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临床试验/NCT07311421
NCT07311421招募中不适用

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

Beijing Shijitan Hospital, Capital Medical University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
49
试验地点
1
主要终点
Blood glucose value

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Blood glucose value

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Beijing Shijitan Hospital, Capital Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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