The number of small, pilot clinical trials to evaluate new wearable devices continues to grow, as the once-untested technology is becoming another research tool for companies focused on developing new sensors for both handheld and wearable products.

Just last week, Propeller Health, a provider of an FDA-cleared digital health system for people with chronic respiratory diseases, announced a development agreement and R&D collaboration with GlaxoSmithKline for its Ellipta inhaler, the drug company’s patented dry powder inhaler. The inhaler will join the ranks of devices used in trials, a number that recently topped 300, according to Bloomberg.

Propeller will develop and manufacture a custom sensor for the Ellipta inhaler that will be used in GSK clinical studies in asthma and chronic obstructive pulmonary disease (COPD). In those studies, Propeller’s new sensor will automatically collect and record data on the inhaler’s usage and wirelessly transmit the information to a central data repository for researchers to analyze. The company also has developed a comparable system for Boehringer Ingelheim’s Respimat inhaler that received FDA clearance earlier this year.

“Using innovative sensor technology to improve the quality of adherence data collected during our studies will advance our understanding of disease and inform our decision-making in the development of new medicines,” David Allen, senior vice president of respiratory research and development at GSK, said as the deal was announced.

This year also marked the introduction of Apple’s ResearchKit, a new open source software framework designed for medical and health research apps that makes it easier for researchers to recruit volunteer participants for large-scale studies. Researchers are able to ask iPhone users from around the globe to download their iPhone apps and thus participate in medical studies.

The past 12 months also showed a variety of wearable devices from wristbands to Band-Aid-size patches that can provide patients and physicians with a variety of health-related data points beyond the basic Fitbits used by consumers. Among them:

• In March, Mayo Clinic and Gentag agreed to develop the next generation of wearable patch biosensors—the size of a small, disposable bandage—that communicates via a closed loop diabetes management system that is compatible with cellphones. The system, which includes a patent-pooling agreement with Mayo Clinic, allows researchers to monitor movement and develop treatments for obesity and related conditions. Gentag also is working on a clinical trial version of the patch, Gentag President and CEO John P. Peeters, Ph.D., told CWWeekly. He added, “We see a lot of interest not only in wearable but [also] disposable biomarker assays that are as easy to use and allow researchers to monitor movement and develop treatments for obesity and related conditions.”
• In June, Google’s life science group announced that it has developed a new health-tracking wristband that could be used in clinical trials and drug tests, enabling researchers or physicians minute-by-minute data on how patients are faring. The prescription-only wristband can measure pulse, heart rhythm and skin temperature, as well as environmental information such as light exposure and noise levels.
• This past summer, the FDA cleared Proteus Digital Health’s ingestible sensor device for use in the measurement of medication adherence—an expanded indication that communicates with an adhesive patch worn on the body. The company’s patch, which gained initial approval a few years ago to monitor drug compliance, has been improved to record time of ingestion along with steps, rest and heart rate, which it communicates to a mobile app via Bluetooth. “We believe that ingestible devices have the potential to speed clinical trials and improve the real-world effectiveness of medicines in community settings,” George Savage, M.D., Proteus co-founder and chief medical officer, said at the time.
• In August, NeuroMetrix, a developer of wearable medical technology and point-of-care tests designed to help patients and physicians better manage chronic pain and sleep disorders, reported clinical study results from its Quell Wearable Pain Relief device where 81% of 88 study participants reported improvement in chronic pain and overall health. The open label, single-arm, flexible-dosing, 60-day trial involved participants with complex medical histories with arthritis, diabetes, and sciatica and fibromyalgia.
• In November, the FDA announced it was seeking input on the optimal use of remote sensors used in wearable devices, along with telemedicine and health tools in a new docket in the Federal Register. In its ongoing quest for comments on how it can encourage the use of the technologies, the regulatory agency is looking for a better handle on the emerging arena as drug companies aim to use technology to improve clinical trials. The FDA said the benefits of the new tools enable increased data collection and communication, “creating opportunities to overcome geographical and logistical barriers that otherwise might prevent a potential participant from participating in a clinical investigation.”

Given how growing numbers of wearables seem to be a logical fit in the world of clinical trials, there also are a number of hurdles ahead including a challenging infrastructure as well as validation, security, privacy and protocol development issues, Michael Shanler, research director at Gartner Group, wrote in a recent blog posting.

Although the use of mobile devices will expand, wearable devices will be leveraged in fewer than 10% of clinical trials, according to Gartner. Success will depend on the ability to integrate wearables with data exchange and cloud-based analytics, along with the connection to eClinical systems.

“Seismic shifts in this market will not happen until the pharmaceutical lobby has confidence in the underlying system supporting wearables, and that means that clinical validation expertise for wearables must improve,” said Shanler. “Right now, the big IT consultant firms barely understand the clinical domain, let alone the clinical wearable domain, which will be even more specialized.” 

Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology. 

This article was reprinted from Volume 19, Issue 48, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »