Wearable Device-Based Screening for Anemia Risk
ConditionAnemia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital
About this trial
Anemia is a common condition, but it often goes undiagnosed because confirming it requires a venous blood test. This study looks at whether a commercially available wrist-worn smartwatch can help identify people who may have anemia, without taking blood.
The watch continuously records several types of physiological signals, including photoplethysmography (a light-based measure of blood flow), movement, heart rate, blood oxygen saturation, and heart rate variability. Researchers will use these signals to build a computer model that sorts participants into two groups: likely to have anemia, or unlikely to have anemia.
About 400 adults between 18 and 80 years of age will take part at one hospital in Beijing, China. Both patients with anemia and people with normal hemoglobin levels will be included. Each participant will wear the watch and also have a standard venous blood test to measure hemoglobin, which serves as the reference for comparison.
Data from the first 250 participants will be used to develop the model. Data from the next 150 participants will be used to test how well the model works in a separate group. The main question is how accurately the watch-based result matches the blood test result.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 to 80 years, any sex
Willing to participate and able to provide written informed consent
Able to comply with wearable device wear, venous blood sampling, and functional assessment (e.g., six-minute walk test)
For participants with anemia: a hemoglobin test result obtained within 3 days before or after wearable signal acquisition and a hospital diagnostic report, including anemia severity, red blood cell size classification, and anemia type. Anemia is defined according to Chinese sea-level criteria: hemoglobin below 120 g/L in adult men, below 110 g/L in non-pregnant adult women, and below 100 g/L in pregnant women
Disqualifiers
Axillary temperature 37.3°C or higher on the day of data collection or on the preceding day
Acute exacerbation of a severe comorbid condition (e.g., decompensated heart failure, respiratory failure, acute infection)
Skin breakdown, rash, deformity, amputation, or any other condition of the upper limb precluding proper wear of the device
Refusal of, or intolerance to, invasive venous blood sampling
Trial population
Adults aged 18 to 80 years recruited from inpatient wards and outpatient clinics at a single tertiary care hospital in Beijing, China. The population includes both participants with a hospital-confirmed diagnosis of anemia and control participants with hemoglobin within the normal reference range. Anemia is defined according to Chinese sea-level criteria: hemoglobin below 120 g/L in adult men, below 110 g/L in non-pregnant adult women, and below 100 g/L in pregnant women. For participants with anemia, a hemoglobin result obtained within the 3 days and a diagnostic report specifying anemia severity, red blood cell size classification, and anemia type are required. Enrollment targets at least 300 participants with anemia and at least 90 participants with normal hemoglobin. Participants are enrolled consecutively as they present for routine clinical care and meet eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: Model development cohort
Group B: Independent validation cohort
Trial outcomes
Primary outcomes
1
Sensitivity and specificity of the wearable-based deep learning model for binary anemia classification
Agreement between the model-derived anemia versus non-anemia classification and venous hemoglobin measurement as the reference standard. Venous blood sampling is performed within 3 days before or after wearable signal acquisition.Reported as sensitivity and specificity with 95% confidence intervals in the independent validation cohort.
Time frame
Day 1Secondary outcomes
1
Model performance stability under 24-hour continuous wear
Sensitivity and specificity of the model using signals acquired during 24-hour continuous wearable monitoring in hospitalized participants.
Time frame
Day 12
Effect of red blood cell size classification on model estimation accuracy
Model sensitivity and specificity stratified by red blood cell size category (microcytic, normocytic, macrocytic) based on mean corpuscular volume
Time frame
Day 13
Model performance stability under exercise load
Comparison of model classification performance using signals acquired before versus after a six-minute walk test in hospitalized participants.
Time frame
Day 1 (immediately before and after the six-minute walk test)4
Agreement of classification results between left and right wrist placement
Concordance of the model-derived anemia classification between signals acquired with the device worn on the left wrist and on the right wrist in outpatient participants.
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
Huawei Device Co., Ltd
Collaborator
Source ClinicalTrials.gov
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