Validation of Remote Photoplethysmography for Non-Invasive Estimation of Blood Glucose and HbA1c in a Community-Based Population in Jakarta
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Agreement Between rPPG-Derived and Laboratory Blood Glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥18 years
- •Willing to participate and provide informed consent
- •Able to undergo facial scan and blood examination
- •Stable clinical condition
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Agreement Between rPPG-Derived and Laboratory Blood Glucose
时间窗: 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.
Agreement Between rPPG-Derived and Laboratory HbA1c
时间窗: 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.
Correlation and Validation of rPPG Estimates with Laboratory Blood Glucose and HbA1c
时间窗: 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)
Diagnostic Performance of rPPG for Detecting Hyperglycemia and Diabetes Risk
时间窗: 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.
次要结局
未报告次要终点
研究者
Yohanes Firmansyah, dr, MH, MM
Principal Investigator
Tarumanagara University