Wearable Devices–A New Look For The Modern Clinical Trial

Clinical development has historically been a laborious and expensive process that stretches across all therapeutic areas. It is driven by lengthy patient recruitment timelines, increasingly complex study designs, and high procedural costs. Depending on whose data you believe, getting a new drug to market can now cost upwards of $1 billion and take more than 10 years or research and development effort. Additionally, a complex and dynamic regulatory framework has made sponsors reluctant to introduce new technologies to facilitate the development process.

In the last few years there has been significant buzz in the life sciences industry surrounding the use of wearable devices that can be utilized for remote patient monitoring in clinical trials. Many believe wearables have the potential to significantly impact overall trial costs and efficiency. Most recently, wearables have returned to the spotlight due to fresh approaches that harness artificial intelligence/machine learning(AI/ML) to process and analyze larger data streams.

Although intriguing, several issues have hindered adoption of these new technologies, primarily involving patient compliance, cost, concerns around data quality and accuracy, and lack of awareness surrounding these technologies and their utility.  Analysis performed by Fuld + Company, a consultancy in Boston, finds significant pros and cons that must be considered by companies opting to launch a wearable device initiative in trials.

• Data Collection & Patient Monitoring

First, wearables provide a great opportunity for investigators to monitor their patients outside of the clinic, after an investigational drug has been administered or a new device is implanted. “Currently, patients can be equipped with trackers that will monitor heart rate, lung function, breathing patterns, blood pressure, and other basic measurements that may provide insights into how the patient is responding to the treatment,” says Premdharan Meyyan, a consultant with Fuld + Company. “Data from these trackers can be transmitted, in real-time, back to the physician for monitoring purposes. But we still have to ask ourselves, ‘How useful is this information?’ In other words, does this data provide any meaningful insight into the safety and efficacy of the treatment, or is it merely information that is nice to know?”

 According to Meyyan, the short answer is: It depends. Passive continuous tracking of the heart rate of a patient undergoing drug treatment for a retinal disorder, for example, will most likely not provide any mission-critical data. However, it would be highly valuable data for a patient suffering from coronary artery disease who just underwent stent implantation or for classes of drugs, such as non-insulin antidiabetics, that potentially affect cardiovascular function. Therefore, Meyyan believes it will be important for the industry overall to not fall into the trap of collecting additional patient data simply because it can. It will be more important for companies to make a targeted effort to only collect data which ultimately gives a more vivid picture of clinical outcomes, support the end point being pursued, and support the safety and efficacy profile of investigational treatments.

“More intriguing than the currently popular fitness watches, at least in a medical context, will be wearables designed to collect very specific types of patient outcome data,” states Meyyan. “For example, in April 2017, the FDA approved the disposable Cardea Solo ECG monitoring system (Cardiac Insight Inc.) which can be used to diagnose atrial fibrillation (AF) after cardiac ablation. The device is intentionally designed not to interfere with daily activity. We believe this will help to improve patient compliance. Technologies such as Cardea Solo blur the line between traditional diagnostic tools, which are used exclusively by the physician, and wearable devices, which are used jointly by the physician and the patient. Monitoring systems such as Cardea Solo will also demonstrate that wearables have the potential to collect meaningful, actionable data that will ultimately help improve overall patient outcomes.”  

More importantly, there remains an opportunity to develop and market these types of wearable technologies specifically for use in clinical trials to support the development of investigational treatments. In other words, they can be used as patient screening and monitoring tools, rather than simply diagnostic tools. For that to happen, Meyyan notes there is still a lot of work that needs to be done to solidify regulatory standards surrounding the use of wearables for clinical studies.   

• Where Do We Go From Here?

There is certainly a clear patient centricity angle present in the use of mobile and wearable devices in clinical trials. Most everyone today has a cell phone, if not a smart phone, that is carried with them at all times. Consumers are also increasingly relying on fitness tracking devices made by Apple, Fitbit, LINTELEK, and Garmin to monitor their vitals. Consumers will, at some point, demand that same flexibility when participating in clinical trials. After all, why go into a clinic to have a physician or nurse record data when a tracking device can do it for you?

As consumers demand more convenience in their lives, these devices can also make it easier for patients to participate in trials. By eliminating paper logs and trips to the clinic, wearables can help to eliminate two of the bigger challenges inherent in clinical trials, namely patient recruitment and retention.      

Still, Meyyan cautions companies to avoid incorporating wearables into studies simply for the sake of using a novel new device. Doing so may make for advantageous public relations, but will not have a significant impact on the long-term success of development programs, regulatory approvals, and the subsequent return on investment. Instead, sponsors and other key stakeholders must be strategic in deciding which types of studies and treatments will most benefit from incorporating these technologies.

“As the technology around wearables continues to evolve, particularly in the development of non-invasive devices designed for specific diseases and study types, we will likely begin to see greater adoption in clinical trials,” adds Meyyan. “We expect to see a significant uptick in their use over the coming years. In order to derive the most meaningful benefits, companies must be deliberate in defining the most meaningful types of data that can be captured via wearables. The end goal of supporting trials, and being patient-centric, must be held at the forefront incorporating any new technologies.”

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Study shows wearables lack clinical impact, but researchers haven’t lost hope

wearables devices

New research shows that wearables and remote patient monitoring technology have a limited impact on clinical outcomes. But digital health researchers aren't ready to abandon the promise of mobile technology. 

A literature analysis published in the new Nature Partner Journal (npj) Digital Medicine reviewed 27 randomized control studies focused on wearable biosensors and found no statistically significant impact on factors like body mass, waist circumference, body fat percentage, and systolic and diastolic blood pressure. The study adds to a growing body of research indicating that clinical evidence has struggled to keep pace with the hype surrounding wearables.

However, digging into 16 “high-quality” remote patient monitoring studies, the researchers, from Cedars-Sinai Medical Center in Los Angeles, found pockets of promising evidence for certain conditions like an obstructive pulmonary disease, Parkinson’s, hypertension and lower back pain. Even more specifically, interventions that use validated health behavior models and tailored coaching saw the highest success rates. In one study, monitoring technology had a significant impact on blood pressure for adults 55 and older.

Digital health tools could find more clinical success by pairing some of the successful elements outlined in the meta-analysis with a personalized approach to remote monitoring to generate "contextually appropriate, highly tailored messages to patients at the right time and right place," the authors wrote.

But, they added, many of the consumer products on the market have not been rigorously tested, and they warned healthcare leaders to “proceed with caution before implementing and using RPM to reliably change clinical outcomes." Although wearables have been widely touted as a tool to drive healthy habits, integrating those devices into the clinical setting remains a challenge.

"There is a big difference between using these sensors to track sleep for self-betterment and using them to make medical decisions," study co-author Michelle S. Keller, MPH, a clinical research specialist at the Cedars-Sinai Center for Outcomes Research and Education, said in a release.

There are several reasons those gaps exist, including a lack of data, inconsistencies from one study to the next and the fact that many studies were still in the pilot phase.

The study comes at a time when healthcare providers are increasingly interested in using wearables to assist with chronic disease management, and technology companies like Apple and Fitbit are happy to oblige. Apple recently announced its Apple Heart Study in partnership with Stanford to test Apple Watch’s ability to detect irregular heartbeats. Meanwhile, Fitbit devices are being used by Scripps Research Institute as part of the National Institutes of Health’s All of Us research.

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Empatica’s consumer-facing epileptic seizure-detecting wearable gets FDA clearance

Emaptica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone.

The Empatica Embrace is the latest version of a wearable developed by Rosalind Picard, an MIT professor who formerly co-founded a company called Affectiva. Back in late 2011, Affectiva launched an emotional arousal wearable called the Q-sensor based on Picard's research on children with epilepsy at Boston Children's Hospital. In April 2013, though, Affectiva discontinued the Q-sensor and refocused the company on emotional analysis for advertising focus groups. Picard left the company and joined up with Empatica, a company founded by Italians Matteo Lai and Simone Tognetti that was focused on creating a similar wearable.

Empatica developed a clinical version of the sensor called E3, but turned to Indiegogo to fund Embrace, the consumer version of the device, in January 2015. The company ultimately raised $782,666 — more than five times its goal.

Lai stated at the time that the company decided to transition into a consumer device because the need is so great.

"You might have quite a few friends that have epilepsy but they never told you," he said. "One in every 26 people suffers from epilepsy during their lifetime. And 1 percent of the population suffers during any given time."

Lai also said back in 2015 that people with epilepsy often don't want to admit it or have it widely known, so the important thing in creating a consumer device was that it be easy to use but also attractive to wear. Since the company plans to market the device to anyone who might want to use it for tracking stress, activity, or sleep, wearing it doesn't necessarily broadcast that the user has epilepsy.

"It’s a good-looking device," he said. "It’s the first time a medical device product looks beautiful and is something that you want to wear, not something to be ashamed of or a patch that you have to hide on your body because it’s ugly to look at."

Empatica has been seeking FDA clearance since 2015, but was able to crowdfund and sell the device in the meantime by offering it as a generalized health tracker/smartwatch and requiring US users to sign up for a clinical trial in order to use the Alert app, which allows the wearable to detect seizures and alert family members or caregivers.

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UCSD researchers develop wearable, 24-hour GI tract monitor

A wearable device, developed by researchers at the GI Innovation Group out of the University of California San Diego, can track electrical activity in the stomach over a 24-hour period. The device works similarly to how an ECG would work for the heart, but instead it monitors the electrical activities of the gastrointestinal tract. 

In a recent study published by Scientific Reports, researchers found that the device was able to collect data comparable to the clinical gold-standard, which is currently an invasive procedure. 

“Diseases of the gastrointestinal tract (stomach, intestines, etc) are one of the most common complaints in modern medicine,” Armen Gharibans, the paper's first author and a bioengineering postdoctoral researcher at the University of California San Diego, wrote to MobiHealthNews in an email. “Oftentimes, symptoms cannot be attributed to a medical condition despite appropriate workup. These disorders fall under the umbrella of functional disorders and make up more than 50 percent of patient referrals to GI specialists. There is an unmet need for new technologies in gastroenterology, especially ones that can monitor the patient outside of the clinic since GI activity and symptoms can vary greatly day to day.  We believe the technology we're developing can facilitate better understanding of the pathophysiology of these functional GI disorders and lead to novel and more targeted therapies.”

Right now there are limited resources for monitoring GI conditions, forcing many to go to specialized centers for treatment, according to the study. 

The new device is made up of a 3D-printed box that holds the electronics and battery and connects to 10 wearable electrodes. It works as an electrogastrogram (EGG) monitor, and was made from store-bought electrodes that are typically used in ECGs, according to a statement. EGGs often have technological issues including inconsistent results from a single-channel measurement and signal artifacts, which can make it difficult to interpret, according to the study. Researchers aimed to remedy this by using a multi-channel system and artifact removal signal processing methods. 

Researchers also developed a smartphone app to where patients can log their activity, bowel movements, sleep, and symptoms. The data from a smartphone is then synced with the device data for real-time feedback to the users, according to Gharibans.  

In the study, 11 children and one adult tested the device. The children included three males and eight females, aged seven to 17 years with a median BMI of 19. Researchers said that they studied the device on more girls than boys because indigestion is more common among females. 

The study participants underwent an antroduodenal manometry where a flexible catheter placed in the participant's nose monitors pressure in the antrum of the stomach. This procedure is commonly used to study the GI tract. 

Simultaneously, the participants were fitted with the EGG device, with the electrodes were placed over the stomach. Researchers then recorded the results of both the manometry and the EGG results, and found that their device yielded an increase of 0.56 in the mean correlation coefficient between EGG and the manometry method. 

“Our approach is noninvasive, easy to administer, and has promise to widen the scope of populations with GI disorders for which clinicians can screen patients, diagnose disorders, and refine treatments objectively,” the researchers wrote. 

The GI Innovation Group is continuing to work on the product but are still in the research phase, which includes collecting more data from patients, understanding limitations, and improving the analysis method, according to Gharibans. 

“We would like to eventually bring it to market, so we are actively exploring business opportunities and applying for small business grants to allow us to further develop and miniaturize the technology,” Gharibans wrote. 

In the future, Gharibans said the device could monitor a number of GI-related issues, including some very common conditions that impact a large subset of the US population. 

“Since our technology is focused on the stomach, the two main GI conditions that this could really help monitor are functional dyspepsia and gastroparesis,” Gharibans wrote. “Functional dyspepsia (i.e., chronic upset stomach) is reported by up to 20 percent of children and adolescents and is predicted to affect 20 percent to 40 percent of all the US population at least once in their lifetime. Gastroparesis, characterized by delayed gastric emptying in the absence of a mechanical obstruction, affects four percent of the US population, including 70 percent of Parkinson’s patients and 50 percent of diabetes patients. Both of these conditions are under-diagnosed and under-managed”

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How do Clinical Wearables Impact Patient Care and Quality of Life?

Health technology and clinical wearables are hot topics in the healthcare and pharmaceutical industries. They are creating waves of excitement and talking points for debate, while also topping many of the healthcare trends of this year.

One source suggests that 2018 will be the year of digital health technology, and it is quickly becoming apparent that clinical wearables are one of the most sought-after innovations when it comes to digital health. With the market growing and diversifying in compelling ways, it is worth looking at how clinical wearables are improving access to treatment, enhancing quality of life, and helping with the diagnosis and prognosis of certain conditions. 

What are Clinical Wearables? 

Clinical wearables can be defined as health technology that can be worn by the patient. The wearables contain sensors and use a wireless connection to pass data onto a smartphone or similar device. Wearables are being utilized in the healthcare industry in order to help healthcare practitioners collect, analyze, and leverage patient data for clinical trials, while also significantly improving patient care and overall quality of life. 

Clinical wearables aim to diagnose conditions earlier, minimize hospital stays and reduce invasive treatment options. In addition to this, they can help to cut medical cost and speed up rehabilitation times.

How is the Market for Clinical Wearables Growing?

As the years progress, the potential and ultimate value of clinical wearables are becoming more and more evident, which is why the global wearable medical devices market is set to reach $19.5 billion by 2021. In fact, health technology, in general, is a booming industry, growing by nearly 200% between 2010 and 2014. There now exist over 165,000 health-related apps on the Apple App Store, demonstrating just how in-demand this new form of technology is. 

Behind this surge in popularity are a number of factors, including an aging population, an increased patient interest in healthcare and medicine, and lifestyles that are generally more stress-inducing or challenging. Patients are no longer content to simply let medical professionals take the steering wheel with regards to their health. They want to have a say in their patient care and they want a more personal experience. This is where clinical wearables come in to play. 

How do Clinical Wearables Impact Patient Care and Quality of Life? 

Clinical wearables can help with disease management, monitoring and feedback, rehabilitation and health processes. The use of such wearables can help when it comes to the diagnosis and monitoring of a range of diseases (which will be mentioned below). Wearables can also help patients when it comes to adhering to a care plan, reminding them to take drugs, to calm down, or to seek help. 

The data collected by wearables is even being used to assess the effectiveness of new treatment plans while building mutually-beneficial relationships between doctors and patients. According to one study, of the patients surveyed, 96% of the respondents agreed that the use of clinical wearables helped to improve quality of life. There is also evidence to suggest that the use of wearables can even help to improve the well-being of the patient’s family.

Clinical wearables are being used to treat a range of diseases and disorders

Over the years, there have been huge strides in the field of clinical wearables, and today they are being used to monitor and treat a myriad of diseases and disorders. The hope for many is that the data collected from these devices can go on to not only help individual patients, but to resolve widespread pharmaceutical market access issues. 

Sufferers of asthma attacks now have access to an integrated wearable system that can monitor an individual’s environment, meaning it is possible to predict — and even prevent — asthma attacks.

Wearables are being used to help with the treatment of diabetes. In fact, researchers from the University of Texas have created a clinical wearable tool that measures diabetes-related compounds in patients’ sweat, which can be monitored for up to a week. The creators believe that the wearables give patients more control over their care. 

Wearables are also being helped to monitor Chronic Obstructive Pulmonary Disease (COPD), as they are able to track a patient’s heart rate, blood pressure, blood oxygen saturation, and glucose levels. 

It has recently been stated that the future of improved brain health can be achieved through digital health technology. This is certainly something we’re seeing with Alzheimer’s patients, of whom there are an estimated 47 million worldwide. With the use of wearables and patient monitoring devices, patients are now able to stay at home for longer, with the use of sensors that are placed around the individual’s home and on their body. The impact on quality of life is incredible, as the monitors are able to detect if patients miss a meal, have a fall, or don’t emerge from bed. 

Atrial fibrillation (AFib), the most common heart arrhythmia and a leading cause of strokes, is also being monitored by clinical wearables. The Apple Heart Study app is being used by AFib patients so doctors can monitor data on irregular heart rhythms. This is important as, incredibly, two out of three strokes are actually preventable if AFib is detected and appropriately treated.

On top of the disorders and diseases listed above, there are conditions such as obstructive pulmonary disease, Parkinson’s disease, and hypertension that can be improved and monitored with the use of wearables. As we move forward and technology and medical research advances, it is likely that this list will grow significantly and that patients will benefit from improved care and quality of life.

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Garmin Health partnering with the University of Kansas Medical Center on Innovative Digital Health Research

The University Of Kansas Medical Center is partnering with Garmin Health to foster innovation and better understand how healthcare wearables can help in the detection and management of significant medical conditions. Their first research will focus on cardiac care and sleep apnea.

Sleep apnea, a clinically under-detected and costly disorder to study, may affect over 18 million Americans. Garmin Health has worked with the KU Medical Center health experts to study how a wearable equipped with optical sensors could be used to detect sleep apnea and offer a lower cost alternative to an overnight sleep center evaluation.

Healthcare wearables have already increased the public awareness of activity levels while awake,” said Dr. Suzanne Stevens, M.D., Clinical Assistant Professor of Neurology of KU. "This research helps us better understand how wearable can do the same while asleep, helping to detect sleep apnea, which left untreated can affect mood, memory, trigger heart arrhythmias, heart attacks, and even strokes.”

Atrial fibrillation is an irregular and often rapid heart rhythm that can increase the risk of stroke by 500% and can cause a cardiac seizure. It is the most common cardiac arrhythmia, affecting millions of people in the United States alone with rates expected to continually increase. Like sleep apnea, atrial fibrillation has been cumbersome and costly to detect. Unfortunately, in 20% of patients, atrial fibrillation is not identified until they have a stroke.

"Wearable technology capable of early detection and monitoring of heart rhythm disorders will be a revolutionary boon to cardiac care,” said Madhu Reddy, M.D., Associate Professor of Medicine at KU Medical Center and Division Director, Heart Rhythm Services in the Department of Cardiovascular Medicine at The University of Kansas Health System.

"As patients assume increased responsibility for their own health-care, we are committed to develop wearables that can lead to the prevention or detection of serious health conditions. With long battery life, high water rating, and high-quality sensor data, we can provide meaningful features that will help reduce health care costs and provide useful functionality for everyday life,” stated Scott Burgett, Director of Garmin Health Engineering.

Garmin fitness segment develops technologies to enhance and promote healthy and active lifestyles. Garmin Health provides enterprise solutions that leverage Garmin wearables and the high-quality sensor data they produce for use in corporate wellness, population health, and patient monitoring markets.

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LifePlus announces glucose monitoring wearable

Now you can monitor your blood glucose levels just by looking at your wrist if LifePlus has its way. The startup has announced what it has hailed as the first noninvasive continuous blood glucose monitoring multi-sensor wearable.   

Named LifeLeaf, the device has the potential to revolutionize the mushrooming medical wearables segment.

The company announced that the innovative product, whose technological details are not known yet, is undergoing clinical trials in five cities across the world.

The patent-pending invention is based on open standards software and cloud-based analytics. The system gives users real-time notifications and cloud-based AI solutions.

John Trobough, executive chairman of the board, said that the startup, which had been in stealth mode, is excited to announce the introduction of LifeLeaf. He stressed the importance of early detection and management of diabetes and other chronic diseases. He termed LifeLeaf as a unique product and software technology available. “It is truly unique and we are excited to make this multi-sensor capability available to companies and developers globally,” he said.

The multi-sensor smartwatch contains embedded algorithms which extract key parameters, which are then sent to the user’s smartphone interface. Based on the glucose levels, users can decide if they want to alert their doctor.

The device can non-invasively monitor heart rates, chronic health conditions including diabetes, cardiac arrhythmia, congestive heart failure, COPD, sleep apnea, hypertension, respiration rate, blood pressure, and oxygen saturation.

LifeLeaf and LifePlus don’t have clearance from the FDA. The company claims to have the first noninvasive continuous blood glucose monitoring multi-sensor wearable. However, players like Prediktor Medical also have similar wearables currently undergoing development and testing.

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