Raman Spectroscopy-Based Non-Invasive Blood Glucose Detection

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест Raman spectroscopy for blood glucose measurement
  Raman spectroscopy non-invasive blood glucose measurement group

Первичные конечные точки

• Blood glucose value [Срок оценки: At the single baseline]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Китай · 2 центра

• Beijing Shijitan Hospital — Пекин
• Beijing Shijitan Hospital — Haidian

Идентификаторы

NCT: NCT07311421 · IIT2025-029-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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