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Completed

NCT Number: NCT06017349

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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

Primary outcomes

  1. The results were analyzed by consensus error grid (CEG)

    Time frame: After 2 days of blood glucose measurements

    The proportion of the results lie within zone A and zone B of the consensus error grid (CEG)

Secondary outcomes

  1. Mean Absolute Relative Difference (MARD)

    Time frame: The day after the blood glucose measurement

    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.

  2. The 20/20% agreement rates

    Time frame: The day after the blood glucose measurement

    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

  3. Accessibility evaluation Questionnaire for non-invasive glucose meter

    Time frame: The day after the blood glucose measurement

    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.

Sponsors and collaborators

Lead sponsor

Lepu Medical Technology (Beijing) Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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