BIRKIRKARA, Malta – Umana Medical Technologies has developed a tattoo with sensors to measure vital signs like electrocardiogram data and other biomarkers. The Umana T1 Heart Monitor is made from a clear film with conductive sensors. Once the tattoo is applied, a small lightweight device is attached to store and share a stream of accurate real-time vital signs, such as ECG data and respiration rate, which are shared directly with clinicians. The monitor is part of an ecosystem of medical software, a smartphone app, online dashboards, data-analysis algorithms, and online and offline data access. An independent clinical trial was launched this month with 2,000 patients at the national hospital in Malta, Portugal, and the United Kingdom. “Finally, we are able to accurately collect and monitor patients’ important medical data without interfering with their day-to-day activities,” said Dr. Samuel Meilak, who is leading the clinical trial, in a statement. “The ease of access, coupled with the data analysis capabilities are complete game-changers.” The device will be launched across Europe in 2018.
UNITED KINGDOM – Researchers from the University of Bath have created an adhesive patch that measures the glucose levels of people with diabetes through their skin, according to a study published recently in Nature Nanotechnology. The patch draws glucose out from fluid between cells across hair follicles, which are individually accessed through an array of miniature sensors using a small electric current. The glucose collects in tiny reservoirs and is measured, and readings can be taken every 10 to 15 minutes over several hours. “The monitor developed at Bath promises a truly calibration-free approach, an essential contribution in the fight to combat the ever-increasing global incidence of diabetes,” said Richard Guy, one of the researchers, in a statement. The researchers hope the technology can eventually become a low-cost wearable sensor that sends glucose measurements to the patient’s phone or smartwatch, alerting them when they need to take action.
CHICAGO – A wearable patch can detect hypoglycemia in patients with Type 1 diabetes, according to research presented recently at the Encocrine Society’s annual meeting.
Researchers at Radboud University Medical Center in the Netherlands studied the use of VitalConnect’s HealthPatch to determine if a continuous monitor could detect hypoglycemia, Hypoglycemia, which speeds the heart rate and alters heart rate variability, and alert patients earlier.
“Timely detection of impending hypoglycemia is critical to avoid severe, potentially life-threatening hypoglycemia,” said Dr. Marleen Olde Bekkink, one of the researchers, in a statement. “Our proof-of-principle study found that measuring heart rate variability using a wearable device in an outpatient setting seems promising for alerting to upcoming hypoglycemia.”
Study subjects wore the adhesive patch on their chest, as well as a continuous glucose meter, for five days at home. They recorded any low blood sugar level, verified by fingerstick measurement.
The patient’s heart rate data was transmitted wirelessly to an iPad or iPod, and researchers used an algorithm they developed to determine various parameters of heart rate variability. They conducted their primary analysis on 39 hypoglycemic events that occurred in 10 subjects and found that the algorithm detected clear patterns of change in heart rate variability at the start of hypoglycemia in 72% of the subjects.
Olde Bekkink said the team of researchers will now refine the algorithm to increase its accuracy and precision before being able to use the biosensor in daily practice for patients. Future developments will include creating a smartphone hypoglycemia alert.
NEW YORK – The Juvenile Diabetes Research and Cam Med, a developer of microfluidic-based drug delivery technologies, are partnering to develop an insulin pump for next-generation artificial pancreas systems. The funding commitment from JDRF will enable Cam Med to further the development of the Evopump, an ultra-thin and flexible, bandage-like patch pump. “The Evopump represents the type of miniaturized and user-centric design that could substantially reduce the burden of living with Type 1 diabetes and remove obstacles preventing some people, particularly children, from using devices that could improve their glucose management,” said Jaime Giraldo, program scientist, research, at the JDRF, in a statement.
BETHESDA, Md. – Researchers with the National Institute of Health’s National Institute of Biomedical Imaging and Bioengineering have developed a wearable patch that can regulate blood sugar levels in people with Type 2 diabetes through microneedles. The base of the experimental patch is material called alginate, a gum-like natural substance extracted from brown algae, which is mixed with therapeutic agents and poured into a microneedle form to make the patch. Researchers infused the alginate with a formula of biochemical particles that stimulates the body’s own insulin production when needed and curtails that stimulation when normal blood sugar concentration is reached. The responsive delivery system of the patch can meet the body’s need for days instead of being used up all at once. “This experimental approach could be a way to take advantage of the fact that persons with Type 2 diabetes can still produce some insulin,” said Richard Leapman, scientific director at NIBIB, in a statement.
BENGALURU, India – Open-source hardware provider ProtoCentral is crowdfunding for its HeartyPatch single lead electrocardiogram patch. The device can calculate heart rate, R-R intervals and heart rate variability, and the data can be connected to the Internet of Things via Bluetooth. HeartyPatch also works with a mobile app for a Cloud-connected HRV monitor. By making the HeartyPatch project open-source and available, ProtoCentral intends to lower the barriers of entry to heart rate variability studies without worrying about intellectual property, according to the startup’s crowdfunding page.
TAIPEI, Taiwan – Medical technology company Kinpo Electronics has received approval to market its wearable electrocardiogram monitor directly to consumers in Europe. The company will market the BC1 Patch under its own brand, XYZlife. “Along with mobile network enhancement, we will be able to collect and monitor patients’ status on real-time basis,” said Simon Shen, CEO of Kinpo Electronics. The BC1 Patch provides long term and real-time monitoring, historical observation and dedicated reports for clinicians and users. It features a calling function, which can immediately contact doctors or caregivers when irregular signs are detected.
ATLANTA – A phase I clinical trial conducted by Emory University, in collaboration with researchers from the Georgia Institute of Technology, has found that influenza vaccination using a patch with dissolvable microneedles was safe and well-tolerated by study participants, according to results published in a recent issue of The Lancet medical journal. The study also found that the patch was equally effective in generating immunity against influenza and was strongly preferred by study participants over vaccination with a hypodermic needle and syringe. “Having the option of a flu vaccine that can be easily and painlessly self-administered could increase coverage and protection by this important vaccine,” said Dr. Nadine Rouphael, principal investigator of the clinical trial. The researchers also are working to develop microneedle patches for use with other vaccines, including measles, rubella and polio.
MOUNTAIN VIEW, Calif. – A wearable patch developed by Somnarus can effectively detect sleep apnea, according to study results presented at the recent SLEEP 2017 annual meeting of the Associated Professional Sleep Societies. “Our study showed that this wearable home sleep monitor is very comfortable, easy to use and does not negatively affect sleep,” said principal investigator Maria Merchant, CEO of Somnarus Inc., in a statement. Study results showed that the total rate of clinical agreement between SomnoPatch and standard in-lab polysomnography was 87.4% According to the authors, the study results will be used in obtaining approval from the U.S. Food and Drug Administration for the skin-adhesive diagnostic patch, which weighs less than one ounce and records nasal pressure, blood oxygen saturation, pulse rate, respiratory effort, sleep time and body position. An additional home usability study found that 38 out of 39 users were successful in activating the patch and collecting at least four hours of sleep data while relying only on the instructions included with the device.
BOSTON – A pilot to evaluate home-based care in place of hospital admissions was so successful that a second, larger pilot is about to launch.
The Partners HealthCare BWH Home Hospital pilots are a collaboration between PhysIQ, a data analytics provider; VitalConnect, maker of wearable biosensor technology; and Partners HealthCare Brigham and Women’s Hospital.
“We completed our first pilot late last year with excellent results,” said Dr. David Levine, a physician at BWH, who is leading the pilots.
The pilots are focused on evaluating how technology and home-based care delivery can be leveraged to treat patients who would otherwise be admitted to the hospital.
While Levine was reluctant to share actual data, he said his team has found excellent results for quality, safety, patient activity and patient experience in those who participate in a home hospital program compared to those who do not.
“Our home hospital work is proving to be a big win for patients, payers and providers,” said Levine, who explained that more concrete data will be available in a report to be published soon.
The first pilot was a randomized controlled trial that included patients diagnosed at the BWH Emergency Department with exacerbation of heart failure, pneumonia, COPD, cellulitis or complicated urinary tract infection. The 60 patients selected for the pilot were provided with a state-of-the-art home monitoring solution, including the Vital Connect VitalPatch biosensor that continuously streamed patient vital signs. Those vitals were then analyzed by, and viewable through, the physIQ Personalized Physiology Analytics platform.
The second pilot will scale up to 500 patients in the next couple of months. Half of the patients will receive traditional in-hospital treatment and the other half will receive treatment at home.
“We are in a very exciting era of medicine where clinical-grade biosensors and analytics are capable of delivering continuous physiological insight that was traditionally only available in the hospital environment,” Levine said.
In fact, Levine said this kind of collaboration will soon become a necessary and ubiquitous model of health care delivery.
“We foresee that home hospital-like models will be the norm in the coming years,” he said.