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NCT Number: NCT07502690

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kelurahan Semanan

Jakarta, Jakarta Special Capital Region, Indonesia

Location contact

Alexander Halim Santoso

PRINCIPAL_INVESTIGATOR

Amita Pradhani

SUB_INVESTIGATOR

Bryan Anna Wijaya

SUB_INVESTIGATOR

Clement Drew

SUB_INVESTIGATOR

David Wongso

PRINCIPAL_INVESTIGATOR

Diana Dinali

SUB_INVESTIGATOR

Enny Irawaty

SUB_INVESTIGATOR

Ernawati Ernawati

PRINCIPAL_INVESTIGATOR

Hanna Wijaya

CONTACT

[email protected]

+6281223787878

Muhammad Fikri Dzakwan

SUB_INVESTIGATOR

Silviana Tirtasari

SUB_INVESTIGATOR

Steve Geraldo Bustam

SUB_INVESTIGATOR

Triyana Sari

SUB_INVESTIGATOR

Wenny Sanwani

CONTACT

[email protected]

+6281585013412

Wikrama Lokapradhana

SUB_INVESTIGATOR

William Kuswandi

SUB_INVESTIGATOR

Yohanes Firmansyah

PRINCIPAL_INVESTIGATOR

Zita Atzmardina

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Agreement Between rPPG-Derived and Laboratory Blood Glucose

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

    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.

  2. Agreement Between rPPG-Derived and Laboratory HbA1c

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

    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.

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

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

    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)

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Halim Santoso

CONTACT

[email protected]

+6281381606869

Ernawati Ernawati, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Tarumanagara University

Other

Collaborators

  • Universitas Tarumanagara

Registry information

Official study title

Validation of Remote Photoplethysmography for Non-Invasive Estimation of Blood Glucose and HbA1c in a Community-Based Population in Jakarta

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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