xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06017349</url>
    </required_header>
    <id_info>
      <org_study_id>LP-NG -2022-1</org_study_id>
      <nct_id>NCT06017349</nct_id>
    </id_info>
    <brief_title>To Evaluate the Efficacy and Safety of Multi-parameter Non-Invasive Glucose Sensors for for Blood Glucose Measurement</brief_title>
    <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.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lepu Medical Technology (Beijing) Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lepu Medical Technology (Beijing) Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This was a prospective, multicenter, open-label, self-controlled study to evaluate the&#xD;
        efficacy and safety of multi-parameter non-invasive glucose meters for blood glucose&#xD;
        measurement，planned enrollment of 200 patients with type 1 or type 2 diabetes.&#xD;
  &#xD;
        Comparing glucose measurements from the Non-Invasive Glucose monitoring system to venous&#xD;
        blood glucose or fingertip blood glucose to evaluate System accuracy capability.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        At the same time, blood glucose was measured by non-invasive blood glucose meter, Accu-Chek&#xD;
        Guide blood glucose meter and EKF Biosen C-Line. Eight groups of blood glucose values were&#xD;
        collected from each subject during fasting, after breakfast and after lunch.After the end of&#xD;
        blood glucose measurement, the data were recorded, including adverse events and device&#xD;
        defects during the test. The subjects were required to stay in the examination room for 5-10&#xD;
        minutes, during which they completed the product use evaluation questionnaire.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 21, 2022</start_date>
    <completion_date type="Actual">July 18, 2023</completion_date>
    <primary_completion_date type="Actual">July 18, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The results were analyzed by consensus error grid (CEG)</measure>
      <time_frame>After 2 days of blood glucose measurements</time_frame>
      <description>The proportion of the results lie within zone A and zone B of the consensus error grid (CEG)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean Absolute Relative Difference (MARD)</measure>
      <time_frame>The day after the blood glucose measurement</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The 20/20% agreement rates</measure>
      <time_frame>The day after the blood glucose measurement</time_frame>
      <description>the proportion of Non-invasive blood glucose values that were within 20% of paired reference blood glucose values &gt;80 or 20 mg/dL of reference blood glucose values ≤100 mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Accessibility evaluation Questionnaire for non-invasive glucose meter</measure>
      <time_frame>The day after the blood glucose measurement</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">200</enrollment>
    <condition>Diabetes Mellitus</condition>
    <arm_group>
      <arm_group_label>Non-invasive glucose meter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Accu-Chek Guide blood glucose meter</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Being used for quantitative determination of blood glucose concentration in fresh capillary whole blood taken from fingers.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EKF Biosen C-Line</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Using the hexosyl enzymatic method to detect plasma glucose values</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Non-invasive glucose meter</intervention_name>
      <description>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.</description>
      <arm_group_label>Non-invasive glucose meter</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EKF analyzer</intervention_name>
      <description>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.</description>
      <arm_group_label>EKF Biosen C-Line</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Accu-Chek Guide</intervention_name>
      <description>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</description>
      <arm_group_label>Accu-Chek Guide blood glucose meter</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects with diabetes (type 1 or type 2 );&#xD;
  &#xD;
            -  Participants who could understand the purpose of the trial and signed the informed&#xD;
               consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Conditions that prevent good contact between the measuring finger and the sensor,&#xD;
               resulting in unmeasured conditions, such as hand disability, scar, swelling of the&#xD;
               finger, etc.&#xD;
  &#xD;
            -  Diseases that affect the accuracy of hand measurement, such as Parkinson's disease,&#xD;
               upper limb chronic arterial occlusive disease, Raynaud's syndrome, hand or arm trauma&#xD;
               surgery, upper limb arteriovenous fistula, etc.&#xD;
  &#xD;
            -  Fever (axillary temperature &gt;37.3℃) and severe dehydration during screening;&#xD;
  &#xD;
            -  Diabetic ketoacidosis, hyperglycemic hyperosmolar status within 6 months before&#xD;
               signing the informed consent;&#xD;
  &#xD;
            -  Those who were in serious illness within 1 month before signing the informed consent,&#xD;
               such as shock, heart failure, respiratory failure, severe liver and kidney&#xD;
               dysfunction, etc.&#xD;
  &#xD;
            -  Those suffering from mental illness, lack of self-control or unable to express their&#xD;
               personal willingness clearly;&#xD;
  &#xD;
            -  Participants who participated in other drug or device clinical trials within 2 weeks&#xD;
               before signing the informed consent (except those who failed in screening);&#xD;
  &#xD;
            -  Other persons deemed by the investigator to be ineligible for clinical trial&#xD;
               participation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Linong Ji</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University People's Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Peking University People's Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Blood Glucose Self-Monitoring</keyword>
    <keyword>Non-invasive glucose meter</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06017349
  org study id: LP-NG -2022-1
  nct id: NCT06017349
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The results were analyzed by consensus error grid (CEG)
  time frame: After 2 days of blood glucose measurements
  description: The proportion of the results lie within zone A and zone B of the consensus error grid (CEG)
  measure: Mean Absolute Relative Difference (MARD)
  time frame: The day after the blood glucose measurement
  description: 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.
  measure: The 20/20% agreement rates
  time frame: The day after the blood glucose measurement
  description: 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
  measure: Accessibility evaluation Questionnaire for non-invasive glucose meter
  time frame: The day after the blood glucose measurement
  description: 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.
  arm group label: Non-invasive glucose meter
  arm group type: Experimental
  description: 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.
  arm group label: Accu-Chek Guide blood glucose meter
  arm group type: Active Comparator
  description: Being used for quantitative determination of blood glucose concentration in fresh capillary whole blood taken from fingers.
  arm group label: EKF Biosen C-Line
  arm group type: Active Comparator
  description: Using the hexosyl enzymatic method to detect plasma glucose values
  intervention type: Device
  intervention name: Non-invasive glucose meter
  description: 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.
  arm group label: Non-invasive glucose meter
  intervention type: Device
  intervention name: EKF analyzer
  description: 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.
  arm group label: EKF Biosen C-Line
  intervention type: Device
  intervention name: Accu-Chek Guide
  description: 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
  arm group label: Accu-Chek Guide blood glucose meter
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Linong Ji
  role: Principal Investigator
  affiliation: Peking University People's Hospital
  facility: 
  country: China
  responsible party type: Sponsor