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Telemonitoring for Infectious Diseases: A Remote System for Assessing Patient Parameters and Specimen Analysis

Background
Traditional methods for the diagnosis and clinical management of infectious diseases require the direct assessment of a patient?s symptoms, vital signs, and often the collection and analysis of clinical specimens by health care practitioners, usually in a health care setting.  Recent scientific advances in mobile and remote monitoring technologies have enabled home-based telemonitoring of multiple physical parameters in patients with chronic medical conditions including cardiovascular disease, diabetes, hypertension, and asthma. Additionally, advances in rapid diagnostic platforms to detect pathogens have also been recently realized.  There is now a unique opportunity to leverage and integrate the advances made in these two areas of research and their associated technologies and to apply them to the development of portable and continuous monitoring systems to revolutionize the early detection, progression, and/or effects of treatment of patients with infectious diseases.
The emerging development of portable monitoring devices and technologies have yet to be applied to infectious diseases and may have a significant impact on clinical management. Systems that are able to remotely monitor and report physiological status with minimally-invasive specimen collection would be useful ways to inform and support the clinical management of disease, e.g., in premature infants at risk for (or already diagnosed with) RSV, in elderly individuals with chronic illness.  Remote monitoring of patients for the occurrence or worsening of an infectious disease may result in early clinical intervention and optimize the use of available therapies.  Such ?real-time? monitoring of symptoms and/or disease progression would also add value by avoiding unnecessary trips to the ER/physician, and reducing healthcare costs.  While this type of monitoring system is envisioned to be broadly applicable, some patient populations (infants, elderly adults, and immunocompromised individuals) may have greater benefit as they may not show symptoms on examination, yet they may have an increased chance of developing infections due to recent medical procedures or to rapid worsening of a previously diagnosed infectious disease.
Project goal
The overall goal of this solicitation is to develop a device that can, in a non-clinical setting, monitor and report data that reflects the emergence and/or progression of an infectious disease.  The complexity of such a device, and its operation, should allow for its use in patient environments such as a home or a nursing facility and be capable of communicating ?actionable? data to professional healthcare workers.  Ideally, such a device would have an integrated architecture consisting of a physiological monitoring component, and/or a specimen collection apparatus with equipment to analyze the sample, and a communications functionality for data transmission; however, the capability for specimen collection is not required for applications that involve physiological measurements only (i.e. that do not require evaluation of analytes).  A highly desirable feature for a device that requires sample collection might be a visual menu that provides simple instructions for outpatient specimen collection when needed, so that family members or care providers could support the analytical device with minimal training.  The types of information to be collected may include, but are not limited to: physiological measurements (vital signs), analytes (biomarkers) that are present in bodily fluids or breath and measures of behavioral responsiveness to environmental stimuli.  Evidence must be presented that the data collected by the device is directly relevant to the occurrence and/or progression of an infectious disease and that its ultimate use will be to support clinical decision-making.  
Phase I activities include but are not limited to:
?       Development of appropriate tests / physiological measurements to be used for monitoring of disease
?       Proof of concept that the information can be used to infer a clinically-relevant change in disease state 
?       Initial design of integrated device for outpatient monitoring including, if proposed, specimen collection / analysis  
Phase II activities include but are not limited to:
?       Development of prototype device for monitoring and reporting of infectious disease status
?       Development of analytic software (beta version) to evaluate and report results
?       Optimization of any reagents that are required for analytic tests
?       Validation of test procedures to address issues of reproducibility, sensitivity and specificity
 
?       Proof of concept that device can integrate measurement / analysis steps with data transmission 

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