Diabetes Mellitus
Conditions
Keywords
Blood Glucose Self-Monitoring, Non-invasive glucose meter
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.
Interventions
DEVICENon-invasive glucose meter
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.
DEVICEEKF analyzer
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.
DEVICEAccu-Chek Guide
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
Sponsors
Lepu Medical Technology (Beijing) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The results were analyzed by consensus error grid (CEG) | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Relative Difference (MARD) | 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. |
| The 20/20% agreement rates | 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 |
| Accessibility evaluation Questionnaire for non-invasive glucose meter | 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. |
Countries
China
Outcome results
None listed