Wearables in Clinical Trials: An Overview of Challenges

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Wearable Tech-What’s It All About?

Let’s start from the very beginning. What are people talking about when they say “wearables”, “wearable biosensors”, “wearable devices”, or “wearable technology” in clinical trials? In the most basic sense, all these terms refer to relatively mobile devices that you can wear on your person; designed to measure specific biological parameters in your body.

Today, the most obvious example of wearable technology might be something like a fitness tracker worn on your wrist. Some of the cheaper options might exclusively measure your heart rate, whereas more high-end ones typically offer actigraphy options as well. Typically, all commercial wearable actigraphy devices should be able to give you a good estimate of the number of steps you take in any given period, while the higher-end commercial options, as well as clinical-grade devices, can measure (or at least indicate somewhat reliably) other parameters such as the quality of your sleep, what sort of stationary exercise you engage in, etc.

Of course, wearable actigraphs are not exclusively fitted to wristbands. And monitoring the heart rate isn’t always done by combining sensors in a wristband. There are more reliable wearable options for heart monitoring on a clinical level. Other examples of wearable technology include interstitial glucose monitors, which can gather long-term data from your body that reliably indicates your blood glucose levels over a certain period. These monitors are of particular interest in diabetes research.

There are more advanced examples, for instance, there are eyeglasses that were successfully tested for measuring alcohol and vitamin levels in the blood via tear fluid collection, etc. Some biosensors are even designed to be injected into your body. While those are sometimes referred to as “injectables”, they are mostly classified as “wearable devices”. Yes, I suppose you can stretch humor to say that these are the sci-fi chips that conspiracy theories warned you about, although not every injectable biosensor is necessarily a chip.

After all, you’re literally being injected with a minuscule device that gathers data about your body. However, in all seriousness, no research has yet appeared on how these injectables can help comic-book supervillains control your mind, so I’d say you’re relatively safe for now. Jokes aside, the commercial use of injectables is limited, with most options developed for clinical use for the time being.

I could list more examples, but this just about sums up what wearable biometric technology is. The important thing is that using wearable tech in numerous clinical trials has been enormously convenient and helpful in many ways. It has also brought about some of its own unique challenges.

 

Background Context – Then & Now

While the use of wearable technology made gathering data more convenient in many clinical trials which rely on such devices, there are still unique challenges that face the teams that utilize wearable data-gathering devices. This article will highlight some of those challenges and examine potential approaches to mitigate them within the context of Biowearables’ historical challenge mitigations. Because yes, other challenges in the use of Biowearables have been addressed before.

Wearable technology to monitor biological functions is not a new concept, relative to what we consider “new” in the field of clinical trials. In fact, it’s existed for decades. Nevertheless, wearable technology now is revolutionizing the aforementioned field. Because much of the technology needed for this revolution is finally coming of age. The old Holter monitors, which make some famously bulky early cell phone models from a certain Swedish manufacturer seem slim and graceful, were considerably less convenient and unwieldy when compared to the conveniently thin and lightweight patches we now use to measure ECG. I might add that some of these patches last over ten days collecting data without the need for interference.

So as wearable technology improves and comes of age, its uses become more versatile. The use of wearable technology facilitates monitoring several types of data input remotely, which is extremely useful for Decentralized Clinical Trials in particular, and of course, Decentralized Clinical Trials are themselves helpful and convenient in many ways. But you probably already know that. Most wearable technology nowadays offers the option to monitor collected data in real-time via internet connections.

If an internet connection is temporarily interrupted or unavailable for some reason, the data can often be stored on the device for prolonged periods, before being unloaded into a suitable computer at a later time. If you haven’t worked too closely with different types of wearable tech, you may wonder about its functionality for trial participants in remote locations which lack internet connections. Real-time monitoring is preferable, but data storage is a good backup plan in case real-time monitoring faces temporary challenges.

The more urgent questions we’re facing nowadays are: What are the challenges still ahead of wearable technology monitoring equipment, and, in the context of the technology behind this equipment coming of age, how do we overcome said challenges? Since the answers to those two questions are so closely interlinked, let’s discuss them together, from a consolidated perspective.

 

Challenge Mitigation Approaches

The ability to use a wearable biosensor easily and without complications or inconvenience is paramount for trial participants. Does a device hanging on the arm feel heavy when the participant walks from the momentum of arm movement? There’s a challenge. Must the device remain uninterrupted on the participant’s body for over 24 hours as well as be shielded from water? There’s another challenge, particularly on hot summer days! Does the participant need to do anything regarding data collection? You get the picture. Ease and convenience for participants are important.

When a participant encounters an issue with the wearable biosensor, is there a system in place for the technical troubleshooting of issues designed for the participant’s convenience? Who steps in to help? Trial staff members with experience operating the device? A technical team? Is there an easily accessible optional first step to guide the trial participant through simple solutions like restarting a device? If there isn’t, should there be or is it not the right fit for the demographic in question? All of these are more factors to consider.

Then, of course, there are the issues that study teams face with their sites, particularly for sites they haven’t worked closely with before. Do the site personnel understand that despite wearable biosensing devices making things more convenient, the sites still need to maintain an effective relationship with the participant? That day-to-day interaction with some participants may not be completely off the table just because all participants are wearing an advanced interstitial glucose monitor which makes data collection much easier? Or an activity monitoring device, or an injectable biosensor?

This is of particular interest to site personnel who have not been involved with trials that utilize wearable technology. If the study team isn’t sure about that, do they need to distribute some quick videos or literature about the roles of sites in studies that involve wearables, or do they need to schedule time to discuss this issue with some sites individually?

The above-mentioned examples also demonstrate some of the overlappings we talked about. For example, a device with which trial participants face a common issue that requires the intervention of a technical team might be challenging to a trial’s budget, which could develop into an all-around problem that may affect everyone from the sponsors, the study team, and the study sites. And of course, the inconvenience affects the participants themselves.

Now, an obvious resolution or preventive action would be to choose affordable replacement devices which don’t often face issues serious enough to require the intervention of a technical team. That makes for a great resolution/preventive option when selecting devices for a study, but it cannot be relied upon as a stand-alone prevention strategy. Mainly, because affordable alternatives to devices that don’t face certain issues might not always be viable. Still, it’s a great option to explore, as a component of a larger resolution strategy.

Needless to say, we don’t consider this a budgeting challenge for devices being functionally deployed in the field for the first time (after safety testing and such) because technical team interventions are specially accounted for in the budget in those instances, whether the cost is borne by the sponsors or the device manufacturers (who may belong to the same commercial entity in some cases). But you see the point. Challenges may overlap.

 

A Future Perspective

Of course, the ultimate mitigation for challenges comes from improving technology, which is why the context of how wearable biosensor technology evolved was so important to illustrate. But professionally, very few people are empowered to directly drive the development of technology further. In layman’s terms, you can’t rush the tech. The best you can do is to keep doing your job so room for improvement could be identified.

The good news is, as we discussed, the tech is already coming of age. Great leaps have happened, and they’re not showing any signs of abating. Doubtless, in the future, new technology will illustrate the need for new approaches to the mitigation of challenges, because there’s always room for improvement, no matter how many challenges technology addresses. But now, at the end of 2021 and with 2022 dawning, these are examples of approaches you can take to mitigate the challenges of today. Have a happy new year.

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