THE DIGITWIN STUDY

Data is the key

Modern healthcare has made tremendous strides in treating disease and extending lifespans. However, chronic diseases, like cardiovascular disease, remain a major challenge in society. Identifying complex patterns in health biomarkers before clinical symptoms appear has the potential to identify problems while they can be modified, preventing the onset of disease and extending healthspan.

Researchers at the BioMedical Engineering and Imaging Institute (BMEII) at the Icahn School of Medicine and Mount Sinai are undertaking a research study designed to collect and integrate multimodal health data — including imaging, laboratory tests, wearables, and lifestyle measures — into a large dataset that can be used to model health trajectories, including the development of cardiovascular diseases. After the Digitwin Study is complete, the Digitwin cohort data that will be assembled will be the basis of future studies to develop novel AI-driven models to better understand patterns of health and aging over time.

What’s the goal of this study?

The goal of the DIGITWIN STUDY is to amass a comprehensive profile of health data in a cohort of 1,000 individuals within the next 3-5 years. The health data that will be collected will span established clinical laboratory and physical function tests, state-of-the-art whole body MRI imaging, state-of-the-art genetics and multiomics tests, comprehensive lifestyle questionnaire data collection, and use of novel at-home sensors and devices for monitoring activity and health. The depth and breadth of health measures is designed to capture molecular, cellular, organ-level, and organism level data so we can understand how systems interact with each other and impact overall health.

This study is exploratory and observational in nature. It does not provide medical diagnosis, treatment, or clinical recommendations

What’s involved

Health data will be collected during a study visit at Mount Sinai hospital, as well as via at home collection using wearable devices and via questionnaires accessed through the study app. The data collected for the study will encompass the molecular, cellular, and organ-level function of all the key organs and organ systems in the body including the brain, heart,lungs, liver, pancreas, and gut. Other tests will provide data on the individual as a whole.

The health data collected are for research purposes only. The study does not provide individualized medical advice or treatment recommendations and does not evaluate the safety or effectiveness of any AI-based tool . Participants are encouraged to discuss any health concerns with their personal healthcare providers.

Study design

The study will be conducted over 24 months, with tests conducted during annual visits to our center at Mount Sinai in NYC, and others conducted at-home. A baseline visit will be conducted upon enrollment with follow up visits after 1 and 2 years. In between, participants will receive test devices in the mail for blood collection and blood sugar monitoring. Other tests will be completed daily or continuously, such as the Oura ring activity monitor and the air quality monitor.

Study Test How is this done? What’s it for?
Health History, Mental Health, and Lifestyle A comprehensive personal and health history will be collected with a battery of standardized questionnaires to capture the current health profile. These data will be the basis for modeling.
Multiomics, and clinical lab tests State of the art technology for collecting tiny drops of blood at home will be used to provide analysis of the multiomic profile as well as standard clinical blood tests. AMultiomics relates to the 1000’s of chemical byproducts in the blood as cells perform their functions. The multiomics profile provides unique insights into health and the early changes associated with onset of disease. Combining multiomics spanning the areas of proteomics, metabolomics, lipidomics, and gut microbiomics will provide the most comprehensive analysis connecting multiple organ systems in new ways to monitor health.
Gut and oral microbiome A kit to collect a stool sample and saliva sample at home will be provided for subsequent analysis at our labs. There are millions of bacteria in the digestive system, from the mouth to the gut, that play an enormous role in modulating the cellular functions of the body. Studying the gut and oral microbiome is an important factor in determining overall health.
Lifestyle, activity, and current health Questionnaires documenting all the key factors that influence health will be used throughout the study. Questionnaires will be completed remotely through a smartphone app. Key topics include activity, sleep, stress, and nutrition. Lifestyle factors are a key component in overall health. How they interact with and can influence health markers is a major component of the study.
Sensors and Devices Multiple wearable sensors and at-home devices designed to capture continuous or near-continuous data on activity and environment (exposomics) will be provided for use at home during the study. This novel component of the study integrates minimal form-factor wearable technology to provide continuous data on health lifestyle and environment to optimize the understanding of links between daily activities and changes in health metrics.

 

Study Test How is this done? What’s it for?
Vitals and physical function tests Standard measures of vital signs (height, weight, blood pressure, pulse, and respiration), exercise capacity and lung function, leg and grip strength, and electrocardiography (ECG), will be collected during a study visit to our facility. These tests will provide established markers of health – an essential starting point for building next generation models.
Whole body MRI Imaging Non-invasive MRI imaging of multiple organ systems including the brain, heart, whole body composition, and other vital organs. Imaging provides more precise assessment of body composition and heart function, and provides measures that deepen insight into early changes in organ function.
Retinal Imaging A simple and quick scan of the back of the eyes, similar to a visit to the optician. The retina provides a detailed view of the delicate blood vessels in the eyes and provides insight into vascular health. For example, retinal imaging is used to diagnose diabetic retinopathy, a side effect of diabetes.
Genetic analysis Genetic analysis will be done from a simple blood sample. Many conditions are linked to specific genes, and genetic signatures often play a role in many diseases.

At-home tests

Oura Ring

Oura Ring – The Oura ring actively collects over 20 metrics when worn, including heart rate, blood oxygen, body temperature, and sleep measurements throughout the day. These metrics are available via a mobile app that organizes your data into easy-to-understand reports.

Tasso Mini At-Home Blood Collection Device

The Tasso Mini is a small, lightweight, single-use device that attaches to the upper arm. By pressing a button on the device, a virtually painless capillary blood sample is collected on a cartridge within the device. The stable, dried, blood sample within the cartridge is then mailed to the study team for multiomics analysis.

At-Home Dried Blood Collection

Participants will self-collect a small blood sample at home using a fingertip lancet and specialized collection card. Once dried, the sample is mailed for laboratory analysis.  These dried blood spots will be used to assess a broad set of health indicators, including cardiometabolic risk,  hormone levels, thyroid function, nutritional status, organ function, and systemic inflammation. A subset of samples  will also undergo epigenetic analysis to estimate biological age, pace of aging, and immune system aging based on DNA  methylation patterns.

Dexcom Stelo CGM

The Stelo Glucose Biosensor is a continuous glucose monitoring technology from Dexcom and is simple and painless to apply. By sending glucose levels directly to your smartphone, the allows you to see connections between your daily lifestyle choices and glucose levels.

MIR Spirometer

The MIR Spirometer enables users to take accurate and precise measurements of respiratory functions at home, enabling continuous, real-world assessment of lung function, which is relevant for individuals at risk for or managing cardiometabolic diseases and cardiovascular diseases.

Withings Smart Scale

This digital scale provides continuous, at-home weight monitoring, delivering a key metric that can be seamlessly integrated with other health data. By correlating weight trends with blood pressure, CGM, spirometry, and other physiological metrics, this data enhances the study’s ability to track longitudinal health changes and assess individual responses to lifestyle interventions.

Withings Blood Pressure Monitor

This wireless blood pressure monitoring cuff seamlessly integrates with weight, CGM, and spirometry data in the Digital Twin study, enabling daily tracking to enhance cardiovascular health assessment and support personalized interventions, making blood pressure a key metric in comprehensive digital health monitoring.

PurpleAir Home Air Quality Monitor

The home air quality monitor provides real-time tracking
of indoor air quality, capturing PM2.5, VOCs, and CO2 levels to assess environmental impacts on cardiometabolic and respiratory health. By linking air quality data with other study data, it enhances the study’s ability to monitor longitudinal health trends and support personalized
interventions.

Silicones Wristband

Silicones Wristbands for Personal and Home Chemical Exposure Monitoring – The silicone wristbands serve as passive personal chemical exposome monitors, capturing airborne and skin-contact contaminants to assess individual environmental exposures in the study. By analyzing accumulated pollutants alongside other study data, these wristbands provide insights into the impact of chemical exposures on cardiometabolic and respiratory health. Their wearable, non-invasive design enables continuous exposure assessment, supporting a comprehensive understanding of environmental influences on long-term health outcomes.

An Intuitive smarphone app facilitates data collection from at-home tests and survey answers

 

The eHive smartphone app – developed by Mount Sinai researchers – provides an intuitive and user-friendly interface for study participants to provide informed consent to participate during enrollment into the study and for collecting self-reported health and lifestyle data from in-app questionnaires during the study. The app also provides a convenient way for researchers and participants to stay in touch, answer questions, and receive reminders to complete study tests and schedule study appointments at our center in NYC. The app also connects to smart devices at home and facilitates seamless integration of study data in a secure (HIPAA compliant) database.

Who can participate in the study?

To participate in the study, you must be at least 18 years of age, be able to use a smartphone to connect at-home devices for data collection, and be able to complete at-home tests and annual in-person study visits at Mount Sinai in NYC. The study will last for 24 months.

 

If you are intersted in participating in the study, please contact the study team at digitwin@mssm.edu and, thank you!

 

This research study is approved by the Mount Sinai Institutional Review Board (IRB) – Study 25-00148