Clinical Validation of mμSORS for Non-invasive Blood Glucose Detection in Non-diabetic Subjects

NCT ID: NCT06512077

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2024-09-15

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 venous plasma and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS). Venous plasma glucose was set as gold standard. The two measurements were collected synchronously so as to calculate the mean absolute relative difference (MARD) and the consensus error grid (CEG). Accuracy of non-invasive blood glucose testing by mμSORS will be in-depth validated specifically in the 3-10 mmol/l glucose range.

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 glucose tolerance tests and hypoglucose clamp tests on healthy subjects at different time points during the tests. In oral glucose tolerance tests, there will be 9 points as follows: 0-min and post glucose-load 30-min, 60-min, 90-min, 120-min, 150-min, 180-min, 210-min and 240-min. While in hypoglucose clamp tests, blood glucose will be set at around 3.0-4.0mmol/l for about 1.5-2.0 hours, blood glucose will be detected every 10 minutes.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Clinical Validation of mμSORS for Noninvasive Blood Glucose Detection in healthy subjects

Enrolled subjects will perform oral glucose tolerance test or hyperinsulin-hypoglucose clamp test. A measurement session of blood glucose consists of plasma sample and a measurement by mμSORS will be conducted synchronously.

Group Type: EXPERIMENTAL

Multi-channel Microspatial Offset Raman Scattering Spectroscopy (mμSORS) for Noninvasive Blood Glucose Detection

Intervention Type: DEVICE

Blood glucose of participants were measured by venous plasma and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS). The two measurements were collected synchronously and analyzed.

Interventions

Multi-channel Microspatial Offset Raman Scattering Spectroscopy (mμSORS) for Noninvasive Blood Glucose Detection

Blood glucose of participants were measured by venous plasma and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS). The two measurements were collected synchronously and analyzed.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Photonic View Technology Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Wang Weiqing

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weiqing Wang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CCEMD20240701

Identifier Type: -

Identifier Source: org_study_id