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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The results were analyzed by consensus error grid (CEG)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
The results were analyzed by consensus error grid (CEG)
Time Frame: After 2 days of blood glucose measurements
The proportion of the results lie within zone A and zone B of the consensus error grid (CEG)
Secondary Outcomes
- Mean Absolute Relative Difference (MARD)(The day after the blood glucose measurement)
- The 20/20% agreement rates(The day after the blood glucose measurement)
- Accessibility evaluation Questionnaire for non-invasive glucose meter(The day after the blood glucose measurement)