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Not yet recruitingNCT07502690Updated Apr 20, 2026

Validation of Remote Photoplethysmography for Non-Invasive Estimation of Blood Glucose and HbA1c

An observational study in Diabetes Mellitus, Hyperglycaemia (Diabetic) and Hyperglycaemia (Non Diabetic), sponsored by Tarumanagara University. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Tarumanagara University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to evaluate whether a non-invasive facial scan technology using remote photoplethysmography (rPPG) can accurately estimate blood glucose and HbA1c levels in adults living in the community in Jakarta. The study focuses on adults aged 18 years and older, including individuals with or without diabetes.

The main questions it aims to answer are:

  1. Can rPPG-based facial scan estimates of blood glucose and HbA1c match results from standard laboratory blood tests?
  2. How well can rPPG identify individuals with high blood sugar or diabetes risk based on established clinical cut-off values?

Researchers will compare results from the rPPG facial scan with standard laboratory measurements of fasting blood glucose and HbA1c to determine how accurate and reliable the technology is for screening purposes.

Participants will:

  1. Provide basic information such as age, sex, and medical history
  2. Undergo a non-invasive facial scan using a smartphone-based system
  3. Have a blood sample taken to measure fasting blood glucose and HbA1c
  4. Complete all assessments during a single study visit

This study aims to determine whether rPPG can serve as a simple, non-invasive, and accessible tool for early detection and monitoring of diabetes in community settings.

Read the detailed description

Introduction Type 2 diabetes mellitus (T2DM) represents a major global health burden characterized by chronic hyperglycemia and associated complications. Standard monitoring methods, such as fasting blood glucose and glycated hemoglobin (HbA1c), rely on invasive blood sampling and access to laboratory facilities, which may reduce patient adherence and limit early detection. Remote photoplethysmography (rPPG), a non-contact optical technique using facial video analysis, has emerged as a promising alternative for estimating physiological and metabolic parameters. However, evidence regarding its validity in assessing glycemic markers remains limited .

Objective This study aims to evaluate the validity and diagnostic performance of rPPG-based facial scan technology in estimating blood glucose and HbA1c levels compared with standard laboratory measurements.

Methods This study employs an analytical observational design with a cross-sectional diagnostic validation approach conducted in Kelurahan Semanan, Jakarta. A total of 150-300 adult participants will be recruited using a community-based sampling method. Each participant will undergo venous blood sampling for laboratory measurement of fasting blood glucose and HbA1c, alongside a non-contact rPPG facial scan using a smartphone-based system. Agreement between methods will be assessed using Bland-Altman analysis, while correlation analysis (Pearson/Spearman) will evaluate the strength of association. Diagnostic performance, including sensitivity and specificity, will be calculated using clinical cut-offs (≥126 mg/dL for glucose and ≥6.5% for HbA1c).

Expected Results It is expected that rPPG-derived estimates will demonstrate moderate to good correlation with laboratory measurements, with acceptable agreement for screening purposes. The technology is anticipated to show reasonable diagnostic performance in identifying individuals with high glycemic risk. These findings may support the feasibility of rPPG as a non-invasive, accessible screening tool for diabetes monitoring in community settings.

02

Conditions studied

  • Diabetes Mellitus
  • Hyperglycaemia (Diabetic)
  • Hyperglycaemia (Non Diabetic)
  • Hypoglycaemia

Keywords

  • remote photoplethysmography
  • rppg
  • blood glucose
  • HbA1c
  • diabetes mellitus
  • non-invasive monitoring
  • digital health screening
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's planned enrollment of 300 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Tarumanagara University is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population consists of adult individuals aged 18 years and older residing in a community setting in Jakarta, Indonesia. Participants will be recruited through community-based health activities and primary care services. The population includes both individuals with and without a prior diagnosis of type 2 diabetes mellitus, representing a general adult population for glycemic screening. Eligible participants must be able to undergo both non-invasive facial scanning using remote photoplethysmography (rPPG) and standard laboratory blood testing. Individuals with facial conditions that interfere with signal detection, inability to remain still during scanning, or incomplete data will be excluded.

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. Adults aged ≥18 years
  2. Willing to participate and provide
  3. Able to undergo facial scan and blood examination
  4. Stable clinical condition

Exclusion criteria

Exclusion Criteria:

  1. Facial conditions interfering with rPPG signal (e.g., wounds, deformities)
  2. Use of facial coverings obstructing camera detection
  3. Inability to remain still during facial scan
  4. Incomplete data or withdrawal from study
Terms in these criteria, in plain language(1)

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.

05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Community Adults Undergoing rPPG and Laboratory Glycemic Assessment

    This cohort includes adults aged ≥18 years from a community-based population in Jakarta who undergo both non-invasive remote photoplethysmography (rPPG) facial scanning and standard laboratory testing. Participants will receive a smartphone-based facial scan to estimate blood glucose and HbA1c levels, followed by venous blood sampling for fasting blood glucose and HbA1c measurement using standard laboratory methods. No therapeutic intervention is administered, as this is a diagnostic validation study comparing rPPG-derived estimates with laboratory reference values.

06

What researchers measure

Primary outcomes

  1. Agreement Between rPPG-Derived and Laboratory Blood Glucose

    Assessment of agreement between blood glucose values obtained from remote photoplethysmography (rPPG) facial scan and standard laboratory fasting blood glucose measurements using Bland-Altman analysis, including mean bias and limits of agreement.

    Time frame: Single assessment at baseline (during study visit)

  2. Agreement Between rPPG-Derived and Laboratory HbA1c

    Evaluation of agreement between HbA1c values estimated using rPPG facial scan and laboratory HbA1c measurements using Bland-Altman analysis, including bias and limits of agreement.

    Time frame: Single assessment at baseline (during study visit)

  3. Correlation and Validation of rPPG Estimates with Laboratory Blood Glucose and HbA1c

    Measurement of the strength of association between rPPG-derived and laboratory-measured blood glucose and HbA1c values using Pearson or Spearman correlation coefficients (Bland Altman)

    Time frame: Single assessment at baseline (during study visit)

  4. Diagnostic Performance of rPPG for Detecting Hyperglycemia and Diabetes Risk

    Evaluation of sensitivity, specificity, and accuracy of rPPG-derived blood glucose (≥126 mg/dL) and HbA1c (≥6.5%) in identifying individuals with elevated glycemic levels compared to laboratory reference standards.

    Time frame: Single assessment at baseline (during study visit)

07

Study locations

1 site
  • Kelurahan Semanan
    Jakarta, Jakarta Special Capital Region, Indonesia
    • Hanna Wijaya · Contacthannwijaya@yahoo.com · +6281223787878
    • Wenny Sanwani · Contactwenny.sanwani@gmail.com · +6281585013412
    • Ernawati Ernawati · Principal investigator
    • Alexander Halim Santoso · Principal investigator
    • Yohanes Firmansyah · Principal investigator
    • David Wongso · Principal investigator
    • Enny Irawaty · Sub investigator
    • Zita Atzmardina · Sub investigator
    • Silviana Tirtasari · Sub investigator
    • Clement Drew · Sub investigator
    • Wikrama Lokapradhana · Sub investigator
    • Amita Pradhani · Sub investigator
    • William Kuswandi · Sub investigator
    • Triyana Sari · Sub investigator
    • Diana Dinali · Sub investigator
    • Muhammad Fikri Dzakwan · Sub investigator
    • Steve Geraldo Bustam · Sub investigator
    • Bryan Anna Wijaya · Sub investigator
08

References and documents

Publications

  • Zeynali M, Alipour K, Tarvirdizadeh B, Ghamari M. Non-invasive blood glucose monitoring using PPG signals with various deep learning models and implementation using TinyML. Sci Rep. 2025 Jan 2;15(1):581. doi: 10.1038/s41598-024-84265-8. PubMed 39753714 ↗
  • Zanelli S, Ammi M, Hallab M, El Yacoubi MA. Diabetes Detection and Management through Photoplethysmographic and Electrocardiographic Signals Analysis: A Systematic Review. Sensors (Basel). 2022 Jun 29;22(13):4890. doi: 10.3390/s22134890. PubMed 35808386 ↗
  • Shi B, Dhaliwal SS, Soo M, Chan C, Wong J, Lam NWC, Zhou E, Paitimusa V, Loke KY, Chin J, Chua MT, Liaw KCS, Lim AWH, Insyirah FF, Yen SC, Tay A, Ang SB. Assessing Elevated Blood Glucose Levels Through Blood Glucose Evaluation and Monitoring Using Machine Learning and Wearable Photoplethysmography Sensors: Algorithm Development and Validation. JMIR AI. 2023 Oct 27;2:e48340. doi: 10.2196/48340. PubMed 38875549 ↗
  • Santillan A, Travez Proano EI, Jaramillo Encalada IN, Abril Lopez PA, Tricallotis J, Acosta-Espana JD. Structured telemonitoring reduces HbA1c and emergency visits in insulin-treated type 2 diabetes: a controlled cohort study in Ecuador's public hospital. Front Clin Diabetes Healthc. 2026 Feb 9;7:1734589. doi: 10.3389/fcdhc.2026.1734589. eCollection 2026. PubMed 41737571 ↗
  • Qawqzeh YK, Bajahzar AS, Jemmali M, Otoom MM, Thaljaoui A. Classification of Diabetes Using Photoplethysmogram (PPG) Waveform Analysis: Logistic Regression Modeling. Biomed Res Int. 2020 Aug 11;2020:3764653. doi: 10.1155/2020/3764653. eCollection 2020. PubMed 32851065 ↗
  • Kwon TH, Kim KD. Machine-Learning-Based Noninvasive In Vivo Estimation of HbA1c Using Photoplethysmography Signals. Sensors (Basel). 2022 Apr 12;22(8):2963. doi: 10.3390/s22082963. PubMed 35458947 ↗
  • Farenden E, Kelly J, Russell A, Menon A. Remote Monitoring for Type 2 Diabetes: What Do Patients, Healthcare Professionals, and Executives Think? Stud Health Technol Inform. 2024 Jan 25;310:1526-1527. doi: 10.3233/SHTI231276. PubMed 38269728 ↗
  • Chu J, Yang WT, Lu WR, Chang YT, Hsieh TH, Yang FL. 90% Accuracy for Photoplethysmography-Based Non-Invasive Blood Glucose Prediction by Deep Learning with Cohort Arrangement and Quarterly Measured HbA1c. Sensors (Basel). 2021 Nov 24;21(23):7815. doi: 10.3390/s21237815. PubMed 34883817 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) will be shared, including demographic characteristics (age, sex), clinical variables (medical history, fasting status), rPPG-derived measurements (estimated blood glucose and HbA1c), and corresponding laboratory results (fasting blood glucose and HbA1c). Derived variables used in the analysis, such as glycemic risk classifications and diagnostic performance indicators, may also be included. All shared data will be fully anonymized, with no direct identifiers to ensure participant confidentiality.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: De-identified individual participant data (IPD) and supporting documentation will be available beginning 6 months after publication of the primary study results and will remain accessible for a period of 5 years thereafter.

Access criteria: Access to the IPD will be granted to qualified researchers, academic investigators, or institutions upon reasonable request. Applicants must submit a brief research proposal outlining the intended use of the data and agree to a data use agreement that ensures confidentiality and prohibits re-identification of participants. Approved users will have access to de-identified datasets, data dictionaries, and relevant methodological documentation. Data will be shared via a secure electronic platform or institutional repository.

Data sharing details ↗ · lintar.untar.ac.id

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07502690
Lead sponsor
Tarumanagara University
Collaborators
Universitas Tarumanagara
Responsible party
Yohanes Firmansyah, dr, MH, MM (Principal Investigator, Tarumanagara University) — Principal investigator
First posted
Mar 31, 2026
Start date
Mar 23, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Apr 20, 2026

Study contacts

Alexander Halim Santoso
Contact
alexanders@fk.untar.ac.id
+6281381606869
Ernawati Ernawati, Dr.
Contact
ernawati@fk.untar.ac.id
Yohanes Firmansyah, MD
principal investigator · Klinik Citra Semanan
Ernawati Ernawati
principal investigator · Universitas Tarumanagara
Alexander Halim Santoso
study director · Universitas Tarumanagara
Sri Tiarti
study chair · Universitas Tarumanagara
Noer Saelan Tadjudin
study chair · Universitas Tarumanagara
Putu Tommy Yudha Sumatera Suyasa
study chair · Universitas Tarumanagara
David Wongso
study director · DexWellness
Ratheesh Nair
study director · Watch Your Health
Kieren Nathan Wong
study director · Monash University
Jaydee Kirani Wong
study director · Melbourne University
Meiske Yunithree Suparman
study chair · Universitas Tarumanagara

Oversight

Data monitoring committee
Yes
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 Apr 2026. You cannot join it, but the record below documents what was studied.

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