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

Beijing Shijitan Hospital, Capital Medical University

Status

Enrolling

Conditions

Diabetes

Treatments

Diagnostic Test: Raman spectroscopy for blood glucose measurement

Study type

Observational

Funder types

Other

Identifiers

NCT07311421

IIT2025-029-002

Details and patient eligibility

About

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.

Enrollment

49 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.