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/NCT06037512</url>
    </required_header>
    <id_info>
      <org_study_id>2023_002</org_study_id>
      <nct_id>NCT06037512</nct_id>
    </id_info>
    <brief_title>User Evaluation of BGM VGM77</brief_title>
    <official_title>Evaluierung Des Blutglukose Monitoring Systems VGM77 Der Firma Beurer GmbH gemäß DIN EN ISO 15197:2015</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut fur Diabetes Karlsburg GmbH</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut fur Diabetes Karlsburg GmbH</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>
        Performance Evaluation by the User of the Blood Glucose Monitoring System VGM77Compliant with&#xD;
        DIN EN ISO 15197:2015&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 13, 2023</start_date>
    <completion_date type="Actual">June 15, 2023</completion_date>
    <primary_completion_date type="Actual">June 6, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Analysis of system accuracy based on DIN EN ISO 15197</measure>
      <time_frame>1 Day</time_frame>
      <description>Assessment of the analytical measurement performance of the blood glucose monitor</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">106</enrollment>
    <condition>Diabetes</condition>
    <arm_group>
      <arm_group_label>Subject glucometer measurement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Blood glucose measurement BGM for personal use</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>subject</intervention_name>
      <description>blood glucose measurement by subject</description>
      <arm_group_label>Subject glucometer measurement</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>reference</intervention_name>
      <description>blood glucose measurement with reference</description>
      <arm_group_label>Subject glucometer measurement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Male or female patients with hypo-, eu- or hyperglycaemia&#xD;
  &#xD;
            -  The written informed consent had to be signed&#xD;
  &#xD;
            -  The volunteers must be older than 18 years&#xD;
  &#xD;
            -  The volunteers have legal capacity and are able to understand meaning, nature and&#xD;
               possible consequences of the procedures involved&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Pregnancy or lactation&#xD;
  &#xD;
            -  Acute or chronic diseases with the risk of aggravation by the measure&#xD;
  &#xD;
            -  A current constitution that does not allow participating in the study&#xD;
  &#xD;
            -  Participation in another study or activity with the blood glucose measuring system&#xD;
               evaluated in the present study&#xD;
  &#xD;
            -  Application of substances listed in Appendix A of DIN EN ISO 15197:2015&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eckhard Salzsieder, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Institut fur Diabetes Karlsburg GmbH</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Institut für Diabetes Karlsburg GmbH</name>
        <address>
          <city>Karlsburg</city>
          <state>Mecklenburg Vorpommern</state>
          <zip>17495</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06037512
  org study id: 2023_002
  nct id: NCT06037512
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Performance Evaluation by the User of the Blood Glucose Monitoring System VGM77Compliant with
        DIN EN ISO 15197:2015
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Analysis of system accuracy based on DIN EN ISO 15197
  time frame: 1 Day
  description: Assessment of the analytical measurement performance of the blood glucose monitor
  arm group label: Subject glucometer measurement
  arm group type: Experimental
  description: Blood glucose measurement BGM for personal use
  intervention type: Diagnostic Test
  intervention name: subject
  description: blood glucose measurement by subject
  arm group label: Subject glucometer measurement
  intervention type: Diagnostic Test
  intervention name: reference
  description: blood glucose measurement with reference
  arm group label: Subject glucometer measurement
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eckhard Salzsieder, PhD
  role: Study Director
  affiliation: Institut fur Diabetes Karlsburg GmbH
  facility: 
  country: Germany
  responsible party type: Sponsor
  sharing ipd: No