Status:
COMPLETED
Clinical Validation of mμSORS for Non-invasive Blood Glucose Detection in Non-diabetic Subjects
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Shanghai Photonic View Technology Co., Ltd.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single-center, open-label, prospective study. Blood glucose is measured at different time points during oral glucose tolerance test and hypoglucose clamp test in healthy subjects, using both...
Detailed Description
In order to clinically verify the accuracy and safety of non-invasive blood glucose measurement by the mμSORS technology specifically in the 3-10 mmol/l glucose range, this study will conduct oral glu...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Male or female.
- Aged\>=18 years for OGTT participants or aged between 20 and 40 years for hypoglucose clamp tests participants.
- Fasting blood glucose (FPG) \< 6.1 mmol/L and glycated hemoglobin (HbA1c) \< 5.7% during the screening period.
- There are no scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested.
- Confirmed as healthy based on the results of physical examination, medical history, vital signs and clinical laboratory tests.
- 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 :
- With diabetes history.
- Any history of serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry or metabolic abnormality, or any other disease that can interfere with the test results, which the investigator considers significant.
- Alcohol dependency or drug abuse.
- Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial).
- Those who have used any drugs that affect blood glucose levels (such as insulin, oral hypoglycemic drugs, steroid hormones, thyroxine, etc.) within 28 days before screening;
- Pregnancy or lactation period.
- Difficulty in venous blood collection or fainting of needles or blood.
- Other circumstances that the investigator considers inappropriate to participate in the study.
Exclusion
Key Trial Info
Start Date :
July 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06512077
Start Date
July 11 2024
End Date
September 15 2024
Last Update
January 28 2025
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025