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Endocrinology and Metabolism Clinics of... Mar 2020Technological innovations have fundamentally changed diabetes care. Insulin pump use and continuous glucose monitoring are associated with improved glycemic control... (Review)
Review
Technological innovations have fundamentally changed diabetes care. Insulin pump use and continuous glucose monitoring are associated with improved glycemic control along with a better quality of life; automated insulin-dosing advisors facilitate and improve decision making. Glucose-responsive automated insulin delivery enables the highest targets for time in range, lowest rate and duration of hypoglycemia, and favorable quality of life. Clear targets for time in ranges and a standard visualization of the data will help the diabetes technology to be used more efficiently. Decision support systems within and integrated cloud environment will further simplify, unify, and improve modern routine diabetes care.
Topics: Blood Glucose Self-Monitoring; Decision Support Systems, Clinical; Diabetes Mellitus, Type 1; Equipment and Supplies; Humans; Injections, Subcutaneous; Insulin; Insulin Infusion Systems; Inventions; Pancreas, Artificial
PubMed: 31980111
DOI: 10.1016/j.ecl.2019.10.009 -
Sensors (Basel, Switzerland) Aug 2018Rapid diagnosis and screening of diseases have become increasingly important in predictive and preventive medicine as they improve patient treatment strategies and... (Review)
Review
Rapid diagnosis and screening of diseases have become increasingly important in predictive and preventive medicine as they improve patient treatment strategies and reduce cost as well as burden on our healthcare system. In this regard, wearable devices are emerging as effective and reliable point-of-care diagnostics that can allow users to monitor their health at home. These wrist-worn, head-mounted, smart-textile, or smart-patches devices can offer valuable information on the conditions of patients as a non-invasive form of monitoring. However, they are significantly limited in monitoring physiological signals and biomechanics, and, mostly, rely on the physical attributes. Recently, developed wearable devices utilize body fluids, such as sweat, saliva, or skin interstitial fluid, and electrochemical interactions to allow continuous physiological condition and disease monitoring for users. Among them, tear fluid has been widely utilized in the investigation of ocular diseases, diabetes, and even cancers, because of its easy accessibility, lower complexity, and minimal invasiveness. By determining the concentration change of analytes within the tear fluid, it would be possible to identify disease progression and allow patient-oriented therapies. Considering the emerging trend of tear-based biosensing technology, this review article aims to focus on an overview of the tear fluid as a detection medium for certain diseases, such as ocular disorders, diabetes, and cancer. In addition, the rise and application of minimally invasive detection and monitoring via integrated contact lens biosensors will also be addressed, in regards to their practicality and current developmental progress.
Topics: Biosensing Techniques; Contact Lenses; Disease Progression; Humans; Monitoring, Physiologic; Point-of-Care Systems; Tears; Wearable Electronic Devices
PubMed: 30104496
DOI: 10.3390/s18082651 -
Science (New York, N.Y.) May 2018Biomolecular monitoring in the gastrointestinal tract could offer rapid, precise disease detection and management but is impeded by access to the remote and complex...
Biomolecular monitoring in the gastrointestinal tract could offer rapid, precise disease detection and management but is impeded by access to the remote and complex environment. Here, we present an ingestible micro-bio-electronic device (IMBED) for in situ biomolecular detection based on environmentally resilient biosensor bacteria and miniaturized luminescence readout electronics that wirelessly communicate with an external device. As a proof of concept, we engineer heme-sensitive probiotic biosensors and demonstrate accurate diagnosis of gastrointestinal bleeding in swine. Additionally, we integrate alternative biosensors to demonstrate modularity and extensibility of the detection platform. IMBEDs enable new opportunities for gastrointestinal biomarker discovery and could transform the management and diagnosis of gastrointestinal disease.
Topics: Animals; Biosensing Techniques; Electrical Equipment and Supplies; Gastrointestinal Diseases; Gastrointestinal Hemorrhage; Gastrointestinal Tract; Heme; Monitoring, Physiologic; Probiotics; Swine
PubMed: 29798884
DOI: 10.1126/science.aas9315 -
Hypertension (Dallas, Tex. : 1979) Sep 2020Out-of-office blood pressure measurement is an essential part of diagnosing and managing hypertension. In the era of advanced digital health information technology, the... (Review)
Review
Out-of-office blood pressure measurement is an essential part of diagnosing and managing hypertension. In the era of advanced digital health information technology, the approach to achieving this is shifting from traditional methods (ambulatory and home blood pressure monitoring) to wearable devices and technology. Wearable blood pressure monitors allow frequent blood pressure measurements (ideally continuous beat-by-beat monitoring of blood pressure) with minimal stress on the patient. It is expected that wearable devices will dramatically change the quality of detection and management of hypertension by increasing the number of measurements in different situations, allowing accurate detection of phenotypes that have a negative impact on cardiovascular prognosis, such as masked hypertension and abnormal blood pressure variability. Frequent blood pressure measurements and the addition of new features such as monitoring of environmental conditions allows interpretation of blood pressure data in the context of daily stressors and different situations. This new digital approach to hypertension contributes to anticipation medicine, which refers to strategies designed to identify increasing risk and predict the onset of cardiovascular events based on a series of data collected over time, allowing proactive interventions to reduce risk. To achieve this, further research and validation is required to develop wearable blood pressure monitoring devices that provide the same accuracy as current approaches and can effectively contribute to personalized medicine.
Topics: Blood Pressure Monitoring, Ambulatory; Blood Pressure Monitors; Humans; Hypertension; Prognosis; Remote Sensing Technology; Wearable Electronic Devices
PubMed: 32755418
DOI: 10.1161/HYPERTENSIONAHA.120.14742 -
Proceedings of the National Academy of... Aug 2020Pencils and papers are ubiquitous in our society and have been widely used for writing and drawing, because they are easy to use, low-cost, widely accessible, and...
Pencils and papers are ubiquitous in our society and have been widely used for writing and drawing, because they are easy to use, low-cost, widely accessible, and disposable. However, their applications in emerging skin-interfaced health monitoring and interventions are still not well explored. Herein, we report a variety of pencil-paper-based on-skin electronic devices, including biophysical (temperature, biopotential) sensors, sweat biochemical (pH, uric acid, glucose) sensors, thermal stimulators, and humidity energy harvesters. Among these devices, pencil-drawn graphite patterns (or combined with other compounds) serve as conductive traces and sensing electrodes, and office-copy papers work as flexible supporting substrates. The enabled devices can perform real-time, continuous, and high-fidelity monitoring of a range of vital biophysical and biochemical signals from human bodies, including skin temperatures, electrocardiograms, electromyograms, alpha, beta, and theta rhythms, instantaneous heart rates, respiratory rates, and sweat pH, uric acid, and glucose, as well as deliver programmed thermal stimulations. Notably, the qualities of recorded signals are comparable to those measured with conventional methods. Moreover, humidity energy harvesters are prepared by creating a gradient distribution of oxygen-containing groups on office-copy papers between pencil-drawn electrodes. One single-unit device (0.87 cm) can generate a sustained voltage of up to 480 mV for over 2 h from ambient humidity. Furthermore, a self-powered on-skin iontophoretic transdermal drug-delivery system is developed as an on-skin chemical intervention example. In addition, pencil-paper-based antennas, two-dimensional (2D) and three-dimensional (3D) circuits with light-emitting diodes (LEDs) and batteries, reconfigurable assembly and biodegradable electronics (based on water-soluble papers) are explored.
Topics: Electric Power Supplies; Electrodes; Electronics; Equipment Design; Graphite; Humans; Monitoring, Physiologic; Paper; Skin; Wearable Electronic Devices
PubMed: 32661158
DOI: 10.1073/pnas.2008422117 -
Journal of Diabetes Science and... Nov 2020This article is the work product of the Continuous Glucose Monitor and Automated Insulin Dosing Systems in the Hospital Consensus Guideline Panel, which was organized by...
This article is the work product of the Continuous Glucose Monitor and Automated Insulin Dosing Systems in the Hospital Consensus Guideline Panel, which was organized by Diabetes Technology Society and met virtually on April 23, 2020. The guideline panel consisted of 24 international experts in the use of continuous glucose monitors (CGMs) and automated insulin dosing (AID) systems representing adult endocrinology, pediatric endocrinology, obstetrics and gynecology, advanced practice nursing, diabetes care and education, clinical chemistry, bioengineering, and product liability law. The panelists reviewed the medical literature pertaining to five topics: (1) continuation of home CGMs after hospitalization, (2) initiation of CGMs in the hospital, (3) continuation of AID systems in the hospital, (4) logistics and hands-on care of hospitalized patients using CGMs and AID systems, and (5) data management of CGMs and AID systems in the hospital. The panelists then developed three types of recommendations for each topic, including clinical practice (to use the technology optimally), research (to improve the safety and effectiveness of the technology), and hospital policies (to build an environment for facilitating use of these devices) for each of the five topics. The panelists voted on 78 proposed recommendations. Based on the panel vote, 77 recommendations were classified as either strong or mild. One recommendation failed to reach consensus. Additional research is needed on CGMs and AID systems in the hospital setting regarding device accuracy, practices for deployment, data management, and achievable outcomes. This guideline is intended to support these technologies for the management of hospitalized patients with diabetes.
Topics: Adult; Blood Glucose; Blood Glucose Self-Monitoring; COVID-19; Child; Consensus; Coronavirus Infections; Diabetes Complications; Diabetes Mellitus; Drug Dosage Calculations; Equipment and Supplies; Female; Hospitalization; Hospitals; Humans; Insulin; Insulin Infusion Systems; Monitoring, Physiologic; Pandemics; Pneumonia, Viral; Pregnancy
PubMed: 32985262
DOI: 10.1177/1932296820954163 -
Orthopaedics & Traumatology, Surgery &... Feb 2016Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the... (Review)
Review
Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the life-long pathway of a device; this is "traceability". European regulations enact free circulation of medical devices throughout the European Union, with each member state being responsible for safety within its own territory. Medical devices are divided into 3 categories of increasing risk. CE marking mandatory for medical devices distributed within the EU, and count as market authorizations. They are delivered with 5-year validity by what is known as a "notified body". Health authorities are responsible for monitoring the market and any incidents. New regulations are presently being drawn up to improve efficiency and transparency. Materials vigilance is founded on mandatory declaration of medical device incidents. At local level, it comprises local reporters responsible for informing the National Health Products Safety Agency (Agence nationale de sécurité du médicament et des produits de santé [ANSM]) of any incidents and taking all necessary precautions. At national level, the ANSM assesses the safety, efficacy and quality of healthcare products; it centralizes and assesses materials vigilance reports and takes the requisite decisions. Materials vigilance is further organized at the European and international levels, to harmonize legislation regarding medical devices. Traceability is intended to rapidly identify medical device bearers in case of product recall. Each center is to organize the traceability of its devices; manufacturers' obligation of traceability ceases with the healthcare establishment or user. CE marking involves strict labeling rules to ensure safety of use. A change in the organization of traceability is presently underway, in the form of international Unique Device Identifiers, with harmonized label data, barcodes and standardized terminology. A European and later international database will be set up. The objective is to make Unique Device Identifiers mandatory within the EU by 2017.
Topics: Equipment Failure; Equipment and Supplies; European Union; Humans; Patient Safety; Product Labeling; Prostheses and Implants; Reference Standards
PubMed: 26822532
DOI: 10.1016/j.otsr.2015.05.013 -
Diagnostic and Interventional Radiology... Jul 2018Cardiovascular devices and hemodynamic monitoring systems continue to evolve with the goal of allowing for rapid clinical intervention and management. Cardiovascular... (Review)
Review
Cardiovascular devices and hemodynamic monitoring systems continue to evolve with the goal of allowing for rapid clinical intervention and management. Cardiovascular devices including the CardioMicroelectromechanical (CardioMEMS) device, implantable loop recorder, and right ventricular (RV) leadless pacemaker are now widely used for treatment and monitoring of advanced cardiac conditions, as many of these devices have been shown to significantly improve patient outcomes. Additionally, hemodynamic monitoring devices have shown utility in monitoring patients with aortic aneurysms after endovascular aortic repair (EVAR) for early detection of Type I and Type II endoleaks. There is limited published data regarding the imaging features of these devices. As these devices become more widely used, it is important for radiologists to become familiar with the normal imaging features and potential complications. The goal of this review is to summarize the data regarding the use of leadless cardiovascular devices including the CardioMEMS device, implantable loop recorder, and RV leadless pacemaker, and to present cases demonstrating their utility and normal imaging features.
Topics: Equipment Design; Equipment and Supplies; Humans; Monitoring, Physiologic; Pacemaker, Artificial; Radiography; Tomography, X-Ray Computed
PubMed: 30091710
DOI: 10.5152/dir.2018.17462 -
Proceedings of the National Academy of... Jan 2020Piezoelectric materials, a type of "smart" material that generates electricity while deforming and vice versa, have been used extensively for many important implantable...
Piezoelectric materials, a type of "smart" material that generates electricity while deforming and vice versa, have been used extensively for many important implantable medical devices such as sensors, transducers, and actuators. However, commonly utilized piezoelectric materials are either toxic or nondegradable. Thus, implanted devices employing these materials raise a significant concern in terms of safety issues and often require an invasive removal surgery, which can damage directly interfaced tissues/organs. Here, we present a strategy for materials processing, device assembly, and electronic integration to 1) create biodegradable and biocompatible piezoelectric PLLA [poly(l-lactic acid)] nanofibers with a highly controllable, efficient, and stable piezoelectric performance, and 2) demonstrate device applications of this nanomaterial, including a highly sensitive biodegradable pressure sensor for monitoring vital physiological pressures and a biodegradable ultrasonic transducer for blood-brain barrier opening that can be used to facilitate the delivery of drugs into the brain. These significant applications, which have not been achieved so far by conventional piezoelectric materials and bulk piezoelectric PLLA, demonstrate the PLLA nanofibers as a powerful material platform that offers a profound impact on various medical fields including drug delivery, tissue engineering, and implanted medical devices.
Topics: Absorbable Implants; Drug Delivery Systems; Electricity; Electronics; Equipment Design; Micro-Electrical-Mechanical Systems; Monitoring, Physiologic; Nanofibers; Pressure; Prostheses and Implants; Tissue Engineering; Transducers; Ultrasonics
PubMed: 31871178
DOI: 10.1073/pnas.1910343117 -
Biosensors & Bioelectronics Apr 2021Recent progress in biosensors have quantitively expanded current capabilities in exploratory research tools, diagnostics and therapeutics. This rapid pace in sensor... (Review)
Review
Recent progress in biosensors have quantitively expanded current capabilities in exploratory research tools, diagnostics and therapeutics. This rapid pace in sensor development has been accentuated by vast improvements in data analysis methods in the form of machine learning and artificial intelligence that, together, promise fantastic opportunities in chronic sensing of biosignals to enable preventative screening, automated diagnosis, and tools for personalized treatment strategies. At the same time, the importance of widely accessible personal monitoring has become evident by recent events such as the COVID-19 pandemic. Progress in fully integrated and chronic sensing solutions is therefore increasingly important. Chronic operation, however, is not truly possible with tethered approaches or bulky, battery-powered systems that require frequent user interaction. A solution for this integration challenge is offered by wireless and battery-free platforms that enable continuous collection of biosignals. This review summarizes current approaches to realize such device architectures and discusses their building blocks. Specifically, power supplies, wireless communication methods and compatible sensing modalities in the context of most prevalent implementations in target organ systems. Additionally, we highlight examples of current embodiments that quantitively expand sensing capabilities because of their use of wireless and battery-free architectures.
Topics: Artificial Intelligence; Bioelectric Energy Sources; Biosensing Techniques; COVID-19; Electric Power Supplies; Electrophysiological Phenomena; Equipment Design; Humans; Pandemics; Remote Sensing Technology; SARS-CoV-2; Telemetry; Wearable Electronic Devices; Wireless Technology
PubMed: 33556807
DOI: 10.1016/j.bios.2021.113007