Peking University People's Hospital
Beijing, Beijing Municipality, China
NCT Number: NCT06017349
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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)
Time frame: The day after the blood glucose measurement
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 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
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.
Lepu Medical Technology (Beijing) Co., Ltd.
Industry
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.
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