Wearable Device-Based Screening for Anemia Risk

NCT07796542 | Not Yet Recruiting

• 1 other identifier: PUMCH-WEAR-ANEMIA-2026
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Keywords

anemia screening; wearable device; smartwatch; photoplethysmography; non-invasive diagnosis

Outcome Measures

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.

  Day 1

Secondary Outcomes (4)

• Model performance stability under 24-hour continuous wear

  Day 1

• Effect of red blood cell size classification on model estimation accuracy

  Day 1

• Model performance stability under exercise load

  Day 1 (immediately before and after the six-minute walk test)

• Agreement of classification results between left and right wrist placement

  Day 1

Study Arms (2)

Model development cohort

First 250 participants. Wearable multimodal physiological signals and venous hemoglobin measurement are collected in parallel and used for deep learning model development and tuning.

Independent validation cohort

Subsequent 150 participants. Data are used for independent testing of the model and to support iterative optimization.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• For control participants: hemoglobin within the normal reference range -

You may not qualify if:

• 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
• Concurrent participation in another interventional clinical trial -

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Huawei Device Co., Ltd: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (5)

• Zhu J, Sun R, Liu H, Wang T, Cai L, Chen Z, Heng B. A Non-Invasive Hemoglobin Detection Device Based on Multispectral Photoplethysmography. Biosensors (Basel). 2023 Dec 30;14(1):0. doi: 10.3390/bios14010022.

  PMID: 38248399 BACKGROUND

• Li L, Luo R, Medina A, Rozelle S. THE PREVALENCE OF ANEMIA IN CENTRAL AND EASTERN CHINA: EVIDENCE FROM THE CHINA HEALTH AND NUTRITION SURVEY. Southeast Asian J Trop Med Public Health. 2015 Mar;46(2):306-21.

  PMID: 26513934 BACKGROUND

• Li M, Hu Y, Mao D, Wang R, Chen J, Li W, Yang X, Piao J, Yang L. Prevalence of Anemia among Chinese Rural Residents. Nutrients. 2017 Feb 24;9(3):192. doi: 10.3390/nu9030192.

  PMID: 28245576 BACKGROUND

• Liu X, Wang B, Man S, Bao H, Huang Y, Yu C, Lyu J, Wang L, Li L, Liu H. Variations in the Prevalence of Anemia of Varying Severity Among Urban Non-Pregnant Women - China, 2021. China CDC Wkly. 2024 Mar 8;6(10):175-180. doi: 10.46234/ccdcw2024.036.

  PMID: 38523814 BACKGROUND

• Shwarz M. Burden of anemia in the United States from 1990 to 2019: a systematic analysis of the Global Burden of Disease Study 2019. Front Public Health. 2025 Oct 3;13:1653222. doi: 10.3389/fpubh.2025.1653222. eCollection 2025.

  PMID: 41112644 BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Jian Li, PhD

CONTACT

010-69155027; lijian@pumch.cn

Miao Chen, PHD

CONTACT

+86 18618230229; chenm@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Hematology

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 1, 2026
• Study Start: September 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)