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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 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.
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-minļ¼30-minļ¼60-minļ¼90-minļ¼120-minļ¼150-minļ¼180-minļ¼210-minļ¼240-minļ¼270-minļ¼ and 300-min.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Validation of mμSORS for Noninvasive Blood Glucose Detection | Experimental | Enrolled subjects will perform oral glucose tolerance test. A measurement session of blood glucose consists of plasma sample and a measurement by mμSORS will be conducted synchronously. |
|
| 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. | 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. | 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, <3.9 mmol/L and >10.0 mmol/L. | 2 months |
| Incidence of Treatment-Emergent Adverse Events |
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Inclusion Criteria for healthy subjects:
Inclusion Criteria for patients with type 2 diabetes:
Exclusion Criteria for healthy subjects:
Exclusion Criteria for patients with type 2 diabetes:
Based on self-representation of gender identity
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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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| 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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Safety in the patients.
| 2 months |