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

Diabetes Mellitus Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06017349
• Other study ID #: LP-NG -2022-1
• Status: Completed
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: July 18, 2023

Study information

• Verified date: August 2023
• Source: Lepu Medical Technology (Beijing) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lepu Medical Technology (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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