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This was a prospective, multicenter, open-label, self-controlled study to evaluate the efficacy and safety of multi-parameter non-invasive glucose meters for blood glucose measurement,planned enrollment of 200 patients with type 1 or type 2 diabetes.
Comparing glucose measurements from the Non-Invasive Glucose monitoring system to venous blood glucose or fingertip blood glucose to evaluate System accuracy capability.
At the same time, blood glucose was measured by non-invasive blood glucose meter, Accu-Chek Guide blood glucose meter and EKF Biosen C-Line. Eight groups of blood glucose values were collected from each subject during fasting, after breakfast and after lunch.After the end of blood glucose measurement, the data were recorded, including adverse events and device defects during the test. The subjects were required to stay in the examination room for 5-10 minutes, during which they completed the product use evaluation questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive glucose meter | Experimental | The noninvasive glucose meter was entrained on the finger, Glucose concentration levels were measured by measuring physiological parameters related to metabolic heat and local oxygen supply. |
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| Accu-Chek Guide blood glucose meter | Active Comparator | Being used for quantitative determination of blood glucose concentration in fresh capillary whole blood taken from fingers. |
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| EKF Biosen C-Line | Active Comparator | Using the hexosyl enzymatic method to detect plasma glucose values |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive glucose meter | Device | Blood glucose levels were measured while fasting, after breakfast, and after lunch,Place your index finger into the non-invasive blood glucose meter and wait for the instrument to display the reading. |
| Measure | Description | Time Frame |
|---|---|---|
| The results were analyzed by consensus error grid (CEG) | The proportion of the results lie within zone A and zone B of the consensus error grid (CEG) | After 2 days of blood glucose measurements |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Absolute Relative Difference (MARD) | It is calculated by taking the absolute difference between the two values, dividing it by their average. A smaller MARD value indicates a smaller relative difference between the two values, indicating higher consistency between them. | The day after the blood glucose measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linong Ji | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 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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| EKF analyzer | Device | Blood glucose levels were measured while fasting, after breakfast, and after lunch,After collecting venous blood and separating plasma, blood glucose detection is performed using the EKF analyzer with the hexokinase method. |
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| Accu-Chek Guide | Device | Blood glucose levels were measured while fasting, after breakfast, and after lunch,Use Accu-Chek Guide blood glucose meter to prick the finger and obtain blood for glucose measurement |
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| The 20/20% agreement rates |
the proportion of Non-invasive blood glucose values that were within 20% of paired reference blood glucose values >80 or 20 mg/dL of reference blood glucose values ≤100 mg/dL |
| The day after the blood glucose measurement |
| Accessibility evaluation Questionnaire for non-invasive glucose meter | The questionnaire covers the subjects' self-monitoring of blood glucose status, their awareness and expectations of non-invasive testing, as well as their subjective feelings after using a non-invasive blood glucose meter. | The day after the blood glucose measurement |