Raman Spectroscopy-Based Non-Invasive Blood Glucose Detection (Raman Glucose)

December 26, 2025 updated by: Beijing Shijitan Hospital, Capital Medical University

Clinical Study of Non-invasive Blood Glucose Detection Technology Based on Raman Spectroscopy

Diabetes is a chronic metabolic disease that is widely prevalent globally, with its incidence rate continuously increasing, posing significant challenges to patient health and public health systems. In China, the number of diabetes patients ranks first in the world, with an adult prevalence rate as high as 12.8%. The core of diabetes management is blood glucose control. However, traditional finger-prick blood testing methods are inconvenient and have low patient compliance. In recent years, non-invasive blood glucose detection technologies have become a research hotspot. Among them, optical methods, especially spectroscopy techniques, are considered to have the most application potential due to their non-invasive, convenient, and stable characteristics.

Raman spectroscopy, as an important branch of spectroscopy, has advantages such as non-invasiveness and high specificity, and has been successfully applied to blood glucose detection in laboratory settings. However, its clinical application is still in the exploratory stage. Foreign research has validated its feasibility, and domestic research has also made certain progress, but overall, it is still in its infancy. This study aims to compare the consistency and accuracy of Raman spectroscopy non-invasive blood glucose detection with traditional finger-prick blood glucose detection by comparing the blood glucose values measured by the two methods at the same time point. Additionally, the study will assess the participants' satisfaction and acceptance of the two methods through questionnaires. The results of this study will provide a scientific basis for the clinical application of Raman spectroscopy technology and offer references for the promotion of non-invasive blood glucose detection technologies. This will help advance the development of non-invasive blood glucose detection technologies and improve the treatment compliance and quality of life of diabetes patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100080
        • Recruiting
        • Beijing Shijitan Hospital
        • Contact:
      • Haidian, Beijing Municipality, China, 100080
        • Recruiting
        • Beijing Shijitan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Individuals aged 18-75 years, either healthy or with diabetes, including both males and females, who have signed the informed consent form. There are no requirements regarding race, education level, or economic status.

Description

Inclusion Criteria:

Age range: 18-75 years old. Gender: unlimited. Health status: patients with diagnosed diabetes or healthy volunteers. Nail health status: no obvious infection, discoloration, peeling and other lesions of the nail, so as to ensure the accuracy of Raman spectroscopy measurement.

Willing to participate in the study and sign the informed consent.

Exclusion Criteria:

Nail diseases: such as fungal infections, psoriasis, trauma resulting in nail damage or deformity.

The presence of factors that influenced the measurement results: Participants who used nail polish, fake nails, or nail products. Recent use of drugs containing heavy metals (which may affect nail composition) and skin conditions are not appropriate for such tests.

Pregnant or lactating women. People with serious chronic diseases (such as terminal cancer, end-stage renal disease) or mental illness.

Non-cooperation or inability to complete the entire research process, such as refusal or inability to complete Raman spectrum acquisition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Fingertip blood to measure blood sugar
Raman spectroscopy non-invasive blood glucose measurement group
Blood glucose was measured using Raman spectroscopy noninvasive blood glucose measurement
Diagnostic test: Raman spectroscopy for blood glucose measurement
Raman spectroscopy non-invasive blood glucose measurement group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose value
Time Frame: At the single baseline
Blood glucose value was assessed as a primary outcome measure in this study. It reflects the concentration of glucose in the blood and serves as a critical indicator for evaluating the metabolic status, particularly in the context of diabetes management.
At the single baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Shijitan Hospital, Capital Medical University

Collaborators

Beijing Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

August 27, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2025-029-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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