Skin patch technologies could enable clinical laboratories to monitor patients’ vitals and report to medical professionals in real time
Pathologists and clinical laboratory leaders have read many Dark Daily ebriefings on the development of skin patches over the years that do everything from monitoring fatigue in the military to being a complete lab-on-skin technology. Now, researchers at the University of California San Diego (UCSD) have developed a wearable patch that can monitor cardiovascular signals and other various biochemical levels in the body simultaneously.
The researchers believe there is enormous potential for such a patch in helping patients monitor conditions such as hypertension or diabetes. They also foresee a scenario where the patch could be used in settings where vitals must be constantly monitored. They hope to develop future versions of the patch that can detect more biomarkers within the body.
“This type of wearable would be very helpful for people with underlying medical conditions to monitor their own health on a regular basis,” Lu Yin, a PhD student and co-first author of the study, told New Atlas. “It would also serve as a great tool for remote patient monitoring, especially during the COVID-19 pandemic when people are minimizing in-person visits to the clinic,” she added.
Combining Precision Medicine with Telehealth and the Internet of Things
About the size of a postage stamp and consisting of stretchy polymers that conform to the skin, the UCSD patch monitors blood pressure and contains sensors that measure different biochemical levels in the body, such as:
The sensors are carefully arranged on the patch to eliminate interference between the signals, noted a UCSD press release.
In their published research, the UCSD researchers wrote of their new skin patch monitoring device, “Intertwined with concepts of telehealth, the internet of medical things, and precision medicine, wearable sensors offer features to actively and remotely monitor physiological parameters. Wearable sensors can generate data continuously without causing any discomfort or interruptions to daily activity, thus enhancing the self-monitoring compliance of the wearer, and improving the quality of patient care.” (Photo copyright: University of California San Diego.)
“Each sensor provides a separate picture of a physical or chemical change. Integrating them all in one wearable patch allows us to stitch those different pictures together to get a more comprehensive overview of what’s going on in our bodies,” said Sheng Xu, PhD, Principle Investigator, Xu Research Group at UCSD, Assistant Professor in the Department of NanoEngineering Department, and a co-first author of the study, in the press release.
The UCSD researchers developed their skin patch to monitor specific biomarkers that can affect blood pressure.
“Let’s say you are monitoring your blood pressure and you see spikes during the day and think that something is wrong,” co-first author Juliane Sempionatto, PhD, a postdoctoral researcher at California Institute of Technology (Caltech) and co-first author of the study, told New Atlas. “But a biomarker reading could tell you if those spikes were due to an intake of alcohol or caffeine. This combination of sensors can give you that type of information,” she added.
The blood pressure sensor sits near the center of the patch and consists of a set of small transducers welded to the patch via a conductive link. Voltage applied to the transducers send ultrasound waves through the body which bounce off arteries and create echoes that are detected by the sensor and converted into an accurate blood pressure reading.
The chemical sensor releases the drug pilocarpine into the skin to induce sweat and then measures the chemicals contained in the sweat to provide readings of certain biochemical levels.
The glucose sensor located in the patch emits a mild electrical current to the body that stimulates the release of interstitial fluid and then reads the glucose level in that fluid.
“The novelty here is that we take completely different sensors and merge them together on a single small platform as small as a stamp,” Joseph Wang, D.Sc, SAIC Endowed Chair, Distinguished Professor of NanoEngineering, Director of the Center for Wearable Sensors at UCSD, and co-author of the study told New Atlas. “We can collect so much information with this one wearable and do so in a non-invasive way, without causing discomfort or interruptions to daily activity.” (Photo copyright: University of Southern California San Diego.)
Skin Patch Measurements Closely Match Those of Traditional Devices
Test subjects wore the patch on their neck while performing various combinations of the following tasks:
exercising on a stationary bicycle,
eating a high-sugar meal,
drinking an alcoholic beverage, and
drinking a caffeinated beverage.
The results of the measurements taken from the patch closely matched measurements collected by traditional monitoring devices such as a:
For now, the patch must be connected to an external power source which transmits the reading to a counter-top machine, but the researchers hope to create a wireless version in the future.
“There are opportunities to monitor other biomarkers associated with various diseases,” Sempionatto said in the UCSD press release. “We are looking to add more clinical value to this device.”
Other Similar Skin Patch Monitoring Technologies
Though an important breakthrough, the UCSD’s device is not the first skin patch monitor to be developed.
Multiple research and clinical studies are underway that hope to prove the accuracy and safety of wearable devices at detecting and monitoring certain health conditions. It’s a worthy goal.
Skin patches, such as the one created at UCSD, could enable clinical laboratories to provide value-added service to medical professionals and patients alike. Medical labs could potentially monitor skin patch readings in real-time and notify physicians and patients of changes in biomarkers that require attention.
Further, as this technology is developed, it will likely find a ready market with the latest generation of consumers who are more willing than previous generations to buy their own diagnostic tests for home use. These “next-generation” healthcare consumers have demonstrated their willingness to use Apple watches, Fitbits, and similar wearable devices to monitor their condition during exercise and other health metrics.
Pathologists and clinical laboratory managers should not overlook the potential for robust consumer demand to accelerate development and market adoption of such skin patches.
Medical laboratories may find opportunities guiding hospital telehealth service physicians in how clinical lab tests are ordered and how the test results are used to select the best therapies
Telehealth is usually thought of as a way for patients in remote settings to access physicians and other caregivers. But now comes a pair of studies that indicate use of telehealth in inpatient settings is outpacing the growth of telehealth for outpatient services.
This is an unexpected development that could give clinical laboratories new opportunities to help improve how physicians in telehealth services use medical laboratory tests to diagnose their patients and select appropriate therapies.
Dual Surveys Compare Inpatient and Outpatient Telehealth
Service Use
Definitive Healthcare (DH) of Framingham, Mass., is an analytics company that provides data on hospitals, physicians, and other healthcare providers, according to the company’s website. A survey conducted by DH found that use of telehealth solutions—such as two-way video webcams and SMS (short message service) text—has increased by inpatient providers from 54% in 2014 to 85% in 2019, a news release stated.
Meanwhile, a second Definitive Healthcare survey suggests
use of telehealth in outpatient physician office settings remained essentially
flat at 44% from 2018 to 2019, according to another news
release.
For the inpatient report, Definitive Healthcare polled 175 c-suite
providers and health
information technology (HIT) directors in hospitals and healthcare systems.
For the outpatient survey, the firm surveyed 270 physicians and outpatient
facilities administrators.
DH’s research was aimed at learning the status of telehealth
adoption, identifying the type of telehealth technology used, and predicting possible
further investments in telehealth technologies.
Most Popular Inpatient Telehealth Technologies
On the inpatient side, 65% of survey respondents said the most used telehealth mode is hub-and-spoke teleconferencing (audio/video communication between sites), Healthcare Dive reported. Also popular:
Fierce
Healthcarereports that the telehealth technologies showing the largest
increase by hospitals and health networks since 2016 are:
Two-way video/webcam between physician and
patient (70%, up from 47%);
Population health management tools, such as SMS
text (19%, up from 12%);
Remote patient monitoring using clinical-grade
devices (14%, up from 8%);
Mobile apps for concierge services (23%, up from
17%).
“Organizations are finding new and creative ways through telehealth to fill gaps in patient care, increase care access, and provide additional services to patient populations outside the walls of their hospital,” Kate Shamsuddin, Definitive Healthcare’s Senior Vice President of Strategy, told Managed Healthcare Executive.
DH believes investments in telehealth will increase at
hospitals as well as physician practices. In fact, 90% of respondents planning
to adopt more telehealth technology indicated they would likely start in the
next 18 months, the news releases state.
Most Popular Outpatient Telehealth Technologies
In the outpatient telehealth survey, 56% of physician
practice respondents indicated patient portals as the
leading telehealth technology, MedCity
News reported. That was followed by:
Hub-and-spoke teleconferencing (42%);
Concierge services (42%);
Clinical- and consumer-grade remote patient
monitoring products (21% and 12%).
While adoption of telehealth technology was flat over the
past year, 68% of physician practices did use two-way video/webcam technology
between physician and patient, which is up from 45% in 2018, Fierce
Healthcare reported.
The graph above, taken from the Definitive Healthcare 2019 survey, shows the percentage of telehealth use among surveyed outpatient settings. “The results show how telehealth continues to be one of the core linchpins for providers,” Kate Shamsuddin, Definitive Healthcare’s Senior Vice President of Strategy, told Healthcare Dive. (Graphic copyright: Definitive Healthcare.)
MedCity News reports that other telehealth technologies in
use at physician practices include:
Mobile apps for concierge service (33%);
Two-way video between physicians (25%);
SMS population management tools (20%).
Telehealth Reimbursement and Interoperability Uncertain
Why do outpatient providers appear slower to adopt
telehealth, even though they generally have more patient encounters than
inpatient facilities and need to reach out further and more often?
Definitive Healthcare reports that 20% of physician practice
respondents are “satisfied with the practice’s current solutions and services,”
and though telehealth reimbursement is improving, 13% are unsure they will be
reimbursed for telehealth services.
The Centers
for Medicare and Medicaid Services (CMS) states that Medicare
Part B covers “certain telehealth services,” and that patients may be
responsible for paying 20% of the Medicare approved amount. CMS also states
that, effective in 2020, Medicare
Advantage plans may “offer more telehealth benefits,” as compared to
traditional Medicare.
“There is not only a need for more clarity around reimbursement policies, but also a need for more interoperable telehealth solutions that can be accessed through electronic health record or electronic medical record systems, as well as a better understanding about what types of telehealth options are available,” said Jason Krantz (above), CEO, Definitive Healthcare, in the outpatient telehealth survey news release. (Photo copyright: Definitive Healthcare.)
The increase in telehealth use at hospitals—as well as its
increased adoption by physician offices—may provide clinical laboratories with opportunities
to assist telehealth doctors with lab test use and ordering. By engaging in telehealth
technology, such as two-way video between physicians, pathologists also may be
able to help with the accuracy of diagnoses and timely and effective patient
care.
Clinical laboratory leaders aiming for patient-centered care and precision medicine outcomes need to acknowledge that patients do not want to be in hospitals or travel to physician offices and patient care centers for blood tests. It can be inconvenient, sometimes costly, and often painful.
That’s why disease management methods such as remote patient monitoring are appealing to many people. It’s a big market estimated to reach $1 billion by 2020, according to a Transparency MarketResearch Report. The study also associated popularity of devices such as heart rate and respiratory rate monitors with economic pressures of unnecessary hospital readmissions.
But can remote patient monitoring be used for more than to check heart rates, monitor blood glucose, and track activity levels? Could such technology be effectively leveraged by medical laboratories for remote blood sampling?
Microsampling versus Dried Blood Collecting
Remote patient monitoring must be able to address a large number of diseases and chronic health conditions for it to continue to expand and gain acceptance as a viable way to care for patients in different settings outside of hospitals. However, as most clinical pathologists and laboratory scientists know, clinical laboratory testing has an essential role in patient monitoring. Thus, there is the need for a way to collect blood and other relevant samples from patients in these remote settings.
One promising approach is the development of new microsampling technology that can overcome past obstacles of dried blood collection. Furthermore, microsampling-enabled devices can make it possible for medical laboratories to reach out to the homebound to secure accurate and volumetrically appropriate samples in a cost-effective manner.
“One well-established fact in today’s healthcare system is that an ever-greater proportion of patients want clinical care that is less invasive and less intrusive,” noted Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report. “Patients want to take more control over their treatment and be more effective at maintaining the stability of their chronic conditions, and often are happier than those who need to travel to have chronic conditions monitored. To meet this need there has been significant innovation, particularly in the area of remote blood sampling using microsampling technology.”
For decades, medical laboratories have tried various methods for acquiring and transporting blood samples from remote locations. One such non-invasive alternative to venipuncture is called dried blood spot (DBS) collecting. It involves placing a fingerprick of blood on filter paper and allowing it to dry prior to transport to the lab.
But DBS collected bio samples often do not contain enough hematocrit (volume percentage of red blood cells) for laboratories and clinical pathologists to provide accurate reports and interpretations. Reported reasons DBS cards have not penetrated a wide market include:
Hematocrit bias or effect;
Costly card punching and automation equipment; and,
Possible disruption to existing lab workflows.
Microsampling Technology Enables Collection of Appropriate Samples
Microsampling has to have the capability to enable labs to deliver quality results from reliable blood samples. This remote sampling technology makes it possible for phlebotomists to offer a comfortable collection alternative for homebound patients and rural residents. It also can be useful for physicians stationed in remote areas. Patients themselves can even collect their own blood samples.
Volumetric Absorptive Microsampling (VAMS) technology enables accurate samples of blood or other fluids from amounts as small as 10, 20, or 30 microliters, according to Neoteryx, LLC, of Torrance, Calif., the developer of VAMS. The technology is integrated into the company’s Mitra microsampler blood collection devices (shown above) in formats for patient use and for medical laboratory microsample accessioning and extraction. Click here to watch a video on the Mitra Microsampler Specimen Collection Device. (Photo copyright: Neoteryx.)
One company developing these types of products is Neoteryx, LLC, of Torrance, Calif. It develops, manufactures, and distributes microsampling products. Patients with the company’s Mitra device use a lancet to puncture their skin and draw a small amount of blood, collect it on the device’s absorptive tip, and then mail the samples to a blood lab for testing (Neoteryx does not perform testing).
“Technologies such VAMS are driving [precision medicine] in an extremely cost-effective manner, while only requiring minimal patient effort. Patients are taking a more active role in their healthcare journeys, and at-home sampling is supporting this shift,” stated Fasha Mahjoor, Chief Executive Officer, Neoteryx, in a blog post. (Photo copyright: Neoteryx.)
Advantages of Microsampling
Patient satisfaction survey data collected by Neoteryx suggest patients are comfortable with their role in blood collection:
70% are comfortable or very comfortable with the process;
86% say it is easy or very easy to use the Mitra device;
92% report it is easy to capture blood on the device’s tip;
55% of Mitra device users are likely or very likely to choose microsampling over traditional venipuncture; and,
93% noted they are likely or very likely to choose the device for child care.
A list of published studies describes certain advantages of VAMS technology that have implications for medical laboratories and clinical pathologists:
Microsampling has benefits and implications for therapeutic drug monitoring, infectious disease research, and remote specimen collection;
Dried blood microsamples from fingerstick can generate reliable data “correlating” to traditional blood collection processes;
Bioanalytical data collected with the Mitra device are accurate and dependable; and,
In a study for a panel of anti-epileptic drugs, VAMS led to optimized extraction efficiency above 86%, which means there was no hematocrit bias.
Learn More by Requesting the Dark Daily Microsampling White Paper
Rise of patient-centered care and remote patient monitoring;
Dried blood collection over the years and the hematocrit effect;
A look at microsampling and how it takes blood collection out of the clinic;
How Volumetric Absorptive Microsampling (VAMS) technology works;
Patient satisfaction data;
Research about microsampling including extensive graphics;
Launching new VAMS technology; and,
Frequently asked questions.
Innovative medical laboratory leaders who want to increase their understanding of how microsampling technology and remote patient monitoring relates to the goal of becoming a patient-centered lab are encouraged to request a copy of the white paper. It can be downloaded at no cost by clicking here, or placing https://www.darkdaily.com/how-to-create-a-patient-centered-lab-with-breakthrough-blood-collection-technology-9-2018/ into your browser.
New service allows patients statewide to access urgent care via telephones and other devices as Cleveland Clinic positions itself to be a 24/7 provider of choice
Urgent care by telephone is the latest patient-centric and customer-friendly medical service to be offered by the Cleveland Clinic. It is also the first 24-hour online statewide healthcare service of its kind in Ohio, a milestone that has implications for pathologists and clinical laboratory executives because lab testing is often required in support of patients wanting access to urgent care, particularly after hours.
Implantable devices with this technology could be designed to perform some of the same kinds of assays currently handled in medical labs
Implantable diagnostic devices that report results wirelessly to patients’ physicians could be both a threat and an opportunity for clinical laboratories and pathology groups. News of clearance by the Food and Drug Administration (FDA) of an implantable monitoring device for home use by heart patients demonstrates that such technology is improving with rapid speed.
Could Implantable Monitoring Devices Replace Some Medical Lab Tests?
Patients use CardioMEMS from the comfort of their homes. The implantable monitoring device measures pulmonary artery pressures and heart rates and transmits that data wirelessly to physicians. It was last summer when the FDA cleared the CardioMEMS Heart Failure Management System, manufactured by St. Jude Medical of St. Paul, MN. Such implantable technology could eventually perform certain assays currently handled in medical laboratories. (more…)
