<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/NCT01709851</url>
  </required_header>
  <id_info>
    <org_study_id>GMD_05</org_study_id>
    <nct_id>NCT01709851</nct_id>
  </id_info>
  <brief_title>Performance Study to Test the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes</brief_title>
  <official_title>A Single-center, Open, Pilot Trial to Investigate the Performance of the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Menarini Group</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over the last years, a number of systems for continuous subcutaneous glucose monitoring have&#xD;
      been marketed and are routinely used in patients with diabetes to obtain more detailed&#xD;
      information about 24-hour glucose profiles.&#xD;
&#xD;
      In the hospital, numerous factors influencing glycemic control and possibly leading to&#xD;
      glucose excursions out of the desired range exist, e.g. interventions for which the patient&#xD;
      has to remain fasting or medications such as corticosteroids or vasopressors. A reliable&#xD;
      continuous glucose signal could help to observe levels of glycaemia not only at defined&#xD;
      time-points but continuously, making it possible for physicians and nursing staff to better&#xD;
      adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo-&#xD;
      or hyperglycaemia.&#xD;
&#xD;
      In the hospital setting, vascular access is granted in the majority of patients and could as&#xD;
      well be used as an alternative site for continuous glucose monitoring.&#xD;
&#xD;
      The aim of the present study is to assess accuracy of the glucose data obtained by means of&#xD;
      an intravascular microdialysis-based CGM system against venous blood glucose reference&#xD;
      measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Point Accuracy of the microdialysis signal</measure>
    <time_frame>72 hours</time_frame>
    <description>MARD (mean absolute relative difference), MARE (mean absolute relative error), %Press analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate accuracy of the microdialysis signal</measure>
    <time_frame>72 hours</time_frame>
    <description>R-EGA (rate error grid analysis) and P-EGA (point error grid analysis)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Type 1 Diabetes - vMD and sMD</arm_group_label>
    <description>Patients will undergo vascular (vMD) and subcutaneous microdialysis (sMD) using the GMD-system (GlucoMen(R)Day-system)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 1 diabetes - vMD</arm_group_label>
    <description>Patients will undergo vascular microdialysis (vMD) using the GMD-system (GlucoMen(R)Day-system)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vascular microdialysis using the GMD-system</intervention_name>
    <description>Glucose levels will be monitored by means of vascular microdialysis using the GlucoMen(R)Day system</description>
    <arm_group_label>Type 1 diabetes - vMD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vascular and subcutaneous microdialysis using the GMD-system</intervention_name>
    <description>Glucose levels will be monitored by means of vascular and subcutaneous microdialysis using the GlucoMen(R)Day system</description>
    <arm_group_label>Type 1 Diabetes - vMD and sMD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with type 1 diabetes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained after being advised of the nature of the study&#xD;
&#xD;
          -  Male or female aged 18 - 75 years (both inclusive)&#xD;
&#xD;
          -  Type 1 diabetes treated with multiple daily insulin injection or continuous&#xD;
             subcutaneous insulin infusion for 12 months&#xD;
&#xD;
          -  Body mass index 20.0 - 29.5 kg/m² (both inclusive)&#xD;
&#xD;
          -  HbA1c &lt; 86.0mmol/mol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female of childbearing potential who is pregnant, breast-feeding or intend to become&#xD;
             pregnant or is not using adequate contraceptive methods.&#xD;
&#xD;
          -  Skin pathology or condition prohibiting needle insertion as judged by the&#xD;
             investigator.&#xD;
&#xD;
          -  History of bleeding disorder.&#xD;
&#xD;
          -  History of heparin-induced thrombocytopenia (HIT)&#xD;
&#xD;
          -  Current participation in another clinical study.&#xD;
&#xD;
          -  Significant acute or chronic illness that might interfere with subject safety or&#xD;
             integrity of results as judged by the investigator.&#xD;
&#xD;
          -  Lipodystrophy&#xD;
&#xD;
          -  Current treatment with systemic (oral or i.v.) corticosteroids or any anticoagulation&#xD;
             medication.&#xD;
&#xD;
          -  Blood donation or blood loss of more than 500 mL within 12 weeks prior to the study&#xD;
             day.&#xD;
&#xD;
          -  Known hypersensitivity to Fondaparinux sodium (Arixtra®).&#xD;
&#xD;
          -  Significant history of alcoholism or drug abuse or a positive result in urine&#xD;
             drug/alcohol screen.&#xD;
&#xD;
        Study day exclusion criteria:&#xD;
&#xD;
          -  Non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00&#xD;
             hours the evening before the visit) except if slight intake of rapidly absorbable&#xD;
             carbohydrates has been necessary in order to prevent hypoglycaemia.&#xD;
&#xD;
          -  Positive result of alcohol breath test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas R. Pieber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Graz, Dept. of Internal Medicine, Endocrinology and Metabolism</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>April 15, 2013</last_update_submitted>
  <last_update_submitted_qc>April 15, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 16, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 diabetes</keyword>
  <keyword>Intravascular continuous glucose monitoring</keyword>
  <keyword>Subcutaneous continuous glucose monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</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/NCT01709851
org study id: GMD_05
nct id: NCT01709851
lead sponsor: 
collaborator: 
has dmc: No
Over the last years, a number of systems for continuous subcutaneous glucose monitoring have
      been marketed and are routinely used in patients with diabetes to obtain more detailed
      information about 24-hour glucose profiles.

      In the hospital, numerous factors influencing glycemic control and possibly leading to
      glucose excursions out of the desired range exist, e.g. interventions for which the patient
      has to remain fasting or medications such as corticosteroids or vasopressors. A reliable
      continuous glucose signal could help to observe levels of glycaemia not only at defined
      time-points but continuously, making it possible for physicians and nursing staff to better
      adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo-
      or hyperglycaemia.

      In the hospital setting, vascular access is granted in the majority of patients and could as
      well be used as an alternative site for continuous glucose monitoring.

      The aim of the present study is to assess accuracy of the glucose data obtained by means of
      an intravascular microdialysis-based CGM system against venous blood glucose reference
      measurements.
observational model: Case-Only
time perspective: Prospective
measure: Point Accuracy of the microdialysis signal
time frame: 72 hours
description: MARD (mean absolute relative difference), MARE (mean absolute relative error), %Press analysis
measure: Rate accuracy of the microdialysis signal
time frame: 72 hours
description: R-EGA (rate error grid analysis) and P-EGA (point error grid analysis)
arm group label: Type 1 Diabetes - vMD and sMD
description: Patients will undergo vascular (vMD) and subcutaneous microdialysis (sMD) using the GMD-system (GlucoMen(R)Day-system)
arm group label: Type 1 diabetes - vMD
description: Patients will undergo vascular microdialysis (vMD) using the GMD-system (GlucoMen(R)Day-system)
intervention type: Device
intervention name: Vascular microdialysis using the GMD-system
description: Glucose levels will be monitored by means of vascular microdialysis using the GlucoMen(R)Day system
arm group label: Type 1 diabetes - vMD
intervention type: Device
intervention name: Vascular and subcutaneous microdialysis using the GMD-system
description: Glucose levels will be monitored by means of vascular and subcutaneous microdialysis using the GlucoMen(R)Day system
arm group label: Type 1 Diabetes - vMD and sMD
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Thomas R. Pieber, MD
role: Principal Investigator
affiliation: Medical University of Graz
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1