Preclinical Research of mμSORS for Noninvasive Blood Glucose Detection

Status Not yet recruiting

Clinical Trial Summary

This is a single-center, open-label, prospective study. Blood glucose was measured at different time points during oral glucose tolerance testing in patients with type 2 diabetes mellitus, 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 validated. MARD for two measurement methods in different blood glucose ranges and the safety outcomes of mμSORS such as adverse events will also be assessed.

Clinical Trial Description

In order to clinically verify the accuracy and safety of non-invasive blood glucose measurement by the mμSORS technology, and to explore the feasibility of non-invasive detection in multi-indicators of mμSORS, this study will conduct an oral glucose tolerance test on patients with type 2 diabetes. There will be 12 collection points of blood samples as follows: 0-min and post glucose-load 15-min，30-min，45-min，60-min，75-min，90-min，105-min，120-min，135-min，150-min， and 180-min. Approximately 4ml of whole blood was collected at each time point for venous plasma glucose and serum insulin measurement. The blood glucose value measured by mμSORS will be obtained synchronously at the above 12 time points. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05921344
Study type	Interventional
Source	Shanghai Jiao Tong University School of Medicine
Contact	Bei Tao, Dr.
Phone	+86-13916558450
Email	taobei1981@hotmail.com
Status	Not yet recruiting
Phase	N/A
Start date	June 20, 2023
Completion date	January 31, 2024

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