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The Journal of Clinical Endocrinology... Jun 2023Diabetes technologies represent a paradigm shift in type 1 diabetes care. Continuous subcutaneous insulin infusion (CSII) pumps and continuous glucose monitors (CGM)... (Review)
Review
Diabetes technologies represent a paradigm shift in type 1 diabetes care. Continuous subcutaneous insulin infusion (CSII) pumps and continuous glucose monitors (CGM) improve glycated hemoglobin (HbA1c) levels, enhance time in optimal glycemic range, limit severe hypoglycemia, and reduce diabetes distress. The artificial pancreas or closed-loop system connects these devices via a control algorithm programmed to maintain target glucose, partially relieving the person living with diabetes of this constant responsibility. Automating insulin delivery reduces the input required from those wearing the device, leading to better physiological and psychosocial outcomes. Hybrid closed-loop therapy systems, requiring user-initiated prandial insulin doses, are the most advanced closed-loop systems commercially available. Fully closed-loop systems, requiring no user-initiated insulin boluses, and dual hormone systems have been shown to be safe and efficacious in the research setting. Clinical adoption of closed-loop therapy remains in early stages despite recent technological advances. People living with diabetes, health care professionals, and regulatory agencies continue to navigate the complex path to equitable access. We review the available devices, evidence, clinical implications, and barriers regarding these innovatory technologies.
Topics: Humans; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Pancreas, Artificial; Insulin; Blood Glucose; Blood Glucose Self-Monitoring; Insulin Infusion Systems
PubMed: 36734145
DOI: 10.1210/clinem/dgad068 -
Biosensors & Bioelectronics Jul 2023Current in-vitro 2D cultures and animal models present severe limitations in recapitulating human physiopathology with striking discrepancies in estimating drug efficacy... (Review)
Review
Current in-vitro 2D cultures and animal models present severe limitations in recapitulating human physiopathology with striking discrepancies in estimating drug efficacy and side effects when compared to human trials. For these reasons, microphysiological systems, organ-on-chip and multiorgans microdevices attracted considerable attention as novel tools for high-throughput and high-content research to achieve an improved understanding of diseases and to accelerate the drug development process towards more precise and eventually personalized standards. This review takes the form of a guide on this fast-growing field, providing useful introduction to major themes and indications for further readings. We start analyzing Organs-on-chips (OOC) technologies for testing the major drug administration routes: (1) oral/rectal route by intestine-on-a-chip, (2) inhalation by lung-on-a-chip, (3) transdermal by skin-on-a-chip and (4) intravenous through vascularization models, considering how drugs penetrate in the bloodstream and are conveyed to their targets. Then, we focus on OOC models for (other) specific organs and diseases: (1) neurodegenerative diseases with brain models and blood brain barriers, (2) tumor models including their vascularization, organoids/spheroids, engineering and screening of antitumor drugs, (3) liver/kidney on chips and multiorgan models for gastrointestinal diseases and metabolic assessment of drugs and (4) biomechanical systems recapitulating heart, muscles and bones structures and related diseases. Successively, we discuss technologies and materials for organ on chips, analyzing (1) microfluidic tools for organs-on-chips, (2) sensor integration for real-time monitoring, (3) materials and (4) cell lines for organs on chips. (Nano)delivery approaches for therapeutics and their on chip assessment are also described. Finally, we conclude with a critical discussion on current significance/relevance, trends, limitations, challenges and future prospects in terms of revolutionary impact on biomedical research, preclinical models and drug development.
Topics: Animals; Humans; Lab-On-A-Chip Devices; Biosensing Techniques; Drug Development; Microphysiological Systems; Liver
PubMed: 37060819
DOI: 10.1016/j.bios.2023.115271 -
JMIR MHealth and UHealth Nov 2023Consumer sleep trackers (CSTs) have gained significant popularity because they enable individuals to conveniently monitor and analyze their sleep. However, limited...
BACKGROUND
Consumer sleep trackers (CSTs) have gained significant popularity because they enable individuals to conveniently monitor and analyze their sleep. However, limited studies have comprehensively validated the performance of widely used CSTs. Our study therefore investigated popular CSTs based on various biosignals and algorithms by assessing the agreement with polysomnography.
OBJECTIVE
This study aimed to validate the accuracy of various types of CSTs through a comparison with in-lab polysomnography. Additionally, by including widely used CSTs and conducting a multicenter study with a large sample size, this study seeks to provide comprehensive insights into the performance and applicability of these CSTs for sleep monitoring in a hospital environment.
METHODS
The study analyzed 11 commercially available CSTs, including 5 wearables (Google Pixel Watch, Galaxy Watch 5, Fitbit Sense 2, Apple Watch 8, and Oura Ring 3), 3 nearables (Withings Sleep Tracking Mat, Google Nest Hub 2, and Amazon Halo Rise), and 3 airables (SleepRoutine, SleepScore, and Pillow). The 11 CSTs were divided into 2 groups, ensuring maximum inclusion while avoiding interference between the CSTs within each group. Each group (comprising 8 CSTs) was also compared via polysomnography.
RESULTS
The study enrolled 75 participants from a tertiary hospital and a primary sleep-specialized clinic in Korea. Across the 2 centers, we collected a total of 3890 hours of sleep sessions based on 11 CSTs, along with 543 hours of polysomnography recordings. Each CST sleep recording covered an average of 353 hours. We analyzed a total of 349,114 epochs from the 11 CSTs compared with polysomnography, where epoch-by-epoch agreement in sleep stage classification showed substantial performance variation. More specifically, the highest macro F1 score was 0.69, while the lowest macro F1 score was 0.26. Various sleep trackers exhibited diverse performances across sleep stages, with SleepRoutine excelling in the wake and rapid eye movement stages, and wearables like Google Pixel Watch and Fitbit Sense 2 showing superiority in the deep stage. There was a distinct trend in sleep measure estimation according to the type of device. Wearables showed high proportional bias in sleep efficiency, while nearables exhibited high proportional bias in sleep latency. Subgroup analyses of sleep trackers revealed variations in macro F1 scores based on factors, such as BMI, sleep efficiency, and apnea-hypopnea index, while the differences between male and female subgroups were minimal.
CONCLUSIONS
Our study showed that among the 11 CSTs examined, specific CSTs showed substantial agreement with polysomnography, indicating their potential application in sleep monitoring, while other CSTs were partially consistent with polysomnography. This study offers insights into the strengths of CSTs within the 3 different classes for individuals interested in wellness who wish to understand and proactively manage their own sleep.
Topics: Humans; Female; Male; Prospective Studies; Sleep; Polysomnography; Sleep Stages; Fitness Trackers
PubMed: 37917155
DOI: 10.2196/50983 -
The Science of the Total Environment Jun 2023Despite advances in medicine and innovations in many underpinning fields including disease prevention and control, the Spaulding classification system, originally... (Review)
Review
A review of Spaulding's classification system for effective cleaning, disinfection and sterilization of reusable medical devices: Viewed through a modern-day lens that will inform and enable future sustainability.
Despite advances in medicine and innovations in many underpinning fields including disease prevention and control, the Spaulding classification system, originally proposed in 1957, remains widely used for defining the disinfection and sterilization of contaminated re-usable medical devices and surgical instruments. Screening PubMed and Scopus databases using a PRISMA guiding framework generated 272 relevant publications that were used in this review. Findings revealed that there is a need to evolve how medical devices are designed, and processed by cleaning, disinfection (and/or sterilization) to mitigate patient risks, including acquiring an infection. This Spaulding Classification remains in use as it is logical, easily applied and understood by users (microbiologists, epidemiologists, manufacturers, industry) and by regulators. However, substantial changes have occurred over the past 65 years that challenge interpretation and application of this system that includes inter alia emergence of new pathogens (viruses, mycobacteria, protozoa, fungi), a greater understanding of innate and adaptive microbial tolerance to disinfection, toxicity risks, increased number of vulnerable patients and associated patient procedures, and greater complexity in design and use of medical devices. Common cited examples include endoscopes that enable non- or minimal invasive procedures but are highly sophisticated with various types of materials (polymers, electronic components etc), long narrow channels, right angle and heat-sensitive components and various accessories (e.g., values) that can be contaminated with high levels of microbial bioburden and patient tissues after use. Contaminated flexible duodenoscopes have been a source of several significant infection outbreaks, where at least 9 reported cases were caused by multidrug resistant organisms [MDROs] with no obvious breach in processing detected. Despite this, there is evidence of the lack of attention to cleaning and maintenance of these devices and associated equipment. Over the last few decades there is increasing genomic evidence of innate and adaptive resistance to chemical disinfectant methods along with adaptive tolerance to environmental stresses. To reduce these risks, it has been proposed to elevate classification of higher-risk flexible endoscopes (such as duodenoscopes) from semi-critical [contact with mucous membrane and intact skin] to critical use [contact with sterile tissue and blood] that entails a transition to using low-temperature sterilization modalities instead of routinely using high-level disinfection; thus, increasing the margin of safety for endoscope processing. This timely review addresses important issues surrounding use of the Spaulding classification system to meet modern-day needs. It specifically addresses the need for automated, robust cleaning and drying methods combined with using real-time monitoring of device processing. There is a need to understand entire end-to-end processing of devices instead of adopting silo approaches that in the future will be informed by artificial intelligence and deep-learning/machine learning. For example, combinational solutions that address the formation of complex biofilms that harbour pathogenic and opportunistic microorganisms on the surfaces of processed devices. Emerging trends are addressed including future sustainability for the medical devices sector that can be enabled via a new Quintuple Helix Hub approach that combines academia, industry, healthcare, regulators, and society to unlock real world solutions.
Topics: Humans; Artificial Intelligence; Cross Infection; Disinfectants; Disinfection; Endoscopes; Equipment Contamination
PubMed: 36963674
DOI: 10.1016/j.scitotenv.2023.162976 -
Physiological Measurement Nov 2023Photoplethysmography is a key sensing technology which is used in wearable devices such as smartwatches and fitness trackers. Currently, photoplethysmography sensors are... (Review)
Review
Photoplethysmography is a key sensing technology which is used in wearable devices such as smartwatches and fitness trackers. Currently, photoplethysmography sensors are used to monitor physiological parameters including heart rate and heart rhythm, and to track activities like sleep and exercise. Yet, wearable photoplethysmography has potential to provide much more information on health and wellbeing, which could inform clinical decision making. This Roadmap outlines directions for research and development to realise the full potential of wearable photoplethysmography. Experts discuss key topics within the areas of sensor design, signal processing, clinical applications, and research directions. Their perspectives provide valuable guidance to researchers developing wearable photoplethysmography technology.
Topics: Photoplethysmography; Wearable Electronic Devices; Fitness Trackers; Signal Processing, Computer-Assisted; Heart Rate
PubMed: 37494945
DOI: 10.1088/1361-6579/acead2 -
Nanotechnology Sep 2023The future of medical diagnostics calls for portable biosensors at the point of care, aiming to improve healthcare by reducing costs, improving access, and increasing... (Review)
Review
The future of medical diagnostics calls for portable biosensors at the point of care, aiming to improve healthcare by reducing costs, improving access, and increasing quality-what is called the 'triple aim'. Developing point-of-care sensors that provide high sensitivity, detect multiple analytes, and provide real time measurements can expand access to medical diagnostics for all. Field-effect transistor (FET)-based biosensors have several advantages, including ultrahigh sensitivity, label-free and amplification-free detection, reduced cost and complexity, portability, and large-scale multiplexing. They can also be integrated into wearable or implantable devices and provide continuous, real-time monitoring of analytes, enabling early detection of biomarkers for disease diagnosis and management. This review analyzes advances in the sensitivity, parallelization, and reusability of FET biosensors, benchmarks the limit of detection of the state of the art, and discusses the challenges and opportunities of FET biosensors for future healthcare applications.
Topics: Biosensing Techniques; Point-of-Care Systems; Transistors, Electronic
PubMed: 37625391
DOI: 10.1088/1361-6528/acf3f0 -
Journal of Diabetes Science and... Nov 2023Diabetes management and treatment requires the use of many devices that frequently must puncture the skin, creating a risk of unintentional retention in the body as a... (Review)
Review
BACKGROUND
Diabetes management and treatment requires the use of many devices that frequently must puncture the skin, creating a risk of unintentional retention in the body as a retained diabetes device. In this article, we reviewed case studies about retained diabetes devices and presented analyses of the success rate of current imaging techniques in identifying retained devices and the success rate of device removal.
METHODS
PubMed and Google Scholar were searched for articles about retained diabetes devices. Relevant articles that included sufficient details about discovery and removal of the device were included. The success rate of identification and the success rate of removal of retained devices were both calculated as percentages.
RESULTS
Sixteen case studies of retained diabetes devices were identified. These devices included parts of continuous glucose monitors and infusion sets, a lancet, and various types of needles for insulin injection. Each case is presented with details about the year of publication, the retained diabetes device, the company that produced the device, the age and gender of the patient, the type of diabetes that the patient had, the location of the device, the reason for initial discovery of the retained device, the process of locating the device, the success rate for removal of the device, and the removal procedure of the device. Analysis revealed a 100% success rate for the use of imaging technology including X-rays and computed tomography to identify a retained diabetes device. The patients with retained diabetes devices had a 62.5% success rate for eventual removal of the device.
CONCLUSIONS
With the increasing use of injected, inserted, and implanted diabetes wearables for digital health, it is likely that some of the devices will detach, break apart, or otherwise become retained in the body. It is important to be aware of available technologies to identify retained diabetes devices so that it will be possible in most cases to surgically remove these devices if they detach or become retained.
Topics: Humans; Diabetes Mellitus, Type 1; Insulin; Skin; Needles; Tomography, X-Ray Computed
PubMed: 35787699
DOI: 10.1177/19322968221105895 -
Sensors (Basel, Switzerland) Nov 2023Analytical devices for bacterial detection are an integral part of modern laboratory medicine, as they permit the early diagnosis of diseases and their timely treatment.... (Review)
Review
Analytical devices for bacterial detection are an integral part of modern laboratory medicine, as they permit the early diagnosis of diseases and their timely treatment. Therefore, special attention is directed to the development of and improvements in monitoring and diagnostic methods, including biosensor-based ones. A promising direction in the development of bacterial detection methods is optical sensor systems based on colorimetric and fluorescence techniques, the surface plasmon resonance, and the measurement of orientational effects. This review shows the detecting capabilities of these systems and the promise of electro-optical analysis for bacterial detection. It also discusses the advantages and disadvantages of optical sensor systems and the prospects for their further improvement.
Topics: Surface Plasmon Resonance; Biosensing Techniques; Optical Devices; Colorimetry
PubMed: 38067765
DOI: 10.3390/s23239391 -
Annual Review of Analytical Chemistry... Jun 2023The development of wearable devices provides approaches for the realization of self-health care. Easily carried wearable devices allow individual health monitoring at... (Review)
Review
The development of wearable devices provides approaches for the realization of self-health care. Easily carried wearable devices allow individual health monitoring at any place whenever necessary. There are various interesting monitoring targets, including body motion, organ pressure, and biomarkers. An efficient use of space in one small device is a promising resolution to increase the functions of wearable devices. Through integration of a microfluidic system into wearable devices, embedding complicated structures in one design becomes possible and can enable multifunction analyses within a limited device volume. This article reviews the reported microfluidic wearable devices, introduces applications to different biofluids, discusses characteristics of the design strategies and sensing principles, and highlights the attractive configurations of each device. This review seeks to provide a detailed summary of recent advanced microfluidic wearable devices. The overview of advanced key components is the basis for the development of future microfluidic wearable devices.
Topics: Humans; Microfluidics; Biological Assay; Motion; Self Care; Wearable Electronic Devices
PubMed: 36888989
DOI: 10.1146/annurev-anchem-091322-082930