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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 healthy subjects and 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 effect of mμSORS on safety in the patient 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 construct a model, this study will conduct oral glucose tolerance tests on healthy subjects and patients with type 2 diabetes at different time points during the OGTT. There will be 12 points as follows: 0-min and post glucose-load 10-min,30-min,60-min,90-min,120-min,150-min,180-min,210-min,240-min,270-min, and 300-min. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05504005
Study type Interventional
Source Shanghai Jiao Tong University School of Medicine
Contact
Status Not yet recruiting
Phase N/A
Start date August 19, 2022
Completion date December 31, 2022

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