March 2020—Data management, diabetes care, the demand for continuous glucose monitoring, and device cleansing were up for discussion when CAP TODAY publisher Bob McGonnagle led a point-of-care glucose testing roundtable in January. Joining him were Todd Cullen of Arkray, Corinne Fantz, PhD, DABCC, of Roche, and Susan Fuhrman, MD, of OhioHealth Laboratory Services. Here is what they said. Click the link to use CAP TODAY’s product comparison guide to bedside glucose testing systems.
Todd, as we begin 2020, what’s topmost in your mind as you look at the point-of-care testing field and at Arkray’s challenges and opportunities, and in terms of what you’re hearing from your customers?
Todd Cullen, director of marketing, Arkray: Arkray’s focus has been long-term care from a point-of-care perspective and blood glucose monitoring. Our challenge over the many years I’ve been with Arkray, and it continues to this day, is access to high-quality, accurate diagnostic products, blood glucose monitors at the bedside, but cost has been a significant challenge for long-term care facilities, where almost 30 percent of the population has diabetes. It’s the cost of managing their residents’ diabetes. The expensive control solution testing, safety lancets, and ancillary products make it challenging for them to manage their residents’ diabetes outside of standard, inexpensive blood glucose meters that they can buy from certain distributors. So one of the challenges we’ve taken on is trying to provide high-quality products they can trust from an accuracy perspective, with ease of use, but that won’t cost them significant money out of their pocket, because blood glucose monitoring in long-term care is not reimbursed.
One of the big challenges has been a request from our customers for continuous blood glucose monitoring and questions about how manufacturers like us and others are addressing that for them. As they see it out in the consumer market, how can we translate that into the point-of-care market? In a hospital setting they do have limited access to that, but it hasn’t been an option in long-term care. So the biggest challenge that Arkray and other manufacturers will see over the next year and over several years is how we address that continuous glucose monitoring request from our customers. It seems to be the next step for them.
Dr. Fuhrman
Dr. Fuhrman, we know that diabetes is almost epidemic, and Todd has given us a good idea about the challenges in long-term care facilities and the percentage of the population there that has diabetes. What are the diabetes and glucose-testing–related challenges and the opportunities at OhioHealth?
Susan Fuhrman, MD, system director of OhioHealth Laboratory Services and president, CORPath LLC: We have hundreds and hundreds of glucose meters and thousands of users, and keeping all of that organized—because of the sheer volume—is difficult. The other thing we’ve struggled with and we finally have down is data management. With thousands of blood glucose results a day, the only way to ensure that everything is accurate is to have the results real-time downloaded into the laboratory information system. If you look at the different ways diabetes is handled in medical centers and in hospital computer systems, most of the computer systems have these diabetic flow sheets, but the algorithms for the laboratory information systems are different. In some instances we’ve found that people were hand-entering results into those worksheets prior to the results crossing over to the lab system, so we would end up with two results in the same place or two results in different places that weren’t exactly the same and it was problematic. Getting our arms around that and making sure all of our results are electronically transmitted real time has been key.
I spoke at the CAP meeting in September last year on this subject, and several participants questioned me about our laboratory information system—how did we do it and how did we make sure it was real time?—because it is a pain point for everyone. I would say the biggest advocate for making sure this makes sense is a good diabetic care clinical team, because they will want this fixed.
Can you share with us what your solution was? Did you use a middleware vendor? Did you use a special product like Alere’s RALS or one of the others that are out there?
Dr. Fuhrman (OhioHealth): We did use the RALS system, but we had had time delays built in. RALS is meant to be handled for point of care. The main way it happens is that the instrument does the testing and the result goes over. If you want it to hold, you can have it held for one of your point-of-care coordinators to send it to the LIS or you can set a time limit for a hold. But you can’t have your users release it like they would for a regular lab test.
So we had a hold in place and we took the hold off because we figured that the risk of having a result transmitted that somebody then had to repeat was so much less than the risk of the wrong number being put in. We originally had the hold because we were worried that people would test again and then there would be two and three results, and that turns out to have been a small problem compared with the large problem that we would have when we didn’t have immediate transmission, because those nurses are dosing the insulin right then and there, and if they don’t have the results in the computer, they have to hand-enter it to get their algorithms to work. So it had a profound effect to do that immediate transmission of results. I gather from talking to others that everyone doesn’t do it that way, and it’s expensive to have all that software working in concert.
You’re probably also saving a lot of testing materials, too, correct? You would have many fewer repeats.
Dr. Fuhrman (OhioHealth): I think we do have fewer repeats, though that wasn’t our intention. The other thing is that we’re also accurately capturing all of our volume, which is important.
Could you comment briefly on the status of continuous blood glucose monitoring at OhioHealth? Is it ready for prime time in your system and, if so, where is it being used?
Dr. Fuhrman (OhioHealth): I know that there are patients who are on insulin pumps who have continuous monitoring as part of their insulin pumps, but it’s all part of an implantable device. Those are the only ones I’m aware of that are in use. The CAP Point of Care Testing Committee recently looked at a new FDA-approved device that withdraws blood from the patient at frequent intervals and then analyzes it, and because it’s removing blood from the patient it’s categorized as a laboratory test. Because of the complexities around it, it has presented substantial challenges from the laboratory standpoint.
Dr. Fantz, what can you tell us about the overall environment and what’s top of mind for you, Roche, and your customers as we begin the new year?
Corinne Fantz, PhD, DABCC, director of medical and scientific affairs, Roche Diagnostics point of care: There’s a greater need to manage large populations of diabetics and at lower cost. So we’re looking at telehealth as a solution for some of that, and we’ve seen great programs, one in particular at the University of Mississippi Medical Center. They save the state millions of dollars in improving their diabetes care management using the telehealth program. That’s the wave of the future.
Dr. Fuhrman mentioned some of those aspects of managing care from the internal customer perspective, solutions like middleware, and having the result available for insulin dosing. There are solutions that are coming that look broadly at the nursing workflow as they’re taking care of patients and how all of that can be combined to improve the management of patients in the hospital.
The challenge we’re seeing with continuous glucose monitoring is that it has been focused in pediatrics and outpatient care, but clinicians—and we’re hearing this over and over—would like to see it in hospitals. From a lab medicine perspective there are questions—how are you going to monitor and manage those patients in a hospital situation, and how are you going to test and validate those continuous glucose monitors if they’re not considered laboratory tests? So there’s a lot to be answered there, but the desire to have a continuous glucose monitoring system throughout the patient’s stay, whether inpatient or outpatient, is there for sure.
So at Roche and at Arkray, when you go into an institution, somebody quickly comes around to the question of, What can you do for us in continuous glucose monitoring? Correct?
Dr. Fantz (Roche): Yes, in managing large populations and also helping the workflow.
Dr. Fuhrman (OhioHealth): It’s interesting, Corinne, because from a laboratory standpoint, the oxygen saturation is now routinely done with a finger monitor, and that is not a laboratory test. I always imagined that when we got to continuous glucose monitoring it would be like that—it would be foolproof and it would be a different measure; that is, it wouldn’t be within the laboratory realm because it wouldn’t be a lab test. Do you have any thoughts on that?
Dr. Fantz (Roche): I think that would be ideal, but what we don’t know is what the effects are of the drugs that are onboard in those patients and would interfere with the measurement technology. That is yet to be tested in patients in hospitals. In the ambulatory environment, you typically don’t see patients on 30-plus drugs, but when you put them in the hospital and they’re in those ICU-type environments, the complexity of that patient changes. Is the technology going to hold up in that environment? I don’t think we know the answer. Ideally, we would be able to correct for that or manage it, but it remains to be seen.
Dr. Fuhrman (OhioHealth): Right, we still haven’t completely cracked the nut on using the glucose monitors for acutely and critically ill patients. This makes it one step more complicated.
I’d like to ask a question of all three of you. Given what we’ve been talking about, might it be the case that patients could be on continuous glucose monitoring but then need some kind of serial draw for a central lab test just to establish that the values were correct? Todd, do you have a sense of that?
Cullen
Todd Cullen (Arkray): Yes, from the experience we’ve had and the seminars I’ve attended, that’s exactly what the situation is, especially in light of the variability seen with some diagnostic devices. If the resident or patient coming into that facility is an unknown person, you do need to establish that baseline testing to move forward. One of the other challenges is if you have someone come into a hospital or long-term care facility and they’re already on their own CGM, how do you manage that? What’s the protocol?
Dr. Fuhrman (OhioHealth): The other thing that’s tricky is if you’re going to draw the blood and send it to the lab, you’ve got glycolysis going on no matter what you do, even if you use the sodium fluoride tube. You have about an hour—you’ve got to figure that you’re probably talking a 10 percent drop that you can’t stop, and that will differ depending on the metabolic state of the patient. That’s one of the preanalytic factors that affects the lab glucose and is fairly significant.
Dr. Fantz (Roche): Serial measurement would be the right thing to do initially when we are learning about these systems and how they perform with a variety of drugs onboard. We don’t know everything about them yet, and early on there’ll be more suspicion around whether they work accurately and for what patient populations they’re intended. In the laboratory today you don’t see as many delta checks for things because there’s more stability in the instrument; they’re primarily used for patient identification and contamination rather than instrument performance. So I think it will be a progression—with more trust, there will be less checking.
We all remember the question about the use of whole blood glucose monitors for critically ill patients. Todd and Dr. Fantz, has that issue in your mind largely been resolved, or do you still find yourself having to address it with customers?
Todd Cullen (Arkray): It is still an issue. As far as I know, it’s still a requirement in that particular hospital market that you have to have that critically ill claim on a blood glucose meter. They’ve had a bit of a reprieve on that from an enforcement perspective, but it has not changed. So the devices that we’re developing for those types of markets still have to conform, especially under the new FDA point-of-care guidelines for blood glucose monitoring.
Dr. Fantz (Roche): Yes, some of the devices still carry the limitations for use in a critically ill population, so you need to focus on the intended use and where it’s been tested and approved by the FDA.
Dr. Fuhrman, how has that affected life at OhioHealth? Was it a major cause of concern, and is it still?
Dr. Fuhrman (OhioHealth): You could categorize it as a major cause of concern because the glucose meters that we went with had been recently FDA approved, and the FDA had only recently put in that requirement. So the older meters didn’t have a claim but they didn’t have a not claim, whereas the meters that we went to specifically said they had not been approved for use in critically ill patients. But after talking with the CAP and with our colleagues in the point-of-care world, it was clear, and somewhat odd, that critically ill had not been defined by anybody. So we got together with our clinicians, nurses, and lab folks, and we just came up with a pretty narrow definition for critically ill that we could follow. Other places have done something similar. The most important thing is to do no harm. You don’t want to remove point-of-care testing from patients who need it.
In our 2019 point-of-care panel discussion, concern was expressed about infection control in point-of-care devices. Several people spoke about contamination as a major concern. Dr. Fantz and Todd, is that concern still warranted?
Dr. Fantz (Roche): Yes, it absolutely is still a concern. I think people are surprised about the cleaning requirements. The time you need to wait in between patients is sometimes overlooked. But auditing best practices can help put the focus back on the patient and the reasons why those steps are necessary to decrease the risk. I’m not sure you can eliminate all contamination, but you do your best to follow the best practices and keep the patient top of mind.
Todd Cullen (Arkray): One of the big challenges we have in our market specifically is cross-contamination with multi-resident meters. The challenge we have is in their workflow and how they’re managing that large population and cleaning and disinfecting those devices on a regular basis and making sure there is no cross-contamination of pathogens. There’s a significant focus in long-term care facilities on making sure there isn’t any infectious disease cross-contamination. They’re fined for not following procedures. So we do have guidelines we help them out with to try to manage that.
Dr. Fantz (Roche): It’s not just the instruments, though. It’s the strip, too. It’s following the proper procedure with changing gloves and cleaning with the wipe cycles.
Todd Cullen (Arkray): Yes, absolutely. There’s a protocol we have that has been adopted by the CMS and others that they’re following, and we make sure as a manufacturer we follow the protocol when they’re using our devices, because even micro-blood and other things you can’t see are cross-contaminating all the time.
Dr. Fuhrman, would you care to comment on this infection control issue?
Dr. Fuhrman (OhioHealth): I have an excellent point-of-care team that goes out and regularly looks at the meters. We also audit the cleanliness. We include it in all of our training. And if we go to see a meter and we see anything, we immediately meet with the nurse manager in the area and point it out and discuss it and let them know it’s a big issue. They’re doing much better than they had been, and I think it’s because they have a better sense of how important this is and the issues around infection control. There’s been a lot more visibility in many arenas, so we’ve gotten a fair amount of traction on it.
Dr. Fuhrman, several of your colleagues in last year’s panel discussion expressed the desire to see the IVD industry come up with devices that were more self-cleansing, a little more automated for their sterilization and so on. I would assume you’d enjoy seeing an advance like that in some of the testing devices.
Dr. Fuhrman (OhioHealth): Yes, I would. I was talking with my team the other day, and I said, “Wouldn’t it be nice if we could somehow use the kind of UV cleaners they now have for cellphones?” That’s in addition to the wiping. You could stick them on a shelf. They’d all go to the same place. You’d press the button and they’d get a quick, deep UV clean. It wouldn’t be a substitute for cleaning; it would be an adjunct.
The technology is there. I suppose the UV light might not do wonderful things to the plastic of the devices. I will refer to the manufacturers present to see what they think of that idea.
Todd Cullen (Arkray): There is a device out there that we have seen. It was presented to Arkray in a long-term care facility, and it’s basically that. It’s a UV light. It’s like a toaster oven, and you can put all of your devices in there and it basically cleans and disinfects and is kind to those devices. Ultraviolet light doesn’t cause a lot of damage to the devices.
The challenge we have as a manufacturer is validating that it kills all of the viruses and bacteria you’re looking for, and then you’ve got to submit that to the FDA as a proper disinfecting process. So it’s expensive and time-consuming. It took upward of a year for a 510(k) to do that, to validate that product. And if you update your product you’ve got to redo that every time. So it can be a challenge. It’s a smart idea, a valid idea, but there are regulatory concerns that in some cases would prohibit it.
Dr. Fuhrman (OhioHealth): I was thinking the same thing, that it would be difficult to make a claim that it could take the place of cleaning. So I was thinking you wouldn’t make that claim, but you would be able to say to folks, “This is going to be better.” It’s just an easier claim to say “better” than the other claim. But I see where you’re coming from and it is a shame and an example of how we are sometimes not encouraged to do things we would otherwise do.
Dr. Fantz (Roche): The wipes go through a similar process—the instrument you use and the wipes you use to clean it all get approved by the FDA. So there are a limited number of brands of wipes you can use for a certain instrument.
Dr. Fuhrman (OhioHealth): Do the wipes we use have an expiration date? If so, how do we manage that?
Dr. Fantz (Roche): Roche isn’t a wipe manufacturer, so I don’t know the answer, but I’m guessing there is an expiration date on the bottle. I was focusing on the brands of wipes that are used for a certain instrument. Those have to go through clearance and require a huge number of testing cycles. So it’s expensive to test and validate new cleaning systems, whether it’s a wipe or UV light or whatever you’re going to use for your instrument, and it’s tied to that particular instrument so any changes or updates would have to be revalidated.
The other piece of this that gets transferred is the strip. If you’re sticking your finger—a bloody finger from a previous contaminated patient—into the vial of strips, that’s another source of contamination that’s difficult to control. And we’ve looked at other strip distribution devices, and they’re also expensive and sometimes difficult to work with. But it is something we think about.
In the January 2020 issue of CAP TODAY, David Sacks [MD, PhD, of the NIH], who is an expert in this area, talked about the possibility that the trial reported in 2009 that found an increase in mortality with tight glycemic control may have been affected by the quality of the glucose measurements, though it can’t be known because there’s no information about the analytical performance of those methods, and that tight glycemic control therefore could have value as was found in the original van den Berghe trial, published in 2001. What are your thoughts on the state of tight glycemic control today?
Dr. Fantz
Dr. Fantz (Roche): I think it is worthy. We have a retrospective lens on those studies, and maybe they could have been done a little better. What people realized is that spiking glucose in hospitalized patients isn’t good and they’ve been trying to control it better, though maybe not as tight as the original studies indicated. But as we understand that better and the precision of the instruments gets better, those studies can improve with the data we’re generating. It deserves a re-look, and I would support Dr. Sacks’ opinion on that.
Dr. Fuhrman (OhioHealth): It’s not my area of expertise, but I would definitely trust David. This is what he does and he’s world renowned for it. One of the things I was interested in, and I’m not a student of this area, is that with the continuous glucose monitors and the insulin pumps, patients were believed to be perfectly controlled—that was the concept. I don’t know if we have enough data on those perfectly controlled patients, but I would think that would be the gold standard, if and when the data become available.
Todd and Dr. Fantz, do you have any thoughts, questions, or issues you’d like to raise in closing?
Todd Cullen (Arkray): From an industry perspective, we’re trying to support our customers in managing the entire diabetes disease state, not just blood glucose monitoring. What we’ve seen more and more from our customers, what they’re requesting, is from a holistic perspective, how can we surround that particular patient and support their disease management, not just by measuring blood sugar? That is, how are we supporting them from a population health perspective, wellness, and all of those aspects of managing the person’s diabetes—keep them in control, provide better outcomes at a reduced cost, and prevent or minimize the risks for some of the comorbidities? So we as an industry—and this is where Arkray’s focus is—should be looking at more than in vitro diagnostic testing. It’s the holistic view that is needed.
Dr. Fantz (Roche): It’s an exciting time in glucose management. A lot of new technologies are coming for inpatients and outpatients, and with those technologies we will be able to do what Todd raises: population management for the patients and helping improve their lives. I’d also say that as a manufacturer we need to help health systems manage those populations by making the workflows of the point-of-care coordinators and laboratory staff easier on a daily basis.
Dr. Fuhrman, do you have thoughts about how manufacturers can help your health system do an improved job in this area?
Dr. Fuhrman (OhioHealth): Corinne is right on with the workflow. When I look at what we’re doing for blood glucose monitoring and where we have issues and where we see gaps, it has to do with that workflow and understanding exactly what the nurses are doing, what their constraints are, how integrated their workflow is to whatever electronic medical record they’re using, because they’re doing the vast majority of that work in that record. So the more integrated the manufacturers can be and the better we deal with that data and the better those systems talk to each other and the more flexible they can be, that will help things on the hospital side.
On the industry side, I agree with Todd. When you take a big step back to the big picture, the issue is we need to get these patients diagnosed faster and we need to have a societal way of handling them, following up, making sure they’re not lost to follow-up, making sure their medications are available and that they have access. We need to get the costs down—we can’t have the patients have that burden because if they don’t deal with the disease sooner rather than later, it will be much more expensive. And that’s an issue that we as a society have to get our arms around.