Speaker 1:

Welcome to AACE Podcasts. Thanks for tuning in as we elevate clinical endocrinology by taking deep dives into trends and topics that can help us improve our patient care and global health. Find the latest episodes on aace.com/podcasts. And now let's meet the endocrine experts who will be talking with us today.

Dr. Tangpricha:

Hello, everyone. My name is Vin Tangpricha, and welcome to this AACE Podcasts! Today we're going to be talking about the AACE Consensus Statement, Use of Diabetes Technology for Management of Adults with Diabetes. I'm the editor-in-chief of Endocrine Practice, and this AACE Consensus Statement, Use of Diabetes Technology for Management of Adults with Diabetes will appear in the November issue of Endocrine Practice. Today, we're fortunate to be joined by two of the authors, Dr. McGill and Dr. Donihi, who are both very versed in diabetes technology. Dr. Donihi, do you want to introduce yourself?

Dr. Donihi:

Sure, I would love to. So, as you said, my name is Amy Donihi. I'm a professor and clinical pharmacy specialist at the University of Pittsburgh School of Pharmacy. Currently, I'm also a diabetes care and education specialist and a certified insulin pump trainer at UPMC Center for Endocrinology and Diabetes. However, I spent most of my career practicing in the inpatient setting at UPMC. My clinical practice and research interests really focus on inpatient diabetes management, diabetes education, diabetes technology, and facilitation of safe transitions from patients from hospital to home. I'm one of the founding members of UPMC Diabetes Patient Safety Committee, and that was put together in 2001, and I've served as the co-chair of this system-wide committee since 2010. It's really great to be here today, and truly it has been an honor to serve as vice chair of this Consensus Statement.

Dr. Tangpricha:

Thank you for your service. I saw that there was some focus on inpatient diabetes and I was happy to see that. Dr. McGill, do you want to introduce yourself?

Dr. McGill:

Thanks, Vin. I'm Janet McGill, Professor of Medicine at Washington University School of Medicine in St. Louis. I do primarily diabetes, inpatient, outpatient, telemedicine, however diabetes needs to be managed. I am a huge advocate of diabetes technology.

Dr. Tangpricha:

Yes. Diabetes is so important to endocrinology practice, and every endocrinologist should know how to manage diabetes, and I'm really excited about diabetes technology. I think that goes right into our first question to Dr. Donihi, what do you consider Diabetes Technology? What is all under that umbrella?

Dr. Donihi:

So, diabetes technology can mean a lot of things, but generally it refers to devices or software or some kind of system that's designed to help people monitor or manage their diabetes a little bit easier than the traditional ways of doing that. So, when we talk about technology for our Consensus Statement, we're talking about advanced technology. For instance, even fingerstick blood glucose monitoring is technology, but we're talking more about the advanced features. So, continuous glucose monitoring, automated insulin delivery devices, smart insulin pens. So, we're talking about advanced technology to make things easier for patients and safer for patients.

Dr. Tangpricha:

Yeah, the field is moving so fast. It's so hard to keep up with all the technology that's coming out.

Dr. Donihi:

Absolutely.

Dr. Tangpricha:

Does that include iPhone apps and different other company apps?

Dr. Donihi:

I would consider those apps part of technology. The initial 2021 guideline that AACE put together did mention apps. We unfortunately didn't have room in our Consensus Statement to include all the apps, and there are many, many apps. So yes, I would include that under the bucket, but that is not something we focused on in our Consensus Statement.

Dr. Tangpricha:

Okay, great. And I noticed this is a Consensus Statement, not a guideline. Is there anything that we should know that made it a Consensus Statement, not a guideline?

Dr. McGill:

This was the assignment that we were given by AACE, and I think it's very appropriate, in part because diabetes technology changes so rapidly and data is emerging weekly, monthly, annually, daily. I think a Consensus Statement captures the big ideas.

Dr. Tangpricha:

That makes a lot of sense. I know sometimes guidelines are too strict and don't allow you to make statements that are appropriate for clinical care in today's practice, so I think that does make sense. So, maybe we'll ask the first question. What is the goal of this particular Consensus Statement?

Dr. Donihi:

Our goal was really to serve as an update to that 2021 AACE clinical practice guideline on the use of advanced technology in the management of persons with diabetes. We really aim to provide an up-to-date evidence-informed guidance to help with that shared decision making that should be taking place between healthcare professionals and patients. We really wanted to target all healthcare professionals, not just the endocrinologists. So, this was a multidisciplinary committee and anybody who would care for adults specifically with diabetes. Given that we were given a word limit and a reference limit, we couldn't talk about everything we wanted to talk about, which I know in the first couple meetings of our task force we were a little frustrated with, but I think the end product really is a valuable resource and I hope people will benefit from it.

Dr. Tangpricha:

Thank you. You mentioned that it was an update from the 2021 guideline, and Dr. McGill said that the practice of diabetes technology is evolving so quickly. How will this guideline be updated as new technologies come?

Dr. McGill:

AACE does a pretty good job of updating guidelines. Some appear on the website that may not appear in print form. Some are discussed at meetings. I think it's important to look at the big picture of technology use in diabetes and for individual practitioners to stay abreast of the current and emerging data. So, our technology partners are doing more studies, they're doing better studies. There are many real-world studies that inform our current use.

Dr. Tangpricha:

And so, what topics are being covered in this current Consensus Statement? Can you cover, Amy, which ones are being updated from the 2021 technology guideline?

Dr. Donihi:

Sure. So, we identified five areas that really needed to be updated since that publication. The first thing we talked about was continuous glucose monitoring devices, and then automated insulin delivery devices. The third was smart insulin pens and insulin patches. Insulin patches weren't even mentioned in the 2021 guidance document. The fourth was emerging technology and the fifth was finally telemedicine. And just to add on to what Dr. McGill just said, the fast, rapid pace of all this technology means that as soon as this hits Endocrine Practice, this paper, there's going to be other studies that have already been published and it's going to need to be continually updated. So, hopefully we wrote it in such broad strokes that it will remain applicable. We really tried to not name specific products so this way we wouldn't be outdated or we wouldn't have the Consensus Statement not be valid so soon. And so, hopefully that will help make this last a little bit longer before we need to update it.

Dr. Tangpricha:

I think that's an important point. There's always a new CGM that comes out and that Consensus Statement can go obsolete very quickly if you name a CGM that no longer exists, so I really appreciate that. So I guess that goes to our next question. What are the big things that have changed since 2021? Perhaps Dr. McGill, can you answer on that for us? What are the biggest changes you think?

Dr. McGill:

Everything has changed. We have more CGM systems than we had in 2021, and we see additional ones coming out in the near future. The insulin pumps, we've had new pumps come on board. The algorithms for the current AID systems have been updated and upgraded and are improved and provide better opportunities for tight glycemic control. The smart pens have gotten smarter, so we now have connected pens with apps just like pumps, and we have emerging technologies like continuous ketone monitoring that we will soon use either this year or 2027, and we're excited about that.

Dr. Tangpricha:

That's great. I guess our next question is, CGMs, I believe, really revolutionized the way we take care of diabetes, but not everyone has access to CGMs. So, what were the big barriers for use in people with diabetes? Dr. Donihi, do you want to tackle that one?

Dr. Donihi:

Sure. So, you're right, not everybody has access to CGMs or technology. There's definitely access barriers. Many individuals with diabetes are managed by their primary care clinicians who may not be familiar with technology and may lack the resources to support the implementation of them. So, I think that's probably the biggest barrier for implementation of CGMs. Also, there's also a lack of educators out there to instruct patients in the correct way of applying the sensor, interpreting the data and whatnot. So, that puts a lot of pressure on those primary care physicians.

Dr. Tangpricha:

When I read the statement, it seemed that the committee was recommending CGMs for everyone who had diabetes, and I thought that was a big step compared to 2021. Am I reading that correctly?

Dr. Donihi:

You certainly are reading that correctly. Yes, we are recommending CGMs for any person with diabetes in whom sensing glucose would help manage them.

Dr. Tangpricha:

That's great to hear, because I think these devices have really helped everyone with diabetes. So, I think you touched on an important topic about the comfort level with CGMs among primary care. What are some easy things that primary care physicians should be looking at or what could increase their comfort in prescribing CGMs? Dr. McGill, what are some quick pointers on how to prescribe it and then what are they looking at?

Dr. McGill:

Use of CGM and prescribing of CGM simply requires practice. You have to learn how it's packaged so that you prescribe the right amount for people. Understand that commercial payers will often allow CGM to be prescribed through pharmacy channels, but Medicare requires the DME channel. I think if primary care really understood how relatively easy it is to prescribe it, how easy it is for patients to use it, and how valuable it is, and then how easy it is to interpret the data given these really incredible downloads that we see that have a high level of granularity. There is a learning curve. There are many opportunities for primary care, but they need practice.

Dr. Tangpricha:

I think that's a good point. I think AACE provides a lot of these programs that people could come to and learn how to interpret the CGMs and just have a basic understanding what they're looking at. But if you were going to teach two things, what does a primary care doctor need to look at on the report? What are the focus areas?

Dr. McGill:

So, you look at two things. You look at the metrics, the mean blood glucose, start with that. Where is that? What is that number? What's the variability? What are the time in ranges? But don't forget to look at the trends. Because the trends will tell you if that mean blood glucose represents a nice flat smooth profile or a very erratic profile with lows mixed with highs and that sort of troublesome and challenging profile.

Dr. Tangpricha:

Yeah, that's great. That's really great pointers, especially someone starting out. And like you said, just getting comfortable with looking at the metrics, looking at the trends, I think that's so key. I'm going to change gears a little bit and ask Dr. Donihi a question about inpatient CGM use, and I think that's something you're very passionate about. So tell us about when that's really ... I know it's happening, but when is it really going to be universal? I mean, I think we have the technology now to make that happen.

Dr. Donihi:

Sure. I mean, the current inpatient glycemic management guidelines do support letting people who have a personal CGM before admission continue it during hospitalization. However, CGMs are currently not FDA approved for use for managing or for determining doses of insulin while the patient is in the hospital. That being said, there are some studies that have looked at hybrid protocols, so using the CGM in conjunction with point-of-care blood glucose monitoring, and those studies have shown that people who continue their CGM have less severe hypoglycemia and less time in hypoglycemia. So, many of the studies also show better time in range, but not all of them do. And a lot of that has to do with the fact that just putting the CGM on somebody isn't going to make you take care of their glycemic control better if you don't have a good glycemic protocol, but at least it improves the safety.

So, I definitely think that hopefully we'll get some FDA clearance and we'll be able to use these. But using them with a hybrid protocol and doing confirmation point-of-care tests, a lot of hospitals do have policies in place that allow patients to wear their CGM and not have to have glucose checks as frequently as they were before.

Dr. Tangpricha:

I know I'm putting you on the spot, but when do you predict that inpatient CGM use might be available for management of diabetes, especially in the critical illness phase, a DKA, that sort of thing?

Dr. Donihi:

I think in the critical illness phase it's probably not going to happen as quickly as it might in the non-ICU phase, and that's because we know that when the CGM measures the glucose in the interstitial fluid, that's affected by fluid changes, that's affected by clinical picture changes. So, I honestly don't have any idea when that will come. I've been hoping for it though for the past few years.

Dr. Tangpricha:

It would make things so much easier, especially managing DKA in the unit, I think.

Dr. Donihi:

Great. And I think another thing that has to happen too is there has to be a good way of getting the CGM data into the electronic medical record, which right now doesn't exist easily for the vast majority of hospitals.

Dr. Tangpricha:

Now, let's talk about insulin pumps. I know that's a big part of diabetes tech and it's really been the excitement in the field. Dr. McGill, tell us about how do you approach insulin pumps? What are these? Explain what is closed loop, what are the automated or hybrid closed-loop pumps? Tell us what's been going on in pumps.

Dr. McGill:

As you know, insulin pumps we thought were terrific, and these same pumps we now call dumb pumps because they were not connected to CGMs. Current pumps are mostly hybrid where the CGM input informs and governs the basal rate. Some pumps use adjustment of this basal rate, even when the pump detects a rise in blood sugar indicating a meal, basal rate will increase. Others use auto boluses, which are a fraction of the usual bolus. Patients are expected to put in either carbohydrates or indicate how many units they'd like to take when they take in food. These pumps have lots of other features. There are activity modes that reset the target, sleep modes, for example. So, the hybrid closed-loop pump does a fantastic job, but does require user input. A completely closed pump has an algorithm that senses food intake by rise in blood sugar and is a little more aggressive at covering that food intake. So right now we have one closed-loop pump. We may be seeing more of these as the algorithms improve, so very exciting.

Dr. Tangpricha:

That's super exciting. It's really revolutionized how endocrinologists manage diabetes, especially those who want as near normal glucose as possible. I know the statement didn't cover dual hormone pumps, but do you ever see those coming in the future, Dr. McGill? I mean, I think that's the biggest next breakthrough, or maybe it isn't, I don't know. What do you think?

Dr. McGill:

They're under investigation and it's complicated because it may require a dual chamber, dual catheters. Not all products are compatible with insulin or should be given in the same ratio all day long. It's a very complicated topic. It's being worked on, but I'm not sure that it's ready for prime time.

Dr. Tangpricha:

Okay. For our listeners, we're talking about insulin and glucagon in the same pump. So, I've heard those were in investigation like Dr. McGill was saying. I don't know, maybe there won't be a need for that, but it does help with the overshoot of the insulin for people who might have hypoglycemia, I would think. Let's talk about someone who has a pump and is admitted to the hospital, and this is a common situation. What do we do? Do we let them ... And if they're well controlled, like time in range is 90% and no hypoglycemia, should we let them continue on their pump? Amy, do you want to tackle that one?

Dr. Donihi:

Sure. So, when we're talking about insulin pumps, as Dr. McGill said, using them in the traditional manual setting, that is something that we have been doing now for many years, and the guidelines pretty much support that under a couple caveats. One, the person is alert and aware enough to be able to manage their pump, because usually in the hospital, the professionals there, the nurses, the physicians don't know how to use that pump, so the patient really needs to be alert and able to do it themselves.

Two, they have to have their supplies because hospitals typically do not have supplies to give them when they need to do their sensor or their cartridge changes or their pod changes, depending on what pump they have. And third, there really needs to be some policy or some protocol or procedure that is available in the hospital and that there's somebody there that can support the patient if needed. So, those are the things for continuing the pump.

Specifically to automated insulin devices, which is what we talked about in our Consensus Statement, there's really no consensus over the safety of them, and part of that's because, remember, they require the use of the CGM, and CGMs are not FDA approved in the hospital setting. So, I mean, the most recent European guideline kind of says that if the patient comes in on an AID and you're not sure if they're going to be stable or have rapidly changing things, that the best thing to do would be put them back into manual, or as Dr. McGill said, dumb mode. That being said, I think that AIDs can be used in the hospital, assuming that, again, you have that policy, that procedure, and that you are telling the patient they need to do point-of-care checks to verify the accuracy of their CGM device and that they're doing it well. So, a lot of monitoring and continual assessment of that patient would be needed.

Dr. Tangpricha:

It sounds like if a patient’s coming in the hospital and they're coming in for maybe some sort of elective surgery and it's going to be a quick recovery and they can handle it, maybe they could continue on their pump, but if they're not able to handle the workload, then they shouldn't be on the pump. Dr. McGill, you had something to add?

Dr. McGill:

Yeah, so continued use of insulin pump systems requires that the patient be alert, oriented, and competent. At Barnes Hospital, we allow them to continue their AID mode, which is our best opportunity to reduce hypoglycemia and significant hyperglycemia. The bolus doses are given in conjunction with finger-stick glucoses, so it's sort of an adjunctive use. However, there are big problems. The problems are surgery. They might need to remove the pump or the sensor, depending on the extent of the surgery, the location of the surgery, whether or not their grounding device is used during the surgery. MRIs may require removal of the pump and/or the sensor. If the patient does not have supplies to reconnect, it becomes a problem. So, we have opportunities for improvement of use of diabetes technology in the inpatient environment.

Dr. Tangpricha:

Yeah, I think there's a lot to consider, and I guess it's going to continually evolve as we work through this. I thought in the last few minutes of the podcast, I know we couldn't cover the entire statement, but maybe both of you could share some of the important technology that we haven't yet covered and what are the key takeaways from the guidelines. So, maybe Dr. McGill, do you want to talk about a topic that we didn't cover and what your key takeaway from the statement is?

Dr. McGill:

Sure. Other topics include use of smart pens, which might be highly beneficial for patients who need help calculating doses for review later of their doses and the connectivity with CGM, for example. We encourage greater use of smart and connected pens. We are also very excited about the continuous ketone monitor, that will require that all of us, endocrinologists and everybody get up a learning curve to learn when and how to use it. So, we're all staying tuned and we're quite excited about this, in addition to the improvements that are just simply ongoing in AID systems and in CGMs.

Dr. Tangpricha:

I have to admit, I haven't used the continuous ketone monitor, but it sounds like I'm not alone. I want to learn how to use those. Dr. Donihi, do you want to cover a topic that we didn't talk about and give us a couple of your takeaways from the statement?

Dr. Donihi:

I have to agree that what Dr. McGill said are pretty much the topics that I'm most excited about, and not only the smart insulin pens, but also the insulin patches. I think these types of devices make it so much easier for patients that are on multiple daily doses of insulin to be able to have a little bit of freedom, not be able to carry their rapid acting mealtime insulin pen with them when they go out during the day would be a definite benefit from an insulin patch. So, it's not connected to a CGM, it's not smart, but it definitely improves quality of life for the patients, and that's some of the things that we found when we looked at the literature. But I think the biggest takeaway that I really want people to come home with is that diabetes technology is really just rapidly evolving, and clinicians and persons with diabetes just really need to make sure that they stay abreast of all the developments, which again, happen, as Dr. McGill said, monthly, weekly, and even daily.

Dr. Tangpricha:

Yeah, I agree. I think we're going to have to have you back sooner than later. I think it won't be five years since the next update. I think this will probably have to be updated sooner than later, but this has been a great conversation with both of you. I think we've learned so much. I direct the audience to the Endocrine Practice publication November. It's a great guideline and has lots of tables, so I hope everyone finds it useful, and thank you very much for writing the guidelines. Dr. McGill, before we close, do you want to mention the other authors? I don't want to forget those folks.

Dr. McGill:

So, many thanks to all of the authors who contributed to this guideline. Every single one was an active participant, did a literature review, wrote sections, and participated in discussions. I want to particularly thank my co-chair, Amy Donihi, Halis Akturk, Matthew Freeby, Evana Gupta, William Horton, Nomin Jadun, Sanam Lathief, Sigfrido Lopez, Jerry Tan, and Rodolfo Galindo. What a great group.

Dr. Tangpricha:

That's amazing. Well, thank you very much. This has been great, and hope to see you at a future AACE meeting and potentially podcast next year.

Dr. Donihi:

Thank you.

Dr. Tangpricha:

Thank you.

Dr. McGill:

Thank you.

Speaker 1:

Thanks for listening to another great AACE podcast. Join us for another episode at aace.com/podcasts and help us in our mission to elevate clinical endocrinology. Together we are AACE.