- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07502690
Validation of Remote Photoplethysmography for Non-Invasive Estimation of Blood Glucose and HbA1c
Validation of Remote Photoplethysmography for Non-Invasive Estimation of Blood Glucose and HbA1c in a Community-Based Population in Jakarta
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:
- Can rPPG-based facial scan estimates of blood glucose and HbA1c match results from standard laboratory blood tests?
- 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:
- Provide basic information such as age, sex, and medical history
- Undergo a non-invasive facial scan using a smartphone-based system
- Have a blood sample taken to measure fasting blood glucose and HbA1c
- 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.
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ernawati Ernawati, Dr.
- Email: ernawati@fk.untar.ac.id
Study Contact Backup
- Name: Alexander Halim Santoso
- Phone Number: +6281381606869
- Email: alexanders@fk.untar.ac.id
Study Locations
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Jakarta Special Capital Region
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Jakarta, Jakarta Special Capital Region, Indonesia
- Kelurahan Semanan
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Contact:
- Wenny Sanwani
- Phone Number: +6281585013412
- Email: wenny.sanwani@gmail.com
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Contact:
- Hanna Wijaya
- Phone Number: +6281223787878
- Email: hannwijaya@yahoo.com
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Principal Investigator:
- Ernawati Ernawati
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Sub-Investigator:
- Enny Irawaty
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Sub-Investigator:
- Zita Atzmardina
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Principal Investigator:
- Alexander Halim Santoso
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Sub-Investigator:
- Wikrama Lokapradhana
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Sub-Investigator:
- Amita Pradhani
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Sub-Investigator:
- William Kuswandi
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Sub-Investigator:
- Diana Dinali
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Sub-Investigator:
- Muhammad Fikri Dzakwan
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Sub-Investigator:
- Clement Drew
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Sub-Investigator:
- Silviana Tirtasari
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Sub-Investigator:
- Triyana Sari
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Principal Investigator:
- Yohanes Firmansyah
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Principal Investigator:
- David Wongso
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Sub-Investigator:
- Steve Geraldo Bustam
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Sub-Investigator:
- Bryan Anna Wijaya
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged ≥18 years
- Willing to participate and provide informed consent
- Able to undergo facial scan and blood examination
- Stable clinical condition
Exclusion Criteria:
- Facial conditions interfering with rPPG signal (e.g., wounds, deformities)
- Use of facial coverings obstructing camera detection
- Inability to remain still during facial scan
- Incomplete data or withdrawal from study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement Between rPPG-Derived and Laboratory Blood Glucose
Time Frame: Single assessment at baseline (during study visit)
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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.
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Single assessment at baseline (during study visit)
|
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Agreement Between rPPG-Derived and Laboratory HbA1c
Time Frame: Single assessment at baseline (during study visit)
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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.
|
Single assessment at baseline (during study visit)
|
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Correlation and Validation of rPPG Estimates with Laboratory Blood Glucose and HbA1c
Time Frame: Single assessment at baseline (during study visit)
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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)
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Single assessment at baseline (during study visit)
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Diagnostic Performance of rPPG for Detecting Hyperglycemia and Diabetes Risk
Time Frame: Single assessment at baseline (during study visit)
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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.
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Single assessment at baseline (during study visit)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yohanes Firmansyah, MD, Klinik Citra Semanan
- Study Director: David Wongso, DexWellness
- Principal Investigator: Ernawati Ernawati, Universitas Tarumanagara
- Study Director: Alexander Halim Santoso, Universitas Tarumanagara
- Study Director: Ratheesh Nair, Watch Your Health
- Study Chair: Sri Tiarti, Universitas Tarumanagara
- Study Chair: Noer Saelan Tadjudin, Universitas Tarumanagara
- Study Chair: Putu Tommy Yudha Sumatera Suyasa, Universitas Tarumanagara
- Study Director: Kieren Nathan Wong, Monash University
- Study Director: Jaydee Kirani Wong, Melbourne University
- Study Chair: Meiske Yunithree Suparman, Universitas Tarumanagara
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20260324
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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