Utilizing Digital Biomarkers Derived from Wearable Devices and Patient-Reported Outcomes

TechDoctor Inc. (Representative Director: Kazumichii Minato, Headquarters: Chuo-ku, Tokyo; hereinafter, TechDoctor) will participate as a research and development sub-implementing organization in a research project led by Associate Professor Tadashi Hosoya of the Department of Collagen Disease and Rheumatology, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, and supported by the Japan Agency for Medical Research and Development (AMED)'s FY2025 Research Project for Rare and Intractable Diseases (Medical Devices).

This research targets Systemic Lupus Erythematosus (SLE) and aims to optimize treatment and improve treatment adherence by integrating and analyzing biological data obtained from wearable devices with Patient-Reported Outcomes (PROs) to create and utilize "Digital Biomarkers*" – objective indicators of disease status.

Building upon the knowledge accumulated through R&D in FY2024, TechDoctor will embark on the research and development of a Software as a Medical Device (SaMD) with a view toward its practical application as a clinical support tool.

In this research, TechDoctor will be responsible for wearable data analysis, AI/machine learning model study, and the development of a prototype implementing a disease activity prediction algorithm.

■ Background and Necessity of the Research

Systemic Lupus Erythematosus (SLE) is an autoimmune disease that primarily affects women in their 20s to 40s, causing chronic inflammation in various organs throughout the body. It is one of the more common collagen diseases, with an estimated 60,000 to 100,000 patients in Japan. While treatment outcomes in the acute phase have improved due to recent advances in pharmacotherapy, managing the risk of relapse in the chronic phase and judging the safe tapering or discontinuation of medication remain critical clinical challenges.

SLE symptoms and progression vary significantly from patient to patient, and there are limits to the information a physician can gather during a consultation, suggesting the possibility of not fully grasping the overall picture of disease activity.

In response to these challenges, previous research and initiatives have shown the potential to grasp the condition of SLE more comprehensively and objectively by utilizing symptoms reported by the patients themselves (PROs) and continuous biological data such as heart rate, sleep, and activity obtained from wearable devices. Objective indicators based on such data are expected to be utilized as digital biomarkers in SLE clinical practice.

In this research, by leveraging this data and visualizing disease activity, we will explore the ideal form of clinical support that contributes to improving the accuracy of treatment decisions and optimizing treatment with a view to relapse risk.

■ Previous Research Results and International Conference Presentation

Through R&D conducted with Institute of Science Tokyo under the support of AMED's FY2024 Research and Development Program for Medical Devices (Challenge Type), fundamental studies and accumulation of knowledge leading to this research project have progressed.

In the process, it was suggested that combining biological data acquired from wearable devices with patient-reported outcomes (PROs), in addition to medical information obtained in clinical settings, could more accurately grasp the disease status of SLE.

These research results were presented at the European Congress of Rheumatology and attracted significant attention.

https://prtimes.jp/main/html/rd/p/000000060.000071267.html

Building upon this knowledge, this research will focus on the R&D of Software as a Medical Device with a view toward practical application as a clinical support tool.

■ R&D Overview

Japan Agency for Medical Research and Development (AMED) FY2025 Research Project for Rare and Intractable Diseases (Medical Devices)

Research and Development Project Title:
Development of a Clinical Guidance Program Medical Device for SLE Utilizing Wearable Devices and Personal Health Records

(Reference) Call for Proposals Information

https://www.amed.go.jp/koubo/11/02/1102C_00112.html

Principal Investigator:
Tadashi Hosoya, Associate Professor

Department of Collagen Disease and Rheumatology, Graduate School of Medical and Dental Sciences, National University Corporation Institute of Science Tokyo

[Objective of this R&D]

This research aims to realize a Software as a Medical Device that visualizes the "disease activity" of SLE as a quantitative score using digital biomarkers to support clinical practice.

Through this, we aim to build a mechanism for evaluating the treatment status objectively and in a shareable format among healthcare professionals. Concurrently, with SLE as a model case, we will explore the feasibility of implementing a platform that can be expanded to other designated intractable diseases in the future.

[Method]

Using a newly established patient cohort, we will verify the extensibility and usefulness of indicators based on the knowledge gained from previous research. In addition, we will develop indicators that allow for intuitive grasping of disease stability and exacerbation trends.

Furthermore, we will work on the development of a prototype of a program medical device that contributes to clinical support, while verifying its consistency with the expert physician's judgment of disease activity.

* This program is currently under development and cannot be used for diagnosis or treatment at this time.

■ Social Significance and Future Prospects

By further deepening the knowledge gained through this research, it is expected that in the future, physicians and patients will be able to be presented with the risk of SLE relapse and the outlook for symptom changes with higher accuracy. By sharing this information between physicians and patients, it is believed that more planned therapeutic interventions will become possible, such as encouraging consultation during the prodromal phase of relapse, deciding on early treatment, and optimizing and safely reducing medication dosage.

Furthermore, in SLE, patients often suffer from fatigue, mental distress, and unpredictable symptom fluctuations even during maintenance therapy. The visualization of the disease condition and future prediction through this initiative is also expected to be a source of support for patients to understand their own condition and live their daily lives while facing the disease.

The clinical support mechanism aimed for in this research is intended to assist in the practice of high-quality medical care, based on objective data, in a greater number of clinical settings. We aim to show a path toward "informed treatment participation (shared decision-making)" in SLE clinical practice, where the uncertainties are visualized and physicians and patients discuss treatment policies based on shared information.

TechDoctor will continue to explore the possibilities of objective evaluation methods in the field of intractable diseases through the analysis of biological data utilizing wearable devices, contributing to the development of data-driven medicine.

[ About TechDoctor ]

TechDoctor Inc. advocates the vision "Towards an era where data improves well-being" and is promoting the development and social implementation of "Digital Biomarkers*" that derive health-related insights from daily sensing data, including that from wearable devices. We are working toward the realization of AI-driven medicine based on data, in collaboration with medical, pharmaceutical, food-related companies, and research institutions.

Representative Director: Kazumichii Minato
Chief Medical Officer: Keisuke Izumi
Headquarters: Kyobashi Edogrand 4F, 2-2-1 Kyobashi, Chuo-ku, Tokyo
Established: June 21, 2019

Business Description: Development and operation of the digital biomarker development platform "SelfBase," and provision of digital medical solutions.
URL: https://www.technology-doctor.com/

* Digital Biomarker

A digital biomarker is an indicator that continuously and objectively evaluates the presence of a disease, changes in disease status, and the effect of treatment, based on routine biological data acquired from smartphones, wearable devices, and other sources.

While conventional biomarkers are "point data" measured temporarily at medical institutions, digital biomarkers are characterized by their ability to continuously acquire "line data" from daily life. Based on indicators such as exercise, sleep, and heart rate, they are expected to be used for early detection of disease, monitoring the efficacy and safety of treatment, and even as new endpoints in drug development. Development has been progressing overseas since around 2019, and attention is growing in Japan as well.