Raman Spectroscopy-Based Non-Invasive Blood Glucose Detection

NCT07311421 | Recruiting

• 1 other identifier: IIT2025-029-002
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetes

Keywords

Diabetes Management; Raman Spectroscopy; Non-invasive Blood Glucose Detection; Clinical Application

Outcome Measures

Primary Outcomes (1)

• Blood glucose value

  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

Study Arms (2)

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

Interventions

Raman spectroscopy for blood glucose measurement DIAGNOSTIC_TEST

Raman spectroscopy non-invasive blood glucose measurement group

Raman spectroscopy non-invasive blood glucose measurement group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Institute of Technology: collaborator
• Beijing Shijitan Hospital, Capital Medical University: lead

Study Sites (2)

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100080, China

RECRUITING

Beijing Shijitan Hospital

Haidian, Beijing Municipality, 100080, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Yuanyuan Miao

CONTACT

+86 18815015576; miaoyuanyuan1001@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: December 31, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)