<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/NCT01730885</url>
  </required_header>
  <id_info>
    <org_study_id>BGStar</org_study_id>
    <nct_id>NCT01730885</nct_id>
  </id_info>
  <brief_title>A Trial Investigating the Accuracy and Precision of the BGStar® and iBGStar® Blood Glucose Meter in Subjects With Type 1 Diabetes</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Profil Institut für Stoffwechselforschung GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Profil Institut für Stoffwechselforschung GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Due to continuing technological progress and better understanding of the needs for glucose&#xD;
      monitoring, the performance requirements of blood glucose meters, primarily regarding their&#xD;
      accuracy, are constantly debated and keep evolving as a consequence. Recently a discussion&#xD;
      was initiated by the Food and Drug Administration (FDA) to improve the accuracy of BG meters&#xD;
      in the point-of-care testing setting by asking for fulfilment of higher requirements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean absolute relative deviation (MARD) from paired reference values of BGStar®, iBGStar® and comparator BG meter measurements at stable hypoglycaemic, euglycaemic and hyperglycaemic levels and overal</measure>
    <time_frame>6 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>BGStar</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Comparision</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comparison of different Blood Glucose Meters</intervention_name>
    <arm_group_label>BGStar</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated informed consent obtained before any trial-related activities.&#xD;
             Trial-related activities are any procedures that are carried out as part of the trial,&#xD;
             including activities to determine suitability for the trial.&#xD;
&#xD;
          2. Male or female subjects aged 18-74 years (both inclusive).&#xD;
&#xD;
          3. Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months.&#xD;
&#xD;
          4. Body mass index 18.0-28.0 kg/m2 (both inclusive).&#xD;
&#xD;
          5. HbA1c ≤ 9.0 % by local laboratory analysis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known or suspected hypersensitivity to lancet fingerpricks / needle injections.&#xD;
&#xD;
          2. Previous participation in this trial. Participation is defined as having performed at&#xD;
             least one BG meter measurement as part of the study.&#xD;
&#xD;
          3. Receipt of any investigational medicinal product within 30 days before randomisation&#xD;
             in this trial.&#xD;
&#xD;
          4. Formation of callus on the fingertips or any other skin condition that may hamper&#xD;
             fingerprick blood sampling and/or insufficient capillary blood volume sampling (&lt; 50&#xD;
             μL) during test fingerprick(s).&#xD;
&#xD;
          5. Haemoglobin &lt; 8.0 mmol/L (male) or &lt; 6.4 mmol/L (female), total leukocyte count &lt; 3.0&#xD;
             x 109/L, thrombocytes &lt;100 x 109/L, serum creatinine levels ≥ 126 μmol/L (male) or ≥&#xD;
             111 μmol/L (female), bilirubin &gt; 3x the upper limit of normal (ULN), and alanine&#xD;
             aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)&#xD;
             and gamma-glutamyl transferase (γ-GT) &gt; 2 x ULN.&#xD;
&#xD;
          6. Suffer from or history of a life threatening disease (i.e. cancer except basal cell&#xD;
             skin cancer or squamous cell skin cancer), or any clinically significant respiratory,&#xD;
             metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of&#xD;
             diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Profil Institut für Stoffwechselforschung GmbH</name>
      <address>
        <city>Neuss</city>
        <state>NRW</state>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>February 4, 2014</last_update_submitted>
  <last_update_submitted_qc>February 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01730885
org study id: BGStar
nct id: NCT01730885
lead sponsor: 
collaborator: 
has dmc: No
Due to continuing technological progress and better understanding of the needs for glucose
      monitoring, the performance requirements of blood glucose meters, primarily regarding their
      accuracy, are constantly debated and keep evolving as a consequence. Recently a discussion
      was initiated by the Food and Drug Administration (FDA) to improve the accuracy of BG meters
      in the point-of-care testing setting by asking for fulfilment of higher requirements.
allocation: Non-Randomized
intervention model: Factorial Assignment
masking: None (Open Label)
measure: Mean absolute relative deviation (MARD) from paired reference values of BGStar®, iBGStar® and comparator BG meter measurements at stable hypoglycaemic, euglycaemic and hyperglycaemic levels and overal
time frame: 6 hours
arm group label: BGStar
arm group type: Other
description: Comparision
intervention type: Other
intervention name: Comparison of different Blood Glucose Meters
arm group label: BGStar
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor