POC panel talks diabetes care, data management, CGM

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, 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?

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.