EndoSense: Continuous Real-Time Monitoring of Health Markers in Endocrine and Metabolic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in 24-hour systolic blood pressure
研究概览
简要总结
The goal of this trial is to learn whether wearable devices and hormone sampling can measure how the body changes during daily-life challenges in adults with endocrine or metabolic disorders. These disorders include conditions such as high blood pressure, adrenal disorders, diabetes, obesity, thyroid disorders, pituitary disorders, and other hormone-related conditions.
The main questions it aims to answer are:
Can wearable devices measure changes in blood pressure, heart rate, sleep, activity, temperature, and glucose during changes in salt intake, meals, fasting, and short exercise? Do these changes differ between people with different endocrine or metabolic disorders? Are wearable devices acceptable and practical for participants to use at home?
There is no comparison group in this study. Each participant will serve as their own comparison by completing different study phases.
Participants will wear study devices at home to measure blood pressure, heart rate, activity, sleep, temperature, and glucose, follow a low-salt diet for about 1 week and then a high-salt diet for about 1 week, using study instructions, complete meal, fasting, and short exercise tasks, give urine and saliva samples, and possibly blood samples, during the study. Optionally wear a hormone sampling device for about 27 hours, complete short questionnaires about symptoms, sleep, physical activity, and their experience using the devices.
The study will help researchers understand whether wearable monitoring can support future diagnosis and care for people with endocrine and metabolic disorders.
详细描述
EndoSense is a monocentric, single-arm, non-randomized, before-and-after interventional study conducted at the University Hospital Zurich within the European ENDOTRAIN consortium. The study is designed to evaluate whether continuous wearable monitoring, combined with dynamic hormone sampling, can capture meaningful physiological and endocrine responses during standardized environmental challenges in adults with endocrine or metabolic disorders.
Current diagnostic approaches in endocrinology often rely on single time-point measurements, although many endocrine and metabolic processes vary across the day and in response to salt intake, meals, fasting, sleep, and physical activity. EndoSense addresses this gap by combining home-based physiological monitoring with structured dietary and activity modules. The study will assess whether wearable-derived data can provide clinically relevant information on blood pressure, heart rate, heart rate variability, activity, sleep, temperature, and glucose patterns, and whether these data correspond to dynamic hormonal changes.
Each participant will complete a structured home-monitoring protocol. The protocol includes a baseline home-monitoring period followed by sequential dietary sodium modulation, starting with a low-sodium phase and followed by a high-sodium phase. Standardized mixed-meal, fasting, postural, and short exercise modules are included to characterize postprandial, fasting, hemodynamic, and stress-related physiological responses. These modules may be adapted or omitted according to the participant's underlying condition, safety considerations, and preferences after consultation with the study physician.
During the home-monitoring phase, participants will wear several study devices. These include devices for periodic blood pressure and pulse monitoring, continuous glucose monitoring, activity and movement assessment, sleep monitoring, and temperature monitoring. Data from these devices are collected for research purposes only and will not guide clinical care during the study. Participants will also complete brief electronic diaries and questionnaires to document adherence, symptoms, sleep, physical activity, usability, and acceptance of the study devices.
A subset of participants who provide separate consent will undergo dynamic hormone sampling using the U-RHYTHM system. This device collects subcutaneous interstitial fluid samples over approximately 27 hours and is used to study day-night and short-term hormone patterns. The hormone sampling module is optional and will be performed at selected time points during the protocol and, when appropriate, during routine clinical assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis or suspected diagnosis of at least one endocrine or metabolic disorder, including:
- •Overweight or obesity, defined as body mass index of 25 kg/m² or higher
- •Essential hypertension
- •Diabetes mellitus, including type 1 diabetes, type 2 diabetes, gestational diabetes, maturity-onset diabetes of the young, or unclassified diabetes
- •Hypoglycemia
- •Endogenous hypercortisolism
- •Primary aldosteronism
- •Endogenous or exogenous adrenal insufficiency
- •Congenital adrenal hyperplasia
- •Polycystic ovary syndrome
- •Adrenocortical tumor or adrenal incidentaloma
- •Functional or non-functional pituitary tumor
- •Pituitary insufficiency
- •Polyuria-polydipsia syndrome
- •Hyponatremia
- •Functional or non-functional neuroendocrine tumor
- •Osteoporosis
- •Lipid disorder
- •Thyroid disorder
- •Hypoparathyroidism or hyperparathyroidism
- •Inborn error of metabolism
- •People undergoing gender-affirming hormone therapy
排除标准
- •Known or suspected severe skin disorder or allergy that may interfere with wearable sensor placement, such as extensive eczema, psoriasis, chronic ulcers, or severe tape intolerance
- •Known impaired wound healing or strong keloid tendency that would make repeated skin application or microneedle use unsuitable
- •Pregnancy or lactation, for participation in home monitoring or dynamic hormone sampling
- •Known or suspected bleeding disorder, such as von Willebrand disease
- •Current treatment with anticoagulant or antiplatelet therapy at a dose that increases bleeding risk
- •Severe acute or chronic medical condition that, in the investigator's opinion, would interfere with study procedures or compromise participant safety, such as decompensated heart failure, unstable angina, or acute systemic infection
- •Current lithium treatment, because the intervention may alter lithium levels
- •Recent travel across more than 4 time zones within the past 14 days, if study endpoints rely on circadian hormone profiles
- •Ongoing shift work, if study endpoints rely on circadian hormone profiles
- •Inability to give informed consent
- •Inability to comply with study procedures
结局指标
主要结局
Change in 24-hour systolic blood pressure
时间窗: From Day 6 (end of low-sodium phase) to Day 13 (end of high-sodium phase)
Change in mean 24-hour systolic blood pressure (mmHg), measured using a validated cuffless automated home blood pressure device, comparing the last 24 hours of the high-sodium diet phase to the last 24 hours of the low-sodium diet phase.
次要结局
- Change in 24-Hour Diastolic Blood Pressure(Day 6 to Day 13)
- Change in Resting Heart Rate(Day 6 to Day 13)
- Change in Heart Rate Variability(Day 6 to Day 13)
- Change in Mean Interstitial Glucose Concentration(Day 6 to Day 13)
- Change in Percentage of Time in Target Glucose Range(Day 6 to Day 13)
- Change in Plasma Aldosterone Concentration(Day 6 to Day 13)
- Change in Plasma Renin Concentration(Day 6 to Day 13)
- Change in Interstitial Cortisol Rhythm (Area Under the Curve)(27-hour U-RHYTHM sampling window at end of each phase (Day 6-7 vs. Day 13-14))
- 24-Hour Urinary Sodium Excretion(Day 7 and Day 14)
- Change in EQ-5D Visual Analog Scale Score(Day 1, Day 7 and Day 14)
- Change in Pittsburgh Sleep Quality Index Global Score(Day 1, Day 7 and Day 14)
- System Usability Scale Score(Day 7 and Day 14)
- International Physical Activity Questionnaire-Short Form Score(Day 1, Day 7 and Day 14)
研究者
Felix Beuschlein
Prof. Dr. med
University of Zurich