Novel Wearable-based Real-time Temperature Monitoring in Hospitals for Febrile Adverse Events in Patients with Cancer: A Prospective Cohort Study (Preprint)
Authors: Kim Yun Kwan , Ahn Seo-Yeon , Song Chae-Bin , Hong YeWon , Kim Ray , Baek Hee Jo , Kook Hoon , Kim Mihee , Song Ga-Young , Jang Ho Cheol , Jung Sung-Hoon , Yang Deok-Hwan , Lee Je-Jung , Kim Hyeoung-Joon , Kim Gyung Chul , Kim Hoo Hyun , Lee Young-Shin , Ahn Jae-Sook 
Published: November 2024

BACKGROUND

Cancer is among the leading causes of mortality worldwide. Chemotherapy is an effective treatment for patients with cancer; however, febrile neutropenia after chemotherapy may result in decreased neutrophils, increasing infection risk. Although early fever detection is crucial for infection prevention, periodic temperature measurements have inherent limitations. Wearable devices (WD) that use real-time body temperature (RBT) measurements are currently being developed to detect fever. However, their clinical maturity and usability remain unverified.

OBJECTIVE

We evaluated the clinical feasibility of a novel WD by comparing temperature agreement and early fever detection between the WD and a reference in patients with cancer. We also verified the clinical maturity of the RBT monitoring system, including its capacity for early fever detection and monitoring cancer treatment and post-treatment changes. Finally, satisfaction and convenience of use for clinicians and patients were analyzed when the WD-based RBT monitoring system was applied in a hospital setting.

METHODS

This prospective study included patients with hematologic diseases and high-risk infections in the cancer ward of Chonnam National University in Hwasun. We used data from 47 patients to establish the inclusion and exclusion criteria for early fever detection and temperature comparison between the reference and WD groups. We assessed the body temperature agreement between the MT100D (SEERS Technology Co., Ltd.) as the WD and an auxiliary thermometer as a reference. We further evaluated the MT100D’s early fever detection rate and the early response system’s clinical efficiency based on fever detection. Finally, we performed a usability test to check the satisfaction and convenience of users and clinicians using the RBT monitoring system.

RESULTS

A comparison of the MT100D and the reference revealed an average difference of -0.19 ± 0.35°C and an inter-class correlation coefficient of 0.78, indicating good agreement. Subsequently, the fever detection performance of the RBT monitoring system achieved sensitivity, specificity, and an area under the receiver operating characteristic curve of 81.50%, 96.32%, and 96.60%, respectively. The early fever detection rate was 75.0%, and our RBT system detected fever 1.24 hours earlier than the reference. In a survey, the MT100D and RBT monitoring systems received high ratings of 4.81 and 3.81 out of 5 points, respectively.

CONCLUSIONS

Among patients with cancer, including those at a high risk of fever, the MT100D demonstrated a good degree of agreement with the reference. This demonstrates the RBT monitoring system’s high early fever detection rate. Consequently, the RBT monitoring system utilizing MT100D can be employed as a reliable system for early detection of neutropenia risk in patients undergoing chemotherapy.

CLINICALTRIAL

KCT0008874