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/NCT05994755</url>
    </required_header>
    <id_info>
      <org_study_id>v1.0 22042023</org_study_id>
      <nct_id>NCT05994755</nct_id>
    </id_info>
    <brief_title>Association Between Cardiac ARRHYTHMIAs and Glycemic Variability in Patient With Type 2 Diabetes Monitored Through FREEstyle Libre and Bluetooth Technology.</brief_title>
    <acronym>ARRHYTHMIAFREE</acronym>
    <official_title>Association Between Cardiac ARRHYTHMIAs and Glycemic Variability in Patient With Type 2 Diabetes Monitored Through FREEstyle Libre and Bluetooth Technology. (ARRHYTHMIA FREE)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Antonio Rapacciuolo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Federico II University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to investigate the association between hypoglycemia, glycemic&#xD;
        variability and cardiac arrhythmias in patients with diabetes Type II (T2D) already implanted&#xD;
        with implantable cardiac defibrillator (ICD) and monitored remotely through Bluetooth&#xD;
        technology and CGM (continuos glucose monitoring).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Studies have shown that, when diabetes is present, there is a 35% to 60% greater risk of&#xD;
        developing atrial fibrillation (AF). Diabetic patients with AF had a 61% increase in total&#xD;
        mortality, a 77% increase in cardiovascular death and a 68% increase in heart failure. The&#xD;
        greatest risk with the combination of AF and Type 2 Diabetes Mellitus (T2D) is a 79% increase&#xD;
        in thromboembolic risk, particularly stroke.Hypoglycemia, frequently asymptomatic, may lead&#xD;
        to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality&#xD;
        in patients with T2D.&#xD;
  &#xD;
        However, these conclusions need to be tempered by the limitations of all studies available to&#xD;
        date, making it difficult to determine the onset and burden of AF, especially when it is not&#xD;
        a monitored end-point.Since prospective randomized trials would be unethical, future research&#xD;
        should focus on establishing whether such a link exists by employing an observational design&#xD;
        and taking advantage of modern tools for long-term, real-life monitoring.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 30, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>association between hypoglycemia, glycemic variability and cardiac arrhythmias</measure>
      <time_frame>6 months</time_frame>
      <description>Incidence of cardiac arrhythmias (atrial fibrillation, atrial flutter, PVC...) detected through remote monitoring and correlation with hypoglycemic episodes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>association between hypoglycemia, glycemic variability and heart failure</measure>
      <time_frame>6 months</time_frame>
      <description>The relationship between cardiovascular disease (heart failure and ischemic heart disease) at baseline and clinically relevant cardiovascular disease in relation to TBR and TAR.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">58</enrollment>
    <condition>Diabetes</condition>
    <condition>Arrhythmias</condition>
    <condition>Atrial Fibrillation</condition>
    <condition>Heart Failure</condition>
    <eligibility>
      <study_pop>
        <textblock>
          patients with Type II Diabetes already implanted with ICD and monitored remotely through&#xD;
          Bluetooth technology and CGM (continuos glucose monitoring).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patient already wearing CIEDs with Bluetooth technology&#xD;
  &#xD;
            2. Diabetes Type II, no insulin-treated&#xD;
  &#xD;
            3. Over 18 years of age&#xD;
  &#xD;
            4. Patient in Sinus Rhythm at the time of the enrollment&#xD;
  &#xD;
            5. Ability to provide informed consent for registry participation and be willing and able&#xD;
               to comply with the protocol described evaluations&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject who is, or is expected to be inaccessible for follow-up&#xD;
  &#xD;
            2. pregnancy&#xD;
  &#xD;
            3. Patients with persistent and longstanding persistent AF&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Antonio Rapacciuolo, Prof.</last_name>
      <phone>081 1962 2964</phone>
      <email>antonio.rapacciuolo@unina.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Federico II University</name>
        <address>
          <city>Naples</city>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Federico II University</investigator_affiliation>
      <investigator_full_name>Antonio Rapacciuolo</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>diabetes type II</keyword>
    <keyword>cardiac arrhythmias</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
      <mesh_term>Arrhythmias, Cardiac</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05994755
  org study id: v1.0 22042023
  nct id: NCT05994755
  lead sponsor: 
  has dmc: Yes
  The aim of this study is to investigate the association between hypoglycemia, glycemic
        variability and cardiac arrhythmias in patients with diabetes Type II (T2D) already implanted
        with implantable cardiac defibrillator (ICD) and monitored remotely through Bluetooth
        technology and CGM (continuos glucose monitoring).
  Studies have shown that, when diabetes is present, there is a 35% to 60% greater risk of
        developing atrial fibrillation (AF). Diabetic patients with AF had a 61% increase in total
        mortality, a 77% increase in cardiovascular death and a 68% increase in heart failure. The
        greatest risk with the combination of AF and Type 2 Diabetes Mellitus (T2D) is a 79% increase
        in thromboembolic risk, particularly stroke.Hypoglycemia, frequently asymptomatic, may lead
        to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality
        in patients with T2D.
  
        However, these conclusions need to be tempered by the limitations of all studies available to
        date, making it difficult to determine the onset and burden of AF, especially when it is not
        a monitored end-point.Since prospective randomized trials would be unethical, future research
        should focus on establishing whether such a link exists by employing an observational design
        and taking advantage of modern tools for long-term, real-life monitoring.
  observational model: Cohort
  time perspective: Prospective
  measure: association between hypoglycemia, glycemic variability and cardiac arrhythmias
  time frame: 6 months
  description: Incidence of cardiac arrhythmias (atrial fibrillation, atrial flutter, PVC...) detected through remote monitoring and correlation with hypoglycemic episodes.
  measure: association between hypoglycemia, glycemic variability and heart failure
  time frame: 6 months
  description: The relationship between cardiovascular disease (heart failure and ischemic heart disease) at baseline and clinically relevant cardiovascular disease in relation to TBR and TAR.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Antonio Rapacciuolo, Prof.
  phone: 081 1962 2964
  email: antonio.rapacciuolo@unina.it
  facility: 
  country: Italy
  responsible party type: Sponsor-Investigator
  investigator affiliation: Federico II University
  investigator full name: Antonio Rapacciuolo
  investigator title: Principal Investigator
  mesh term: Atrial Fibrillation
  mesh term: Arrhythmias, Cardiac
  mesh term: Diabetes Mellitus
  sharing ipd: Undecided