To Evaluate the Efficacy and Safety of Multi-parameter Non-Invasive Glucose Sensors for for Blood Glucose Measurement

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Non-invasive glucose meter; Device: Accu-Chek Guide; Device: EKF analyzer

• Registration Number: NCT06017349
• Lead Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.

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 Timeline

• Study Start: 2022-09-21
• Primary Completion: 2023-07-18
• Study Completion: 2023-07-18
• Status Verified: 2023-08
• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Study First Posted: 2023-08-30
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-invasive glucose meter	Non-invasive glucose meter	The noninvasive glucose meter was entrained on the finger, Glucose concentration levels were measured by measuring physiological parameters related to metabolic heat and local oxygen supply.
Accu-Chek Guide blood glucose meter	Accu-Chek Guide	Being used for quantitative determination of blood glucose concentration in fresh capillary whole blood taken from fingers.
EKF Biosen C-Line	EKF analyzer	Using the hexosyl enzymatic method to detect plasma glucose values

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China