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| Name | Class |
|---|---|
| Shanghai Photonic View Technology Co., Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Validation of mμSORS for Noninvasive Blood Glucose Detection in healthy subjects | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-channel Microspatial Offset Raman Scattering Spectroscopy (mμSORS) for Noninvasive Blood Glucose Detection | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute relative deviation (MARD) of venous plasma glucose and glucose values measured by mμSORS at each time point of OGTT and hypoglucose clamp tests. | Glucose will be measured using both intravenous sampling (plasma) and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS) detection synchronously. | 2 months |
| Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by mμSORS at each time point of OGTT and hypoglucose clamp tests. | Glucose will be measured using both intravenous sampling (plasma) and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS) detection synchronously. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| MARD for two measurement methods in different blood glucose ranges. | Plasma glucose ranges 3.9-10.0 mmol/L and <3.9 mmol/L. | 2 months |
| Incidence of Treatment-Emergent Adverse Events. | Safety outcomes. |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Weiqing Wang, Dr. | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
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| 2 months |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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