Hello. Welcome to this satellite symposium at the American Diabetes Association 2022 meeting in New Orleans. My name is Vivian Fonseca. I'm professor of medicine and assistant dean for clinical research at the Tulane University which is just down the street from from the convention. And I'm very pleased to welcome you all to new Orleans as well as welcome you to this symposium on the current foundational role of sensor based continuous glucose monitoring in diabetes management. We have a excellent faculty here today with my colleagues and good friends. Richard berg installed, Eden miller and Eugene right. We'll be covering a wide range of aspects about C. G. M. And its use in type two diabetes discussing recent clinical trials analyses and advancing supporting sensor based C. G. M. To guide therapeutic intervention in type two diabetes. So we have some specific objectives for our discussions this evening. First of all we want to demonstrate how see GM devices have become more seamless and easy to use. Technology can be easily applied now across the entire provider spectrum. Primary care physicians specialists, all people caring for persons with diabetes secondly, let's make clinicians comfortable with deployment and interpretation of the metrics that we're getting the kind of reports that we are getting such as the ambulatory glucose profile so that they can make use of that information and focus on how the new accurate data will change their practice and improve the long term metrics of the patient and understand The importance of a number of other metrics. Diamond range. How does that glucose management indicator. How does that relate to a one C and look at some new evolving glycemic metrics that will be driving a C g m centric care over the next few years. Such as the new device centric analysis features like the glucose pattern insights report and we'll go into more detail on that. The most important pattern on freestyle, liberate devices to enhance clinical decision making and make it easy to for people to use and effective in the application of technology and talk about a rationale for why. See GM is becoming a standard of care for a broad range of people with diabetes, not just type one as it was first envisioned, But across the board and including a wide range of people with type two diabetes. And as you know, diabetes is a major cause of morbidity and mortality in people with diabetes. And there's been a lot of emphasis recently on CkD and uh cardiovascular disease and diabetes. And good glycemic control still matters. Despite other things that matter, they knowing what your blood glucose is and keeping it under good control. Matters over the many years of diabetes, one of the problems of people with complicated diabetes is that these complications are irreversible. So treating them early is very important. Uh what is called a disc glycemic legacy or metabolic memory seems to persist on. It's very hard to reverse any complications if not impossible. And there are other factors involved in glucose control is not sufficient but it's really necessary in in people with diabetes overall because microvascular complications also matter. The challenge of glucose management is that we have to keep it in balance. On the one hand, we need timely effective, stable glycemic control. And on the other hand, you have the side effects of therapy, particularly hypoglycemia. We want to find a treatment strategy that gives you good metrics on glycemic control. And in the past we've used hemoglobin A one C which correlates very well with complications and reducing that prevents uh some of these complications. And but it returns to therapy can be challenging as well as this hypoglycemia problem with fear of hypoglycemia among patients, difficulties in those deterioration and that it requires better management and better metrics to guide our patients to get to better glycemic control without hypoglycemia. And we've learned that from trials where we try to achieve nearly normal glycemic trials like a chord in advance with severe hypoglycemia was a major limiting factor. And it's it's really quite incredible how the landscape is changing. We have newer therapies that are driving that in some respects but also the ability to test blood glucose in continuous uh immediate way with new technologies that allows people to treat hypoglycemia promptly as it's beginning to occur so that you don't get a CBO hypoglycemia. And one of another problem that causes patients a lot of distress of which hypoglycemia is very much far off Is this glucose variability of fluctuation with high and low and the key problem for patients with diabetes. And new technologies like sensor based C. G. M. Have provided us with very very good tools to control that this. So this is an unprecedented time with lots of data. Lots of metrics and I hope that today we can go through how we manage people well, address these metrics and come up with a good strategy for preventing long term complications. So avoiding hypoglycemia, avoiding variability and treating it all well is critically important. And part of that is the ability to monitor blood glucose not only easily non invasively but continuously. And we have been blessed to have many different ways to do continuous glucose monitoring over the last few years. Not only in many different ways but the technology has advanced so much that it's much more precise. We have tools to record it and transmit the data to the uh physicians and other clinicians. So that action can be taken promptly appropriate metrics can be looked at in in the clinic and all these will be discussed as we go along this evening. So not just a one C. But you can look at for example the whole ambulatory glucose profile which is an average over a few days or a couple of weeks or also on a daily basis. To avoid the highs and the lows and all this has been proven in clinical trials and real world data which I will discuss. But it came as a big relief in very early studies showed that within a few days of using continuous glucose monitoring. The C. G. M. Group had a marked reduction in hypoglycemic events Following that other clinical trials were done. These are fairly old and you'd know them very well both in type one in the impact trial and in type two the replace trial demonstrating that continuous glucose monitoring. It was very effective in reducing hypoglycemia. I'm talking today mainly about freestyle liberals. So these are the trials freestyle library. There are other clinical trials with other modalities and other methods of doing continuous glucose monitoring. so here is the impact trial in type one. Whether you look at the the time in uh below 70 which is Hypoglycemia defined as hypoglycemia less than 55 which is severe hypoglycemia, very severe Hypoglycemia requiring assistance. So you use the metric of less than 45 all those times were decreased with continuous glucose monitoring compared to finger stick control patients. Maybe that was not a surprise in type one diabetes, which is welcome even in type two where the rates of hypoglycemia less but still a major problem. And in fact I would put you a greater problem in people who are older and have a lot of comorbidities like heart disease which gets worse. You have arrhythmias and so on. So what are we, what's new, what are we learning and we want to discuss a lot of new things today. We'll talk about reducing hypoglycemia as I just mentioned and show you some other data. Talk about the impact on critical glycemic metrics define things like diamond range. How does this relate to A one C levels and finally talk about cost effectiveness. What a difference this has made over the last couple of years And talk about some new things including new randomized trials which are still being done. There's one just done in the UK hasn't been fully published yet but was presented at the very recent meeting on flash glucose monitoring using the freestyle, liberate two in people with type one diabetes. And it showed that this impatience with Type one with an a one C greater than 7.5. Ah And they good didn't have hypoglycemic uh an awareness of multiple hypoglycemia events. But they had not previously used CgF at least in the previous three months. And they were not taking GLP one receptor agonists or SGL T two innovators if you were taking Metformin. And the top line reports to impressive things. One is that diamond range was better in those using the Liberator to And at over six months that translated to a one c. That was .5% lower in those. Uh we're using see GM compared to routine blood glucose monitoring. But there was an analysis of cost effectiveness of this. And it showed that it was well cost is very well received in by and by the economist with the reduction in uh Events and an impact on quality of life. With the cost quality cost of about less than $7,000 per quality. Well below the nice threshold which is 26,000. Well below what we often considered to be an appropriate cost effective metric in the United States. Also time hypoglycemia. Time in hypoglycemia was significantly reduced 42 fewer minutes per day with less than 70. So The investigators recommended universal funding for freestyle liberation type one diabetes. And at six months, as I pointed out, the A one C was lower. Not only did the liberate two unit users achieve a lower A one C. They were also five times more likely to achieve a .5 Percent A one C reduction. Which is really very meaningful. And some of them actually achieved less 1% a one C reduction. And this all occurred at a much greater rate in people using C. G. M. Compared to blood glucose testing. So here are the baseline characteristics. A lot of people not well controlled with time and range but a significant improvement. I think there's room to be better. And as we go along we're learning more and more how to use this and we'll hear this from our speakers today. But while doing that we're reducing hypoglycemia. So if you like these are the uh illustration of the diamond range. You see the difference between baseline and at 24 weeks self monitoring of glucose here in in pink. Not very different but an improvement in the continue flash glucose monitoring group. And this is what you would see using the metric of a G. P. Uh that you will hear more about another interesting recent development has been covid epidemic and how people have been managing their diabetes better during covid using uh continuous glucose monitoring. Using other tools like tele monitoring. This has occurred both in adults as well as in Children and here in the United States. The CMS has been much more liberal with its uh use and approval of C. G. M. And flash glucose monitoring in people with Type two diabetes during the pandemic. Partly related to the fact that uncontrolled diabetes was is an important risk factor for severity of covid infection. So here's data from the U. K. Extracted from Liberal View users uh and it showed that diamond range improved and more people achieve the target when they were using a C. G. M. Uh there is another way of looking at it but broken down by age between January 2020 before the pandemic and then later on in June within a few months. And there was a significant improvement uh as well as the proportion achieving Diamond range greater than 70% which is an important metric that we that we use in practice. So and I want to turn to Going beyond Type one diabetes as well as during an acute crisis like the COVID epidemic And think about how we can manage type two diabetes across the spectrum of the type two in a wide range of people, not just people on insulin therapy, which fairly widely used today in increasing very rapidly, particularly those on M. D. I. But also people on a mix of insulin and oral agents as well as people not on insulin where it might actually help and finally going up beyond clinical trials and looking at real world evidence. So let's look at some of the real world evidence. Here's a prospective observational study from Italy. They measured a one C as the primary metric. They took a population that was uncontrolled over the previous one year despite the basal bolus regimen. And some people use freestyle, some use of glucose monitoring and after three months of using the freestyle libre. The A one c. was reduced by .8%. And the subgroup analysis showed that those with very poor control, both poor control as well as uh uh I would say I don't want to say good control. Less than nine is not good but less uh poorly controlled patients both responded very well with significant reductions in a onesie and this is compatible with other european studies. Looking at real world evidence from chart review and electronic medical records across multiple countries. Austria France Germany and now we're getting data from right across the world showing a significant production in A one C. And it doesn't matter what you know age group with because in older people, younger people obviously those who have very high A one C. At baseline tend to have greater drops in their A one C. Those who had long duration of insulin use of short duration obese. Not so obese. They all responded. But let's turn to the interesting group uh which is people with type two diabetes who are not taking insulin. And in general, as you are aware, uh there is less use of C. G. M. In this population. So years of paper in the BMJ open looking at flash glucose monitoring in people with not being treated with insulin randomized control trial comparing it uh control self monitoring of blood glucose. So These people were using their finger stick glucose monitoring and they were randomized to flash glucose monitoring for 12 weeks or continuing their usual care and you're at the baseline characteristics. And then you see a reduction in a one C. In both groups. They're getting attention coming into a study uh divide uh devices are being provided to them both for self glucose monitoring and flash glucose monitoring. But the flash glucose monitoring group had a greater reduction in in a one c years in percentage and years million municipal leaders when you look at other metrics for outcomes and we'll be discussing these in much greater detail years time and range showing an uh this is a baseline both groups more or less equal and then a significant increase in diamond range in the uh flash glucose monitoring group compared to self glucose monitoring. If you look in diamond hypoglycemia, it was significantly less a big drop in those using flash glucose monitoring. And uh these patients were given questionnaires about their quality of life, about their satisfaction with treatment, which is actually a very important metric in in the era of what are called patient reported outcomes. And here you see that the total scores showed an improvement in flash glucose monitoring with no change in self glucose monitoring. Uh They emphasize things like convenience, flexibility and that they would recommend it. two other people with type two diabetes whether they were using insulin or not. So let's look at a few other studies. This is from uh real world data. Non randomized trials showing reduction in a one C after initiation of sensor based glucose monitoring systems, baseline A one C that was very high short of reduction. Just like in the other studies. Now, one of the issues is integrating this into practice. And you'll hear more from my colleagues about this in actual practical terms, we've had also some data presented by Richburg install and others about incorporating it into electronic medical records. And I hope that he will elaborate on this a little bit more. But last year he presented data on integrating glucose monitoring into the electronic medical records at his center which is the International diabetes center in Minnesota. And this was very unique at the time but it in real time transfer data from Liberal View cloud based system into the E HR platform and I hope that we will see more and more of this in time to come right now. It's not possible. It doesn't happen at my institution but we are able to look at liberal view and other cloud based systems. We also look at what's available on the patient's phone or their readers and and can have a good discussion with their patients. So the average glucose profile and you you're much more about this from from Rich. He was one of the pioneers in this area and has emphasized its its value. This is a single page report that you get, first of all certain metrics about time and rage. Here's a visualization of this time and range in green. The time that is spent high. You can see that this patient is a fair amount of time in the high range and although lo is very little, it's very important, particularly very low. And fortunately this patient doesn't have that much. And importantly, you see the actual profile through the day and you see the reduction that's occurring during the night. Unfortunately this patient is not getting hypoglycemic during the night but it's getting some peaks during the day and maybe on certain days. And we could have a discussion with the patient to improve this smoothing out the variability and get better glucose control. I also want to point out that in europe now they have freestyle, liberate three with updated accuracy. It's approved and it's become available for the in the last couple of months. It is actually it gives you very rapid and more frequent measurements. So almost like a continuous glucose monitor. There are other advantages. One is in size and you see the thickness is in an overall size. This is Uh much smaller than the current one. The relative difference from the true blood glucose is now less than what it used to be and only liberate two and liberate three have hit this mark of getting down to 9.2% for adults on M. A. R. D. It's also more environmentally sustainable with less uh plastic and overall the price is the same as the previous generations of the device. When you compare it with what's available with the lab and the Yellow Springs analyzes the gold standard there um there there is a small degrees of difference. Obviously there's a big difference between interstitial fluid and blood glucose. Some collaboration is done for that. But the the mean amplitude of glucose excursion relative difference is is very very low, less than 10% is considered to be very good. And this of course both in the hyper range as well as when it's very high. So recently in diabetes UK which is like the A. D. A. In in the United Kingdom. They announced that the nice guidelines recommended wider access to flash glucose monitoring and continuous glucose monitoring to all adults with type one diabetes. They also recommended that all Children with Type one should have access to see GM. And that some people with type two diabetes who are using insulin intensive therapy with two or more injections should also have access to flash glucose monitoring if they experienced recurrent or severe hypoglycemia, whether they have disability which means they cannot do finger protesting. And the people are advised who have been advised to test very very frequently. Now our our recommendations in the United States are much more liberal than that. You don't have to test eight times a day in order to be eligible to have this and you don't need a full intensive insulin therapy regimen. Ah The nice guidelines have also updated the use of See GM. And people with type two diabetes particularly if they have recurrent hypoglycemia or severe hypoglycemia hypoglycemia unawareness where it would not be picked up unless uh these people were I have a using C. G. M. Or flash glucose monitoring. And for those where you recommend testing very very frequently. So overall see GM has evolved from being something that was available just to a few people. The accuracy has improved the costs have come down and it's become a foundational therapy. It's part of the therapeutic process that you don't use insulin alone without monitoring. And this is today the best way to be monitoring your patients. And then uh we have a number of metrics that we will hear about and we'll also hear how we can integrate this into the electronic health record. So the objectives of our symposium are to demonstrate how as devices become more seamless and easy to use. See GM technology can and should be applied across the spectrum to Pc PS and specialists and you'll be hearing from uh both of these groups here today. Make clinicians comfortable with the deployment and interpretation of A. G. P. Particularly and other metrics such as time and range and the glucose management indicator. How those relate to A one C. And other metrics such as located albumin et cetera. And uh look at some newer devices, new advances in the technology focusing of course today on freestyle, liberal and provide a rationale for Y. C. G. M. Is becoming the standard of care. Thank you very much. I'd like now like to hand over to my colleague Richburg, install
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