Thank you Eden for that great presentation. I'm gonna move on now to a little bit of a deeper dive into incorporating C. G. M. Based glucose patterns insight report with the G. P. I. R. And treatment prompting patients with type two diabetes and we're going to focus on refining and simplifying the clinical decision making process based on the C G. M. First of all, let's start with the standardized A G. P. Report which you are slightly familiar with. It is a standardized report that was developed by the International Diabetes Center of the I. D. C. And it shows a standard set of information and graphs and you can see a copy of this report over here on the right panel. It includes the time and range targets the subject time and rain values and a G. P. Figure here in the mid panel and then the daily glucose profiles in the bottom panel. Now there's a planned update to this a G. Re. P report that will include the upper panel time and range metrics will look like the G. P. I. Report and we'll see some examples of that primarily with the color coding of the GDP figure to match this time and range colors. So let's talk about why do we need a G. P. I. Report or glucose patterns insight report. First, nurse practitioners may not be diabetes specialists or experts but they treat patients with diabetes you're very busy and have limited time with patients to address their health care needs and in fact there was a study out of Canada that shows that diabetes if you look at the reason for visits. If you hold a number of practitioners, it's about number five on the list. For reasons for patients to visit. If you polled patients for the same practitioners, a large number of patients, What is the primary reason that they go their reason for visit? It doesn't make the top 18. So while diabetes is top of mind for us in these talks, if we get out into clinical practice, diabetes is not 123 or four. Top on the top of the list. So we need something that's gonna make this very easy to understand what are the patterns we see in diabetes. So all commissions would benefit from a way to make it easier faster and safer to make a better clinical decision for the patients living with diabetes. So, a useful performance improvement tool which will show you would permit a non expert nurse practitioner to make a better clinical decision with minimal disruption to their workflow, easier, taking no more or perhaps less time faster and without adding additional risk for adverse events such as hypoglycemia. Were safer. So now we see the glucose patterns insight report, I will refer to it as the G. P. I report or glucose patterns insight report and you can see several of the characteristics again, Why do we need this because non diabetes specialists treat patients with diabetes. The care strategy here is to identify and work on one pattern at a time by simplifying the assessment and therapy change process by focusing on what is called the most important pattern for our purposes of discussion here. The most important patterns hierarchically will be lows than highs with some lows then high pattern. And the reason behind that is that we want to always address the low glucose patterns first. Once those low glucose patterns are mitigated at the next visit, you can you can address the other pattern you want to address the high patterns when the lows are fully mitigated and taking care not to make the lows worse while addressing the highs. And this concept of high glucose variability that can sometimes get in the way of addressing hives without making lows worse in this glucose patterns, insight report, we discuss patient lifestyle behaviors that may be contributing to variability. With a consideration to discuss a different therapies that may address variability. So if we look at the updates here, what the glucose, you have the standard A G. P. Report here on the left hand panel and this is the glucose patterns insight report the new report and you can see that it is divided up into three sections. First thing you notice here is that we've removed the time and range consensus targets which were here in the upper left hand corner. We retain the color coded target time and range targets here. We have a different A. G. P. Designed down at the bottom that is now color coded so that it matches these timing range targets up here in the upper left hand corner now and it shows the critical pattern you can see highlighted here on this graph. This is the critical pattern to be recognized and and dealt with at this visit. And then in this middle section we have what we call considerations for the clinician and these may include medication or lifestyle consideration. We've removed the daily glucose profiles that you see at the bottom here and we've removed this area underneath the target here of glucose variability. So with this report, the problem statement becomes, does the glucose patterns insight report improve? A nurse practitioners decision making. So we designed a study calling the reading study And here's how it's set up. We took 10 cases from clinical data. These cases were reviewed by experts in the A. G. P. And we generated both an A. G. P. For each case and for that same patient we generated a glucose patterns insight report. So we had 20 reports from 10 cases and generating the reports this way allowed us to have head to head comparisons. We uh enlisted 35 clinicians and you can see the subject specifics over here. 20 physicians, 15 non physicians across these categories. Nurse practitioner, p A clinical pharmacist, 19 male, 16 female 22 practicing greater than equal to 10 years, 13 practicing less than 10 years. And you can see what we did here in round one, we gave the first group all the 10 A. G. P. S. The Second Group of 18 We gave all groups all these glucose patterns insight report. Then we crossed over the group that got the gps in the first round. Got the same cases now with glucose patterns insight report and similarly those that got the glucose patterns insight report in the first round got the same cases with the A. G. P. And the P. C. P. S. Were asked for their first best therapy change and not allowing simultaneously simultaneous changes for the study. And here's an example of what you might see and this is a case of an overnight load. The patients, the clinicians were given their labs, you can see the A one C. Was 7.5. Their medication regimen in this case the Metformin was at max does GLP one was at Max Dose And they had glitch aside breakfast dose at five mg and a dinner dose at five mg. With this A G. P. The commission was asked to select the first best therapy change and they had a grid or a box here of things that they could change and you can see here the Metformin that change the GLP one. They could add a large gene, insulin, they could change the grip aside at breakfast or dinner or they could add a nova log here and or they could have no change. So these were the options and they were given 60 seconds to be able to make these changes. They were given the same clinical scenario with the Now the glucose patterns insight report and again the goal was to test which report served them better in their clinical decision making. So the case breakdown. They had the most important pattern for five of the cases was the low glucose pattern. High glucose patterns were the most important pattern for three highs with some lows and one and then there was one that was actually in good control. We wanted to have that in there. And the reason we focused on the low glucose pattern is the dominant ones that we wanted to test Is because the hypoglycemia prevalence in patients with type two diabetes is rarely reported by patient But we know that greater than 25% of insulin using patients with type two diabetes show severe hypoglycemia. And there's this growing link between hypoglycemia and cardiovascular disorders in type two. So what we wanted to do is analyze each page, each pattern subset separately for each case. We wanted to classify the therapy decisions as addresses the most important pattern. You can see that in green, which meant that they decreased insulin to address the low glucose or they worsen the most important pattern, which meant they added insulin to address low glucose, which clearly would not be recommended. And then the third scenario would be that they prolonged the most important pattern. They had no therapy change to address the most important pattern or low glucose. And we wanted to track the primary care clinicians deliberation time for each of these cases. So what did we learn? Well, as I said, there were five cases that had the low glucose pattern identified as the most important pattern in all five of those cases, the therapy decisions with the A. G. P. Improved with the glucose patterns insight report compared to the A. G. P. But also the time to address these patterns improved with the glucose patterns insight report and we'll see a breakdown of that. But you can see that really there was no significant difference in high glucose patterns. People recognize that equally well, highs with some lows and when there was good control. So the real big thing here was I think a safety signal that people recognized the low glucose pattern and they recognized it fast. Some details on this that with the glucose patterns insight report. There were three times more likely to identify and treat hypoglycemia. It took them 50%, they were 50% less likely to make treatment decisions that worsened hypoglycemia. Remember they either could address it or they could do something that would make it worse or prolong it And they were about 50% less likely to make treatment decisions that would prolong the hypoglycemia. So in all three of these clinical scenarios, they improved with the glucose patterns insight report. But one of the other things we want to take the test was, How long did it take them to do this? Because we recognize that commissions don't have much time when they're seeing with patients. And there was a significant increase decrease in the time to identify and treat hypoglycemia with the glucose patterns insight report. So what we have is improved clinical decision making in less time. That's a very important point here that it took you less time to get to a good clinical decision. Now what are some of the feedback that we received from the commission's with respect to the glucose patterns insight report and the A. G. P. Report. Well 2: one. The conditions preferred the glucose patterns in tight report With 23 out of 35 conditions and why they listed as the reasons it was less busy than the A. G. P. Report. Some said it was cleaner and easier to interpret. They preferred the color coding of the A. G. P. To match the time and range metrics that they had on the top. And they like the boxes that highlighted the most important pattern with the A. G. P. Figure. This was a key to really draw your eye to what is the most important pattern for those who chose the A. G. P. 12 were about a third. uh they like the daily glucose traces with about half of the 12 that use those in clinical decision making and others preferred the blue color. So I think the lesson that we've learned here is that it's not the glucose patterns insight report or the A. G. P. It is the glucose patterns report and the A. G. P. That really aids clinicians in their decision making. So let's look at some individual cases of what these low glucose patterns look like and how clinicians performed. Here we have low glucose patterns overnight. You can see the labs down here at the bottom and the medications A one C. All the other labs are okay. A one C was at 7.2% Matt Foreman was at Max Dose. GLP, one was at Max Dose and the patient was receiving bedtime Gloria, jean NovoLOG with breakfast, lunch and dinner. This is the A. G. P. Report here. On the left. Just to the right of that is the glucose patterns insight report. And just to orient you again, you can see the time and range metrics here at the top average glucose here. The glucose management indicator over here at the bottom we see the glucose patterns uh the A G. P. That's color coded to match the time and target time and ranges here And in this middle middle section here we have the considerations for the clinicians. So what do we see if we looked at how many correctly address the low hypoglycemia. The hypoglycemia or low glucose here. There were three with the a. g. p. That number went up to 18 with the glucose patterns insight report. Now this is a case where there's low patterns that need to be addressed. Only three picked that up on the a. g. p. Whereas 18 picked it up in the glucose patterns inside report. But if we looked at what they would have chosen to do therapeutically 17 would have worsened the hypoglycemia with the google with the A. G. P versus only seven with the glucose patterns insight report and the prolonged you can see also improved and these are the different actions that they would have used that would have worsened or prolonged versus what they would have done here to address the most important pattern. Another example overnight lows again, you can see the A. G. P. Here. The glucose patterns inside report labs A one CS 7.5 max dose of the of metformin GLP one and GIP aside at breakfast and dinner seven would have only only seven would have identified the low pattern address the hypoglycemia with the A. G. P. That number jumped to 19 with the glucose patterns insight report and similar findings for worsening hypoglycemia and prolonged hypoglycemia here. So the glucose patterns insight report. Absolutely help clinicians arrive at a better decision. A safer decision. So if we looked at the effects of this reporting tool on, the therapeutic decision making this comparative reading study with primary care clinicians, We started with the premise for this, the discordance between the quantity and kinds of new therapies for type two diabetes. An improved outcome highlights an unmet need for tools to help primary care clinicians make appropriate therapeutic adjustment. This novel CGM based glucose patterns, insight report of the GpR that identifies patterns of sub optimal glycemic control highlights the clinically most important pattern and offers therapy considerations to consider and address the most important pattern to assess the utility of this report in clinical decision making. A reading study was conducted comparing it against the current standardized A. G. P. Report And the clinical data from 10 subjects with type two diabetes were used to generate these complementary glucose patterns inside report and a gps and non specialists. This is important. Non specialist primary care clinicians were evaluate were to evaluate each case and each report designed alongside the A one c medication regimen to make a therapy change recommendation. What we saw is that the therapy changed recommendations were categorized by whether they address the most important pattern present with a priority on treating hypoglycemia. If it occurs coincident with other patterns within a given case and the reason for that is clear hypoglycemia can be a safety issue in these patients. The primary care clinicians address the most important patterns equally well with each reports in 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. E patient care, Practicing clinicians recommendations. Using one report addressed hypoglycemia while using the other report did not Within this subset. All but one in all but one instance or 99 of the practicing commissions correctly address low glucose patterns with the G. P. I. R. Or the glucose patterns intact. Report when they did not for the same case with the A. G. P. That's pretty impressive. And these findings indicate that the glucose patterns insight, report AIDS and the identification and treatment of hypoglycemia that would otherwise be missed. Using the current standardized reports. Thank you very much for your time and attention.
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