scholarly journals The Use of Remote Monitoring Technologies: A Review of Recent Regulatory Scientific Advices, Qualification Opinions, and Qualification Advices Issued by the European Medicines Agency

2021 ◽  
Vol 8 ◽  
Author(s):  
Marieke J. H. J. Dekker ◽  
Pieter Stolk ◽  
Anna M. G. Pasmooij
Keyword(s):  
Remote Monitoring ◽  
Glucose Monitoring ◽  
Sampling Interval ◽  
European Medicines Agency ◽  
The Novel ◽  
Measure Validation ◽  
Regulatory Guidance ◽  
European Regulatory ◽  
Sleep Parameters ◽  
Monitoring Technologies

Aims: Recently, the use of novel remote monitoring technologies (RMTs) in trials has gained much interest. To facilitate regulatory learning, we evaluated qualification opinions (QOs) and advices (QAs) and scientific advices (SAs) of the Committee for Medicinal Products for Human Use (CHMP) to gain insight in the types of devices that are intended to be used in clinical trials for supporting/submitting application for obtaining marketing authorization (registration trials) and the main recommendations of the CHMP.Methods: QOs, QAs, and SAs of the CHMP that assessed RMTs between 2013 and 2019 were eligible for our study. The following information was extracted from the documents: year of advice/opinion, device and endpoints used, type of endpoint (primary, secondary, exploratory, or safety), and main recommendations of the CHMP.Results: In total two QOs, four QAs, and 59 SAs were included in our study (total of SAs between 2013 and 2019 = 4,054). In the SAs, accelerometers to measure activity and/or sleep parameters (n = 31) were the most frequently used devices, followed by mobile applications (n = 6) and glucose monitoring devices (n = 6). Usually, these measures were proposed as secondary or exploratory endpoints (n = 32). The main recommendations of the CHMP were related to relevance of the (novel) outcome measure; validation; precision, accuracy, sensitivity, and specificity; compliance; sampling interval; and data handling and privacy.Conclusions: Although there was a trend toward an increased use over time, the use of RMTs in registration trials is still relatively rare. In the absence of formal European regulatory guidance on mHealth technologies, insight in the main recommendations of the CHMP may stimulate the use of novel RMTs in a regulatory context.

scholarly journals Remote monitoring technologies in Alzheimer’s disease: design of the RADAR-AD study

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Marijn Muurling ◽  
◽  
Casper de Boer ◽  
Rouba Kozak ◽  
Dorota Religa ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Remote Monitoring ◽  
Rating Scales ◽  
Functional Decline ◽  
Cognitive Domain ◽  
Subjective Rating ◽  
Functional Domain ◽  
Smartphone Applications ◽  
Monitoring Technologies

Abstract Background Functional decline in Alzheimer’s disease (AD) is typically measured using single-time point subjective rating scales, which rely on direct observation or (caregiver) recall. Remote monitoring technologies (RMTs), such as smartphone applications, wearables, and home-based sensors, can change these periodic subjective assessments to more frequent, or even continuous, objective monitoring. The aim of the RADAR-AD study is to assess the accuracy and validity of RMTs in measuring functional decline in a real-world environment across preclinical-to-moderate stages of AD compared to standard clinical rating scales. Methods This study includes three tiers. For the main study, we will include participants (n = 220) with preclinical AD, prodromal AD, mild-to-moderate AD, and healthy controls, classified by MMSE and CDR score, from clinical sites equally distributed over 13 European countries. Participants will undergo extensive neuropsychological testing and physical examination. The RMT assessments, performed over an 8-week period, include walk tests, financial management tasks, an augmented reality game, two activity trackers, and two smartphone applications installed on the participants’ phone. In the first sub-study, fixed sensors will be installed in the homes of a representative sub-sample of 40 participants. In the second sub-study, 10 participants will stay in a smart home for 1 week. The primary outcome of this study is the difference in functional domain profiles assessed using RMTs between the four study groups. The four participant groups will be compared for each RMT outcome measure separately. Each RMT outcome will be compared to a standard clinical test which measures the same functional or cognitive domain. Finally, multivariate prediction models will be developed. Data collection and privacy are important aspects of the project, which will be managed using the RADAR-base data platform running on specifically designed biomedical research computing infrastructure. Results First results are expected to be disseminated in 2022. Conclusion Our study is well placed to evaluate the clinical utility of RMT assessments. Leveraging modern-day technology may deliver new and improved methods for accurately monitoring functional decline in all stages of AD. It is greatly anticipated that these methods could lead to objective and real-life functional endpoints with increased sensitivity to pharmacological agent signal detection.

scholarly journals Enhancing Safety During a Pandemic Using Virtual Care Remote Monitoring Technologies and UML Modeling

2021 ◽  
Author(s):  
Elizabeth M. Borycki ◽  
Andre W. Kushniruk ◽  
Ryan Kletke ◽  
Vivian Vimarlund ◽  
Yalini Senathirajah ◽  
...  
Keyword(s):  
Remote Monitoring ◽  
Virus Disease ◽  
Grey Literature ◽  
Object Oriented ◽  
Signs And Symptoms ◽  
Use Cases ◽  
Virtual Care ◽  
The Future ◽  
Government Websites ◽  
Monitoring Technologies

Objectives: This paper describes a methodology for gathering requirements and early design of remote monitoring technology (RMT) for enhancing patient safety during pandemics using virtual care technologies. As pandemics such as COrona VIrus Disease (COVID-19) progress there is an increasing need for effective virtual care and RMT to support patient care while they are at home. Methods: The authors describe their work in conducting literature reviews by searching PubMed.gov and the grey literature for articles, and government websites with guidelines describing the signs and symptoms of COVID-19, as well as the progression of the disease. The reviews focused on identifying gaps where RMT could be applied in novel ways and formed the basis for the subsequent modelling of use cases for applying RMT described in this paper. Results: The work was conducted in the context of a new Home of the Future laboratory which has been set up at the University of Victoria. The literature review led to the development of a number of object-oriented models for deploying RMT. This modeling is being used for a number of purposes, including for education of students in health infomatics as well as testing of new use cases for RMT with industrial collaborators and projects within the smart home of the future laboratory. Conclusions: Object-oriented modeling, based on analysis of gaps in the literature, was found to be a useful approach for describing, communicating and teaching about potential new uses of RMT.

scholarly journals Remote monitoring in heart failure: current and emerging technologies in the context of the pandemic

Heart ◽  
2021 ◽  
Vol 107 (5) ◽  
pp. 366-372
Author(s):  
Donya Mohebali ◽  
Michelle M Kittleson
Keyword(s):  
Heart Failure ◽  
At Risk ◽  
Remote Monitoring ◽  
Reliable Method ◽  
Healthcare Delivery ◽  
Rapid Expansion ◽  
Monitoring Technology ◽  
Remote Healthcare ◽  
Monitoring Technologies

The incidence of heart failure (HF) remains high and patients with HF are at risk for frequent hospitalisations. Remote monitoring technologies may provide early indications of HF decompensation and potentially allow for optimisation of therapy to prevent HF hospitalisations. The need for reliable remote monitoring technology has never been greater as the COVID-19 pandemic has led to the rapid expansion of a new mode of healthcare delivery: the virtual visit. With the convergence of remote monitoring technologies and reliable method of remote healthcare delivery, an understanding of the role of both in the management of patients with HF is critical. In this review, we outline the evidence on current remote monitoring technologies in patients with HF and highlight how these advances may benefit patients in the context of the current pandemic.

scholarly journals Accuracy of flash glucose monitoring and continuous glucose monitoring technologies: Implications for clinical practice

2018 ◽  
Vol 15 (3) ◽  
pp. 175-184 ◽  
Author(s):  
Ramzi A Ajjan ◽  
Michael H Cummings ◽  
Peter Jennings ◽  
Lalantha Leelarathna ◽  
Gerry Rayman ◽  
...  
Keyword(s):  
Continuous Glucose Monitoring ◽  
Diabetes Care ◽  
Interstitial Fluid ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
Glucose Sensing ◽  
Sensor Data ◽  
Flash Glucose Monitoring ◽  
Fluid Sensor ◽  
Monitoring Technologies

Continuous glucose monitoring and flash glucose monitoring technologies measure glucose in the interstitial fluid and are increasingly used in diabetes care. Their accuracy, key to effective glycaemic management, is usually measured using the mean absolute relative difference of the interstitial fluid sensor compared to reference blood glucose readings. However, mean absolute relative difference is not standardised and has limitations. This review aims to provide a consensus opinion on assessing accuracy of interstitial fluid glucose sensing technologies. Mean absolute relative difference is influenced by glucose distribution and rate of change; hence, we express caution on the reliability of comparing mean absolute relative difference data from different study systems and conditions. We also review the pitfalls associated with mean absolute relative difference at different glucose levels and explore additional ways of assessing accuracy of interstitial fluid devices. Importantly, much data indicate that current practice of assessing accuracy of different systems based on individualised mean absolute relative difference results has limitations, which have potential clinical implications. Healthcare professionals must understand the factors that influence mean absolute relative difference as a metric for accuracy and look at additional assessments, such as consensus error grid analysis, when evaluating continuous glucose monitoring and flash glucose monitoring systems in diabetes care. This in turn will ensure that management decisions based on interstitial fluid sensor data are both effective and safe.

scholarly journals Enhancing Standards and Principles in Digital Mental Health With Recovery-Focused Guidelines for Mobile, Online, and Remote Monitoring Technologies

2019 ◽  
Vol 70 (12) ◽  
pp. 1080-1081 ◽  
Author(s):  
Karen L. Fortuna ◽  
Robert Walker ◽  
Daniel B. Fisher ◽  
George Mois ◽  
Stephanie Allan ◽  
...  
Keyword(s):  
Mental Health ◽  
Remote Monitoring ◽  
Monitoring Technologies

scholarly journals Continuous glucose monitoring: review of promising technologies

2019 ◽  
Vol 252 ◽  
pp. 02012
Author(s):  
Monika Klimek ◽  
Tytus Tulwin
Keyword(s):  
Glycemic Control ◽  
Continuous Glucose Monitoring ◽  
New Technologies ◽  
Glucose Monitoring ◽  
Flash Glucose Monitoring ◽  
Uncontrolled Diabetes ◽  
Monitoring Technologies

Despite the progress we have made in the management of diabetes it is still incurable and aggravating disease affecting all domains of quality of life. Uncontrolled diabetes associated with hyperglycemia leads to serious microvascular and macrovascular long-term complications. The proper long-term glycemic control is a key strategy for preventing the development or slowing the progression of diabetes complications, thus there is a crucial role of new technologies in the diabetes care. New technologies in diabetology are developing dynamically in recent years and therefore this is a topical issue. In this paper we describe current and developing continuous glucose monitoring technologies and their usefulness in promoting optimal glycemic control, influence on personalized diabetes managements and the functioning of patients. Moreover we review knowledge about flash glucose monitoring and close-loop system. This review examines studies published before 31st August 2018.

Use of remote monitoring with continuous glucose monitoring in young children with Type 1 diabetes: the parents’ perspective

2019 ◽  
Vol 36 (11) ◽  
pp. 1453-1459 ◽  
Author(s):  
M.‐A. Burckhardt ◽  
L. Fried ◽  
K. Bebbington ◽  
M. Hancock ◽  
J. A. Nicholas ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Young Children ◽  
Continuous Glucose Monitoring ◽  
Remote Monitoring ◽  
Glucose Monitoring

scholarly journals DO OLDER ADULTS AND THEIR CHILDREN AGREE ABOUT THE USE OF LOCATION TRACKING, IN-HOME SENSORS, AND WEB-CAMERAS?

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S371-S371
Author(s):  
Clara Berridge
Keyword(s):  
Older Adults ◽  
Decision Making ◽  
Adult Children ◽  
Remote Monitoring ◽  
Social Life ◽  
Adult Women ◽  
Location Tracking ◽  
Structured Interviews ◽  
Meals On Wheels ◽  
Monitoring Technologies

Abstract On the dyad and aggregate level, we compare preferences of older adult women and their adult children for three remote monitoring technologies: location tracking, in-home sensors, and Web-cameras. Their assessments of each technology’s impact on privacy, safety, independence, freedom, relationship with family member, social life, and identity are also compared. Twenty-eight individual, in-depth structured interviews were conducted with 18 women who are Meals on Wheels clients and 10 of their adult children. Adult children preferred each technology more than their mothers did and underestimated both their mothers’ ability to comprehend the functions of the technologies and the importance of engaging them fully in decision making. For both groups, privacy was the most-cited concern, and participants perceived significant overlap between values of privacy, independence, identity, and freedom. Shared decision-making tools are needed to promote remote monitoring use consistent with older adults’ values and to prevent conflict and caregiver overreach.

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