<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/NCT01729546</url>
  </required_header>
  <id_info>
    <org_study_id>IDT-1212</org_study_id>
    <nct_id>NCT01729546</nct_id>
  </id_info>
  <brief_title>Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus</brief_title>
  <official_title>Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus [Following EN ISO 15197:2003 - 7.3 System Accuracy Evaluation] Part 40 of Study IDT-2010</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm</source>
  <brief_summary>
    <textblock>
      In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and&#xD;
      several POCT (point-of-care testing) devices against two laboratory methods will be&#xD;
      performed. This evaluation will be performed according to ISO (International Organization for&#xD;
      Standardization) 15197 System Accuracy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Evaluation of System Accuracy according to ISO 15197</measure>
  </primary_outcome>
  <enrollment type="Actual">114</enrollment>
  <condition>Diabetes</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>7 Blood glucose monitoring systems</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  People with diabetes Typ 1 or Typ 2 and people without diabetes&#xD;
&#xD;
          -  for BG adjustment people with diabetes Typ 1 or Typ 2&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy or lactation period&#xD;
&#xD;
          -  severe acute diseases&#xD;
&#xD;
          -  severe chronic diseases&#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>
  <location>
    <facility>
      <name>Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/24681433</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Freckmann G, Schmid C, Pleus S, Baumstark A, Link M, Stolberg E, Haug C, Sieber J. System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems. Clin Chem Lab Med. 2014 Jul;52(7):1079-86. doi: 10.1515/cclm-2013-0976.</citation>
    <PMID>24681433</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>January 13, 2015</last_update_submitted>
  <last_update_submitted_qc>January 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SMBG (self-monitoring of blood glucose)</keyword>
  <keyword>POCT</keyword>
  <keyword>System Accuracy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01729546
org study id: IDT-1212
nct id: NCT01729546
lead sponsor: 
collaborator: 
In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and
      several POCT (point-of-care testing) devices against two laboratory methods will be
      performed. This evaluation will be performed according to ISO (International Organization for
      Standardization) 15197 System Accuracy.
measure: Evaluation of System Accuracy according to ISO 15197
intervention type: Device
intervention name: 7 Blood glucose monitoring systems
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
url: http://www.ncbi.nlm.nih.gov/pubmed/24681433
description: Related Info
citation: Freckmann G, Schmid C, Pleus S, Baumstark A, Link M, Stolberg E, Haug C, Sieber J. System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems. Clin Chem Lab Med. 2014 Jul;52(7):1079-86. doi: 10.1515/cclm-2013-0976.
PMID: 24681433
responsible party type: Sponsor
mesh term: Diabetes Mellitus