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

NCT ID: NCT06017349

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2023-07-18

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Non-invasive glucose meter

Intervention Type: DEVICE

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.

Accu-Chek Guide blood glucose meter

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

Group Type: ACTIVE_COMPARATOR

Accu-Chek Guide

Intervention Type: DEVICE

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

EKF Biosen C-Line

Using the hexosyl enzymatic method to detect plasma glucose values

Group Type: ACTIVE_COMPARATOR

EKF analyzer

Intervention Type: DEVICE

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.

Interventions

Non-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.

Intervention Type: DEVICE

EKF 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.

Intervention Type: DEVICE

Accu-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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lepu Medical Technology (Beijing) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linong Ji

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

LP-NG -2022-1

Identifier Type: -

Identifier Source: org_study_id