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/NCT05969665</url>
    </required_header>
    <id_info>
      <org_study_id>2023-D0040; kt23vanderstouwe</org_study_id>
      <nct_id>NCT05969665</nct_id>
    </id_info>
    <brief_title>Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors</brief_title>
    <official_title>Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors After Cardiac Rehabilitation - A Randomised Controlled Trial: MITIGATE-RF</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Basel, Switzerland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Basel, Switzerland</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>
        The study aims to assess the effect of smart watches and continuous glucose measuring devices&#xD;
        on cardiovascular risk factors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Within a period of 4 months 100 patients will be recruited and randomised to the intervention&#xD;
        or control arm (1:1) for a duration of 3 months. Randomisation will be stratified by age,&#xD;
        sex, BMI, diabetes, blood pressure, and duration after finishing cardiac rehabilitation.&#xD;
        Patients randomised to the intervention arm will be given a smart watch as well as a&#xD;
        continuous blood glucose measurement device with detailed instructions. At baseline and at&#xD;
        the end of the study questionnaires will be answered and anthropomorphic measurements&#xD;
        attained. Blood samples will be drawn at baseline and after an intervention period of 3&#xD;
        months in all subjects. Additional data on sleep, temperature, heart rate (resting and&#xD;
        exercise), breathing rate, activity and exercise, oxygen saturation and daily weight will be&#xD;
        collected through the Fitbit web application programming interface (API).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>single-centre, randomized controlled, open-label trial</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in cardiovascular risk factor score blood pressure</measure>
      <time_frame>at baseline and after 3 month</time_frame>
      <description>For the risk factor blood pressure 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC (European Society of Cardiology) -Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.&#xD;
  Goals according to ESC Guidelines:&#xD;
  Systolic 120-130 mmHg (18-69y.) Systolic &lt; 140 mmHg (70y.) Diastolic &lt; 80 mmHg (all ages)&#xD;
  Points according to goals:&#xD;
  2 = age related SBP (systolic blood pressure) &amp; DBP (diastolic blood pressure) goals&#xD;
  1 = &lt; 140 mmHg, &gt; 130 mmHg 18-69yr. or &lt; 140 mmHg and &gt; 90 mmHg DBP &gt;70yr 0 = SBP &gt; 140 mmHg</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in cardiovascular risk factor score LDL</measure>
      <time_frame>at baseline and after 3 month</time_frame>
      <description>For the risk factor LDL 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.&#xD;
  Goals according to ESC Guidelines:&#xD;
  LDL &lt;1.4 mmol/l and 50% reduction from baseline&#xD;
  Points according to goals:&#xD;
  2 = &lt; 1.4 mmol/l&#xD;
  1 = &lt; 1.8 mmol/l 0 = &gt; 1.8 mmol/l</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in cardiovascular risk factor score HbA1c</measure>
      <time_frame>at baseline and after 3 month</time_frame>
      <description>For the risk factor HbA1c 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.&#xD;
  Goals according to ESC Guidelines:&#xD;
  DM (diabetes mellitus) HbA1c &lt; 7.0% or &lt; 6.5% in recent diagnosis No DM &lt; 5.7% (cut-off prediabetes)&#xD;
  Points according to goals:&#xD;
  2 = &lt; 5.7 %&#xD;
  1 = 5.7 - 6.5 % 0 = &gt; 6.5 %</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in cardiovascular risk factor score BMI</measure>
      <time_frame>at baseline and after 3 month</time_frame>
      <description>For the risk factor BMI 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.&#xD;
  Goals according to ESC Guidelines:&#xD;
  BMI 20-25 kg/m2 AC (Abdominal circumference) &lt; 102 (men) &lt; 88 (women) WHR (waist to hip ratio) 0.75-0.9 men &amp; 0.70-0.85 women&#xD;
  Points according to goals:&#xD;
  2 = BMI and AC in range&#xD;
  1 = only BMI or AC in range 0 = nothing in range</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in cardiovascular risk factor score physical activity</measure>
      <time_frame>at baseline and after 3 month</time_frame>
      <description>For the risk factor physical activity 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.&#xD;
  Goals according to ESC Guidelines:&#xD;
  &gt; 150min/week moderate PA (mPA), better 300min/week (self-reported) or &gt; 75min/week vigorous PA (vPA), better 150min/week (self-reported)&#xD;
  Points according to goals:&#xD;
  2 = &gt; 300 min. mPA or &gt; 150 min. vPA&#xD;
  1 = &gt; 150 min. mPA or &gt; 75 min. vPA 0 = &lt; 150 min. mPA or &lt; 75 min. vPA Or mix or mPA and vPA respectively</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in cardiovascular risk factor score nutrition</measure>
      <time_frame>at baseline and after 3 month</time_frame>
      <description>For the risk factor nutrition 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.&#xD;
  Goals according to ESC Guidelines:&#xD;
  ≥ 5 portions fruit/vegetables a day Unsalted nuts ≥ 3x/week Reduction in saturated fats&#xD;
  Points according to goals:&#xD;
  2 = 5/day OR 4/day + nuts 3x/week + reduction in saturated fats&#xD;
  1 = 4/day OR 3/day + nuts 3x/week + reduction in saturated fats 0 = &lt; 4/day</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in cardiovascular risk factor score smoking</measure>
      <time_frame>at baseline and after 3 month</time_frame>
      <description>For the risk factor smoking 0 or 3 points will be awarded.&#xD;
  Points according to goals:&#xD;
  Smoking (yes/no) 3 = no 0 = yes</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Coronary Heart Disease</condition>
    <condition>Physical Activity</condition>
    <condition>Cardiovascular Risk Factors</condition>
    <arm_group>
      <arm_group_label>Wearing a smartwatch and glucose measuring device</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention will be wearing a smart watch as well as continuous glucose monitoring with direct feedback via an application. Participants will wear these devices for 3 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Fitbit Inspire 2</intervention_name>
      <description>A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months.</description>
      <arm_group_label>Wearing a smartwatch and glucose measuring device</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Abbott Freestyle Libre 3</intervention_name>
      <description>A continuous glucose measuring device (Abbott Freestyle Libre 3) with its respective app will be worn by the patients in the intervention group for 3 months.</description>
      <arm_group_label>Wearing a smartwatch and glucose measuring device</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Informed Consent signed by the subject&#xD;
  &#xD;
            -  Completed outpatient cardiac rehabilitation&#xD;
  &#xD;
            -  Diagnosis of coronary heart disease&#xD;
  &#xD;
            -  Access to a smartphone for the duration of the study&#xD;
  &#xD;
            -  18 years or older on the date of consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diseases which limit physical activity including angina with incomplete&#xD;
               revascularisation, arrhythmogenic cardiomyopathy, stroke with residual disease, and&#xD;
               major orthopaedic disorders&#xD;
  &#xD;
            -  Known or suspected non-compliance&#xD;
  &#xD;
            -  Inability to follow the procedures of the investigation, e.g., due to language&#xD;
               problems, psychological disorders, dementia, etc. of the subject&#xD;
  &#xD;
            -  Diabetic patients receiving insulin therapy&#xD;
  &#xD;
            -  Lack of proficiency with smart phone/watch&#xD;
  &#xD;
            -  Current participation in any other clinical trial, which may confound the results of&#xD;
               this trial.&#xD;
  &#xD;
            -  NYHA (New York Heart Association) class III or IV congestive heart failure&#xD;
  &#xD;
            -  Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jan Gerrit van der Stouwe, Dr. med.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Basel, Switzerland</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jan Gerrit van der Stouwe, Dr. med.</last_name>
      <phone>+41 61 265 44 44</phone>
      <email>jangerrit.vanderstouwe@usb.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Patrick Badertscher, Dr. med.</last_name>
      <phone>+41 61 265 52 14</phone>
      <email>patrick.badertscher@usb.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital Basel</name>
        <address>
          <city>Basel</city>
          <zip>4031</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Jan Gerrit van der Stouwe, Dr. med.</last_name>
        <phone>+41 61 265 44 44</phone>
        <email>jangerrit.vanderstouwe@usb.ch</email>
      </contact>
      <contact_backup>
        <last_name>Patrick Badertscher, Dr. med.</last_name>
        <phone>+41 61 265 52 14</phone>
        <email>patrick.badertscher@usb.ch</email>
      </contact_backup>
      <investigator>
        <last_name>Jan Gerrit van der Stouwe, Dr. med.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Patrick Badertscher, Dr. med.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Otmar Pfister, Prof. Dr. med.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>blood pressure</keyword>
    <keyword>lipids</keyword>
    <keyword>glucose level</keyword>
    <keyword>smoking</keyword>
    <keyword>weight</keyword>
    <keyword>diet</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Coronary Disease</mesh_term>
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
    </condition_browse>
    <!-- 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/NCT05969665
  org study id: 2023-D0040; kt23vanderstouwe
  nct id: NCT05969665
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to assess the effect of smart watches and continuous glucose measuring devices
        on cardiovascular risk factors.
  Within a period of 4 months 100 patients will be recruited and randomised to the intervention
        or control arm (1:1) for a duration of 3 months. Randomisation will be stratified by age,
        sex, BMI, diabetes, blood pressure, and duration after finishing cardiac rehabilitation.
        Patients randomised to the intervention arm will be given a smart watch as well as a
        continuous blood glucose measurement device with detailed instructions. At baseline and at
        the end of the study questionnaires will be answered and anthropomorphic measurements
        attained. Blood samples will be drawn at baseline and after an intervention period of 3
        months in all subjects. Additional data on sleep, temperature, heart rate (resting and
        exercise), breathing rate, activity and exercise, oxygen saturation and daily weight will be
        collected through the Fitbit web application programming interface (API).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: single-centre, randomized controlled, open-label trial
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Change in cardiovascular risk factor score blood pressure
  time frame: at baseline and after 3 month
  description: For the risk factor blood pressure 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC (European Society of Cardiology) -Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
  Goals according to ESC Guidelines:
  Systolic 120-130 mmHg (18-69y.) Systolic < 140 mmHg (70y.) Diastolic < 80 mmHg (all ages)
  Points according to goals:
  2 = age related SBP (systolic blood pressure) & DBP (diastolic blood pressure) goals
  1 = < 140 mmHg, > 130 mmHg 18-69yr. or < 140 mmHg and > 90 mmHg DBP >70yr 0 = SBP > 140 mmHg
  measure: Change in cardiovascular risk factor score LDL
  time frame: at baseline and after 3 month
  description: For the risk factor LDL 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
  Goals according to ESC Guidelines:
  LDL <1.4 mmol/l and 50% reduction from baseline
  Points according to goals:
  2 = < 1.4 mmol/l
  1 = < 1.8 mmol/l 0 = > 1.8 mmol/l
  measure: Change in cardiovascular risk factor score HbA1c
  time frame: at baseline and after 3 month
  description: For the risk factor HbA1c 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
  Goals according to ESC Guidelines:
  DM (diabetes mellitus) HbA1c < 7.0% or < 6.5% in recent diagnosis No DM < 5.7% (cut-off prediabetes)
  Points according to goals:
  2 = < 5.7 %
  1 = 5.7 - 6.5 % 0 = > 6.5 %
  measure: Change in cardiovascular risk factor score BMI
  time frame: at baseline and after 3 month
  description: For the risk factor BMI 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
  Goals according to ESC Guidelines:
  BMI 20-25 kg/m2 AC (Abdominal circumference) < 102 (men) < 88 (women) WHR (waist to hip ratio) 0.75-0.9 men & 0.70-0.85 women
  Points according to goals:
  2 = BMI and AC in range
  1 = only BMI or AC in range 0 = nothing in range
  measure: Change in cardiovascular risk factor score physical activity
  time frame: at baseline and after 3 month
  description: For the risk factor physical activity 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
  Goals according to ESC Guidelines:
  > 150min/week moderate PA (mPA), better 300min/week (self-reported) or > 75min/week vigorous PA (vPA), better 150min/week (self-reported)
  Points according to goals:
  2 = > 300 min. mPA or > 150 min. vPA
  1 = > 150 min. mPA or > 75 min. vPA 0 = < 150 min. mPA or < 75 min. vPA Or mix or mPA and vPA respectively
  measure: Change in cardiovascular risk factor score nutrition
  time frame: at baseline and after 3 month
  description: For the risk factor nutrition 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
  Goals according to ESC Guidelines:
  ≥ 5 portions fruit/vegetables a day Unsalted nuts ≥ 3x/week Reduction in saturated fats
  Points according to goals:
  2 = 5/day OR 4/day + nuts 3x/week + reduction in saturated fats
  1 = 4/day OR 3/day + nuts 3x/week + reduction in saturated fats 0 = < 4/day
  measure: Change in cardiovascular risk factor score smoking
  time frame: at baseline and after 3 month
  description: For the risk factor smoking 0 or 3 points will be awarded.
  Points according to goals:
  Smoking (yes/no) 3 = no 0 = yes
  arm group label: Wearing a smartwatch and glucose measuring device
  arm group type: Experimental
  description: The intervention will be wearing a smart watch as well as continuous glucose monitoring with direct feedback via an application. Participants will wear these devices for 3 months.
  arm group label: Standard care
  arm group type: No Intervention
  description: The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive.
  intervention type: Device
  intervention name: Fitbit Inspire 2
  description: A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months.
  arm group label: Wearing a smartwatch and glucose measuring device
  intervention type: Device
  intervention name: Abbott Freestyle Libre 3
  description: A continuous glucose measuring device (Abbott Freestyle Libre 3) with its respective app will be worn by the patients in the intervention group for 3 months.
  arm group label: Wearing a smartwatch and glucose measuring device
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jan Gerrit van der Stouwe, Dr. med.
  role: Principal Investigator
  affiliation: University Hospital, Basel, Switzerland
  last name: Jan Gerrit van der Stouwe, Dr. med.
  phone: +41 61 265 44 44
  email: jangerrit.vanderstouwe@usb.ch
  last name: Patrick Badertscher, Dr. med.
  phone: +41 61 265 52 14
  email: patrick.badertscher@usb.ch
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Heart Diseases
  mesh term: Coronary Disease
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia