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

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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Non-invasive glucose meter; Device: Accu-Chek Guide; Device: EKF analyzer

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: Accu-Chek Guide blood glucose meter; Being used for quantitative determination of blood glucose concentration in fresh capillary whole blood taken from fingers.	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
Active Comparator: EKF Biosen C-Line; Using the hexosyl enzymatic method to detect plasma glucose values	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The results were analyzed by consensus error grid (CEG)	The proportion of the results lie within zone A and zone B of the consensus error grid (CEG)	After 2 days of blood glucose measurements

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Absolute Relative Difference (MARD)	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 day after the blood glucose measurement
The 20/20% agreement rates	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	The day after the blood glucose measurement
Accessibility evaluation Questionnaire for non-invasive glucose meter	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.	The day after the blood glucose measurement

Collaborators and Investigators

• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
• Investigators: Principal Investigator: Linong Ji, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Blood Glucose Self-Monitoring; Non-invasive glucose meter
• Other Study ID Numbers: LP-NG -2022-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No