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

NCT06017349 | Completed

• 1 other identifier: LP-NG -2022-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Blood Glucose Self-Monitoring; Non-invasive glucose meter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Absolute Relative Difference (MARD)

  The day after the blood glucose measurement

• The 20/20% agreement rates

  The day after the blood glucose measurement

• Accessibility evaluation Questionnaire for non-invasive glucose meter

  The day after the blood glucose measurement

Study Arms (3)

Non-invasive glucose meter

EXPERIMENTAL

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

Accu-Chek Guide blood glucose meter

ACTIVE COMPARATOR

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

Device: Accu-Chek Guide

EKF Biosen C-Line

ACTIVE COMPARATOR

Using the hexosyl enzymatic method to detect plasma glucose values

Device: EKF analyzer

Interventions

Non-invasive glucose meter 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.

Non-invasive glucose meter

EKF analyzer 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.

EKF Biosen C-Line

Accu-Chek Guide 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

Accu-Chek Guide blood glucose meter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with diabetes (type 1 or type 2 );
• Participants who could understand the purpose of the trial and signed the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Linong Ji

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 30, 2023
• Study Start: September 21, 2022
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

CN (1)