NCT06512077

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

Clinical Validation of Multi-channel Microspatial Offset Raman Scattering Spectroscopy (mμSORS) for Non-invasive Blood Glucose Detection in Non-diabetic Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-07-11
• Primary completion: 2024-08-31
• Completion: 2024-09-15
• First posted: 2024-07-22
• Last updated: 2025-01-28

Locations

1 site across 1 country: China