To Evaluate the Efficacy and Safety of Multi-parameter Non-Invasive Glucose Sensors for for Blood Glucose Measurement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Open-label, Self-controlled Clinical Trial Protocol to Evaluate the Efficacy and Safety of a Multi-parameter Non-Invasive Glucose Sensors for Measuring Blood Glucose.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Non-invasive glucose meter
* Device: EKF analyzer
* Device: Accu-Chek Guide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with diabetes (type 1 or type 2 ); Participants who could understand the purpose of the trial and signed the informed consent form. Exclusion Criteria: Conditions that prevent good contact between the measuring finger and the sensor, resulting in unmeasured conditions, such as hand disability, scar, swelling of the finger, etc. Diseases that affect the accuracy of hand measurement, such as Parkinson's disease, upper limb chronic arterial occlusive disease, Raynaud's syndrome, hand or arm trauma surgery, upper limb arteriovenous fistula, etc. Fever (axillary temperature >37.3℃) and severe dehydration during screening; Diabetic ketoacidosis, hyperglycemic hyperosmolar status within 6 months before signing the informed consent; Those who were in serious illness within 1 month before signing the informed consent, such as shock, heart failure, respiratory failure, severe liver and kidney dysfunction, etc. Those suffering from mental illness, lack of self-control or unable to express their personal willingness clearly; Participants who participated in other drug or device clinical trials within 2 weeks before signing the informed consent (except those who failed in screening); Other persons deemed by the investigator to be ineligible for clinical trial participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-invasive glucose meter<br>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. | Device: Non-invasive glucose meter<br>* 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.<br>|
| Active Comparator: Accu-Chek Guide blood glucose meter<br>Being used for quantitative determination of blood glucose concentration in fresh capillary whole blood taken from fingers. | Device: Accu-Chek Guide<br>* 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<br>|
| Active Comparator: EKF Biosen C-Line<br>Using the hexosyl enzymatic method to detect plasma glucose values | Device: EKF analyzer<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Glucose Self-Monitoring, Non-invasive glucose meter