This protocol outlines a planned observational study of 100 female participants to evaluate the feasibility of multimodal physiological and lifestyle monitoring in Korean medicine primary care.
Observational (n=100)
Yes
Does multimodal physiological and lifestyle monitoring provide feasible and applicable cardiometabolic profiling in female patients in primary Korean medicine settings?
This protocol outlines a prospective observational study to validate multimodal cardiometabolic monitoring in female patients within primary Korean medicine settings.
Background: Accurate prediction of cardiovascular disease (CVD) risk requires integrating multiple biological signals and lifestyle factors. In South Korea, CVD is a leading cause of mortality. While multi-signal observational research is warranted, a targeted preliminary study is essential before large-scale trials. Given well-established sex differences in glycemic variability and continuous glucose monitoring (CGM) profiles, initializing data collection within a female cohort is crucial to capture distinct metabolic nuances.Methods: This protocol for a pilot prospective multicenter observational study aims to validate a methodology evaluating multidimensional cardiometabolic profiles within primary Korean medicine (KM) settings. One hundred female participants (aged 20-59) will be recruited from 4 KM clinics. Cardiovascular markers (blood pressure, pulse wave velocity, heart rate variability) will be acquired using the KOROT P3 Accurate device. Continuous glucose changes will be monitored using the CareSens Air CGM system, while biochemical markers (lipid profiles, HbA1c) will be assessed via a portable blood analyzer. Participants will log food intake by photographing meals using a smartphone application. Statistical analysis will evaluate glucose dynamics, variability indices, and their correlations with cardiovascular autonomic function.Conclusion: This protocol describes a study in females to evaluate the feasibility and real-world applicability of a clinical research model involving KM-based lifestyle therapy or dietary interventions. By combining conventional biochemical markers with continuous physiological monitoring in naturalistic settings, this research represents a step towards “bio-observability” and may enable more precise risk management in women.
Chu et al. (Mon,) conducted a observational in Cardiovascular disease risk (n=100). Multimodal physiological and lifestyle monitoring was evaluated on Feasibility and real-world applicability of a clinical research model. This protocol outlines a planned observational study of 100 female participants to evaluate the feasibility of multimodal physiological and lifestyle monitoring in Korean medicine primary care.