Thank you, Ashley for that great intro into what we're gonna talk about next. What we are gonna talk about what I want to talk to you about is moving beyond hemoglobin A one C and the new standards for assessing glycaemic control. My name is Eugene Wright. I'm the medical director for performance improvement at the Charlotte Area Health Education Center and a consulting associate in the Department of Medicine at Duke University Medical Center. I'm gonna be talking about this evening incorporating C G M based glucose patterns, insight reports are often referred to as the GP I R and treatment prompts in type two diabetes. We will focus on refining and simplifying clinical decision making based on C G M. So what's the most important pattern that you see in this A GP over here in the middle section? Here, here's some laboratory information and demographic information about your patient. You see that they're on Metformin, a maximum dose A G LP one at a maximum dose, they get glipiZIDE, a Sophia at breakfast and at dinner. So you see in this patient who is has the labs with an A one C of 7.5% on a maximum dose of Metformin and A G LP one receptor Agnes and breakfast and dinner doses of a phony urea lipo. You can see at the A GP here, what their pattern looks like on this ambulatory glucose profile report. When considering a therapy change, what would you recommend for this patient? And I've tried to outline over here in the left-hand panel about 11 options that you could conceivably have when looking at this A GP. And you can see that for Metformin, you could remove or decrease it, you could remove or decrease the G LP one, you could add or increase the guardian and guardian and so forth or make no change at all. Let's talk a little bit about the standardized A GP report. This report was developed at the International Diabetes Center or the I DC. And it shows a standard set of information and graphs you can see in here, you have the target time and range uh values, you have the subjects time and range values over here to the right of that. You have the A GP figure here that's drawn out graphically and the daily glucose patterns. Each of these boxes represents one of the 14 days that the patients is wearing the sensor. Now, there's a planned update to this uh a GP report in which these, the A GP graphic will have color coded, matching the time and range targets here. Now, the GP I report or the glucose patterns, insight report looks a little bit different. And you can see here on the right, how this program, how this uh profile looks. Well, why does it look like this? Well, the intended users are that primary care practitioners typically are not diabetes specialists but treat a lot of patients with diabetes. The care strategy in this is to identify and work on one pattern at a time. We want to simplify the assessment and therapy change process by focusing on what's called the most important pattern. And the hierarchy of that is looking for lows, then highs with some lows and then high pattern. So by doing this, if we address the low glucose patterns, first, we can mitigate the risk for hypoglycemia and then at subsequent visits, address the other patterns, we only address the high patterns when the low patterns have been mitigated and taking care not to make the lows worse when addressing the highs. And then there are patients where you have high variability or highs with some lows that may prevent addressing the highs without making the lows worse. And in that case, we wanna consider lifestyle behaviors that may be contributing to this variability. And we may wanna even consider different medication choices that have less variability associated with them. Now, why do we need this GP I report? Well, we've already indicated that primary care practitioners may not be diabetes specialists but do treat a lot of patients with diabetes. Most of us in primary care are very busy and have limited time with patients to address their total health care needs. And we have other things other than diabetes that we have to focus on. There's a discordance that we've noticed between the quantity and kinds of new therapies for type two diabetes and improved outcomes highlights an unmet need for tools to help primary care practitioners make appropriate therapeutic adjustments. And primary care practitioners would benefit from a way to make it easier, faster and safer to make a better clinical decision for their patients living with diabetes. Well, in the spirit of performance improvement, a useful performance improvement tool would permit the non expert primary care practitioner to make a better clinical decision with minimal disruption to workflow, easier making, taking no more or less time if possible faster without adding additional risk for adverse events such as hypoglycemia or safer. Now, the GP I report updates from the A GP. So it's not one or the other. It is the A GP and the new GP I report and you can see that here, you have the old A GP report on the left, the new A GP, the new GP I report here in this intersection and it updates from this A GP and what the updates involve were removing this time and range consensus targets. Here, you see those aren't represented in the new report. There's a different A GP figure design here and it's color coded that seems to match these bars up here for the patients, time and range and other targets. The most important thing that I think is it shows the critical A GP patterns and you can see highlighted in this box here box here is what is identified as the most important pattern. So this draws your eye immediately to the area that you need to focus on and really keeps you from getting distracted with some of the other things that may be going on. It has a section in here that's considered lifestyle or medication considerations that you might consider and it's removed the daily glucose profiles and the glucose variability section here and up here for variability. So this report is less condensed, it's a little more informative and directed. Well, we decided to do a study in the problem statement. Does this GP I report improve primary care practitioners decision making? So here's our study design and report preparation. We took 10 cases from clinical data. We had a specialist assessment of these and identified the most important pattern. What we did was we generated the A GP for these 10 cases and for the same 10 cases, we generated the glucose patterns insight report. So there are 20 reports from 10 cases allowing each report to be head to head comparison. So we recruited 35 primary care practitioners and you can see the subjects here, 20 physician and 15 non physician practitioners, 19 males, 16, female, 22 practicing for greater than, or equal to 10 years and 13, practicing less than 10 years. And we divided them up into two groups, 18 in this group and uh, 17 in this cohort in round one, this top 17 all got to read a GPS. Round one. The second group got to read the same, uh, glucose data, but with the GP I report and then we crossed over for round two. So if you read the A GP in the first round, you got to read the same 10 cases in the second round, using the glucose patterns, insight report and vice versa. What's important to note that we ask each practitioner for their first best therapy change, not allowing simultaneous changes. And that's if directly important because sometimes we get caught up in seeing two or three patterns that we want to adjust, not recognizing that any one decision may affect others down the stream. So we only allowed one change at a time. So here's an example of what uh was an overnight low. See the patient here, the A one C of 7.5%. You can see the medications here and the instructions were on this card to select the first best therapy change. And you can see the 11 choices that were here. You can see the A GP report for this patient. They were presented with this and they were presented with the same patient in the second round, but using the glucose patterns insight report and you can see this report, let me go back and the A GP report, same data just displayed differently. So give you a bit of the case breakdown in this. When we looked at the most important pattern in the number of cases, the 10 cases were broken down. As you see here, five low glucose, three high glucose, one highs with some lows, one with no pattern that was already in good control. The reason we focused on hypoglycemia was that hypoglycemia prevalence in type two patients with type two diabetes is often under recognized. But we know that in insulin using patients, type two can occur, hypoglycemia can occur greater than 25% of the time and they can show severe hypoglycemia. Also, there's a growing link between hypoglycemia and cardiovascular disorders. So we really wanted to focus on this from a safety perspective. So what we did is we analyzed each pattern sub and subset separately. For each case, we class classified the decision as addressing the most important pattern. I e decreasing insulin to address lows worsen the most important pattern. Adding insulin for instance to it would increase the incidence of lows or prolonging the most important pattern if we made no change to address lows when they were picked up and we wanted to also track the practitioners deliberation time. So how did we do that? What did we learn well with the most important pattern. The five cases that had low glucose, the therapy decisions with the A GP versus the glucose patterns insight report was improved with the glucose patterns insight report. And we know that the time to reach that decision was improved, there was really not much change for high glucose patterns, highs with some lows or no pattern at all. But the biggest change was in the one that we were focusing on is in the low glucose pattern. Now, as we look at that report, the A G VA GP report, compared to the GP I report, the GP I report benefit was three times more likely to identify and treat hypoglycemia with the GP I report, they were 50% less likely to make a treatment decision that would worsen hypoglycemia using the GP I report. And they were 50% approximately 50% less likely to make treatment decisions that would prolong hypoglycemia. And these were statistically significant changes. But wait, we also needed to make this faster. And we noticed that there was a significant reduction in the time or improvement in decision making time using the GP I report compared to the standard report. So it actually took less time to make a better decision. Now, if we look at some of the feedback from the subjects on their, their perspectives of the GP I and the A GP report, the GP I report was preferred 2 to 1 over the A GP report with 23 of 35 practitioners. Some of the reasons they offered were that the GP I report was less busy than the A GP report. It was cleaner and easier to interpret. They preferred the color coded A GP to match the time and range targets and metrics. They like the boxes that highlighted the most important pattern within the A GP figure. And this is important because it directs you right away to what is the most important pattern for you to treat at that time. Now, for those who chose the A GP report uh over the GP I report about 12 of the 35 the features that they found most useful were the daily traces. Six of the 12 use those in decision making and they preferred the blue color palette for the A GP figure. It's important to note here that it's not the GP I or the A GP. It is the GP I and the A GP. If you can make all the decisions you need to make with the GP I report, you don't need to look at the A GP. If you would prefer to get additional information that is not on the GP I report such as the daily uh figures and the daily graphics, you can look at the A GP report. So let's take a look at a couple of the individual cases and how people did uh as a group on this. Here's a case of overnight lows. You can see the medications listed here, the labs here and the medications listed at the bottom. You see the A GP report on the far left and the GP I report here in the middle. Now, this is a case where the patient had significant overnight lows. And you can see that's highlighted here in the A G in the GP I report. But how did they do addressing hypoglycemia? Only three, only three of the 35 addressed that using the A GP report, that number jumped to 18 using the uh G GP I report a sixfold increase. Now, what's also interesting, 17 worsened hypoglycemia using the A GP report while only seven worsened hypoglycemia in their clinical decision making using the GP I report. And similarly, those that would have prolonged 15, prolonged uh hypoglycemia using the A GP. And that number was reduced to only 10 using the uh GP I report a significant increase in recognizing the most significant problem of hypoglycemia overnight. Using the GP I report. Here's another example, case three, same set up here old A GP report, current GP I report medications and laboratory values here, seven addressed the hypoglycemia using the A GP report number jumped to 19 using the GP I report, 16 would have worsened hypoglycemia using the A GP report. That number dropped to only seven using the GP I report. And you can see so on the changes that they would have made uh in this using one report versus the other. So we were convinced of the value of this report and mind you, it took them statistically less time to do it. And when you've only got 60 seconds to make a decision, every second adds up. So what was the effect of this report designed on the changes to the primary care practitioners decision making? Well, the novel C G M based glucose patterns insight report that identifies patterns of suboptimal glycaemic control highlights the clinically most important pattern and offers therapy considerations to address that most important pattern. To assess the utility of this report in clinical decision making. A reading study was conducted comparing the current standardized glucose report or the A GP to the glucose patterns insight report clinical data as we've talked about from 10 subjects were used to generate complementary G pr S the glucose patterns insite report and A GPS. And importantly, nonspecialist primary care practitioners evaluated each case in each report designed alongside with the A one C, the medication regimen can make a therapy recommendation. Therapy recommendations were categorized by whether they address the most important pattern with a priority on treating hypoglycemia if it occurs, coincident with other patterns with a within a given case. Well, primary care practitioners address the most important pattern equally equally well, with each report in cases presenting with patterns other than hypoglycemia. And arguably hypoglycemia is probably the most important thing when you're talking about safety in making changes, no one wants to make hypoglycaemia worse across all cases. And all subjects therapy change categorizations were different in 79 instances with 67 of these instances presented as hypoglycemia. And what that means is that a primary care practitioner recommendation using one report addressed hypoglycemia. While that using the other report did not within this subset of 67 in all but one instance or 99% the primary care practitioners correctly addressed low glucose with the GP I R or the glucose Patents Insight report. When they did not put the same case, using the A GP. These findings indicate that the GP I R aids in identification and treatment of hypoglycemia that would otherwise be missed using current standardized reports. So let's go back and look at this case again. What's the most important pattern here you see with the A GP report, we'll flash up the GP I R report. You can see that's highlighted here and the most appropriate therapy decision would be to remove or decrease the dinnertime dose of lipoid in this case to reduce this overnight hypoglycemia. And you can see that's outlined for you very nicely here in the considerations for the C for the clinician. Thank you very much for your time and attention on this and we'll be happy to take questions
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