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Application Study of the Non-Invasive Blood Glucose Meter Based on multiple µ-spatially offset Raman spectroscopy (mµSORS) in Real Clinical Settings

Application Study of the Non-Invasive Blood Glucose Meter Based on multiple µ-spatially offset Raman spectroscopy (mµSORS) in Real Clinical Settings

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110357
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-10-13
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes

Interventions

Gold Standard:Gold standard: Venous plasma glucose concentration
Reference standard: Capillary blood glucose from fingerstick.
Index test:mµSORS non-invasive glucose concentration

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diabetes or healthy subjects, Male or female; 2. Age: 18 years old or older; 3. There are no scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested; 4. Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.

Exclusion criteria

Exclusion criteria: 1. Any history of alcohol dependency or drug abuse, and serious clinical diseases such as cognitive impairment, psychiatry abnormality, or any other disease that can interfere with the test results, which the investigator considers significant; 2. Pregnancy or lactation period; 3. Difficulty in venous blood collection or fainting of needles or blood; 4. Other circumstances that the investigator considers inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Mean Absolute Relative Deviation (MARD);Proportion of each interval in the Consensus Error Grid (CEG);Clarke Proportion of each range;

Countries

China

Contacts

Public ContactWang Weiqing

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

wqingw@shsmu.edu.cn+86 21 6437 0045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026