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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
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.
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Mean absolute relative deviation (MARD) of venous plasma glucose and glucose values measured by mμSORS at each time point of OGTT.
Glucose will be measured using both intravenous sampling (plasma) and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS) detection synchronously.
Time frame: Four months.
Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by mμSORS at each time point of OGTT.
Glucose will be measured using both intravenous sampling (plasma) and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS) detection synchronously.
Time frame: Four months.
MARD for two measurement methods in different blood glucose ranges.
Plasma glucose ranges 3.9-10.0 mmol/L, \<3.9 mmol/L and \>10.0 mmol/L.
Time frame: Four months.
Incidence of Treatment-Emergent Adverse Events
Safety outcomes.
Time frame: Four months.
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