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Our guest today is James Malone, an endocrinologist and health care executive with over 30 years of experience in the field of diabetes.

James has seen firsthand the challenges that many people with type 2 diabetes (T2D) face when it comes to daily insulin management. Despite advancements in diabetes care over the years, the process of managing T2D remains just as complex and manual as it was when he first started practicing medicine.

While the majority of people with diabetes live with T2D, most of the industry’s innovation is focused on complicated systems for “power users” with type 1 diabetes (T1D). This leaves people with T2D struggling with the complex requirements of diabetes management with too few tools to help.

James will discuss the difficulties of managing T2D, the importance of self-management, and the disparities that exist between T1D and T2D patients. He will also share his thoughts on what health care professionals and diabetes innovators can do to provide better care for the underrepresented and more prevalent diabetes population.

So join us as we delve into the ongoing struggles faced by T2D patients and explore the steps to better care for this patient population.

James Malone is an endocrinologist and chief medical officer, Bigfoot Biomedical, which can be reached on Facebook, Twitter @bigfootbiomed, LinkedIn, and Instagram.

He shares his story and discusses his KevinMD article, “Lack of innovation is leading to disparities in diabetes care.”

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Transcript

Kevin Pho: Hi, and welcome to the show. Rate and review at KevinMD.com/rate. Subscribe at KevinMD.com/podcast. Today on the show, we have Jim Malone. He’s an endocrinologist and health care executive. His KevinMD article is titled “Lack of innovation is leading to disparities in diabetes care.” Jim, welcome to the show.

James Malone: Thank you, Kevin. Pleased to be here.

Kevin Pho: So we’ll get into the article in a little bit, but first off, briefly share your story and journey to where you are today.

James Malone: Yeah, sure, Kevin. So I got interested in diabetes pretty early in life. In elementary school, my best friend, named Don, had type 1 diabetes, and I was literally the only person that knew it. He and I did a lot of sports activities together, and he relied on me for hypoglycemia treatment when he would go low.

That memory of Don kind of stayed with me as I went through my medical training, and it kept coming back to diabetes, diabetes. So as I was thinking about what specialty to go into, I kind of naturally fell into diabetes, and I’ve been doing that now for almost 40 years.

Kevin Pho: All right. So in your decades-long career as an endocrinologist and a diabetes specialist, what would you say today are some of the biggest challenges that we face in treating diabetes?

James Malone: Boy, there are many challenges. You know, diabetes is a chronic disease. People have to live with it day in and day out, and they don’t have an endocrinologist or a nurse educator by their side every day. So they have to learn how to make decisions day to day to keep their diabetes under control. That’s why it’s incumbent on us as health care professionals to provide them the tools that they can use, and to provide good communication, so when they do have an issue, a challenge, they know who they can call and can get some guidance on how to get out of that predicament.

Kevin Pho: So I’m a primary care physician. Obviously, diabetes takes up a huge part of my own practice. Now, speaking from your perspective as an endocrinologist, what are some tips that you could share with people like me, other primary care physicians who have to take care of a lot of diabetic patients every single day?

James Malone: Yeah, it’s a real challenge, Kevin, because there are really too few endocrinologists for the number of people with diabetes in the country. In 2022, there were 37 million people in the U.S. with diabetes, and about 90 percent of those have type 2 diabetes. A large majority are cared for by primary care physicians like yourself, and most patients do well with a primary care physician.

But the challenge is knowing when an endocrinologist is needed. Often, that is the transition from oral agents to insulin. Some primary care physicians aren’t really comfortable managing insulin, because it is complex. It can cause hyperglycemia if you don’t give enough, and hypoglycemia if you give too much, and oftentimes they will refer to an endocrinologist at that point. Anytime that a primary care physician feels that they’re a little uncomfortable with treatment, but feels that the patient needs a little extra, that’s when a referral to an endocrinologist would make sense.

Kevin Pho: All right. Let’s talk about your KevinMD article, titled “Lack of innovation is leading to disparities in diabetes care.” Now, tell us, how did this article come together?

James Malone: Yeah, it came together, Kevin, because in my experience, both in practice and in industry, I’ve really seen that over the last 10 to 20 years, most of the innovation that we’ve seen in diabetes technology has been focused on type 1 diabetes.

And I love type 1 diabetes. It’s a disease that goes right to your heart, because it usually begins with children, and they absolutely need insulin to maintain their health, so they need intensive insulin treatment from day one. That’s not the case with type 2 diabetes. Type 2 diabetes usually begins in adulthood. It’s a gradual progression, where a person can start off with diet and exercise and maybe one medication, and then they go to two medications, three medications, and then finally they need an injectable. That’s the natural course of type 2 diabetes. So the innovation that I’ve seen over the last 10 to 20 years has been really focused on the more intensively treated type 1, and I don’t think we’ve done enough to make that technology available to the larger population of type 2.

Kevin Pho: All right. So tell us about some of these technologies that you’re referring to that could be applied to type 2 diabetics.

James Malone: Yeah, I think the first one is continuous glucose monitoring. There are now systems, as you know, Kevin, that can monitor the glucose every one to five minutes without having to prick your finger four or more times a day. This technology has really matured to the point that it is accurate and reliable. All people with type 1 diabetes should be on a CGM device, and now it’s been recognized that people with type 2, even if they’re not on insulin, can really benefit from being on a CGM device. And especially when you’re on insulin, where the blood glucose is more variable, that’s where CGM technology is really useful.

The second innovation that I want to mention is how to dose the insulin. I mentioned earlier how difficult it is to manage the highs and lows, knowing how much to take for a certain amount of carbohydrates, and there are now some innovations in insulin dosing programs, like software applications and smart insulin pen devices, that can actually guide the person to take the right insulin dose. When you combine CGM with a dosing device, then you’re really getting at some effective therapy for people who take injections.

Kevin Pho: Now, walk us through a story or a case study, let’s say, of a typical type 2 diabetic that you want to apply some of these technologies to, whether it’s a continuous glucose monitor or using that data to help with insulin dosing. So tell us a typical case study, in your ideal world, that these technologies can be applied to.

James Malone: Yeah, sure. So an example is a type 2 patient who has just been put on insulin. Normally, the first type of insulin that’s used is called a basal, or long-acting, insulin, typically given at bedtime, and it controls blood glucose overnight and keeps it under control during the day. That’s a pretty easy therapy to begin, and most primary care physicians are comfortable prescribing the basal insulin.

Unfortunately, that basal insulin will not sustain over the course of type 2 diabetes, and the person will begin having high blood glucoses after a meal. We call that postprandial hyperglycemia, and it’s just the fact that the insulin response has become sluggish. The body can’t compensate for the food, and so the blood glucose can go quite high after a meal. When that happens, a person needs a rapid-acting insulin, or what we call the bolus insulin, before meals to control that post-meal surge. That’s where insulin therapy can become more complex, because it’s not just one dose you’re taking at bedtime. It’s a variable dose before each meal.

If that type 2 person requires MDI, then they could really benefit from a CGM device that really shows them how their glucose is responding 24 hours a day: before meals, after meals, and at bedtime. When you match that with an insulin pen device that can actually show them or recommend a dose for that meal, then they can really improve their overall diabetes management, keeping them safe from hyperglycemia and hypoglycemia.

Kevin Pho: For those who aren’t familiar with continuous glucose monitoring, can you tell us how exactly they work?

James Malone: Yeah, it’s a wonderful technology, where a small cannula, a plastic introducer, is put under the skin, typically in the arm, or it can be in the abdomen or leg. It doesn’t actually measure blood glucose. It measures what’s called the interstitial glucose, which is glucose in the tissue that is almost the same as blood glucose, but you don’t have to enter a blood vessel to monitor it. That sensor will record the blood glucose either every minute in some CGM devices or every five minutes in other CGM devices, and the person can look on a reader or their smartphone and see minute to minute what their glucose level is doing.

Kevin Pho: And for type 2 diabetes, are these generally covered by Medicare and other insurers?

James Malone: Well, unfortunately, not. Congress has been slow to approve these kinds of devices for type 2 diabetes. It is becoming more reimbursable for those on insulin, but oftentimes you have to show why the patient needs the device. As a diabetes specialist, I think all patients can benefit from knowing what their blood glucose is, because then they know: Are they eating too much? Are they eating too little? What effect does exercise have? And importantly, what’s the right insulin dose for the situation they’re in?

So my hope is that CGM devices would be covered for anyone with type 2 diabetes, in addition to the already reimbursed type 1 diabetes.

Kevin Pho: Now, for those type 2 diabetics that a CGM device would be appropriate for, and insurance doesn’t cover it, in general, what’s the cost to the patient?

James Malone: The cost to the patient can range anywhere from about $50 to $100 per month.

Kevin Pho: And in a family medicine exam room, what kind of patient would lead me to think, “Hey, this patient would benefit from a CGM device”?

James Malone: Well, like every device, it’s not meant for every single person, so you’re right that it really has to be personalized. You want a patient who’s engaged in their treatment, who wants to do self-treatment when you or your nurse educator is not around to educate them, and who is receptive to instructions on, “Gee, what do I do when I see fluctuations?” Those are the type of engaged patients that can really make the best use of this technology.

Kevin Pho: We’re talking to Jim Malone. He’s an endocrinologist and health care executive. His KevinMD article is titled “Lack of innovation is leading to disparities in diabetes care.” So, Jim, what’s the path forward? We have these technologies that hopefully could be applied more to type 2 diabetics. What do you see as the path forward?

James Malone: Yeah, the path forward, Kevin, is really to make these technologies as easy as possible. I mean, everyone says you want easy technology, and it’s much easier said than done, but particularly with type 2 diabetes, these individuals are typically older. The average age is between 40 and 60 when they develop diabetes, and so they’re not naturally tech-savvy people. The technology has to be appropriate for their level of understanding, and it can be taught by a nurse educator in an education session.

So I really see the goal of people in industry like myself as making this technology as easy as possible, both for the patient and for the health care professional who is going to be monitoring these glucose profiles and providing guidance to the patient, as they either see them in their clinic or even review their patterns offline in a virtual way, and to make the care not episodic but more continuous. That partnership between the patient and the health care professional is so important to really optimize the technologies that we’re developing now.

Kevin Pho: And as a primary care physician, if I’m interested in placing a patient on continuous glucose monitoring, what are my next steps? What do I do next?

James Malone: Well, I think the first thing is to become familiar with the technology. There are a lot of CME courses now that are really geared toward primary care, because the CGM device provides so much data. It can be overwhelming to a primary care physician who isn’t used to looking at all those glucose parameters, the variability, and what the standards of care are. So do a CME and get familiar with the technology and how to read CGM, and then try it out. Find that engaged patient who wants to partner with you to try a new technology, and you’ll both learn together.

Kevin Pho: And my final question: What are some of your take-home messages that you want to leave with the KevinMD audience?

James Malone: Yeah, Kevin, what I really want to emphasize is that I think type 2 diabetes is not being treated well in our country or anywhere around the globe. All the technology advances have been really geared toward type 1 diabetes, and we know that 90 percent of people with diabetes have type 2, and they’ve been kind of left behind in the technology innovation.

So I think that it’s incumbent on all of us as health care professionals to become familiar with this technology and begin to introduce it to our type 2 patients, who are not as well controlled as type 1 but can suffer the same complications as those with type 1. And so we all need to do a better job of treating type 2 diabetes, particularly those who are on insulin.

Kevin Pho: Jim, thank you so much for sharing your time and insight, and thanks again for being on the show.

James Malone: Thank you, Kevin.