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

Lepu Medical Technology

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Accu-Chek Guide; Device: Non-invasive glucose meter; Device: EKF analyzer

Study type: Interventional

Funder types: Industry

Identifiers

NCT06017349

LP-NG -2022-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Non-invasive glucose meter

Experimental group

Description:

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.

Treatment:

Device: Non-invasive glucose meter

Accu-Chek Guide blood glucose meter

Active Comparator group

Description:

Being used for quantitative determination of blood glucose concentration in fresh capillary whole blood taken from fingers.

Treatment:

Device: Accu-Chek Guide

EKF Biosen C-Line

Active Comparator group

Description:

Using the hexosyl enzymatic method to detect plasma glucose values

Treatment:

Device: EKF analyzer