ClinicalTrials.gg
Not yet recruitingNCT07796542WEAR-ANEMIAUpdated Sep 1, 2026

Wearable Device-Based Screening for Anemia Risk

An observational study in Anemia, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Peking Union Medical College Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 115 studies in Anemia with a site in China — 33 open to participants now, 42 under way, 8 of them phase 3. Anemia · China.

Planned enrollment
11th of 18
400 · median 800
Started
2026
with 4 others
Observational
18 of 115
9 open now
Primary completion
2027-06
later than 28 of 41 live
Registered
114th of 115
by date
Lead sponsor
4 of 115
Peking Union Medical College Hospital

Among the 115 studies in Anemia with a site in China, this one is the 11th largest by planned enrollment of the 18 observational ones that give a count, is one of 5 that started in 2026, is one of 18 observational ones, reaches primary completion later than 28 of the 41 other live ones, and was the 114th registered.

Anemia

1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.

Browse Anemia studies →

Open to participants now

33 of the 115 studies in Anemia with a site in China are open now. Recruiting first, the newest first:

28 more — sign in →

All 33 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 115 studies in Anemia with a site in China, or all of them as a file.
02

Study 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.

Read the detailed description

This is a prospective, observational, diagnostic accuracy study conducted at a single tertiary care hospital in Beijing, China. The purpose is to develop and evaluate a deep learning model for non-invasive binary classification of anemia using multimodal physiological signals acquired from a commercially available consumer wrist-worn wearable device.

Study procedures. Participants will be enrolled in two sequential stages. In the first stage, 250 participants will be enrolled for algorithm development and tuning. In the second stage, an additional 150 participants will be enrolled for independent testing of the locked model and for supporting iterative optimization. All participants will undergo wearable signal acquisition and venous blood sampling for hemoglobin measurement, which serves as the reference standard.

Signal acquisition differs by care setting. Hospitalized participants will undergo 24-hour continuous wearable monitoring and paired signal acquisition before and after a six-minute walk test. Outpatient participants will undergo short-duration resting acquisition with the device worn alternately on the left and right wrist. Outpatient participants may undergo up to three additional assessments if they return for routine clinical visits; these visits are opportunistic and recorded as they occur. Hospitalized participants undergo a single acquisition without follow-up.

Reference standard. Anemia is defined according to Chinese sea-level criteria: hemoglobin below 120 g/L in adult men, below 110 g/L in non-pregnant women, and below 100 g/L in pregnant women.

Sample size. The primary endpoint is diagnostic sensitivity. Assuming an expected sensitivity of 70%, an allowable error of 6%, and a confidence level of 95%, at least 225 participants with anemia are required. Allowing for approximately 10% dropout or unusable data, the anemia group is set at 300 or more participants. At least 90 participants with normal hemoglobin will be enrolled to estimate specificity. To support deep learning model training and generalizability assessment, the total target enrollment is 400 participants.

Statistical analysis. Model performance will be reported as sensitivity and specificity. Cross-validation will be used to assess model stability, and an independent test set will be used to assess generalizability.

The wearable device is non-invasive. Study participation does not alter any aspect of the clinical management of participants.

03

Conditions studied

  • Anemia

Browse trials for

Keywords

  • anemia screening
  • wearable device
  • smartwatch
  • photoplethysmography
  • non-invasive diagnosis
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 to 80 years, any sex
  2. Willing to participate and able to provide written
  3. Able to comply with wearable device wear, venous blood sampling, and functional assessment (e.g., six-minute walk test)
  4. For participants with anemia: a 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
  5. For control participants: hemoglobin within the normal reference range -

Exclusion criteria

Exclusion Criteria:

  1. Axillary temperature 37.3°C or higher on the day of data collection or on the preceding day
  2. Acute exacerbation of a severe comorbid condition (e.g., decompensated heart failure, respiratory failure, acute infection)
  3. Skin breakdown, rash, deformity, amputation, or any other condition of the upper limb precluding proper wear of the device
  4. Refusal of, or intolerance to, invasive venous blood sampling
  5. Concurrent participation in another interventional clinical trial -
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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 1

Secondary 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 1

  2. 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 1

  3. 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 1

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 38248399 ↗
  • 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. PubMed 26513934 ↗
  • 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. PubMed 28245576 ↗
  • 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. PubMed 38523814 ↗
  • 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. PubMed 41112644 ↗

Individual participant data

Plan to share: No — Individual participant data include continuous multimodal physiological signal recordings that are potentially identifiable and cannot be adequately de-identified. Raw data will therefore not be shared with other researchers. Aggregate study results will be reported in peer-reviewed publications and in a study summary report, without any information that could identify individual participants.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.

Of 124 non-industry observational studies under Anemia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 9 months is below that.

Counting every sponsor, half of 145 studies reached it within 30 months; a quarter within 12 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Sep 1, 2026
StartEst.
Sep 5, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jul 15, 2027
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07796542
Collaborators
Huawei Device Co., Ltd
Responsible party
Chen Miao (Chief, Department of Hematology, Peking Union Medical College Hospital) — Principal investigator
First posted
Sep 1, 2026
Start date
Sep 5, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jul 15, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

Jian Li, PhD
Contact
lijian@pumch.cn
010-69155027
Miao Chen, PHD
Contact
chenm@pumch.cn
+86 18618230229

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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