Clinical trial NCT06017349: To Evaluate the Efficacy and Safety of Multi-parameter Non-Invasive Glucose Sensors for for Blood Glucose Measurement
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Blood Glucose Self-Monitoring
Non-invasive glucose meter
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The results were analyzed by consensus error grid (CEG)
timeFrame: After 2 days of blood glucose measurements
Secondary outcomes:
measure: Mean Absolute Relative Difference (MARD)
timeFrame: The day after the blood glucose measurement
measure: The 20/20% agreement rates
timeFrame: The day after the blood glucose measurement
measure: Accessibility evaluation Questionnaire for non-invasive glucose meter
timeFrame: The day after the blood glucose measurement
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Linong Ji
role: PRINCIPAL_INVESTIGATOR
References: