The wearable era is coming: top 15 devices for clinical trials
With the popularity of wearable devices such as Apple Watch and fitness trackers, that can collect data on a 24/7 basis, there is no denying that this technology has become common in most people’s daily routine. The number of activated devices has more than doubled over the last 3 years. According to Statista, more than 325 million wearable gadgets are connected to the internet.
Constant data stream
Wearables make people’s experience measurable and trackable in a way that was impossible before, and they enable them to passively monitor health data around the clock, even when they are sleeping.
With greater adoption of technology and a greater value, wearable technology is also revolutionizing the way clinical trials are conducted by changing the ways of collecting, processing, and visualizing data. For example, a sensor can be used to track pulse transit time information, data that is incredibly meaningful for researchers and patients, for example in various sleep studies to detect sleep apnea, sleeping disorders or hypopnea. Another case is when blood pressure apps and wearables can track the pressure of the patients with hypertension and send them alerts about when to record pressure, and they can also give lifestyle guidance.
Right now, ClinicalTrials.gov, a global registry of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description.
Expanding the depth of data with regulators
Currently, the industry is quite enthusiastic about this relatively new category of devices. On the one hand, regulators are very interested in digital health and are motivated to help to introduce innovative methods of data collection in clinical trials. On the other hand, the issue of having a clear framework for regulating and channeling the use of wearables in clinical trials remains open since there are still many unresolved points. It is a given that all devices must go through quality and safety checks and be approved by the FDA before they can be released into the market. However, another key factor is whether a gadget is classed as a wearable medical device (WMDs) or not, for if it does not qualify as a WMD, it goes to the market unregulated. This explicitly calls for more data and a better understanding of methodologies, terminology and technical standards when it comes to bringing mobile health trackers into the intricacies of clinical research. Among the most debated issues raised by the industry leaders and regulators today are questions on what the data source is and what should be reported as results etcetera.
As it is, a lot of standardization work remains to be done that would help to harmonize the field and facilitate the development and adoption of best practices for technology implementation, remote data collection, analysis, and interpretation.
For pharma and CROs looking into ways to innovate and upgrade their studies and make them more effective, but who have reservations about introducing breakthrough technologies, a consultation with a reliable vendor should be the first step. Data MATRIX company, a leading eClinical provider in the Eastern European market, has announced the release of its new generation ePRO in February 2019, also becoming a pioneer provider of ePRO in Russia. As of now, over 1,000 clinical trial patients have tested the app, with all the data being collected in full compliance with local and international regulations. But the company does not stop there, honing and upgrading its software in order to achieve full synchronization with wearable solutions including BGM and CGM glucometers, electronic scales, mobile EСG and other certified 510k wearable devices via Bluetooth®️ and Wi-Fi. The goal of these initiatives is to make the process of gathering patient’s data even more streamlined and reliable.
Top 15 list of wearable devices
Litmus Health, a real-world data firm, examined more than 190 brands and manufacturers and has provided a report about remote monitoring and leveraging wearable devices and sensors in clinical trials.
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ActiGraph, GT9X Link;
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ActiGraph, WGT3X-BT;
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Apple Watch Series 4 GPS;
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Atlas Shape;
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Empatica E4;
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Fitbit Ionic;
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Garmin Vivomore HR;
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Huawei Band 3 PRO;
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Oura;
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Polar A370;
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Samsung Gear Fit2 PRO;
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Spire Health Tag;
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Strive Apex HR;
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VitalConnect VitalPatch;
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Withings Steel HR.
“We are witnessing a big step forward in facilitating the adoption of wearable technologies in clinical trials. It is safe to assume that in just 5 years, clinical development is going to look very different сompared to the traditional means of health‐related data collection, and more data will be collected with automated tools. All these gadgets with a focus on data quality and transparency appear to be tremendously cost-saving and efficiency-maximizing solutions, — Max Stevens, Chief Strategy and Development Officer of Data MATRIX.
