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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
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.
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
Peking University People's Hospital
Beijing, Beijing Municipality, China
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)
Time frame: After 2 days of blood glucose measurements
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.
Time frame: 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
Time frame: 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.
Time frame: The day after the blood glucose measurement
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.