Advancements and Challenges in Diabetes Management

Learn about the state of digital therapeutics for disease management such as diabetes care in terms of cost, outcomes, integration, and more with Dr Mansur Shomali, CMO at Welldoc. 

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Please share your name, title, and a brief overview of your professional history. 

I am Dr Mansur Shomali. I am an endocrinologist. I see patients with chronic conditions like diabetes and cardiovascular disease in Baltimore at MedStar Health. My faculty appointment is at the University of Maryland School of Medicine where I'm a clinical associate professor of medicine. And for the last few years I've been serving as chief medical officer at WellDoc, which is a digital health company that builds software that helps people with chronic disease management. So I've been able to actually work both in the clinical setting as well as in the R&D setting with regards to digital therapeutics. So I'm really excited to be able to share my experiences with you today. 

How has the expanded accessibility and utilization of digital therapeutics influenced disease management and patient care across the health care spectrum? 

First of all, we now with technology have the ability to deliver the right treatment to the right patient at the right time. So we don't have to wait for a doctor's appointment or an emergency situation where an individual with a chronic condition gets a problem that ends up in the emergency room or in acute care. We can now actually take care of people where they are, deliver interventions when they're needed, and notify care teams as appropriate and optimize health care utilization. We couldn't do that before without this technology. And you might say, well, why is that? Well, it's because digital therapeutics give us 5 Vs. And I like the 5 Vs because there's a lot of alliteration and the letter of V is a very strong consonant. 

Variety, velocity, veracity, volume, and value. So the variety is that we can capture information about our patients with activity trackers, glucose monitors, continuous glucose monitors, blood pressure monitors, weight scales. We capture a variety of data and that data can be shared with care teams in ways that it never could before. 
Velocity. That data comes in in real time if we wanted to, and that's where we can make time-critical interventions.

Veracity. Well, it's accurate data. So when a patient comes to see me in my office and I don't have a digital therapeutic on board or a digital health tool that they're using, I ask them, are you being active? Are you taking your medicines? How are you doing with your glucose values? And they might say, good, not good, whatever it is. But it's never really the actual data that I'm looking for. And sometimes patients sort of minimize trouble to sort of please me as their doctor and I'm not getting the accurate information that I need. But when you're connecting to data in real time, you have a lot of confidence in the data for medical decision making. That's what I mean by veracity. 

Volume. The other V is really critical because this much data can be very overwhelming. We get a lot of it, but how we build our tools to curate the data in such a way that I can make decisions with it in real time, that's critical because if you just throw a data set at an average doctor with thousands of data points, you're not going to get very effective results that way. But computers are really good at scanning data, looking for patterns, and then providing decision support that way. 

And finally, the last V is value. The data is extremely valuable. Not only can we improve our patients' lives, improve their outcomes, but we reduce the health care expenditures to the care system because patients are not ending up in the ED, they're not ending up in an acute care situation. We can actually help them get better before they actually get into trouble. And not only that, it makes my job as a clinician so much easier because for the first time, I can actually have the data that helps me adjust the treatment plan rather than me guessing, “Well maybe we'll try this drug, Mr. Jones, maybe this will work.” I'll actually have information that says what's working, what's not working. 

How do digital therapeutics currently compare to traditional pharmaceutical treatments in terms of efficacy, patient outcomes, and cost?

Another good question. I think that we started off by using this term digital therapeutic to almost make an analogy between pharmaceuticals. In fact, some people like to call, they use the word ‘digiceuticals’. So we're talking about software that competes with pharmacotherapy, pills, injections, FDA-cleared medications, that sort of thing. It's an interesting comparison. I don't know if I would've thought of it that way if I were the creator of the term digital therapeutics, but to answer your question, if you look at the instance of diabetes, for example, and you look at the top 20 diabetes medications out there that are cleared by the FDA that clinicians are prescribing and patients are using on a grand scale, you might say that the average A1C reduction is about one A1C point, maybe even less for some medications like metformin and DPP-4 inhibitors. But let's say one point, and that's an important clinical outcome because the FDA says that for a drug to be considered effective at improving diabetes, there's a threshold of about 0.4 or 0.5 A1C reduction. So you have drugs that are lowering A1C by about a point. 

Well, there are studies with digital tools that show the A1C lowering can be up to something like 2 percentage points. So you can actually double the clinical outcome just from the perspective of an A1C result in diabetes with a digital tool versus a pharmaceutical. And there are no side effects. I mean, as we know, especially with the GLP-1 medications, the SGLT2 medications, there are side effects. There's tolerability, nausea, GI, kidney issues, those sort of things that we have to worry about. Well, digital therapeutics don't have side effects. So I think they compare very favorably with regards to cost savings. We have data that people using these digital tools cost the health care system less. There are signals that seem to suggest improvements in blood pressure, improvements in weight, improvements in satisfaction with their health. So if you're going to compare drugs with digital therapeutics, I think digital tools compare favorably well. 

However, I think it's a false choice because in a sense what digital tools do is they amplify the benefit of medications. So it's not like you're using one or the other in a comparison. You're actually using both at the same time. And you may actually need fewer medications if someone is using the digital tool to optimize nutrition, activity, lifestyle. And we have data to suggest that you're going to need fewer doses of medicines and fewer medicines and save pharmacy costs if you are using a digital tool, so I think a lot of favorable comparisons. 

What are some of the key challenges facing the development, approval, and integration of digital therapeutic solutions in health care practices? 

I think there are a lot of challenges. Number one, for people living with chronic medical conditions like diabetes, they actually have to learn how to use the digital technology in everyday life and integrate that with how they manage their disease condition. And because these tools are often mobile tools, they work on the cell phone, it does make it easy. The other things that make it easy are when the tools are digitally connected with one another so that there's no need for manual entry of data. So if there's an app and an activity tracker and a blood pressure monitor and a weight scale and a CGM device and they're all Bluetooth enabled and connecting to the app on the phone, that makes it really easy. When we ask patients to actually work harder for their health, we're not going to get as good outcome. 

So one challenge is can we let it fit in with a patient's life without increasing the burden of the disease? The second challenge I would say would be for the health care providers. Health care providers, my generation, they haven't grown up prescribing digital health tools. We've learned in residency and fellowship and all of our medical training to prescribe medications, to do procedures, those sort of things. So digital health isn't really part of the curriculum of medical school and training. 

So my children, my daughter is pre-med, and she probably has the expectation that these tools are out there because in every field of life, banking, entertainment, people are using apps on their phones. So why not for health reasons? So there needs to be a pivot among health care providers to use these tools and the tools have to be integrated into the workflow, the clinician. So again, if the clinician has to work harder to use the tools, it's not going to be as successful. 

And the third challenge is for health systems and health plans and the overall ecosystem of medicine, how do we get these tools to deliver the right information about populations so that a care manager or population health manager can take that data and plan out interventions at a system-wide level? So again, 3 levels: the person with the condition, the clinician, and then the health system in general.

Considering the challenges outlined, there is a growing need for standardized evaluation criteria in digital health care solutions. The Peterson Health Technology Institute (PHTI) announced its intention to create an assessment framework for these solutions to encourage participation. From your perspective, how can we effectively tackle these challenges to offer guidance and information to stakeholders for evaluating such solutions?

I think a common set of requirements makes a lot of sense. And that's because right now, every stakeholder, every health plan, every health system, they're trying to do their own evaluation of every digital health product, and there's not a lot of uniformity. I think we have to be careful though, with this common set, it should really indicate what should be done, not how it should be done. And the reason is every sort of condition is going to have a different “how”. Every solution is going to have a different “how”, a different way of funding, a different way of integrating. But I think all the categories should be aligned. So for example, integration outcomes, cybersecurity, regulatory policies like the FDA for medical devices, all of those things need to be standardized. But I’d hate for creativity to be stifled by excessive regulation. But I think people are looking for common standards because otherwise it's the wild west out there.

There are many digital therapeutic offerings already on the market across disease states, especially regarding diabetes care. What is the state of prescription digital therapeutics for diabetes care, and what are the anticipated developments in this area of health care over the next few years?

First, I'd like to say that there are probably hundreds if not thousands of apps for diabetes. And so we have to separate out what is a lifestyle app, what is a regulated product by the FDA, what falls under the category of what the FDA guidance calls enforcement discretion? Then there are regulated products that need FDA review, but they're not prescription items because they don't meet the criteria for a prescription product. I'm thinking of the analogy of drugs. You call those over-the-counter drugs like Tylenol, aspirin, they're safe enough to use, but they need to have been approved by the FDA at some point. Then there are the prescription digital tools that require a clinician prescription in the diabetes space. Those are specific tools related to insulin adjustment because insulin is a fairly risky medication and it needs to be prescribed by a clinician, and patients need a certain amount of education to use their insulin safely. So if you look at then all of the digital health products out there, only a really small subset require regulation and the smaller subset require prescription.

One more thing, which is that the FDA does allow for mixed devices. So for example, a prescription device that's an insulin calculator can also deliver coaching on lifestyle. And the coaching on lifestyle might not require a prescription, but it is holistically combined within the solution that does require a prescription. So medical device regulation can be really complicated. And again, the FDA does publish guidance documents and has standards for what needs regulation, what is enforcement discretion. And those regulations really change as the agency has evolved over time. WellDoc, the digital health company that I help in the role of chief medical officer, they were actually pioneering the requirements for how a digital tool should be regulated. Software as a medical device is a relatively new guidance that has come out only after we released our first FDA-cleared product. 

In August 2023, the American Diabetes Association disclosed findings regarding the influence of digital diabetes solutions on all-cause health care resource utilization costs among patients with type 2 diabetes. The results demonstrated that digital diabetes solutions led to notably lower all-cause health care costs than non-users. Considering this data, will standardized guidance and transparent information substantially impact stakeholders evaluating digital therapeutics for various disease states, particularly when they observe results indicating reduced health care costs?

If you imagine a two-by-two table where you have on one axis clinical outcomes and on the other axis cost savings, what you really want to be is you want to be in that square that says your clinical outcomes are better and you're costing the health care system less money. You don't want to be in the other square which says your outcomes aren't better and it's more expensive. So I think data like what you cited in this question is really important for our industry. It's really important to show that not only is health care utilization reduced, not only are we saving money on pharmacy costs, hospitalization costs, ED visit costs, but we're actually improving the health and the life of our patients with chronic conditions like diabetes. I think that as payers and systems become keenly aware of this type of data, they're going to seek out solutions like the digital health tools that we've talked about today.

Considering PHTI's endeavors and studies illustrating the triumph of integrating digital therapeutics, what transformations do you foresee in the treatment landscape for disease states with accessible digital solutions?

This question makes me think about our human desire to explore the galaxy, right? So we want to send people to Mars and colonize Mars. Well, that's a great vision to have, but there are a lot of technical challenges. We don't quite know how we're going to send people to Mars and they're going to live on Mars and they're going to fly back to earth. We just don't have the technology to do that quite yet. But with digital health tools, the technology's there. We just need the creativity, the will, and the know-how to build the solutions and deploy them and integrate them in the health care ecosystem. And so what I think about standardization, like what PHTI is doing, it's going to basically unlock that technology for payers and systems and doctors and patients, and it's going to allow us to build smarter tools. Maybe we want to use more AI. AI seems to be the buzzword in health care today, but we need to do that cautiously, judiciously. We need to make sure that it's safe and effective and we have to gather data and demonstrate outcomes and show cost savings. 

Technology can be really tricky if the solution is siloed. Like let's say there's an app for your diabetes and then an app for your blood pressure, an app for your heart disease, an app for your asthma, or COPD, and they don't all work together. Well, that's a nightmare experience. Who's going to want to use 5 apps to navigate their 5 health conditions? So part of what we need to do also is taking away these siloed solutions and make multi-condition tools that can adapt to a person's individual medical needs. And again, they should also support the treatment plan of the health care provider. So as a clinician, the last thing I'd want to do is recommend a therapy for my patient and then they go off and download an app that tells them to do something different than what I want them to do. So there needs to be alignment with what the care team is recommending to what the patient is doing. And all those things are really tricky, but the beauty is that technology is available. We don't have to think about flying to Mars. We have the tools, we have the software, the coding, the AI algorithms, they're all there. We just have to put them together and use them in health care. 

What is one key takeaway from this interview that you would like the audience to walk away with? 

I think we have to evolve the digital therapeutics industry beyond what is limited as a equivalent to a drug. We have to think of it as a holistic solution. There's this term digital health, but we should just call it health because digital is here to stay. It's not going away. It's just going to get better, more effective and improve outcomes even more. So again, evolution of the technology, it's really what we put our minds to it. It's really the creativity and the will and the desire of health systems, health plans, patients, clinicians, and the whole ecosystem to say, we are going to adopt technology in a really smart manner and we're going to help improve lives and save the system resources.