Well, we'd like to shift gears now and go from clinical trials to the front lines of diabetes care. In this talk, incorporating CGM based glucose patterns, insight reports or the GP IR as it's often referred to and treatment prompts in type two diabetes, we plan to focus on refining and simplifying clinical decision making based on CGM. My name is Eugene Wright and I'm a consulting associate in the Department of Medicine at Duke University Medical Center and also the medical director for performance improvement at the South Piedmont Area Health Education Center here in Charlotte, North Carolina. Let's start off with a question. What do you identify as the most important pattern on this A GP report? You can see the labs here that are OK. We'll assume that that the A one C is 7.5%. You can see this patient's current medication regimen, uh Metformin max dose, G LP one max dose and glipiZIDE. Now, I'm gonna give you an opportunity to choose one first best change that you would make uh therapy wise for this patient. Based on this A GP report, you can see the labs here at the bottom. The medication regimen and you have a little scorecard here if you will, that gives you 11 choices of things that you can do based on this pattern. I'm gonna give you a second or two to quickly just kind of say, what would you do when you see this pattern? Ok, let's talk about the A GP report or the standard report that it has been referred to. It was developed by the International Diabetes Center and it shows a standard set of information and graphs. In the top section, you can see the time and range target values on the left with the subjects uh time and range values on the right. In the middle section, you have the A GP figure or the A GP graphic and in the bottom you have the daily glucose profiles. Now there's a planned update to this uh that will have the upper time and range metrics look more like the GP IR report with some color coding of the A GP to match those targets. This is the glucose patterns, insight report or the GP I report that you see here. And you might ask why was this developed? The intended users are primary care clinicians such as pharmacists who are not necessarily diabetes specialists but treat patients with diabetes. The care strategy of this was to identify and work on one pattern at a time. With the goal to simplify the assessment and therapy change process by focusing on what we call the most important pattern in the priority of low, then highs with some lows, then high. So the strategy is to address the low patterns. First, if a low pattern is mitigated at the next visit, then you'll address what other patterns are there. The second order priority would be to address the high patterns. When once the low patterns have been mitigated, taking care not to make the low patterns worse by addressing the highs. And then finally, this high variability which may prevent addressing highs without making lows worse. We need to discuss with the patient lifestyle behavior, uh different things that can be contributing to this variability and we may even wanna consider different therapy uh that may better address the variability in that group of patients. So why do we need this report? As we said that the primary care clinicians may not be diabetes specialists but they treat patients with diabetes. Typically, we all are very busy and have limited time with patients to address their health care needs. There's a significant discordance between the quantity and kinds of new therapies that we have for type two diabetes and improved outcomes that highlights the unmet need for tools to help primary care clinicians make appropriate therapeutic adjustments. So we would all benefit from a way to make it easier, faster and safer to make a better clinical decision for all of our patients living with type two diabetes. So a useful performance tool would permit the non expert primary care clinician to make a better clinical decision with minimal disruption to workflow, easier, taking no more or less time, ideally faster and without adding additional risk for adverse events such as hypoglycemia being safer. So the glucose patterns update report, the glucose patterns, insight report updates from the A GP report. And you can see here the two reports that are side by side. It's important to note that these are not exclusive. You have both reports available to you, the glucose patterns, uh report updates from the A GP and it removes the time and range target values that you see in the upper left hand corner of the A GP report. There's also a different A GP uh figure designed that's color coordinate with the uh goos patterns, insight report, patient time and range targets at the top. There's a box here that shows in the bottom section, the critical A GP pattern and this quickly draws the user's eye to what is identified as an important or critical pattern to address in the patient in the middle section. Here, we have medication or lifestyle considerations that are added to that to help the user very quickly arrive at some options. And we've removed the daily glucose profiles at the bottom that made the report a little crowded, but those are still available to you on the A GP or standardize. And we've removed some of the glucose variability figures that you see in the top. So the problem statement was, does the glucose patterns insight report, improve primary care clinicians, decision making? So we designed a study and in this study, what we took was 10 patient cases from actual clinical data. We generated 10 A GP reports for these cases and generated for the same patients, 10 glucose patterns insight reports. Now all of these reports were assessed by a female clinicians, uh specialists prior to that, and we arrived at what would be the most important pattern and what would be the most important single first step to take. So, allowing this duplication here generating the reports, 10 reports from each uh for the GP I and the A GP allowed us to have head to head comparisons. And you can see how this was designed. We had 35 primary care clinicians and in round one half of them read A GPS, they were crossed over to uh round two and they read the same cases. Now using the glucose patterns insight report. And similarly, those who got the glucose patterns insight report in the first round in the second round got the same cases. Now with a GPS, now each clinician was asked for the first best therapy change, not allowing simultaneous changes to be made. Some of the specifics. All cases were given the report, the current current A ONE C and the current therapy, they were allowed only 60 seconds up to 60 seconds. To make this because there had to be something that didn't take a lot of time. Now, you can see the subject specifics here and we had physicians and non physician practitioners uh with all groups well represented, you can see some of the male, female characteristics, uh practicing years uh characteristics. But the goal was to have his balanced group as we could looking at these two reports. Now, here's an example of one case, looking at overnight lows and you may recognize this case here, the labs at 7.5% A one C Metformin G LP one and glipiZIDE. Here is your medication regimen and the scorecard that we gave you earlier, here's this patient's a GP report and the scorecard that was given to the clinician is the same patient profile. Now given the glucose patterns insight report with the same scorecard and this is how the each of the clinicians got to look at these 10 cases. Now, the case breakdown, as you can see here, we had a predominance of low glucose patterns. Five cases represented low glucose patterns. There were three cases that represented most important pattern is high glucose, one with highs with some lows. And then there was one that we threw in that had no pattern change was recommended, there was no pattern, it was good con good glucose control. The reason we focused on hypoglycemia prevalence uh in type type two diabetes is that greater than 25% of insulin using patients with type two diabetes can show severe hypoglycemia. And there's a growing link between hypoglycemia and cardiovascular disorders. So, we really wanted to hone in on hypoglycemia as a pattern. We analyzed each pattern uh subset separately. And for each case, we classify the therapy decisions that the practitioners would make as addressing the most important pattern in green, worsening the most important pattern in red. Or in the last case, they could make a decision that would prolong the most important pattern, either no change to address the low glucose. And we also track the P CCS primary care clinicians deliberation time for each case. So what did we learn? Learn here, here are the results for the low glucose patterns where we had five cases. The therapy decisions improved with the glucose patterns, insight report versus the A GP. And the time improved with the glucose patents insight report versus the A GP. To arrive at these decisions. In all of the other cases, high glucose highs with some lows or no pattern. There was no advantage. So let's look at this graphically using the glucose patterns, insight report. The benefit was that you were three times more likely to identify and treat hypoglycemia. 50% less likely to make a treatment decision that would worsen hypoglycemia and about 50% less likely to make a treatment decision that would prolong hypoglycemia. And the benefit was that you tended to do this faster using the glucose patterns insight report. So you're making a better decision faster safer. Now, what are some of the subjective perspectives on the glucose patterns insight report and the A GP report? Well, the glucose patterns insight report was preferred 2 to 1 over the A GP. Why the comments were that? It was less busy than the A GP report. It seemed to be cleaner and easier to interpret. Uh primary care clinicians preferred the color coding uh versus the A GP to uh match the time and range targets. And they like the boxes that highlighted the most important uh figures, the most important patterns. And it gave them an opportunity to very quickly hone in on where they needed to focus their attention for those who preferred the A GP report. Uh They like the daily glucose traces, they out of 12 preferred using those in clinical decision making and some actually preferred the blue color palette uh as opposed to the color coding. But it's important to point out here that both reports are still available to you in the uh report suit. So let's look at some of the individual cases of low glucose patterns and how the glucose patterns insight report really aided practitioners in making this decision. Here's case, two overnight loads we had overnight hypoglycemia. You see the uh on the left, the A GP report in the middle, you see the glucose patterns insight report at the bottom. You see the characteristics of the patient, both the labs and the medication profile. For this report. For this case, the primary care clinicians are correctly addressed the hypoglycemia on only three cases using the A GP that jumped to 18 address that using the glucose patterns insight report, a significant a sixfold increase in recognizing and addressing hypoglycemia using the glucose patterns insight report. Similarly, 17 would have made a decision to worsen hypoglycemia using the A GP where that number dropped over half to seven, using the glucose patterns insight report and not as big a difference but as difference. Nevertheless, in prolonging hypoglycemia, 15 did that with the A GP report, only 10 with the glucose patterns insight report. If we look at another case, same type of response that we see seven addressed the cor hypoglycemia correctly using the A GP jump to 19, almost a threefold increase. Using the glucose patterns insight report over half. Uh as many people worsen hypoglycemia using the glucose patterns Insight report than the A GP report and prolonging hypoglycemia and 12 using the A GP with only nine prolonging it with the glucose patterns insight report. And you can see the changes that they made here very significant change in addressing hypoglycemia patterns using the glucose patterns insight report. So let's think about the effect of this report design on the changes to the primary care clinicians, clinical decision making. This novel CGM based glucose patterns insight report that identifies patterns of suboptimal glycemic control highlights the clinically most important pattern and offers therapy considerations to address this pattern. So to assess the utility of this glucose patterns, insight report in clinical decision making, this reading study was conducted comparing it against the standardized glucose report or the A GP clinical data. From 10 subjects were used to generate complementary glucose pattern insight report and A GPS and nonspecialist primary care clinicians evaluated each case in each report designed alongside the A ONE C and the medication regimens to make suggested recommendations for therapy changes. The cha therapy change recommendations were characterized by whether they address the most important pattern with a priority on treating hypoglycemia as if it occurred coincident with other uh patterns within a given case. What we found was that the primary care clinicians addressed the most important patterns equally well with each report in the cases presenting patterns other than hypoglycemia across all cases. And all subjects therapy change categorizations were different in 79 instances with 67 of these instances presenting hypoglycemia. What this means is that the primary care clinician's recommendation using one report addressed hypoglycemia. While that same using the other report did not with this subset within this subset in all but one instance or 99% of the time primary care clinicians correctly address low glucose with the glucose patterns, insight report when they did not for the same case, using the A GP. These findings indicate that the glucose patterns, insight report aids in identification and treatment of hypoglycemia that would otherwise be missed or overlooked using the current standardized report. So let's go back to our initial question again. And the initial patient, here's the patient characteristics and the A GP. And we put the glucose patterns, insight report next to it here along with your scorecard. And of course, the correct answer here would be to remove or decrease the uh evening or the dinner time glipiZIDE in this case. So now many have asked, well, how do I find this glucose patterns, insight rep in insight report? It is in the Libre View suite of reports. And when you sign into Libre view, your landing page is here and you'll see the tab in the upper right here saying glucose reports and you click on that, you go to the uh A GP the standardized report first and you see right beneath that is the glucose patterns insight report. You can also scroll down and get to the glucose patterns insight report. As you see here, it's good to know that this patient had 100% of their time in the target range. Thank you very much for your attention and uh hope you found this to be informative.
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