Hello everyone from Denver, where I am I'm quarantined, so I'm unable to share the Meet the Professor with you in person. I have tried a couple of times to make this recording and hopefully this will be the right time. Good afternoon, everyone. My name is Jane Lusch. I'm a professor of medicine at the University of Colorado in the Rocky Mountain Regional VA, where I serve as associate director for our Woodland Family Center for Women's Health Research and a associate director of our Diabetes Research Center. I'm pleased to speak to you today about a topic that was assigned to me, which I thought could be quite fun, is TIR, the new A1C. A few short years ago, in 2018, I was president of the American Diabetes Association. At that moment in history, we had 30.3 million people in the United States living with diabetes. We currently have 37.3 million people living with diabetes. Diabetes is very important, and using all the tools that we can to improve the lives of people with diabetes is critically important. These are my disclosures relevant to this talk. I have 30 years of clinical diabetes, mainly practiced at the VA, and I am a consultant for Medtronic Diabetes, representing the older population of individuals with type 1 diabetes. The goals of today's conversation will be to describe the current guidelines for glycemic targets across the spectrum of diabetes, including type 1 diabetes, type 2 diabetes, gestational diabetes, and drug-induced diabetes, specifically as they relate to metrics from CGM. So what I want you to do today is to master at least the information that can be generated using a continuous glucose monitor, and for you to have a clear understanding of the following metrics, time in range, time below range, and time above range. So we will reaffirm the question to, not to, is TIR the new A1C, but where TIR and the other metrics obtained using CGM fit into optimal practice and optimal care for people living with diabetes. So why is this a question that was posed? Well, diabetes technology is evolving in an astonishing pace. Continuous glucose monitors are accurate and somewhat affordable, and they are now covered by many different insurance situations. And most importantly, studies with people living with type 1 diabetes and type 2 diabetes demonstrate benefits in terms of glucose lowering and or hypoglycemia and hypoglycemia awareness. Of note, these studies primarily had benefit to the outcome that they were seeking, whether it was avoidance of hypoglycemia or glucose lowering. But why this question? Who is asking this question? Is it you, the provider? Is it the patient? Or is it the third party? What situation do we want to be replacing TIR with A1C? So let's get back to the basics. What is A1C all about? Well, the A1C is primarily about diagnosis and general monitoring for diabetes. So the A1C test, also known as hemoglobin A1C, or HbA1C, is a simple blood test. And it gives you the ability to speak by using the glucose monitor that is stuck to red blood cell hemoglobin that to measure average blood glucose over three months. It is one of the commonly used tests to diagnose prediabetes and diabetes in combination with glucose metrics. Of note, it is actually the least sensitive of all of these tests for the diagnosis of diabetes. So how do we diagnose diabetes? We diagnose diabetes as of 1999 for the ADA standards of medical care by an A1C level of greater than 6.5% for a fasting blood glucose of 124.6, which is the equivalent of five milliliter. Any random glucose higher than 200 or a two-hour glucose on an oral glucose tolerance test that is above the targeted range. There's also the diagnosis of prediabetes by the World Health Association and the IDF. They term it differently, they call it intermediate glucose tolerance and normal glucose tolerance. So when we're thinking about A1C and the basics, we're thinking about the relationship between ambient or average blood sugars and the A1C tests that you would get. So A1C is an excellent diagnostic tool for diabetes, prediabetes, and intermediate blood leukemia. It could provide a metric of the average blood glucose as a reflection of glucose control in general. But what can it do and why are we asking this question? It cannot determine glucose variability, it cannot detect hypoglycemia, and it can be unreliable in certain ancestry and disease states. So is A1C a tool that is broken? I would contend that it is not. It has many uses for diagnosis and for following people with low risk of hypoglycemia and low levels of glucose variability. But there are many ways, the many faces of A1C. You can get an A1C with all of your blood glucoses in an excellent range over here on the right. But you can also get an A1C of seven if you're having some glucose variability and a fair amount of hyperglycemia and hypoglycemia. But what I have called was a term that was coined by a friend of mine many years ago is a dirty A1C. An A1C in the 7% or goal range, but with many blood sugars that are high and most importantly, many blood sugars that are very low. So when we think of people and we're looking at just their A1C, we will miss these high and low blood glucose. So what exactly is time and range and what can we learn on a continuous glucose meter? Well, first we have to know what are the continuous glucose meters that are currently available? So there are real time CPM systems. These are systems that are continuously monitored and stored in either a receiver or on a phone. And these systems will continuously record blood glucose without prompting. There are intermittently scanned continuous glucose monitors, which now come either with or without an alarm. And there are systems that measure glucose levels continuously, but would require the patient to scan the system in order to upload. Now this scanning can happen every four to eight hours and most glucoses will be captured this way. Each of these systems has the possibility of telling the patient if their glucoses are heading up very quickly or heading down very quickly and can be used for a patient in terms of them getting biofeedback on what's going on with their diabetes and their glucose control moment to moment. A professional CPM is what's called a mass CPM. This is a tool that we can use in clinic to assess whether a person who were concerned about having high glycemic variability in fact does. And that may aid our decision of whether that individual would benefit from a continuous glucose monitor, help them with their safe glucose management. So I would like to reframe this question. Is CGM a better tool for management? So what can I learn from time and age that is similar to what I might learn from an A1C, not when I'm diagnosing a patient, but when I am managing that patient's diabetes. But if somebody has a time and range between 70 and 180 milligrams per deciliter of 70%, they will on average have an A1C of 7%. This is very, very consistent across many studies and all the different CGM tools. So this is something you can really take home with you for management of diabetes in somebody who is on or using or has available to them. So what can I learn from the CGM? Well, I can learn this glucose management indicator, which is a prediction of what the equivalent A1C would be based on 14 days of CGM monitoring, assuming that that is representative of the last few months. But you can learn so much more from a CGM. You can learn about the percent of time above range and how severe the level two hyperglycemia or level one hyperglycemia. You can learn about the time and range and most importantly for safety, you can learn about the time below range and particularly the time below range when the blood sugars are less than 54. This is a lot more information than just A1C or TIF. So there's a lot of information and let me show you, this is the AGP report, which is a continuous standardized continuous glucose monitoring report. We're gonna break this out a little bit in just a second, but it gives you a sense of what's going on over time. And it can also give you the day by day, the last 14 days. So let's just look at the top line that we gain from this. So in this individual, we would be quite concerned. Yes, we would be concerned that the time and range is not achieving the target, but I don't know how old this patient, well, I do actually know how old this patient is, they're relatively young. And so we would really like their A1C to be very good. But what we're most concerned about is that this person has 5% of their time, less than 70, but even more importantly, 5% of their time, less than 54. So this individual is in a very high risk situation for hypoglycemia and development of hypoglycemia unawareness. They also have robust glycemic variability. So hopefully we could use the glucose profiles to assist in optimizing the management strategy for this. So I wanna reframe the question that we're addressing in this meeting, Professor. Under what circumstances can TIR replace A1C? What does this mean for clinical care? And where does it fit in with glucose monitoring? And how does this new tool fit into the post COVID world of telediabetology? So first we need to start with what our TIR goals are. So in a person who is relatively uncomplicated with a good life expectancy with type one or type two diabetes, we would like 70% time and range and less than 5% time below range. This can achieve a fabulous A1C goal and very good safety profiles. When we move to the more high risk individual who has maybe comorbidities or shortened life expectancy, our number one goal is safety. So in this individual, we want to really avoid hypoglycemia and we are willing to loosen up our targets in order to keep them safe and not hypoglycemic. In pregnancy with type one diabetes, we want to minimize hypoglycemia. We want the A1C to be as close to target as possible. And in some instances, we would even want to move over to our gestational diabetes goals where we have 80 to 90% time and range with minimal hypoglycemia and minimal hyperglycemia. But as with all metrics related to diabetes, this is where we start. The individual with diabetes will help us design where we finish in terms of our TII targets and our objectives for their safety. So we're next gonna move to a few cases. And this is where I'm so sad that I'm not there with you in person today. But let's place this in context. It is critical to have clear goals and outcomes in mind when we use CTR. And I would love input from the audience, but I'm not sure that we are set up at the end of the society meeting to allow me to have that kind of input from you. So I'm gonna stop and pretend we have conversations at a few of your times throughout these cases. So the first case is a 31-year-old man diagnosed with new onset type 1 diabetes six months ago. He had an episode of ketoacidosis. He is now preparing for transition from multiple daily injections to automated instant delivery. His current regimen consists of insulin, largene, 24 units of bedtime, meal coverage, insulin to carbohydrate ratio of one to 10, and a correction factor of one to 30 over 120. He does not correct at bedtime because he's scared of hypoglycemia. And this is what we've learned from the CGM. He has very good avoidance of hypoglycemia, but he has only 63% time in range and his A1C is not at full. It's very important in this young individual to get his glucose control optimally managed as quickly as possible. This is what we see on the CGM download. The CGM download, and here is the review of many days. One of the patterns that we are picking up is a drop of glucose through the night. Another pattern that we're picking up is elevated blood glucose before bed. And remember, he told us that he is fearful of nocturnal hypoglycemia. So let's hear from you. What are your considerations? Now I'm gonna have to pretend that I'm you and you're gonna say, should we be using TIR on this patient? And I would say, absolutely yes. This is exactly the patient in whom all of us should be using continuous glucose monitoring to help patients get to their goals. In a 31-year-old individual with a lifetime of diabetes in front of him, optimizing the glycemic control will have a very big impact on his life. Is CGM informative beyond TIR? Yes, it's giving us some patterns. He's pretty good all day long, but in the night and the evening, things fall apart. And how would CGM help you initiate augmented insulin pump therapy? Well, let's sort of think about this in terms of the audience response questions that they asked me to. So here is your audience response question. After reviewing the data for this patient, which of the following is your first area of concern? Is daytime glucose profiles? I think not, we just discussed that. He has a lot of high and very high blood sugars in B1 and normal A1c. So that's something we're concerned about. Are we concerned about his low and very low? Yes, very few very lows. And I'm not too concerned about that right now, but I have it in my mind what I am, but what I think we should be concerned about is his nocturnal profiles. So let's look at that. So he has blood glucose dropping through the night, okay? And he's got elevated blood glucose prior to bed. So if we were to ratchet this entire blood glucose profile lower by trying to treat this, what we might end up with would be daytime hypoglycemia or something worse. So if we correct his bedtime hyperglycemia, he's definitely gonna drop low at night. So all of these factors need to be considered as we get ready to come up with our initial metrics for his CGM and augmented insulin pump system. We would probably like to see him with an overall basal rate that allows us to care for this. And we're also gonna need to educate them that running a blood glucose high before bedtime is going to activate insulin secretion, insulin delivery by the, whatever autobolus the insulin pump patient and insulin pump system the patient has such that he will have a lot of insulin on board if he's going to bed with hyperglycemia. I wish I had time to talk to you about other questions related to this patient, but because I'm not there with you in person, we'll just go to the next case. The next case is one of my all-time favorite patients. He is a gentleman I've taken care of for the last 20 years. He's a 92 year old gentleman with a 70 year history of type 1 diabetes. He had a twin brother also with type 1 diabetes who died very early related to his diabetes complications. He has been shuttered in assisted living during the COVID pandemic. He is now vaccinated with a booster and with my input on his glycemic management. His recent laboratory testing reveals a hemoglobin A1C of 7.8%. He is concerned about elevated glucose levels. His regimen consists of insulin largee, two units in the evening, insulin asphalt, five units for breakfast and two units at lunch and dinner. He had recurrent nocturnal hypoglycemia in third-party cysts when on insulin largee, three or four units daily. He had severe nocturnal hypoglycemia when on insulin deglidac, two units daily and severe nocturnal hypoglycemia when administering lunch or dinner aspart doses greater than two units. When we look at his CGM metrics, what we see is that he's only 40% in range, but he has very few hypoglycemic events. He has a lot of moderately level one hyperglycemia and very little severe hyperglycemia. He's wearing the sensor 93% of the time. We look at his glucose profiles, his glucose profiles through the night, he's running fairly high. And then he comes into the more normal range during the day and a little bit higher at bedtime. What, think about this gentlemen, what are your clinical considerations? I wish that I could hear from you, but I'm pretending that I am hearing from you. Is TIR useful for this patient? Yes, TIR is exquisitely useful for this patient. It has allowed him to sleep at night. It has, he also does a lot of finger stick glucoses because he is very dedicated to glycemic control. Is CTM informative beyond TIR? Yes, I think that we are seeing that he is having very few hyperglycemic events and that is my number one consideration in this individual. And so how is the CTM helping me in this patient? It is telling me that I am keeping him safe. So after reviewing this data, what should be the priority to discuss with this 93 year old patient? Should we be talking to him about optimizing his TIR and getting a TIR of at least 70% and an A1C of seven? Should we be talking to him about blood glucose trends before lunch and dinner? Or should we be asking them to try to optimize his post-dinner nighttime glucose elevations? Or should we tell him, oh my goodness, this is fantastic. No change is recommended at this time. You can tell by my intonation, my feelings on this, I would have no changes recommended at this time. I want to tell you in addition, I also attempted to put this patient on an insulin pump, but it turns out that 92 year old skin and a very low basal insulin, what happened was his basal insulin was not really being seen and he actually threatened to go into DKA or at least developed hyperglycemia in the 6700 range. He was so desirous of using the insulin pump that we gave it a try, but it was the wrong decision for this patient. I think because the basal infusion rates were so low that he really was not absorbing it. Safety is our top priority in this gentleman. And also he has seven years of type 1 diabetes with very few, with no glycemic or cardiovascular complications. So I'm not needing him to have perfect diabetes control. So our third case is a 68 year old woman with a 10 year history of type 2 diabetes who is currently managed on JustMed. She was able to get a CGM through her provider and her CGM data showed some glycemic variability during the day, but in general, she is doing extraordinarily well. She has an estimated ANC of 7.2%, but this individual has background diabetic retinopathy and an EGFR of 58 milligram per deciliter. And an albumin to creatinine ratio of 98. So she is going to be placed on an SGLT2 inhibitor to manage her cardio renal risk. But information from this patient's CGM is useful in decision making. Are we concerned about her glycemic variability? Are we concerned about nocturnal glucose profiles? Do we need her to know more about postprandial glucose values? Or are we helping this patient to see that a change needs to be made? In this patient, based on A1C goals, we may not need to make that big of a change, but because of her cardio renal risk, we do need to encourage her to agree to taking one more medicine for the management of her diabetes. So I would use this CGM chart to help me discuss with her the benefits of potentially going on to an SGLT2 inhibitor. So we have started her on an SGLT2 inhibitor and her glucose profiles have gone almost even, almost no glycemic variability with 97% time and range and a glucose management indicator that would be somewhere around 5.8%. Now was that our goal with this additional medication to lower her blood glucose as dramatically as we did? It was our goal to give her renal protection, but that renal protection came with an incredibly valuable glucose lowering, which will also improve, help hopefully improve the progression of her nephropathy and retinopathy. So we have another question related though to, should CGM be continued in this setting? Yes or no, or only as needed? Now, this is not as easy of a question as it seems. I would look at these data and say, I am not using the data from the CGM to change my management in any way. And so I would say that at this point in this patient's history, there's no reason unless there was further glycemic deterioration to use a CGM for her management of her glucose values. But if the patient is highly engaged with the CGM and that has also allowed her to be very engaged with diet and physical activity and other self-care behaviors related to her diabetes, you could potentially make an argument for yes. I will warn you though that it is very unlikely that any third party payer would allow you to provide this as a covered benefit. So I might have her keep her CGM and then use it only as needed if she was in situations where she happened to be going traveling or she was ill or her sugars were drifting up or down in a way that was concerning. So let's imagine you now have a strong idea of who should have a CGM and you're trying to now implement this in your practice. So you know how to choose the patients who will benefit. So you're now going to need to justify CGM to third party payers and the system within the clinic. And so it's great to have a system within your clinic to determine coverage. Your need in your clinic though, in addition to figuring out who will be covered by this, you will need a team or access to a team that can provide education about the use of the device, strategies for access and review of CGM data. So you can get the data and communicate back and forth with the patient about what they should be adjusting in their glucose management regimen. You need a system to put the data into the electronic health record for documentation of the CGM data. And you will need a billing structures to allow you to implement support of this. The right patient, identify the patient of the right patient has been reviewed in chapter seven of the ADA standards of care. Patients on insulin therapy, patients with inadequate post-traumatic control like a third patient, maybe not a third patient. Patients in high-risk work settings where hypoglycemia could be life-threatening and patients in remote settings where we can manage their diabetes remotely and safely and not have them lose control. But knowing who the patient is, is not enough. You need the patient and you as the provider to have mastery of the CGM technology and interpretation. And when you're justifying the CGM use of third-party payers, as we just mentioned, you need a system to do this. And we need to build an infrastructure and have a billing. So this is where I would have greatly loved input from you as to the barriers in your clinical practice to getting CGM implemented and to being able to communicate back and forth with patients regarding their data and changes. I'm just gonna briefly review some patient and provider considerations. Education on CGM, all aspects can be used through certified diabetes care and education specialists who would either be within your clinic or used within consultation to your clinic and staff to support device and downloads that the device manufacturers are often great partners in facilitating the optimal use by the patient. Troubleshooting for alarms and sensor malfunctions can be done within the practice. And a lot of this can be done through the support from the device manufacturers. These are just some different things that are in my slideshow, but just wanted you to know that as a trainee in endocrinology, you should be taught how to read a CGM just like you would be taught how to read an EKG because the AGP gives us so much more information than time and range. It gives us the profiles, the moments when they're at risk for developing hypoglycemia, moments when they're at risk for developing hyperglycemia. And this is a very robust strategy that should be next year's meet the professor if it isn't one this year. It is also incredibly important to be able to have some way to download these data and communicate back to the patient. Now patients may or may not be comfortable with this kind of technology. And each time you see the patient, you need to have an assessment of their diabetes literacy and numeracy. You need to be able to show them their CGM and ask them what they think of it. Look at their ability to have pattern recognition and to change behaviors or insulin dosing based on that pattern recognition. So is TIR the new A1C? No, but CGM is an incredible tool for glycemic management. TIR can be used to follow glycemic control, should be able to be used instead by fetus criteria. And CGM offers more information than an A1C. In the world of remote care, CGM metrics make state-of-the-art care possible for people that are not seeing face-to-face. Now, we as providers need to advocate for access to CGM for the right patients and for reimbursement for the process of care infrastructure to support implementation of CGM in real-world clinical. So I would like to thank you and apologize again. I managed to be a victim of the COVID pandemic, so I'm not able to be there. So I'm not able to be there today, but I do want to let you know that it is a very big lost opportunity on my part not being with you there today, because the more we understand about the barriers in your clinical settings to get appropriate technology for the right patient at the right time, the better we will be able to advocate for getting this done so that you can take the best care possible of your patients. So thank you very much.

continuous glucose monitoring

CGM

diabetes management

glycemic control

CGM systems

hypoglycemia detection

glucose variability