixTalk episode that you were involved with, Speaker 2 08:03 yes, absolutely, just like we were talking about preventing pre diabetes, but it's also about reversing potentially diabetes, or at least mitigating diabetes, and reducing the risk of complications related to uncontrolled diabetes. Lifestyle plays the ultimate, ultimate role, and if we're able to talk with our patients about this and provide them the support and the details and the information that they need to be able to implement these changes, we'll see great results. And so in line with this, the guidelines also created a new name, which is facilitating behavior change and well being to improve health outcomes versus lifestyle management. And I cannot go into enough how much I love that, because it's not just about saying, Okay, let's make lifestyle changes. This is about facilitating and how to make those changes. And it really emphasizes that importance of behavior change. Speaker 1 08:54 And basically what the guideline has done is re emphasize the consensus report about the nutrition therapy that was published in April 2019, so I think most of the aspect we kind of covered in the lifestyle medicine episode, it kind of unlines and trying to put it all together in this guideline as well. Dr. Sean Kane 09:13 So at least in the critical care arena, it's always since basically 2001 the issue of what is the glycemic goal, at least on the inpatient side, has been a super hot topic, and I know it's also been a hotter topic in the last decade on the outpatient side. So I'm curious, did the 2020 guidelines make any movement in terms of glycemic goals for any of these patients that have diabetes? Speaker 1 09:35 Not really. I would say the A1C goal, as well as the fasting and postprandial blood glucose goals are the same. There's some nuances to the recommendations that have come about, and that's that's pretty interesting. They're emphasizing the use of Ambulatory glucose profile. They're calling it AGP, and checking the time and range. And this is going to be for those who are using the continuous glucose monitors, because they're i. Actually able to print out one of these AGPS. Now this is not a evidence based recommendation. It's currently an expert opinion only. And basically, clinicians are saying that you have this tool available for you use it right? And you're going to use the lower range of 70 and the higher range of 180 that's going to be your time and range. So think about time and therapeutic range kind of an idea when we are dealing with anticoagulation, but now they're bringing that concepts to managing patients blood sugar as well. Dr. Sean Kane 10:31 So Dr. Patel, I understand that our goal is that we want time and range between the 70 to 180 milligrams per deciliter. Is there a percent of time that we're trying to be within that range, or percent of checks that we're trying to be within that range for, right? Speaker 1 10:43 And I want to clarify that this is for the patients who are wearing the continuous glucose monitors that we're trying to hope for this time in range, and we're wanting to achieve at least 70% of the day that their numbers are between that 70 and 180 range that we consider optimal control. But at the same time, if you're improving that number by 5% is still considered better, so little adjustment can help, be Speaker 2 11:08 helpful, and we want to make sure that time in hypoglycemia is less than 4% I mean, while we are trying to stay within that range, we're really trying to prevent hypoglycemia, of course. Dr. Sean Kane 11:19 So if you think about it, this is almost like more real time version of a 1c right? Because a 1c is telling you kind of time within range over a long period of time, just expressed as one number. Where are we going from here with respect to this versus a 1c right? Speaker 2 11:33 I don't see a 1c going away anytime soon, especially because not all our patients are going to have the capacity to have the continuous glucose monitors or not, going to choose to wear CGM. So right now, the recommendations stay the same for a 1c which is minimally twice a year that a 1c is monitored. But if somebody's a 1c is uncontrolled or above whatever their goal is, then every three months. But like you said, it's an average. So if I'm at 8% and Dr. Kane, you're at 8% and Dr. Patel you're at 8% all our blood glucose is still may be very, very different, which will lead to different outcomes. And what they're seeing is that that time and range may help us control diabetes a little bit better and hopefully have more optimal outcomes. Speaker 1 12:20 And this ties very well with the role of CGM. We talked about how we want to maintain certain range so we can lower the A1C and improve the outcomes. And perhaps during the CGM, we are trying to prevent hypoglycemia, and this is where the clinical evidence for CGM comes in play, that there is prevention of hypoglycemia and there is a 1c reduction, and this has been seen in type one patient. For Type two patients, we don't have a good coverage from the insurance companies on wearing the CGM, so that's because, yes, it does help improve A and C in type two patient, but when it comes to reduction in hypoglycemia, we don't have that evidence yet. So yes, definitely for type one patient, type two patient, yes for A and C reduction, not for the hypoglycemia reduction. Speaker 2 13:06 And speaking of the different patients that will be wearing the CGM, the time and range may be a little bit different, just like the goals we have goals that we generally follow for most of the people, there are specific ones, depending on if you're elderly, if you're at a higher risk of hypoglycemia or have hypoglycemia unawareness. So in the same way, your time and range is going to change if you're pregnant versus not, you know, just depending on your other health conditions. Dr. Sean Kane 13:31 So I understand, Dr. Patel, because we've covered this in a previous episode, that there's not just one CGM device out there, right? Are there different options that patients are choosing from, or are patients kind of pushed or shunted because of insurance reasons, towards one device or a different one. Speaker 1 13:44 We have quite a few different CGM devices available, some that are interconnected with the pump, and then some that are just kind of independent, so it depends on what patient is using, as far as their therapy, and how they want to regulate their pump. And there's, you know, glucose readings and things like that. Speaker 2 14:02 And then within the CGM, the standalone as well, there's two different types of real time CGM and the intermittently scanned CGM. And so basically, while they both monitor glucose continuously, it's how you're getting that data. So as the term scanning may have reimply it in order to get that data is you have to scan the sensor with the reading device, and then it'll tell you what happened over the last 24 hours, whereas real time gives you that information through their technology right away. Dr. Sean Kane 14:36 So I understand another kind of newer technology is also how glucagon is being given for hypoglycemia patients. So what is new with glucagon Speaker 1 14:43 for two new formulations, there's intra nasal as well as the subcutaneous auto injector device available, and there's a recently approved by FDA, and so the guidelines have to mention that they're used, and they're kind of saying that the use of these devices shouldn't be limited to a healthcare professional. Meaning, give them to the school nurses you know your kid is at a higher risk of hypoglycemia, teach them to the family members, kind of like the Narcan of the diabetes world. Dr. Sean Kane 15:10 How commonly is a patient with type one or type two diabetes either given a prescription for glucagon or even using glucagon when hypoglycemia happens? Because obviously they're going to start if they're able to with dextrose sources, as opposed to using glucagon for hypoglycemia. What is the current role for glucagon? Now, really, before these new formulations took to the market, Speaker 1 15:30 absolutely, I can speak for the patients that I see that are mostly type two patients. So to this day, luckily, I don't have patients who are frequently experiencing hypoglycemia that I have the need to proactively, you know, prescribe a prescription for a glucagon, but I can see that in a younger, new type one patient, where we don't know how the medications are going to react, or what the child's activity level is and how many times at night they're experiencing hypoglycemia. And so in those patients, they might proactively be provided prescriptions for glucagon, and I Speaker 2 16:05 would definitely look at each patient see what medications they're on, if they're on medications that are likely to cause hypoglycemia. So if they're on the sulfonylureas, or they're on insulin or multiple daily injections of insulin, their risk factors are high. Maybe they have hypoglycemia on awareness. And that might be a person that we might consider prescribing glucagon for, or recommending glucagon for, and then just other risk factors for hypoglycemia. That you know, if we're especially worried whether the patient has type one or type two, might be a good patient to have. Dr. Sean Kane 16:39 So moving on to number five. We've covered some of it, but you know, this whole section on number five deals with newer technologies with diabetes in terms of glucose monitoring, insulin delivery, things like that. So what is kind of new in the 2020 guidelines with respect to technology? Speaker 1 16:53 It's kind of not new, per se, when it comes to the self monitoring of blood glucose. Just wanted to emphasize that the use and the benefit of the SMBG really lies in the type two patients, especially in those who are on multiple daily insulin injections, and when it comes to those who are on oral medication, the evidence is not there, but the guidelines that you're around kind of supports the Use if you need it for making treatment decisions if we need to assess the impact of certain diet changes or exercise changes. And again, patient preference comes into play too. But over the years, because of the change in this particular recommendation, I've actually seen my type two patients in the clinic having harder time getting more frequency be authorized by their insurance. Speaker 2 17:44 And I think it's a reflex for many of us to think, okay, my patient has diabetes, I need to give them a meter. They need to be measuring their blood glucose, but that's an added thing for them. And some patients thrive. They love the data. They want to know exactly where their glucose is at all times, and it motivates them other people, it actually takes away from it, and when they have to do one more thing, they would rather do three less things. And so we really have to determine, and not just make a blanket statement, that all patients should be given this, because it might, in some ways, do more harm than good if we're not using it most appropriately. And so we just want to make sure, especially knowing that the evidence isn't very strong in supporting SMBG for all patients, that we really consider which patients would most benefit from it. And then we talked about continuous glucose monitors. But as the years are going by and the technologies are improving, we are starting to see right as we were saying, The CGMS be used in more and more patients. So what's our role as a pharmacist when it comes to this? Speaker 1 18:46 I think it goes back to saying, you know, identifying patients who would benefit from it, right? So, like, you have the checklist, or, you know, based on the insurance coverage too, you look at that, but let's, let's look at the patient and see if they would benefit from it, it will fit in their lifestyle, in their pocket, cost, etc, etc, right? Speaker 2 19:05 And then teaching them how to use it, teaching them where to insert. Something people complain about is that it may not stay on for as long as it's supposed to. And so there's ways to help make it stick a little bit. And so making sure that we talk about the recommendations for that, and then the whole AGP that you talked about, the data that you get is tremendous. There's so much information that it can be very overwhelming. And so we as pharmacists, we can at least help the patients make sense of some of those like, what those numbers are, when to go see their provider, sooner than later, how to set alerts. I don't know about you guys, but when something's beeping constantly, it drives me crazy, and so just helping patients set their alerts in a way that will help their care, but not kind of take away from it or annoy them too much from it. Speaker 1 19:55 Yeah, and actually, I've heard of pharmacists in the community on. Billing the insurance company in order to put the sensor devices on the patient. And so instead of them going to the doctor's office, I mean, they can totally learn how to put the sensor device on their own, but if they come to the pharmacy, the pharmacy can actually put a new sensor device and a bill for the service too. So there is an opportunity. Dr. Sean Kane 20:19 So for number six, this is kind of the bread and butter of the ADA guidelines, which is the drug therapy and kind of pharmacotherapy management of diabetes. You know, for those who are listening, if you want to visually see, kind of the flow chart for diabetes management, this is figure 9.1 in the ADA 2020 guidelines. The title is glucose lowering medications and type two diabetes, so we're going to be focusing on that. But you can play along at home by taking a look at that figure 9.1 as well. Speaker 2 20:48 And just to orient you to that figure, I love the colors that they use, because it really helps break apart the information and makes it easier to follow the algorithm. And as of these guidelines, first line has remained the same, we initiate Metformin in every patient that we can, unless there's contraindications, and we prescribe comprehensive lifestyle, including weight management and physical activity, to all our patients. Speaker 1 21:16 And something interesting that these guidelines are now recommending is earlier consideration of combination therapy, and this is at the initiation of the therapy, and this is to extend any treatment failure issues that occur in type two patients. So this is based off of verified trial, and it kind of goes along and follows the the outline, and that is determined based on, quote, unquote, the comorbidities, and those are things such as the presence of acvd or ascvd risk factors and the presence of heart failure and CKD to begin with. Dr. Sean Kane 21:50 So what are some of the meds that we would maybe favor in those patients with acvd, heart failure or CKD? Speaker 2 21:56 So we have our two main groups of medications. So you have your sglt, two inhibitors, your sodium glucose co transporter, two inhibitors, and then you have your GLP, one RAs, your glucone like peptide one receptor agonist. Not all the medications within those categories have met all those outcomes for the recommendations, but those are your two main pharmacologic categories, Speaker 1 22:22 and so we're looking at maybe heart failure or CKD, predominant disease. So these are patients who have diabetes, but then they also have heart failure or CKD. They're saying, let's use or prioritize the sglt two inhibitors, the dapagliflozin, canagliflozin or empagliflozin. All three of them have proven benefits in the CVOT trials, the ertugliflozin, which is the fourth agent in this category, we're still awaiting the data from its CVOT trial. And let's say in this patients, the Creatinine clearance or EGFR is too low or they can't, for some reason, be on sglt Two. Then they're recommending to use a GLP one receptor agonist. Speaker 2 23:02 A new thing about this algorithm, that they change is, while we already had people with established ascvd should be placed either on a GLP one ra with proven benefit, or an sglt Two inhibitor. Now we are also considering those patients that have high ascvd risk. Dr. Sean Kane 23:22 Just to point out, some of the GLP ones that do have proven benefit, that would be liraglutide or Victoza or semaglutide, brand name, ozempic, and more for clarity, in a patient who has ascvd, no heart failure, no CKD, we put them on Metformin. Is there a Preferred second line therapy after Metformin, between the sglt two inhibitors and the GLP ones. Do you add both of them? Pick one, then add the next one. What is our order of operations here? Speaker 1 23:49 I think it's going to be, you know, adding one at a time depending on the comorbidity. So if, again, if it's a heart failure or CKD predominant, I'm going to go with my sglt twos first, and then if the A1C is still not controlled, you know, down the line, then you can add a GLP one thereafter. Speaker 2 24:04 But when it comes to just ascvd, then you can choose one or the other. And so for everything, we're going to look at the patient and the patient preferences, of course, but specifically with this, because we can choose one or the other. You know, some people may not prefer to have an injectable, but I just want to be careful that we don't assume that they don't, because there's once a week injectables, and they might say, hey, you know, rather than take something every single day, I'd rather just inject once a week. Speaker 1 24:31 Yeah, and this recommendation about the compelling indication is now, regardless of what the patient's agency is. So you know, before it was like, you know, if even C is uncontrolled, and you look at these indications, and then you add these agents, but now it's just like, if you have diabetes, you have this indication we're putting in addition to Metformin. We're putting you on this drug, even though your agency is almost controlled. Speaker 2 24:56 And then some food for thought, or medication for thought, is. You brought up a great point. If we use both, is it better than using one or the other? Maybe that'll be an update that we do in 2021 Speaker 1 25:07 something that they kind of clarified or maybe made it easy for clinicians to follow, was their guidance on intensifying the injectable therapy. There are no new recommendation, but the chart from last year was just terribly confusing. So I'm so happy to see more streamlined version of that. Another recommendation talking about the injectable therapy was emphasis on use of the insulin product that are analog type and not the human insulin type. And the reason is to, again, prevent the hypoglycemia. We know that human insulins tend to have a little bit more hypoglycemia compared to the analogs. Example of the analog insulins will be like your rapid acting insulins, the aspart, the lispro, or on a longer acting side, will be your glargine or degludec. Dr. Sean Kane 25:50 And just for clarity, is there a specific rationale for why regular insulin causes more hypoglycemia? Is it duration of time that lasts for or do we kind of not know the answer to that? Speaker 1 26:01 We kind of know the answer to that. The regular insulin, for example, it forms a hexamer, and it kind of then releases into the body, you know, slowly thereafter. So if the patient didn't have proper meal with it, or the meal wasn't timed properly, they could have the risk for the delayed hypoglycemia as well. And then we've seen a lot of nocturnal hypoglycemia with the use of NPH, which is another human insulin, which is an intermediate acting insulin. Dr. Sean Kane 26:26 So then, is there any role currently within patients who have type two diabetes? Is there any role for NPH or regular within the guidelines at this point, I Speaker 1 26:35 wouldn't say within the guidelines. But obviously patients insurance is not covering the analog type, or they don't have insurance at all, and they have to go buy quote, unquote, behind the counter insulin, which are available without prescription, but they're stored behind the pharmacy. Those will be your regular and NPH over-the-counter style insulin. Sometimes they have to rely on those. But really the push this time around is to please get the patient the coverage, to have the analog type insulin is covered Absolutely. Speaker 2 27:02 And then, just to make sure that we're completing all the aspects of the pharmacotherapy outside of patients with that established ascvd or high risk of it, CKD or heart failure, then we're going to determine what other agents to use based on other compelling needs, like minimize hypoglycemia, minimize weight gain or promote that weight loss, or if cost is a major issue, then we are going to consider all of that when we're determining maybe those second or third line agents. Dr. Sean Kane 27:30 So number seven is going to be macro vascular outcome management. So macro vascular meaning strokes, heart attacks, things like that that are a result of diabetic complications. I think Speaker 1 27:41 the couple biggest updates in this area was the new blood pressure goal for pregnant female who have pre existing hypertension, so they had high blood pressure, now they have become pregnant. That new goal is less than, or equal to 135 over 85 So yet another number to remember, Dr. Sean Kane 28:00 Dr. Patel, I take exception with this recommendation, just for several reasons. One, it feels like they're just cutting the difference between 140 and 130 systolic two. When you do a manual BP cuff, you don't get an odd number anyway. So where on earth did a 135 over 85 come from? Aside from, they couldn't decide, and they picked halfway, Speaker 1 28:21 you got me there, you know, but the ADA guidelines are all about evidence, right? So they actually, we don't have whole lot of studies with pregnant patients involved, but there was this chip study that involved pregnant patient, and they looked at the outcomes and found to have patients with the average of systolic blood pressure of 133 and diastolic of 85 did better. Well, 133 was a weird number to put, so they kind of kept it to 135 so there we have it. Really the outcome was looking at minimizing the fetal growth impairment and reducing the acceleration of maternal hypertension that we know can cause such complications as the preeclampsia or eclampsia themselves. Dr. Sean Kane 29:04 Statins is another common thing that I think of when I think of macrovascular complications in patients with diabetes. So anything new with the statin arena here? Yes, I Speaker 2 29:13 feel like we've kind of been there was numbers that we looked at then it was based on risk. And so now they've been updated to be more in line with their aha ACC guidelines, the patient has ascvd, we automatically recommend high intensity statins. Speaker 1 29:27 And if they don't have ascvd but still have diabetes, then moderate intensity is the way to go. And then you have patients somewhere in between, and you're going to look at other risk factors and utilize either moderate or high intensity statins accordingly. Interestingly enough, though, looking at statins, one thing but the non statins looks like the EPA only fish oil is recommended based on the merits of the reduce it trial. This is the ecosopentanoic acid specific product. The brand name for this product. Back in the market is with SIPA, and in this reduce the trial, it did show benefits on cardiovascular risk reduction. So this guideline particularly is recommending, yes, you have to have patient on maximally tolerated statin therapy and diet and exercise. We know helps reduce triglycerides, too, despite that, if their triglycerides are remaining elevated, which in this guideline, the range of elevation was between 135 and 499 which we know 135 is considered an okay, triglycerides. But quoting the guidelines, this is what they're recommending Dr. Sean Kane 30:32 always have to be different, right? Yes. And just for clarity, the EPA only product is not fish oil in the sense of fish oil that you get over the counter, which has DHA and EPA. So it would be incorrect to assume that now the ADA guidelines are saying fish oil for these patients, it's a specific form of fish oil that is only available as a prescription that is different than the other Omega three products Speaker 1 30:56 in the market. Yes, definitely. Thank you for highlighting that difference. Yep. So with Dr. Sean Kane 31:01 macrovascular there must also be microvascular outcome management. So this is going to be nephropathy, retinopathy, neuropathies. What's new in this arena, Speaker 1 31:11 technically, looking at patients with nephropathy or established, you know, chronic kidney disease, they're saying twice yearly screening should be done. They're actually emphasizing the importance of RAS agents, so things like ACE inhibitors or ARBs that do not discontinue these agents. If you see a mild elevation in serum creatinine, we know that cut off usually is that 30% bump that we see. If that bump is below 30% and if we don't see any volume depletion anywhere, we don't suspect that patient's going to have further kidney damage, leave them on the agent, if anything, do frequent lab assessments to make sure that their kidneys are protected, but don't discontinue these products. Speaker 2 31:50 And when it comes to the glucose lowering, we talked about that a little bit. And so with the cardiovascular outcome trials, renal outcomes were a part of those trials, but we also have a couple of trials that only looked at renal outcomes as a primary outcome, such as Credence. And we did find beneficial outcomes in patients with chronic kidney disease with the use of sglt two inhibitors, and that's where that recommendation came from. And so as long as the patient's EGFR is greater than or equal to 30 and urinary albumin is greater than 30 milligrams per grams of pre Adnan, especially in those patients with macro albuminuria, or where their urinary albumin is over 300 we should be recommending sglt, two inhibitors in those patients, Speaker 1 32:31 and really looking at other microvascular issues. Foot Care is a common concern, and so now there are actually evidence based recommendations for wearing therapeutic footwear. We know that there are certain pharmacies, independent pharmacies, where foot fitting services are provided by pharmacists, but now this is backed by evidence. We know in high risk patients wearing proper footwear can help with outcomes such as severe neuropathy, foot deformities, ulcers, callous formation, circulations, etc, etc. So the for these patients, therapeutic footwear is recommended. Speaker 2 33:06 And I don't know that patients always realize that this might be a benefit of their insurance. And so definitely recommending patients, you know, look into their insurance or go to the specialty stores that do help patients with therapeutic footwear. We should definitely recommend definitely recommend that for our patients. Dr. Sean Kane 33:24 So Dr. Patel, what is our next item on our top 10 list for the ADA 2020? Updated guidelines? Speaker 1 33:30 I'm promising. We're getting closer to the end here, but the exciting stuff is the management of pediatric diabetes. So there is a new goal for AVC, less than 7% for most patients, and less than 6.5% if there are no additional side effects from the treatment. This goal used to be less than 7.5 for the pediatric patient. So just tightening the gears a little bit, and I think that has to do with the increased obesity epidemic that we are seeing in younger patient population. Dr. Sean Kane 34:04 And when you say pediatric, are we talking less than 18, or are we? Is it more specific to even like adolescents and things like that, correct? Speaker 1 34:13 So that includes younger kids as well as the kids who are in the adolescent age as well. Okay, and Dr. Sean Kane 34:19 I understand liraglutide now has kind of new criteria for use with respect to age as well. Is that correct? Speaker 1 34:25 Correct in type two patients or younger age, so 10 years and older, it is approved. Now we should know that Metformin is still that first line, but they are recommending liraglutide again, going back to seeing more and more obesity in younger patients, and if they have type two diabetes, we should go for it. Obviously. If they have type one, we're going to do the basal and bolus insulin therapy for them. Dr. Sean Kane 34:50 And more for completeness sake, in terms of brand, brand names, liraglutide, that's Victoza. It also has that alternative dosage formulation for weight loss called Saxenda again, taking advantage of that weight loss side effect, if you will. Speaker 1 35:04 Yeah, absolutely, yeah. It's kind of killing two birds with one stone, not this on morbid but Dr. Sean Kane 35:09 yes, great. And then how about number 10, our final number 10. Final number 10 Speaker 1 35:14 is talking about gestational diabetes management, and this kind of goes back and forth. I mean, nothing is substantially different, but they're kind of bringing back the oral option as second line option. Okay, So insulin is still the gold standard therapy if a patient with gestational diabetes needs additional blood glucose control to like diet exercise, you know, dietary modifications and medical nutrition therapy in the couple previous standards of care. They kind of just didn't even talk about whole lot of emphasis on Metformin and glyburide, but now they're saying that, yes, you can bring him back as a second line option if insulin is absolutely a no no. But we should keep in mind these both cross placenta and may have some implications on fetal health as well. Therefore they're not the first line options. Dr. Sean Kane 36:09 So first line is insulin. Would that be a basal bolus strategy? Or kind of depends on the patient in terms of what the requirements are, yeah, usually for Speaker 1 36:17 patients with gestational diabetes, NPH is a game changer. You start out with that basal kind of a format, and if additional control is needed, then you go for the bolus. But usually NPH is the go to, and Dr. Sean Kane 36:31 that's sufficient that you don't need, like rapid acting mealtime and things like that, Speaker 1 36:36 initially not That's correct. Now, that Dr. Sean Kane 36:39 covers gestational diabetes, what happens after the baby is born and now the mother is postpartum, what happens in terms of typical glycemic management for those patients? Speaker 1 36:49 Yeah, you know, previous guidelines kind of focused on what to do during the pregnancy and immediately after postpartum. However, this guidelines kind of expanding the postpartum care, and where the role of the insulin, again, is emphasized in a sense that once the delivery occurs, then the physiologic need for the insulin goes down. And so this is just giving providers a heads up, saying, hey, you need to make sure you adjust the insulin dose. Don't let patient, you know, discharged from the hospital on that dose, and don't see them for three months or four months after so we need to keep that in mind. And they're also emphasizing future risk for gestational diabetes and psychosocial care for the ladies who just have delivered. Makes sense. And as usual, I mean, we talked about the insulin but the use of continuous glucose monitor is also emphasized. We knew that patient population that can benefit from these technology are the type one patients, type two patients, who are on multiple daily injections of the insulins and then gestational diabetes. But they're just kind of emphasizing, and I think this is probably hinting the insurance agencies to say, hey, you need to start covering the patients if they have gestational diabetes and are on insulin therapy, perfect. Dr. Sean Kane 38:11 So Dr. Patel and Dr. Srivastava, she had actually left the room. But thank you, Dr. Srivastava for being a guest on the episode, and Dr. Patel for kind of summarizing, yet again, another annual update from the ADA guidelines. For the listeners that want to see the guidelines. We'll have a link at HelixTalk.com this is episode 110 this document is updated every single year, whether we do our episode or not, so I'd always encourage listeners to check that out. Typically, it's December or January, if I'm not mistaken Speaker 1 38:40 and that's correct. So with that, I'm Dr. Patel, thank you, Dr. Srivastava, and I'm Dr. Kane. And study hard. Narrator - Dr. Abel 38:48 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 - ? 38:59 to suggest an episode, or contact us or 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.