Continuous Glucose Monitoring in the Management of Hospitalized Patients with Hyperglycemia and Diabetes

TRANSCRIPT:

[00:00:00] Jordan Messler: Hi, everyone. Welcome. Thank you for joining us today. I'm Jordan Messer, the Chief Medical Officer here at Glytec. We hope you've been enjoying the sessions we've had so far today. We've had an incredible roster of speakers throughout the day, and we're going to continue that trend with this next session.

I'm very pleased to introduce you all to Dr. Guillermo Umpierrez. Dr. Umpierrez is a professor of medicine at the Division of Endocrinology and Metabolism at Emory University School of Medicine and Chief of Diabetes and Endocrinology at Grady Memorial Hospital in Atlanta. He's the author of more than 400 scientific manuscripts and book chapters and has presented over 300 research abstracts at national and international scientific meetings.

Myself, I was lucky to have an office down the hall from Guillermo when I was an academic hospitalist at Emory. Based at Grady, he's a gifted educator, has done more than almost anyone to raise intention and provide the evidence to improve the care of patients in the hospital with hyperglycemia and diabetes. He means a lot to my career and I know to many of you out there.

I think I speak on behalf of the entire Glytec team when I say how grateful we are to have him with us today and to present our day one keynote on the use of CGMs in the hospital. If you have any questions for Dr. Umpierrez, please add them to the chat throughout the presentation. Any questions we're unable to get to live, we'll make sure a member of our team follows up with you after the conference.

Now without further delay, I'll hand the microphone over to you, Dr. Umpierrez.

[00:01:37] Guillermo Umpierrez: Thank you Jordan, and I'm still miss you at Grady, although I see you once in a while and, and it's a real honor to be part of this meeting. I do remember it was, I believe, early 2000 when the first paper of Glucommander came was published in Diabetes Care, I was privileged to be the reviewer.

And, and of course I know Paul Davidson for forever. I guess it was my first endocrinology attending at Emory. So he's maybe the reason why I became an endocrinologist. So close and we’re so happy to have Glytec and Glucommander are Grady. So, but we're not going to talk about CGM, although I will got a couple of slides.

We're going to talk about CGM. And first, let me tell you I've not received any payment for lectures, but I, Emory University has received funding from this company listed here during the past two years for investigating research studies. And what I will do this is have fun. And first I'm going to tell you the history of glucose monitoring in the hospital.

And second, we're going to concentrate on the CGM. That is the topic that I was asked by Jordan to present, and I will present to you current evidence on the accuracy and safety, what clinical trials there are, how much COVID changed our way of using CGM in the hospital, and address some challenges that we do have.

And I can tell you I'm very hopeful that with improving technologies, CGM will be the way we monitor some high-risk patients in the hospital. We have been pricking fingers for 50 years. And the technology is close to us. Hopefully we move in that way. So a little history and how we do, how we have we people used to do glycemic monitoring the hospital with urinalysis, with the urine, and this has been going on for many centuries.

People used to taste the urine. Of course we heard that the honey urine. But the first clinical examination or test for diabetes was 1841. So, 170 years ago, we tested the urine and added some acid hydrolysis, and they were able to measure chemicals. So from 1841, we have been able to measure glucose in the urine.

And in 1850, just a few years later, people developed, this guy Pavy, developed tablets that were added to the urine show if the glucose expressions in the urine. So, it was a very qualitative way of doing yes or no. And for many years, the urine testing was the main way that people diagnosed diabetes.

We have now, but nobody was able to know if you have much or more glucose scenario as positive or negative. And it was 60 years later in 1925 when the better test came was published. And what is, this is a drop of urine with mixing a test tube with the Benedict’s solutions, and what you see to your left is the different colors and it was also very qualitative.

That's right. We didn't know exactly, but we knew that if you have yellow, orange, or red, you have more than 1.5 to 2 grams percent. This is 1925. So 20 years later came the clinic test, the reagent strips. There was a deep and red urine test, so a dry test, and this is the way we did it for many, many years.

It's easy to perform, painless, stable, widely available. No meter requirements, was extremely cheap. But if you look at the papers published between 1925 to 1970, there was a lot of disagreement and discomfort because we knew that there was an indirect measure of glucose. It really didn't tell you after glucose at that time because you can have your urine, say for a few hours, but overnight it doesn't reflected periods at that time.

So, and there was a lot of medications interference, and it was somewhere around the 1960s when we came with the glucose meters. But before I tell you, it was in 1913 that this guy from the UK discovered the way to test blood glucose. So, 110 years ago we were able to measure glucose employ. Before that was urine.

And up here to the left is the first glucose monitor by by Ames Company that is now called Bayer in the 1960s. And the first reagent blood glucose strips was in 1964. So, for the past 60 years. This is what we've done. I do remember that we had this chem strip that we matched the color and we cut it in little pieces, and then before that, the next thing, you needed to wash it, and it was very convoluted and hard to do.

Now there are so many of them. That's right, so many of them that you can get your glucose in matter of seconds, in less than one minute. So self-glucose monitoring, the American Diabetes Association and the standard of care deleted the self and just says blood glucose monitoring and, and it's the current standard in the hospital in measure glucose in real time.

They or not whenever you test. And it's a good way with some deficiencies, but, but it tells you about hypo and hyperglycemia. But it's useful, but it has to be repeated. And we heard about this amazing presentation from different nurses and nurse practitioners about the implementations of the Glucommander in different hospital, that I love those presentations to have frequent glucose monitoring.

And Glytec mandates to get a glucose 30 minutes and then every hour, and you can space it out every two hours, but it implies a lot from the nursing staff and patients. In the non-ICU the current recommendation is to check blood glucose before meal, and you can also do it at bedtime. So the benefits is so easy to do.

That's right. It’s everywhere, is widely adopted in every single hospital around the country and it's the standard of care. But there are some deficiencies. It doesn't tell you the whole story. So here to the right you'll see that is only measure the blood glucose at a single point of time. There in the open circle.

So you don't know, the glucose excursions up are down throughout the day, like in this patient that you have severe hypoglycemia in the middle of the night and severe hyperglycemia after lunch and dinner. It doesn't tell you what is the direction where you going and it fails to recognize asymptomatic hypoglycemia.

And this is a publication from our group a couple years ago right now, that we designed a protocol that when they blood glucose, but a finger stick was less than 70. We got a page and we went to run to the bedside and we asked the patient, ‘Have you sweated? You feel nervous? How are you doing?’ and about 45% of patients have no symptoms at all.

‘How are you doing?’ ‘Ok.’ ‘But your blood sugar 60 50.’ ‘Okay?’ And the risk factors and predictors of asymptomatic hypoglycemia was age. The older you are, the less likely you are to recognize hypoglycemia, and for some reason that I don't know why. Males also are more likely to have asymptomatic hypoglycemia and those who have impaired kidney.

But age was by far the number one risk factor. So there are several continuous glucose monitors now on the market. There are two of them that you don't need, they're factory calibrated. So we have been working with this CGM in the last few years. So when you look at the different type, you have invasive, intravascular, venous, and arterial, and they were very commonly about 10 to 15 years ago.

There are several papers in the ICU with intravascular, we're going to discuss that in a minute, but what we use right now is minimally invasively, subcutaneous, and there's also the trans there, not in the. So all of them have something, the same characteristics. It measures blood glucose, not really blood glucose, interstitial glucose, because it measures interstitial blood, interstitial glucose between one to 15 minutes.

Okay. And there are more than 15 different devices. So in the ICU there are about 35 different studies that have been recorded. And all of them said about design. There is a good correlation between blood glucose by the laboratory or in the ICU. They use this arterial block on the CGM. And the accuracy has been somewhere in the high nineties, so very nice relationship in Clarke Error Grid A and B.

This is where you want to be here to the left and the block glucose by finger sticks or by the laboratory. And, and of course there is very few, and although there have been many in development, the only one that I'm aware in the United States that have been approved by the FDA is this one that is called OptiScanner.

All of the other have left the market. There is one in Europe. So why is that? Well, there's a lot of concern. I mean, you need frequent blood glucose measurements and blood samples and this OptiScanner that we once wanted to do research is not in the market available to my knowledge. But if you look at the consensus statement, this is increasingly at all in critical care consensus statement about the utilization of CGM in the ICU.

They concluded, one: benefits CGM provide benefits in the prevention and recognition of severe hyper and hypoglycemia. Enables insulin infusion to be adjusted more rapidly and quote unquote potentially more accurately than point of care testing. And it gives you a trend in glucose concentration can be rapidly identified because you can see where your blood glucose coming, if you're going up and down instead of every one or two hours.

So this is the consensus of the ICU. So, but why do we don't have as many of them. First, the intravascular invasive technology has been associated with thrombus formation, catheter occlusion, infections. There's lack of evidence what happen if you have an intravascular or even subcutaneous CGM in the presence of severe hypotension, hypothermia, severe hypoxia. Data is not very clear, and these phenomenon are usually seen in the ICU.

There have been some interfering described, we're doing much better. There's also cost because some of them need a central line, and more importantly, during the last few years, especially after this large clinical trial that is called NICE sugars, there is not much reason or rationale to maximize glycemic control to less than 110 or 120 like we used to do after the RABBIT trial.

And you heard today from our nurses and Barbara McLean, that in, at least in our hospital in the ICU, most time, we target a blood glucose between 140 to 180. So in a systematic review of 37 different studies, both on randomized and observation with studies, the conclusion was that in term of efficacy, the use of SubQ CGM system doesn't appears to improve glycemic control compared to doing finger sticks every hour.

It helped the nurses, it helped the doctors, it helped you the trend. It really doesn't change the outcome. So that was until a couple of years ago with Mr. COVID came on board and that has made our group and others to do tons of clinical research to study the efficacy and how much CGM can help in blood glucose monitoring during the pandemic.

So this is study that we published with a group on Montefiore in New York. And what they did, and we did at that time, is to put the sensor that it can be placed 20 feet away from the patient at the wall or the glass door of the ICU, and the nurses can go and look at the blood glucose. And here to your right, again, the MARD, it was somewhere around 12 to 13, and the Clarke Error Grid A and B was somewhere around 97%.

So very nice accuracy. So it helped in the middle of this pandemic in New York. Imagine this paper was published somewhere around early ‘21, so this was in the following, the pandemic in 2020. What we have done in our institution, like Barbara McLean already mentioned to you earlier today is that you can pair the glucose control with the glucose infusion.

So at Grady Hospital we had an avalanche of patients in the ICU and intermediate care, most of them in respiratory support receiving IV insulin. And of course, gee do glucose every hour was too much to undertake. So what we did is to do what is called remote CGM paired with the Glucommander, with the computerized guided continuous insulin infusion.

So you have the Glucommander. You get your blood glucose and you can adjust and instead of doing finger sticks every hour, we were able to space them out up to six hours. So we only do four blood glucose just to make sure everything was fine. And then of course we have here, for example, you have the, the CGM and you have the insulin infusions, and here you have the blood glucose.

And we always being able to transmit that information to the nurses’ stations. So here you have the cardiology who has been doing this whole monitor now for many, many decades. Now you have a single blood sugar that is now, maybe this is the way you are going to adjust insulin in the future. So in the IC, if I can summarize, so far.

There have been over 30, 40 different studies it’s accurate, but because you can do blood glucose every hour, well maybe it doesn't really change much the outcome. However, if you pair at least in this high risk group of people with a insulin infusion protocol, well, you can reduce the number of finger sticks and in a very accurate way manage your patients, and adjust the insulin therapy.

But we have done several studies now and the number of publications have tripled or quadrupled during the last year, it's the use of factory calibrated continuous glucose monitoring, and here you have just a very, very small list of publications from our groups and others using different type of continuous glucose monitoring in the non-ICU settings.

To have this paper now a few years ago was one of the first who demonstrated that CGM in non-ICU patient is able to recognize hypoglycemia in the top panel and hyperglycemia in the bottom panel. And here you have CGM recognizes a lot of hypoglycemia, especially nocturnal hypoglycemia. And of course, because we don't measure blood glucose in the middle of the night.

In our institution, we do the last finger sticks somewhere in the evening, 9, 10 PM So you're naked between 10:00 PM to 6:00 AM. And in this group of patients, you have significant hypoglycemia recognition, although you see the hypoglycemia recognition throughout the day. And the same is the hyperglycemia, especially for some, especially in the morning.

If you look at every CGM in the hospital, most people have hyperglycemia after breakfast, between breakfast and lunch, and this is what it shows. So we have done studies with both the Libre and the Dexcom. So this is a study that Libre Pro Flash CGM in patients compare to point of care testing, capillary point of care testing, and here you have this is followed by Rodolfo Galindo and it shows a very nice correlation.

This is glucose from the admission to the end to up to 10 days for those who stay for 10 days and CGM in this case, read somewhere around 10 to 12 milligrams below the point of care. But the beauty of this continuous glucose monitoring is that it tells you that there is a lot of blood glucose that is low after midnight.

In general, less than 70. We see significant recognition of low, but I'm very impressed with the nocturnal hypoglycemia. Again, we don't do blood glucose, so CGM is able to recognize hyper and hypoglycemia. And in that study the MARD was about 14. And you see there is a very nice correlation between Clarke Error Grid A and B.

That was the Abbott Libre. What about Dexcom? And we had several papers, not out. This is one parent, Dr. Georgia Davies publishing Diabetes Care last year, and we took 205 patients admitted to general medicine and surgical ward, and what you're looking here is the Clarke Error Grids in the first 12 hours to your left, first 24 hours in the middle, and overall during the hospital stay.

And what we found is that the Clarke Error Grids, a good correlation, was seen in 98.7% of patients. And if this is true, you have to wait for a couple hours, but in the first 12 hours you have a very nice correlation. And of course, that improved over the next 12 hours and after the first day. We also learned with Georgia Davies in this accuracy study that is published in Diabetes Care is that it doesn't matter if you're lean or obese, if you're Black or white.

If you have changes in GFR or if you place the CGM in the abdomen or in the arm. So here you have something to be careful, is that in the low blood glucose range, the lower the average, the lower the test comes out very accurate. Above 70 to eighties could work very well with this MARD about 12 to 13, but in the low blood glucose range, the accuracy is not that well, not that good.

The other thing that we found that we're working on this is anemia. For those patients with hemoglobin less than 70 accuracy is lost. But the good thing for us, and now we're doing several studies in kidney disease, is that the accuracy is maintained with the GFR less than more than 90, 30 to 90 or less than 30.

So we learned a lot about the accuracy, and this is all of these patients admitted to the hospital, general medicine and surgical floor. One of the limitations that we had is that, yeah, you get your device and your smartphone on the reader, but how can you send the information from the bedside to the nurses’ station and with Ilias Spanakis from Baltimore and was is one of his mentors in this.

This is a VA merit grant. He has been working on these, sending the information all the way to the nurses’ station. So here you have, they read the sensor, the receiver, and you transmit with a smartphone to a tablet that is located at the nurses’ station or to the cell phone to the nurse or the provider.

Here you have the cell phone and here you have in the abdomen and then to transmit, so that you can see very well here. As one of my coordinators reading this thing, and I get this information every day. And we have several studies in the hospital, and what we see is that you can see, for example, here in the bottom, each patient you played the CGM, and here's the day one glucose is a little better.

Day two in and out when each day three. So if I'm a doctor, I'm a provider or a professional and taking care of this patient, say, Gee, blood glucose high before and after meal. So if this patient is on, basal/bolus, I will increase both. Here you have the blood glucose, doesn't have much spike, but still above 160.

So I will maybe increase couple of units of basal. And with what we call the hospital glucose profile. Now we can see, get a report every day on the low blood glucose, what we call in target range of 70 to 180, high blood glucose, and also glycemic variability. Or a patient with Type One. You see that they speak a caution, and now we're going to start doing a first trial, this CGM in Type One, and you have this peak from 6:00 AM to 4:00 PM patient call from 50 to 400.

So can you manage this patient with CGM? And the answer is yes. And we have shown with Ilias and the group from Maryland, and Emory is that you can reduce using the CGM with alarms. With this glucose telemetry system, we have a way that the glucose, if you drop below 85 in this study, 80 it beeps. So the nurses were instructed to go to the bedside, confirm the blood glucose by finger sticks and treat before it dropped to 50, 60 or less than that.

And in this paper we saw that we can reduce the hypoglycemic episode per patient significantly, and the percentage in time below range compares to the control group that just do finger sticks with no alarms versus the glucose telemetry system. And in this month, oops, it's just published last week in Diabetes Care.

We reported the first trial in which using CGM to adjust insulin therapy, so we had 180 patients and one group of standard of care with the insulin therapy was adjusted by point of care testing. You see what we do? That's right. You go and look at the blood sugar, three or four blood glucose, and then you say, Yeah, I'm going to go up.

Going to go down, versus if you have insulin adjusted for CGM. And you get the traces that I already said to you. The, we took patient with Type Two and Type One diabetes with glucose between 140 to 400, and the goal was to keep the blood glucose between 140 to 180. And what you see in here is that yes, there is a trend for the reduction of hypoglycemia in particular where I have here to the right.

This lies in the top shows recurrent overall hypoglycemic events. So more than if you have one maybe sort of hypo, you tend to have many more. And in this way you can prevent overall hypoglycemic episodes. And in the pattern is nocturnal hypoglycemic so, so normally, in real life, we don't know much about nocturnal hypoglycemia.

Now we have a way to recognize this thing. So, and if you look, I'm extremely enthusiastic and motivated and maybe hopeful that we can improve glycemic control, reducing hypoglycemia, and help doctors to do it. But there are many challenges. First is not FDA approved. We right now we're doing studies following FDA recommendations in the large clinical trial to correlate the blood glucose by CGM with a laboratory, what is called the Yellow Spring instrument, YSI, because finger sticks ah, may not be the best control.

Second is the technology that primary care physician and hospitals are not very used to doing. So at Emory, we just got a large grant to implement primary care as use of CGM in primary care setting. So, and I think there is a learning curve for our physician to be confident. There must be too much data, overload data and we don't have what we still working on, hypertension, hypothermia, and how, and the main problem that I see is to transmit the information to the EMR so you can really see what is going on when you do this.

Cost is still an issue with these. We do some cost analysis right now and there is limited for CGM data for outcome. The other thing is that we need to recognize that the CGM is not always accurate. Or the point of care testing is not always accurate. So let me just give you one example of a patient, and here you have somebody in, in the black numbers that are point of care testing finger sticks and in the green are CGM.

And here you have that this guy, for example, was here, received a little dose of rapid act insulin for correction, and the blood glucose came down. And here you have hypoglycemia by CGM, by the blood glucose by point care testing was 113. Or here the same thing? 64, 91. So what do you do if you get this discrepancy?

So far it's not happened to come. But you have to do finger sticks if the blood glucose by CGM is less than 80. The other thing is that what happened if you do big time surgery or what we call pronation for COVID. This is studies that we publish with Francisco Pasquel is the CGM used for CABG. So here you have very nice correlation in one of these patients, but in the others it drops and it fails.

Especially when extracorporeal circulation and they cool the patient down or the use of norepinephrine, you have a discrepancy. So what we're doing right now is if patient is using CGM, we don't follow CGM rules in the hospital in the OR. We place a CGM after the patients come back to the floor or to the ICU because of these abnormalities that we see.

The other thing, if the patient has a cardiac arrest, they stop working, but many time even recovered if the patient is successfully resuscitated. Let me, in the next couple minutes, tell you already tell you where we are. I told you the discrepancies or limitations. So what is the future? So we need to have appropriate studies for ADA, FDA approval, already told you.

Those studies are currently undergoing, undergoing. We hope to have data, but sometime mid-2023 or the end. So let's see what it shows. We need to establish an educational and training programs, and this is going to be a tremendous effort from all of us to make sure that those patients are helped in the hospital setting.

We need to have simple data to transmit to electronic health records, and there's a lot of smart people working on that and we also need pharmaco-economic analysis. But I think in the ICU CGM combined to automatic insulin dosing system is the way to go. It facilitates glycemic control. It reduces hypoglycemia and hyperglycemia diminishing or reducing the need for finger sticks.

So hybrid protocol in the ICU, so allows continued validation and paper from Georgia Davies. That's very nice photograph there. It would be so easy if Glytec would be able to do that and been trying to convince people that this may be the way to go. And of course here in the right upper quadrant is the artificial intelligence that I think we all are hopeful that we learn more about.

The other thing is that can you no studies have been done with the long lasting implantable CGM. The problem is that, yeah, it can be there for 90, 180 days, but what happened is you get this MRI in the hospital. So we don't have good data, but what we are doing is closed loop studies. So we have data from the UK, Thabit et al, and we have very small study, but there are three or four studies have been published that the use of closed loop.

So a CGM connected to an insulin infusion algorithm, we'll be able to improve glycemic control, reduce glycemic variability in these patients, and reducing the rate hypoglycemia. So, issues with the closed loop is the, and this is what we're doing right now at Emory, is that they requires a lot of effort.

And of course, is this going to be for research or for clinical care? I'm not sure right now. And for the near future, it's going to be a closed loop would be a research tool. In the way that it requires several hours to be implemented and you need to have a dedicated nurses, and of course not really approved by the FDA.

So what I see in the future is to continue to do point of care testing by finger sticks and time to know is what's going to happen with CGM. But during the past few years in several of these expert panels insist that CGM has the potential to improve care, reducing hypo and hypers. And of course, we just need more data. to the right is the standard of care and I'm the president of the ADA, but still not able to convince everybody and the ADA say, Ah, insufficient data to recommend the widespread use CGM. I kind of agree with that right now data needs to come. So what is it? The Endocrine Society. We just published the Endocrine Society Guidelines for the Management of Non-Critical Care Setting, and one of them was the use of CGM. And the Endocrine Society last couple months ago who says should the question was, should continue. So, CGM uh, with confirmation point of care testing would be prefer equal to bedside point of care. And the recommendation from the Endocrine Society. That was recommendation number one in adults with insulin treated diabetes, hospitalizing non-critical illness, who are a recent hypoglycemia.

Everybody who's taking insulin, that's right, especially those who are older. Male insulin therapy, kidney failure, they suggest the use of real time CGM. We come through confirmatory point of care, testing, monitoring, and this is quite important the come through point of care testing because I tell you that the MARD is not as good with glucose less than 70.

So until we have more data that's going to be needed. So CGM, if I can summarize what I tried to tell you today. Available data from clinical studies, which says that the use of CGM in Type One and Type Two provides a better glucose picture. Glycemic picture compared to point of care testing. A large number of ambulatory and hospital studies shown that you miss a lot of hypos and hypers by point of care testing and CGM is much better and recognized that these large swings of blood glucose concentration.

It recognize nocturnal hypoglycemia. And of course, the reoccurrence of hypoglycemia has been well validated in research studies from our group and others. So let me just say thank you, to Jordan and the group of Glytec for supporting our group at Grady with the use of Glucommander and Glytec for many years.

It really has changed the way we manage patients in our units and we have less hyper and hypoglycemic events. And second, I just have to show you this photograph because I have a huge team of researchers who work with me. To the left is the faculty who dress up with white coats and to the right, uh, group, uh, current group of coordinators.

And this is the group that really have done all the work. Who are a tremendous group of collaborators that I have at Grady. So Jordan, thank you so much and congratulations for this tremendous... I enjoy very much today's presentation.

[00:39:42] Jordan Messler: Great. Thanks Guillermo. That was really fantastic. Uh, really appreciate you taking the time and chatting with us.

I think we have time for a couple of questions, if that's okay. Uh, a few have come in through, uh, during your session. Uh, if there's other questions, please uh, feel free to chat them in. If we don't get to them now, we can certainly respond to you afterwards, but. This is really a very exciting space and you're obviously, you've always been a leader in this space and excited to see where the technology is taking us.

Uh, one question. We have a question from, uh, Raymond, who's asking I think a little bit more about the, uh, the protocol that you utilized at Grady, uh, a using in hybrid protocol specifically was asking, uh, about, uh, getting the blood glucose from the sensors to the EMR. So maybe you can respond to, you know, that piece right now that, you know, getting that the CGM into the EMR, um, how to get those results in and, and then maybe can expand even about the, the protocol used.

[00:40:43] Guillermo Umpierrez: Yeah. And what we have done is they're manually enter the CGM and the blood glucose by point care testing. And this is, uh, there are couple of papers coming out from California, University of California, San Francisco, and implementation, the CGM directed update in data. You get data block glucose every five minutes.

That's right. So 180 or couple hundred blood glucose. Uh, how, how do you do it? So are you going to group them every two hours? Every hour? Are you going to group them every, I mean, I think that there is, first we need to know the accuracy. That's what we need. That's right. Um, and then the implementation.

There's a lot of biomedical engineers working on this and IT people. The first thing we need to know is to convince you. Convince everybody that the accuracy is there in the IC, non-ICU. Um, and then we can proceed. But, uh, but so far the data that I saw it to you and what Barbara showed earlier today from Grady, they entered the data, the point of care testing go directly to the EHR.

Uh, the point of care, the, the CGM interstitial glucose was entered manually every hour.

[00:42:01] Jordan Messler: Right. Yeah, no, it's still a, a gap in that integration. So getting that CGM value is still, uh, sounds like a manual process. So I know you don't have, uh, uh, you know, really asking you to read the tea leaves as you're saying, there's, the initial work is continued to be on the accuracy.

You guys are doing some of that study. You mentioned the y size study you're doing for accuracy. If you had to read the tea leaves on this in terms of FDA clearance for CGM, when, what do you think the timeline is for that. And where do you think the clearance will occur? Obviously you're, you're mentioning both ICU and non-ICU and, and maybe more accuracy in the non ICU because of those hypotension and hypoxemia issues you mentioned.

[00:42:41] Guillermo Umpierrez: So we decided to look at the accuracy in the non-ICU setting. As you said, there's more stable populations and we're taking what we're doing studies in which we do blood glucose controls every 30 minutes for six hours. And of course we have the CGM going at the same time, and we do it from day one to day five.

And each patient gets two sessions of six hours. So you get day one on day four, day two on day five to see how is the accuracy from the beginning to the end. And then we can track down what is the glucose correlate with the laboratory or the Y side. And we're not using the finger stick to point of care testing in that study.

That's what the FDA mandated. Because they, they were not too enthusiastic with the point of care in the way there's only one glucose meter that is approved in the hospital. Not everybody has it. So, so I think that we aren't, I mean, I, I do remember writing about this and reviewing the literature when the glucose meters came to practice.

And in the 1960s, 1970s, there was a lot, a lot of controversies and people yelling and says, No way, this is not accurate. We still have to do laboratory blood glucose trials, but people only got one single blood test in the morning and that's the way and the rest was nothing. So, so I think.

With technologies this day? Uh, I'm, I'm not sure. I mean, I mean, we, it's going to be several hundred people that the data needs to be analyzed and then be reviewed by the FDA and hopefully a finger crossed in high risk population maybe, maybe would be the way of the future, but maybe, maybe not.

to, We just do this studies.

[00:44:46] Jordan Messler: Yeah. Well, you're doing the great work. I think that's all we have time for. Again, thank you so much for joining us as our keynote speaker today. Thanks everyone in the audience for sticking around for our Time to Target conference, really, Uh, Fantastic. As always, Guillermo, you're, you're doing cutting edge and as you said, it takes a team.

You got an incredible team there at Emory and incredible obvious collaborations you're doing nationally. Thank you and thank you everybody.

[00:45:10] Guillermo Umpierrez: Thank you so much.

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