• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » Using wearable devices in clinical trials

Using wearable devices in clinical trials

March 12, 2019 By Danielle Kirsh

imarcBrandy Chittester, chief of clinical operations, IMARC

Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns.

Here’s a look at how researchers are using wearable devices — and what you should consider before using them in your own research.

How wearable devices are advancing medicine

Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description.

This includes wearable devices intended for medical use, as well as testing other medical devices using wearable technology.

Here are just a few examples:

  • A study evaluating the utility of Fitbit for diagnosing sleep apnea
  • A study evaluating the feasibility of using Garmin watches to detect atrial fibrillation
  • A study evaluating the feasibility of using a wearable device to improve arm movement in people who have had a stroke
  • A study assessing the effectiveness of a wearable, automated bionic pancreas system that delivers both insulin and glucagon to young children with diabetes

Benefits of wearable devices in clinical research

Wearable devices can certainly benefit patients, but they can also offer many benefits to clinical researchers.

These benefits include:

  • More convenient and less intrusive for participants, since participants can collect data in the comfort of their own home.
  • Easier to identify a baseline for individual patients and show patterns over time, which can allow for more precise treatment
  • The potential for a larger sample size, since it’s easier to recruit patients remotely
  • More accurate results, since wearable devices can collect data 24 hours a day, seven days a week, and data is more objective than paper diary entries
  • Researchers spend less time on data entry since data is collected in real time
  • Researchers can identify and respond to adverse events more quickly.
  • Data collection may be less expensive, depending on the devices used

Wearable devices in clinical trials: challenges and considerations

Using wearable devices can pose several challenges — including regulatory concerns and logistical issues.

A July 2018 report published in Clinical Pharmacology and Therapeutics called Wearable Devices in Clinical Trials: Hype and Hypothesis, outlines several of these concerns.

Many wearable devices are not medical devices

Although the Internet of Things offers enormous potential for smart, wearable medical devices, many wearable devices do not undergo the same rigorous regulatory process as other medical devices. Many make health claims that are not substantiated by the FDA or any regulatory board.

For instance, doctors have expressed concerns about some wearable devices intended to monitor a baby’s vital signs. Many of these products have not been evaluated by the FDA, and doctors say they can generate false alarms and even lead to unnecessary tests on otherwise healthy infants. Using devices like these in a clinical study that must adhere to FDA regulations could potentially be problematic.

There are also concerns about using wearable medical devices in drug trials since the approval process is different for drugs versus devices.

Challenges with processing data

Most clinical researchers are not accustomed to processing the massive amounts of raw, unfiltered data that is collected via wearable devices. They need to be able to eliminate invalid data, understand which sets of data are required to maintain an audit trail, and which data should be reported as a final result.

There may also be differences in how data is recorded and stored from one device to another, which can create consistency issues.

Ethical and legal challenges

While data obtained by medical devices is protected by patient privacy laws (HIPAA in the United States), those same protections don’t apply to consumer-grade wearable devices like fitness trackers.

Data obtained by consumer-grade devices may contain private health information that can be shared in an aggregate form without explicitly stating who will have access to it.

However, in the European Union, the new General Data Protection Regulation (GDPR) does not distinguish between device type. It requires that all data generated by wearable devices or apps have clearly defined purposes for use. Users must consent to have their data from these devices reused, and they may withdraw their consent at any time.

What’s next for wearable devices in clinical trials

Researchers considering the use of wearable devices in clinical trials need to recognize these factors as they develop their study protocol and conduct risk assessments.

They will need to determine what types of wearable devices are acceptable to use and understand how different device types could impact data collection.

They need to ensure patients understand how to use these devices properly and clearly outline expectations for when and how to wear them during the study.

Additionally, researchers may need to update disclosures and consent forms so patients fully understand what data is being collected, how it will be used and how any personally identifiable information or private health data will be protected.

Our team is excited about the potential for using wearable devices in clinical research, and we have relevant experience in this area.

If you are interested in using wearable devices in an upcoming clinical trial, contact us to learn more about how we can help you achieve compliance and earn approval.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

Filed Under: Blog Tagged With: IMARC

In case you missed it

  • ZimVie sales down more than 11% in Q2 as it streamlines after spinoff
  • Data supports use of Channel Medsystems Cerene cryotherapy
  • The 10 largest orthopedic device companies in the world
  • Nanopath raises $10M Series A for women’s health diagnostics
  • Avenda wins FDA IDE nod for AI-enabled prostate cancer therapy
  • NuVasive chief commercial officer Massimo Calafiore is stepping down
  • Preparing your medical device company for challenging market conditions
  • Dentsply Sirona replaces chief accounting officer amid internal investigation
  • Haemonetics stock rises on Street-beating Q1, raised guidance
  • Surgalign settles on OEM business sale, posts Q2 earnings miss
  • Alcon lowers its 2022 forecast amid strong dollar
  • Masimo beats Street in Q2 as healthcare business catches up
  • Senseonics stock is up as it sticks by revenue guidance
  • Butterfly Network asks judge to dismiss Fujifilm Sonosite IP suit
  • Stereotaxis stock down amid cloudy outlook
  • BD, Labcorp collaborate on flow cytometry-based diagnostics
  • NeuroOne submits special FDA 510(k) application for Evo sEEG electrode

RSS From Medical Design & Outsourcing

  • COVID-19 immunity test developers at MIT seek diagnostic manufacturer
    MIT researchers have developed a device for predicting an individual’s COVID-19 immunity and are looking for a diagnostic company to get it manufactured in large numbers and approved by the FDA. The lateral flow test uses the same technology as at-home rapid antigen COVID-19 tests to measure neutralizing antibodies for SARS-CoV-2 in a blood sample,… […]
  • GE Healthcare picks AI imaging startups for inaugural Edison Accelerator
    GE Healthcare and Nex Cubed have selected seven companies focused on artificial-intelligence-augmented medical imaging for the first cohort of the Edison Accelerator in Canada. The companies will be matched with mentors and test their technologies with GE’s new Edison Digital Health Platform over the next three months. The program will end with innovation showcase presentations… […]
  • Boston Scientific whistleblower launches corruption investigation
    Boston Scientific (NYSE:BSX) is investigating claims that the company violated the U.S. Foreign Corrupt Practices Act in Vietnam. Marlborough, Massachusetts–based Boston Scientific disclosed receipt of a whistleblower’s allegations in its latest filing with the Securities and Exchange Commission. “In March 2022, the company received a whistleblower letter alleging Foreign Corrupt Practices Act violations in Vietnam.… […]
  • 5 essential leadership lessons from Cathy Burzik for medtech’s next generation of women leaders
    Cathy Burzik, a seasoned senior executive in the healthcare industry, has successfully led major medical device, diagnostic, diagnostic imaging and life sciences businesses. Cathy Burzik, CFB Interests (as told to MedExecWomen co-founder Maria Shepherd) One key to being a successful women leader in MedTech: “Play nice, but play to win.” Cathy Burzik, who received a… […]
  • Stratasys plans to buy Covestro’s additive manufacturing business
    Stratasys (Nasdaq:SSYS) said today that it has a deal to purchase the additive manufacturing materials business of Covestro. The deal includes R&D facilities and activities, global development and sales teams across Europe, the U.S. and China, a portfolio of approximately 60 additive manufacturing materials, and hundreds of patents and patents pending, Stratasys said in a… […]
  • New implant design prevents scar tissue without drugs, MIT says
    Mechanically inflating and deflating an implantable device for 10 minutes a day prevents immune cells from building the scar tissue that has been a major obstacle for artificial pancreas researchers. That’s according to new findings from a team of MIT engineers who built mechanical deflection into a two-chambered, soft polyurethane device tested on mice. By… […]
  • Blue Spark’s TempTraq catches fevers faster. Fever prediction is next.
    Blue Spark Technologies developed the first wireless continuous temperature monitor patch, TempTraq, to enable faster fever detection than standard manual readings every four hours. Westlake, Ohio-based Blue Spark is now looking at fever prediction rather than just detecting them. The R&D team is working on developing an AI neural network model built on the company’s… […]
  • Harvard researchers plan to sell at-home, PCR-grade COVID testing system
    The Harvard University researchers who developed an ultrasensitive, PCR-grade nucleic acid detection technology plan to commercialize it as a portable COVID-19 test. Harvard Medical School professor Peng Yin, who also leads the Wyss Institute for Biologically Inspired Engineering’s Molecular Robotics Initiative, founded 3EO Health to sell the device. “In order to optimize the value of… […]
  • FDA reports sterilization challenge progress as EPA takes aim at EtO emissions
    The FDA offered an update on its efforts to make medical device sterilization safer as the EPA identified 23 U.S. facilities where use of ethylene oxide (EtO) presents a risk to communities. The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage… […]
  • AdvaMed defends EtO facilities on EPA’s cancer risk list
    The Advanced Medical Technology Association (AdvaMed) today reacted to the EPA’s listing of commercial sterilization facilities causing elevated risks of cancer with a defense of the facilities and a call for more research. AdvaMed CEO and President Scott Whitaker said all of the listed facilities are in compliance with regulations and warned against closures. “The… […]
  • EPA flags high-cancer-risk EtO sterilization facilities across the country
    The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities. EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices —  and in some cases it’s the only… […]

Primary Sidebar

DeviceTalks Weekly

August 5, 2022
DTW Medtronic's Greg Smith lays out supply chain strategies
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy