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/NCT06034574</url>
    </required_header>
    <id_info>
      <org_study_id>21HH7234</org_study_id>
      <nct_id>NCT06034574</nct_id>
    </id_info>
    <brief_title>A Trial Investigating the Accuracy of Continuous Glucose Monitor Systems (&quot;Supersapiens&quot; Abbott Libre Sense and Dexcom G6) During Exercise in People With Normal Glucose Tolerance</brief_title>
    <acronym>SuperComEx</acronym>
    <official_title>A Trial Investigating the Accuracy of Continuous Glucose Monitor Systems (&quot;Supersapiens&quot; Abbott Libre Sense and Dexcom G6) During Exercise in People With Normal Glucose Tolerance</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imperial College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imperial College London</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>
        A two-phase, observational trial in an exercise laboratory and a prospective real-world&#xD;
        setting to test the hypothesis that The Libre Sense Glucose Sport device has acceptable&#xD;
        accuracy in people with normal glucose tolerance and comparable accuracy in the range of 3.0&#xD;
        to 11mmol/L to clinically approved CGM in people with type 1 diabetes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is two-phase trial including a research facility and home phase existing of five study&#xD;
        related visits:&#xD;
  &#xD;
          -  Screening visit and CPX test (2 hrs per visit)&#xD;
  &#xD;
          -  three exercise sessions completed in a random order at the research facility (2 hrs per&#xD;
             visit) plus an additional visit for people with normal glucose tolerance to undertake a&#xD;
             glucose tolerance test&#xD;
  &#xD;
          -  4 weeks of home-based exercise (3 sessions of ~60 minutes moderate intensity exercise&#xD;
             per week) - Including one glycaemic challenge prior to a single home-based exercise&#xD;
             session&#xD;
  &#xD;
          -  Final visit&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <primary_outcome>
      <measure>%MARD lab phase</measure>
      <time_frame>2 weeks</time_frame>
      <description>To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (lab phase)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>%MARD home phase</measure>
      <time_frame>4 weeks</time_frame>
      <description>To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (home phase)</description>
    </secondary_outcome>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Type 1 Diabetes</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Continuous glucose monitoring</intervention_name>
      <description>Assessment of accuracy of two different continuous glucose monitoring devices during exercise</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          16 healthy volunteers undertaking regular physical activity 8 volunteers with type 1&#xD;
          diabetes undertaking regular physical activity&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Male or female aged 18-65 years (both inclusive)&#xD;
  &#xD;
                 -  Body mass index 18.0-29.9 kg/m2 (both inclusive)&#xD;
  &#xD;
                 -  Normal glucose tolerance (measured via fasting blood glucose levels) or type 1&#xD;
                    diabetes for greater than 1 year&#xD;
  &#xD;
                 -  Participants performing regular physical activity during the last 3 months prior&#xD;
                    to screening&#xD;
  &#xD;
                 -  Mass-specific peak oxygen consumption (VO2peak) &gt;20 ml/kg/min&#xD;
  &#xD;
                 -  For participants with type 1 diabetes&#xD;
  &#xD;
                      -  Stable insulin regimen for 6 months&#xD;
  &#xD;
                      -  HbA1c ≤69mmol/mol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Enrolment in other study, except at the discretion of the Chief investigator&#xD;
  &#xD;
                 -  Known or suspected hypersensitivity to trial product(s) or related products&#xD;
  &#xD;
                 -  Receipt of any investigational medicinal product within 1 week prior to screening&#xD;
                    in this trial&#xD;
  &#xD;
                 -  Suffer from or history of a life-threatening disease (i.e. cancer judged not to&#xD;
                    be in full remission except basal cell skin cancer or squamous cell skin cancer),&#xD;
                    or clinically severe diseases that directly influence the study results, as&#xD;
                    judged by the Investigator. This does not prohibit the participation of patients&#xD;
                    taking medications that influences the metabolism (e.g. statin) or&#xD;
                    cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable&#xD;
                    and is not adapted throughout the run of the trial. Furthermore, it does not&#xD;
                    excluded patients how have celiac disease (or similar diseases or allergies), as&#xD;
                    long as the disease is stable, and patients are able to stay on their specific&#xD;
                    (e.g.) gluten-free diet.&#xD;
  &#xD;
                 -  Participant with a heart rate &lt;35 beats per minute (bpm) at screening (after&#xD;
                    resting for 5 min in supine position)&#xD;
  &#xD;
                 -  Supine blood pressure at screening (after resting for 5 min in supine position)&#xD;
                    outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic&#xD;
                    (excluding white-coat hypertension; therefore, if a repeated measurement on a&#xD;
                    second screening Visit shows values within the range, the participant can be&#xD;
                    included in the trial). This exclusion criterion also pertains to participants&#xD;
                    being on anti-hypertensives&#xD;
  &#xD;
                 -  Significant abnormal ECG at screening, as judged by the Investigator&#xD;
  &#xD;
                 -  Any chronic (metabolic) disorder or severe disease which, in the opinion of the&#xD;
                    Investigator might jeopardise participant's safety or compliance with the&#xD;
                    protocol&#xD;
  &#xD;
                 -  History of multiple and/or severe allergies to drugs or foods or a history of&#xD;
                    severe anaphylactic reaction&#xD;
  &#xD;
                 -  Participant with mental incapacity or language barriers precluding adequate&#xD;
                    understanding or cooperation or who, in the opinion of their general practitioner&#xD;
                    or the Investigator, should not participate in the trial&#xD;
  &#xD;
                 -  Potentially non-compliant or uncooperative during the trial, as judged by the&#xD;
                    Investigator&#xD;
  &#xD;
                 -  Any condition that would interfere with trial participation or evaluation of&#xD;
                    results, as judged by the Investigator&#xD;
  &#xD;
                 -  Female of childbearing potential who is pregnant, breast-feeding or intend to&#xD;
                    become pregnant.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Imperial College Clinical Research Facility</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Exercise</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <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/NCT06034574
  org study id: 21HH7234
  nct id: NCT06034574
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A two-phase, observational trial in an exercise laboratory and a prospective real-world
        setting to test the hypothesis that The Libre Sense Glucose Sport device has acceptable
        accuracy in people with normal glucose tolerance and comparable accuracy in the range of 3.0
        to 11mmol/L to clinically approved CGM in people with type 1 diabetes.
  This is two-phase trial including a research facility and home phase existing of five study
        related visits:
  
          -  Screening visit and CPX test (2 hrs per visit)
  
          -  three exercise sessions completed in a random order at the research facility (2 hrs per
             visit) plus an additional visit for people with normal glucose tolerance to undertake a
             glucose tolerance test
  
          -  4 weeks of home-based exercise (3 sessions of ~60 minutes moderate intensity exercise
             per week) - Including one glycaemic challenge prior to a single home-based exercise
             session
  
          -  Final visit
  measure: %MARD lab phase
  time frame: 2 weeks
  description: To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (lab phase)
  measure: %MARD home phase
  time frame: 4 weeks
  description: To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (home phase)
  intervention type: Device
  intervention name: Continuous glucose monitoring
  description: Assessment of accuracy of two different continuous glucose monitoring devices during exercise
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: No