Thank you Dr Fonseca for for a wonderful introductory lecture. Well we've just heard that randomized controlled trial seemed to support C. G. M. As being foundational in the management of diabetes health care systems today are looking for foundational or transformative innovations to be ones that move us closer to achieving the triple aim in diabetes and C. G. M. If it's going to be used in this way needs needs to help us reach the triple aim for diabetes. So let's see what this triple aim is all about and explore that. Right after my disclosures, striving for the triple A means. We're trying to improve healthcare value and that's all the buzzword these days. Can we have good outcomes at a reasonable cost? And Don Berwick Proposed this in 2008 improve the quality, improve the patient experience and do it at a reasonable cost at least that makes sense. Well that's for a system. How about for diabetes where I kind of made up this version of the triple aim for diabetes. The quality now becomes yes, A one C is still there. But now we have time and range and time below range and checking for cardiovascular and renal disease which are critically important. Patient experience becomes reducing the burden of this. Living with diabetes for 24 7. The diabetes distress associated with that. And I think the way to reduce the cost is to reduce the therapeutic inertia will see gm Well can we overcome that inertia On the clinician side. Yes but also on the patient's side and a large part on the healthcare system side that may not be organized to help the clinician work as a team. And then finally since this discussion this afternoon and the symposium is about C. G. M. Here's what I think the triple aim for C. G. M. Is if we can achieve these three components I think. See GM has a chance of really moving diabetes and the healthcare system along. IFC GM can help guide clinical decisions if C. G. M. Becomes a quality measure in and of itself and if see GM gets the attention of the regulators. So it's part of the labels of drugs and devices and approaches to care. So let's explore that for just a moment and see if we can move it across this way with C. G. M. Being foundational as dr fonseca said, let's start with guiding clinical decision making. There's thousands of data points. You started to see this already in this symposium you can organize them into an A G. P. Report. This is our first version on the left. Well not our first that's a version for on the left hand side and now the latest version is on the right side. You may not have seen yet the colored version but I think you'll appreciate that the timing range bar moves over to the left because it's so central to our decision making. The the A. G. P. Profile now has colors. So you can spot the hypoglycemia at a glance and the hypoglycemia at a glance and you have other key metrics I'll describe at least one of them in just a moment. Then you have the goals all outlined and associated with the achieved timing ranges as well. So that's the layout and the A. D. A. Seemed to think it made sense. Put it in the 20 to 2022 standards of care as a recommended approach for starting an analysis and and guiding decision making um in their standards of care. But it's not just about the numbers. I know we love the numbers. There's thousands of numbers in the A. G. P. But patients are are under a lot of distress or burden just dealing with diabetes 24 7 and all that implies. So If we can reduce that burden just a little bit I think we have a better chance of of achieving that a. one c. That we want to get to. And there are now standard measures of way to document um diabetes distress. So let's keep that in mind as we go forward because that's a critical element as well. So I like to talk about us moving across this bridge sometimes the bridge feels a little unsteady but we've been living in the A. One C. Era. I think we're moving to the C. G. M. Era at least for this management purposes. Yes. A one C. may be around for a long time as a population health measure. But for managing a patient. So I think well you'll see in this symposium that C. G. M. Is hands down the better approach as a quality indicator. Well let's explore that a little bit time and range and time below range. I never think time and range should stand on its own. It should be paired with time below range. Then you have a really good clinical picture. I like to throw in reducing the burden as well. You put these three together now we can really start to impact care. We've got this A G. P. To lead us across the bridge. Maybe up in this corner we should have a measure of diabetes distress or reducing the burden. We'll have to think about that. So you're gonna hear some excellent presentations coming up after mine on interpreting and guiding decisions but I can't help but give you at least the International diabetes center's latest. Thinking on a quick look at this. Um There's been nine steps. There's been five steps. There's been four steps, there's been all kinds of steps for analysis. I'll give you the three step method just look for more green and less red. Go over to the time and range bar and say is there a glucose control clinical problem. And yes there is an incredible amount of data here but if you just look at those two and say am I at the target of greater than 70 or less than four. If not let's go down to this panel and say why isn't this flat and narrow and in range? Where are the issues? Where's the problem? Well Let's tackle the Hypo 1st. It's in red now. It's pretty clear to see let's go to the hyperglycemia once we've minimized that acute risk. Um And this is what we'd like it to look like. If you don't have any copies of these in your clinic, get a copy of a little flatter and narrow one and show patients what we're aiming for on a gradual steady process to titrate, titrate titrate. That's really the key is doing something consistently and regularly and working towards this profile. Now that's where we've been for the last 10 years. This is hard for me to do but it's time to move on to action. So let's wipe that slate clean for a minute and say what does it look like to actually use the C. G. M. To guide management. And here's one approach and you're gonna hear a couple of others in just a moment. I know but it builds on the three steps. I just showed you more green and less. Red is still central I think to my way of thinking but now we start using the word adjustment. It's not just evaluating or looking are analyzing. Can you use time and range and time below range to adjust therapy. Are you a greater than 70. And now we say 2% Or less it's safe to adjust the insulin therapy up if you're on insulin with type two diabetes above that 2% you're starting to run into hypoglycemia potentially. So keep those two numbers in mind. And then we still want this to be flat and narrow and in range. But now we're using these two categories of timing range and time below range to guide how we work on getting it flat, narrow and in range. So I'll blow that up for you if you take Time and range and time below range is only four possible combinations. So we laid them out in a grid. Both can be green. Both can be read, one can be green, one can be read. And the key thing about this we realized is that each one of these has a different management approach. So within 30 seconds, you know where someone stands in their range and now we give you a little medication adjustment guidance of what to do if you're falling in that range. So now it becomes pretty quick and pretty straightforward. Yes. You still have to make the clinical judgment but we're giving you the pathway um to consider uh and that and that and that and that pathway we hope is going to lead to this flat and narrow and in range and this is what the one page handout looks like and I'm not going to go through it today but it's going to be discussed several times during the A. D. A. Um so please stay tuned. But it's really about Um asking about heart disease and kidney disease and heart failure 1st. But moving quickly to say where's my category? And then once you get into these categories you might be told that you're doing fine or you might be told it's time to stop the self honoria. It's time to um decrease the basil insulin. It's time to increase the basil insulin. It's time to think about a GLP one um agonist or or maybe even the new drug tricep appetite once it becomes available since it was just approved in these last few weeks. But Each one of these pathways um has a distinct approach based on your time and range categories. So that's our current approach to help guide management tricep appetite can get your 91% time in range that's pretty powerful. But you've got to have the CGM available to look and see how it's how it's doing. And there's even a new category called time and tight range now because if you can get that type You might want to know what 70-140 is as opposed to just 70-180. And you can see 73 versus 48% for really excellent basil insulin. But here's what this drug could do. So if you've got this approach of clinician guided management and using these categories and adjusting according to your categories. Why do we still get the question? Well are you sure the A. One C. Isn't Okay can I just use the A. One C. I understand this. It makes a lot of sense. But isn't the A. One C. So we want to get people comfortable? That timing range correlates to A one C. About 70% timing range is a 7% A one C. The other thing I want to spend just three minutes on is the G. M. I. This is your personalized A one C. This is the estimated A one C by a different name now based on C G. M A mean glucose and a formula that converts it into your personal a one c. And you've seen this paper possibly published a couple of years ago explaining this. But look at this slide of the mean glucose or the G. M. I. You could put on the bottom versus the lab. A one C. That line, that solid line you all know is what every calculator shows how these correlate. But look at the dots patients really do vary. And so the G. M. I and A one C. Don't always agree. As a matter of fact they agree about 20% of the time precisely. But Up to a third of the time they're more than .5 off it. 20% of the time. They're more than 200.6 off and you would say oh well that must have just been your dataset. You were using randomized controlled trials and maybe that's not really reflective. So I call him my friend and colleague IRL Hirsch who says no wait a minute. I took six, he took 600 patients in his endocrine clinic that have a spectrum of kidney disease and renal disease. And and next diversity. And he found that up to 22% had a 1% difference and it doesn't mean that one is not accurate and one is accurate in terms of measurement. It just says the GMI represents your actual tissue exposure to glucose. The A. One C. Can vary with the lifespan of the red cell and your radio application and these other issues that have been identified. So we're just saying pay some attention to the G. M. I. And I'll just close with this little teaching tool you might say, what's the big deal of seven? Five verses 81? If the A one C. Is 75, the G. M. I. Is 81. Does it really matter? Well, if you say 75 is pretty good, I'm gonna let you be But they really are tissues are exposed to the level of 8 1. You're putting somebody at risk for complications if you have the opposite side and say, well the A one C. Is 81. I'm going to lower you down. We gotta get you closer to seven. But the G. M. I was already closer to seven. You're putting them at risk for hypoglycemia. So it does matter. And there's reasons for these short red cell lifespan or a longer red cell lifespan can cause this gap. And dr Hirsch actually put together a nice table to say, you can just look at the table and say mhm. If the if the A. One C. Is less than the G. M. I. Or greater than the GM I here's some reasons to look for and you may find one that you can actually correct. Other times you just use the GMI as your guiding principle of day to day management. Um And I just want to let you know during the A. D. A. There's going to be several talks. I'm aware of at least this one where the A. One C. And the glucose levels continue to be scrutinized. And compared uh tim Dunn and his team looked at, I'll just highlight here 200,000 glucose is an A. One C. Measurements from 700 laboratories and they really are starting to sort out this correlation. And they saw that it's really not even that line. Like we showed our earl showed they really showed on the left, lower left here on the right side and on the left panel it's curvilinear there is a relationship. But If you start to understand this you can say at an a one c. 6.5. Somebody might have a glucose of 90 or 180. It's remarkable how it really can vary. And I would trust the thousands of daily glucose points. So I'll show you just one other paper was just out this last month caught my attention and I see you where they took. They put it on C. G. M. And they measured the GMI and compared it to a lab A one C. And if there was a big gap in the two those patients we're likely to be in the ICU longer and have a higher mortality rate. So there is something to this mismatch that is clinically important. We need to keep studying so I'm gonna put a check. Bye. See GM in my mind does help guide clinical strategies time and range time below range. Agni how about digital quality measures? Well I was really impressed that last year the N. C. T. Way many of you may know was one of the largest quality measurement organizations in the country. They started to say maybe as we update quality measurements we should be using more digital measures And see GM is a digital measure. It's in the cloud. So we're going to keep doing a one CS and lipids and blood pressure. We're going to be doing foot exams. Were going to be checking for heart risk and kidney risk but maybe it's time to consider G. M. I. And timing range and time below range and sub behavioral health measure as a quality measure and the fact that GMI can be integrated into electronic record all of a sudden makes it a re portable entity because you can upload it from the record into a quality measurement program. So I I think this could fulfill this little loop that we all hear about uploading your sensor and getting it into the record and having a report and having a discussion between your the clinician and the patient. But to have that discussion, you've got to have the data easily accessible. And and and if it's measured as a quality measure, you're more likely to look for it. So I'm putting a check here. Maybe it should be a hatch check because this is coming. But at least the dialogue has started because people tend to use the tools that they are measured by. They do an A. One C. Because they are measured by it. If you're measured by time and range and time below range and GMI, we're more likely to use those tools and then I'll close on the regulatory side. Um again, the regulators, I want to know is anybody using time and range. Is it in trials? Were not going to put it in our package inserts or in our labels? If nobody's using it, It's kind of a catch 22 because people aren't going to use it if they're not going to put it in their labels. But At least there's some data coming at the 88. This this session that you'll you'll probably see this as look time and range is being used more and more and more and more and more studies where it is a clinical outcome. It's not always a primary outcome but it's a clinical outcome. No and finally the regulators want to be sure we're expressing it the same way I won't dwell on this report. But you know what comes off the C. G. M. And publications and regulatory Story thinking is we're gonna group them a little bit different and we're going to say we're going to say less than 70 and less than 54 instead of 54-69 and 54 and less than 54. So the measures may look in little different buckets but this is a good outcome measure. And we're all going to use the timing range consensus targets as well. So I'll conclude by saying I think we've got a solid check on the bottom we've got checks on both of these two. And then in my mind the A. G. P. Metrics the timing range. The G. M. I have a chance to really transform management because they are impacting clinical quality and regulatory aspects of diabetes care. So I look forward to the next discussions um on using this data and look forward to jean writes discussion coming up next thank you very much
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