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| Name | Class |
|---|---|
| Shanghai 10th People's Hospital | OTHER |
| Hanchuan People's Hospital | UNKNOWN |
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This trial is a prospective, multicenter, non-randomized, open-label, self-controlled, paired design clinical study, which will be conducted in 3 research centers, with a total of 210 subjects enrolled, including diabetic patients aged 18 years and above and some healthy subjects. After screening, each eligible subject will have their blood glucose measured simultaneously at specified time points using three methods: non-invasive blood glucose meter (the experimental group), fully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose, and fingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose. The aim of this trial is to evaluate the efficacy and safety of the non-invasive blood glucose meter for blood glucose measurement in diabetic patients.
After screening, the qualified subjects complete the blood glucose measurement in three ways at the following time points on the test day, namely, fasting blood glucose before breakfast, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive blood glucose meter | Experimental | Non-invasive blood glucose meter by the non-invasive blood glucose meter using a Raman spectrum measurement system. |
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| Fully automatic laboratory biochemical analyzer | Other | Fully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose. |
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| Fingertip capillary blood sample | Other | Fingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive blood glucose meter | Device | Blood glucose were detected by non-invasive glucose meter at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast. |
| Measure | Description | Time Frame |
|---|---|---|
| Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by non-invasive glucose meter of mμSORS at each time point indicated. | Glucose will be measured using both intravenous sampling (plasma) and non-invasive meter of mμSORS synchronously. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The MARD were evaluated for non-invasive glucose meter using venous plasma glucose as the control. | The interval between the two methods is less than 10 minutes at each point. | 3 months |
| The ±20% agreement were evaluated for non-invasive glucose meter using venous plasma glucose as the control. |
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Inclusion Criteria:
Inclusion Criteria for healthy subjects:
Inclusion Criteria for patients with type 2 diabetes:
Exclusion Criteria:
Exclusion Criteria for healthy subjects:
Exclusion Criteria for patients with type 2 diabetes:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifei Zhang, Dr. | Contact | 13524640378 | feifei-a@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiqing Wang, Dr. | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | 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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Glucose detection
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Masking Description
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| fully automatic laboratory biochemical analyzer | Device | Blood glucose were detected by fully automatic laboratory biochemical analyzer using plasma sample at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast. |
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| fingertip capillary blood glucose meter | Device | Blood glucose were detected by fingertip capillary blood sample at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast. |
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The interval between the two methods is less than 10 minutes at each point. |
| 3 months |
| The point proportion of A+B region of Clarke error grid analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control. | The interval between the two methods is less than 10 minutes at each point. | 3 months |
| The regression analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control. | The interval between the two methods is less than 10 minutes at each point. | 3 months |
| The bland-Altman analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control. | The interval between the two methods is less than 10 minutes at each point. | 3 months |
| The MARD were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. | The interval between the two methods is less than 10 minutes at each point. | 3 months |
| The ±20% agreement were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. | The interval between the two methods is less than 10 minutes at each point. | 3 months |
| The point proportion of A+B region of Clarke error grid analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. | The interval between the two methods is less than 10 minutes at each point. | 3 months |
| The regression analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. | The interval between the two methods is less than 10 minutes at each point. | 3 months |
| The bland-Altman analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. | The interval between the two methods is less than 10 minutes at each point. | 3 months |
| Incidence of Treatment-Emergent Adverse Events | Safety in the patients. | 3 months |