The ongoing study shows promise in the general development of self-powered wearable biosensors, the researchers say, in a development that has implications for clinical laboratory testing
Years back, it would be science fiction to describe a wearable garment that can not only measure an individual’s biomarkers in real-time, but also generates the power the device needs from the very specimen used for the measurement. Clinical laboratory managers and pathologists may find this new technology to be an interesting milestone on the path to wearable diagnostic devices.
With cases of diabetes on the rise across the globe, innovative ways to monitor the disease and simplify care is critical for effective diagnoses and treatment. Now, a team of researchers at Tokyo University of Science (TUS) in Japan have recently developed a diaper that detects blood glucose levels in individuals living with this debilitating illness.
Of equal interest, this glucose-testing diaper has a self-powered sensor that utilizes a biofuel cell to detect the presence of urine, measure its glucose concentration, and then wirelessly transmit that information to medical personnel and patients. The biofuel cell generates its own power directly from the urine.
Glucose in urine provides valuable data regarding blood sugar levels and can be used as an alternative to frequent blood draws to measure those levels. Monitoring the onset and progression of diabetes is crucial to making patient care easier, particularly in elderly and long-term care patients. Widespread use of these diapers in skilled nursing facilities and other healthcare settings could create an opportunity for clinical laboratories to do real-time monitoring of the blood sugar measurements and alert providers when a patient’s glucose levels indicate the need for attention.
“Besides monitoring glucose in the context of diabetes, diaper sensors can be used to remotely check for the presence of urine if you stock up on sugar as fuel in advance,” said Isao Shitanda, PhD, Associate Professor at the Department of Pure and Applied Chemistry, Faculty of Science and Technology, Tokyo University of Science, in a TUS press release. “In hospitals or nursing care sites, where potentially hundreds of diapers have to be checked periodically, the proposed device could take a great weight off the shoulders of caregivers,” he added.
Through electrochemistry, the scientists created their paper-based biofuel cell so that it could determine the amount of glucose in urine via reduction oxidation reactions, or redox for short. Using a process known as “graft polymerization,” they developed a special anode that allowed them to “anchor glucose-reactive enzymes and mediator molecules to a porous carbon layer, which served as the base conductive material,” the press release noted.
The biosensor was tested using artificial urine at different glucose levels. The energy generated from the urine then was used to power up a Bluetooth transmitter to remotely monitor the urine concentration via a smartphone. The TUS researchers determined their biofuel cell was able to detect sugar levels present in urine within one second. The diaper with its sensor could help provide reliable and easy monitoring for diabetic and pre-diabetic patients.
“We believe the concept developed in this study could become a very promising tool towards the general development of self-powered wearable biosensors,” Shitanda said in the press release.
According to the Isao Shitanda, PhD (above), lead author of the TUS study, 34.2 million people, or just over 10% of the US population, were diagnosed with diabetes in 2020. The federal Centers for Disease Control and Prevention estimates that an additional 7.3 million people have diabetes and are undiagnosed. A self-powered biosensor that detects diabetes and prediabetes in urine could help clinical laboratories and doctors catch the disease early and/or monitor its treatment. (Photo copyright: Tokyo University of Science.)
The World Health Organization (WHO) estimates that 422 million people globally were living with diabetes in 2014, and that 1.5 million deaths could be attributed directly to diabetes in 2019.
A panel of colored squares embedded on the front of the diaper changed color if specific chemical reactions fell outside normal parameters. If such a color change was observed, a smart phone application could relay that information to the baby’s doctor to determine if any further testing was needed.
Since we wrote that ebriefing in 2013, Pixie Scientific has expanded its product line to include Pixie Smart Pads, which when added to a diaper, enable’s caregivers to monitor wearers for urinary tract infections (UTI) and report findings by smartphone to their doctors.
These examples demonstrate ways in which scientists are working to combine diagnostics with existing products to help people better manage their health. Wearable electronics and biosensors are increasingly helping medical professionals and patients monitor bodily functions and chronic diseases.
As clever as these new wearable devices may be, there is still the need to monitor the diagnostic data they produce and interpret this data as appropriate to the patient’s state of health. Thus, it is likely that pathologists and clinical laboratory professionals will continue to play an important role in helping consumers and providers interpret diagnostic information collected by wearable, point-of-care testing technology.
Clinical laboratory leaders will want to pay close attention to a significant development in Maryland. The state’s All-Payer Medicare program—the nation’s only all-payer hospital rate regulation system—is broadening in scope to include outpatient services starting Jan. 1. The expanded program could impact independent medical laboratories, according to the Maryland Hospital Association (MHA), which told Dark Daily that those labs may see hospitals reaching out to them.
The Centers for Medicare and Medicaid Services (CMS) and the state of Maryland expect to save $1 billion by 2023 in expanding Maryland’s existing All-Payer Model—which focused only on inpatient services since 2014—to also include primary care physicians, skilled nursing facilities, independent clinical laboratories, and more non-hospital settings, according to a CMS statement.
Healthcare Finance notes that it represents “the first time, CMS is holding a state fully at risk for the total cost of care for Medicare beneficiaries.”
Value of Precision Medicine and Coordination of Care to Clinical Labs
“If a patient receives care at a [medical] laboratory outside of a hospital, Maryland hospitals would be looking at ways to coordinate the sharing of that freestanding laboratory information, so that the hospital can coordinate the care of that patient both within and outside the hospital setting,” Erin Cunningham, Communications Manager at MHA, told Dark Daily. Such a coordinating of efforts and sharing of clinical laboratory patient data should help promote precision medicine goals for patients engaged with physicians throughout Maryland’s healthcare networks.
The test of the new program—called the Total Cost of Care (TCOC) Model—also could be an indication that Medicare officials are intent on moving both inpatient and outpatient healthcare providers away from reimbursements based on fees-for-services.
CMS and the state of Maryland said TCOC gives diverse providers incentives to coordinate, center on patients, and save Medicare per capita costs of care each year.
“What they are really doing is tracking how effective we are at managing the quality and the costs of those particular patients that are managed by the physicians and the hospitals together,” Kevin Kelbly, VP and Chief Financial Officer at Carroll Hospital in Westminster, told the Carroll County Times. “They will have set up certain parameters. If we hit those parameters, there could be a shared savings opportunity between the hospitals and the providers,” he added. (Photo copyright: LifeBridge Health.)
The TCOC runs from 2019 through 2023, when it may be extended by officials for an additional five years.
How Does it Work?
The TCOC Model, like the earlier All-Payer Model, will limit Medicare’s costs in Maryland through a per capita, population-based payment, Healthcare Finance explained.
It includes three programs, including the:
Maryland Primary Care Program (MDPCP), designed to incentivize physician practices by giving additional per beneficiary, per month CMS payments, and incentives for physicians to reduce the number of patients hospitalize;
Care Redesign Program (CRP), which is a way for hospitals to make incentive payments to their partners in care. In essence, rewards may be given to providers that work efficiently with the hospital to improve quality of services; and,
Hospital Payment Program, a population-based payment model that reimburses Maryland hospitals annually for hospital services. CMS provides financial incentives to hospitals that succeed in value-based care and reducing unnecessary hospitalizations and readmissions.
CMS and Maryland officials also identified these six high-priority areas for population health improvement:
Substance-use disorder;
Diabetes;
Hypertension;
Obesity;
Smoking; and
Asthma.
“We are going to save about a billion dollars over the next five years, but we are also providing better quality healthcare. So it’s going to affect real people in Maryland, and it helps us keep the whole healthcare system from collapsing, quite frankly,” Maryland Gov. Larry Hogan, told the Carroll County Times.
OneCare in Vermont, Different Approach to One Payer
Maryland is not the only state to try an all-payer model. Vermont’s OneCare is a statewide accountable care organization (ACO) model involving the state’s largest payers: Medicare, Medicaid, and Blue Cross and Blue Shield of Vermont, Healthcare Dive pointed out. The program aims to increase the number of patients under risk-based contracting and, simultaneously, encourage providers to meet population health goals, a Commonwealth Fund report noted.
Both Maryland’s and Vermont’s efforts indicate that payment plans which include value-based incentives are no longer just theory. In some markets, fees-for-service payment models may be gone for good.
Clinical laboratory leaders may want to touch base with their colleagues in Maryland and Vermont to learn how labs in those states are engaging providers and performing under payment programs that, if successful, could replace existing Medicare payment models in other states.
Should greater attention be given to protein damage in chronic diseases such as Alzheimer’s and diabetes? One life scientist says “yes” and suggests changing how test developers view the cause of age-related and degenerative diseases
DNA and the human genome get plenty of media attention and are considered by many to be unlocking the secrets to health and long life. However, as clinical laboratory professionals know, DNA is just one component of the very complex organism that is a human being.
In fact, DNA, RNA, and proteins are all valid biomarkers for medical laboratory tests and, according to one life scientist, all three should get equal attention as to their role in curing disease and keeping people healthy.
Along with proteins and RNA, DNA is actually an “equal partner in the circle of life,” wrote David Grainger, PhD, CEO of Methuselah Health, in a Forbes opinion piece about what he calls the “cult of DNA-centricity” and its relative limitations.
Effects of Protein Damage
“Aging and age-related degenerative diseases are caused by protein damage rather than by DNA damage,” explained Grainger, a Life Scientist who studies the role proteins play in aging and disease. “DNA, like data, cannot by itself do anything. The data on your computer is powerless without apps to interpret it, screens and speakers to communicate it, keyboards and touchscreens to interact with it.”
“Similarly,” he continued, “the DNA sequence information (although it resides in a physical object—the DNA molecule—just as computer data resides on a hard disk) is powerless and ethereal until it is translated into proteins that can perform functions,” he points out.
According to Grainger, diseases such as cystic fibrosis and Duchenne Muscular Dystrophy may be associated with genetic mutation. However, other diseases take a different course and are more likely to develop due to protein damage, which he contends may strengthen in time, causing changes in cells or tissues and, eventually, age-related diseases.
“Alzheimer’s disease, diabetes, or autoimmunity often take decades to develop (even though your genome sequence has been the same since the day you were conceived); the insidious accumulation of the damaged protein may be very slow indeed,” he penned.
“But so strong is the cult of DNA-centricity that most scientists seem unwilling to challenge the fundamental assumption that the cause of late-onset diseases must lie somewhere in the genome,” Grainger concludes.
Shifting Focus from Genetics to Proteins
Besides being CEO of Methuselah Health, Grainger also is Co-Founder and Chief Scientific Advisor at Medicxi, a life sciences investment firm that backed Methuselah Health with $5 million in venture capital funding for research into disease treatments that focus on proteins in aging, reported Fierce CEO.
Methuselah Health, founded in 2015 in Cambridge, UK, with offices in the US, is reportedly using post-translational modifications for analysis of many different proteins.
“At Methuselah Health, we have shifted focus from the genetics—which tells you in an ideal world how your body would function—to the now: this is how your body functions now and this is what is going wrong with it. And that answer lies in the proteins,” stated Dr. David Grainger (above), CEO of Methuselah Health, in an interview with the UK’s New NHS Alliance. Click on this link to watch the full interview. [Photo and caption copyright: New NHS Alliance.]
How Does it Work?
This is how Methuselah Health analyzes damaged proteins using mass spectrometry, according to David Mosedale, PhD, Methuselah Health’s Chief Technology Officer, in the New NHS Alliance story:
Protein samples from healthy individuals and people with diseases are used;
Proteins from the samples are sliced into protein blocks and fed slowly into a mass spectrometer, which accurately weighs them;
Scientists observe damage to individual blocks of proteins;
Taking those blocks, proteins are reconstructed to ascertain which proteins have been damaged;
Information is leveraged for discovery of drugs to target diseases.
Mass spectrometry is a powerful approach to protein sample identification, according to News-Medical.Net. It enables analysis of protein specificity and background contaminants. Interactions among proteins—with RNA or DNA—also are possible with mass spectrometry.
Methuselah Health’s scientists are particularly interested in the damaged proteins that have been around a while, which they call hyper-stable danger variants (HSDVs) and consider to be the foundation for development of age-related diseases, Grainger told WuXi AppTec.
“By applying the Methuselah platform, we can see the HSDVs and so understand which pathways we need to target to prevent disease,” he explained.
For clinical laboratories, pathologists, and their patients, work by Methuselah Health could accelerate the development of personalized medicine treatments for debilitating chronic diseases. Furthermore, it may compel more people to think of DNA as one of several components interacting that make up human bodies and not as the only game in diagnostics.
As cognitive and cloud computing continue to advance, and mobile technologies become more accessible across the globe, innovative apps and mobile attachments are using algorithms to replace the need for complex and time-consuming diagnostic tests
Mobile healthcare—also known as mHealth—is attracting plenty of research dollars as entrepreneurs look for ways improve consumers’ access to various medical services in ways that could reduce healthcare costs. For that reason, some mHealth solutions may be used by clinical laboratories and pathology groups to give patients faster access to diagnostic services and information about medical laboratory tests.
Most mHealth solutions excel at doing a single, defined task well. In some cases, they are faster and as accurate as human-based testing or observation. However, few solutions can tackle complex diagnostics, such as determining the pathogens involved in sepsis. And mHealth cannot replace the human element of communication and empathy, which will always have a place in the medical process. (more…)
Once thought to be separate components, the new model of a contiguous mesentery could lead to new medical laboratory tools for diagnosing and treating digestive diseases such as Crohn’s and colorectal cancer
For more than a century, pathology professionals have treated the network of tissue folds surrounding the human digestive system, known as the mesentery, as separate entities. However, new research indicates the mesentery is in fact a single, continuous organ and therefore reverses that thinking. This could impact the way pathologists and medical laboratories currently perform diagnostics and testing of digestive diseases.
