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/NCT06028139</url>
    </required_header>
    <id_info>
      <org_study_id>202208-00017</org_study_id>
      <nct_id>NCT06028139</nct_id>
    </id_info>
    <brief_title>Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes</brief_title>
    <official_title>Continuous Assessment of Risk and Efficacy (CARE) Using Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Singapore General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sengkang General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Heart Centre Singapore</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Singapore General Hospital</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>
        Lifestyle change is key to diabetes management but there are limited resources and time to&#xD;
        support patients in improving lifestyle behaviour in the current healthcare system.&#xD;
        Currently, health coaching for behavioural chance guided by continuous glucose data, wearable&#xD;
        and lifestyle data is not available in primary and tertiary care management of diabetes. This&#xD;
        parallel-group randomised controlled trial (RCT) aims to investigate the effectiveness of a&#xD;
        novel multi-component model of care comprising interventions including the mobile app EMPOWER&#xD;
        and smartwatch, health coaching, and continuous glucose monitoring (CGM).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2025</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>HbA1c</measure>
      <time_frame>6 months</time_frame>
      <description>HbA1c over 6 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical activity as measured by number of steps</measure>
      <time_frame>6 months</time_frame>
      <description>Physical activity over 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity as measured by moderate to vigorous active minutes</measure>
      <time_frame>6 months</time_frame>
      <description>Physical activity over 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity as measured by GPAQ</measure>
      <time_frame>6 months</time_frame>
      <description>Physical activity over 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diet as measured by DASH</measure>
      <time_frame>6 months</time_frame>
      <description>Diet quality over 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sugar sweetened beverages intake</measure>
      <time_frame>6 months</time_frame>
      <description>Sugar sweetened beverages intake over 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient activation score as measured by patient activation measure</measure>
      <time_frame>6 months</time_frame>
      <description>Difference in patient activation score between intervention and control over 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medication adherence as measured by DOSE-Nonadherence scale</measure>
      <time_frame>6 months</time_frame>
      <description>Difference in medication adherence between intervention and control over 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life as measured by EQ-5D-5L</measure>
      <time_frame>6 months</time_frame>
      <description>Difference in quality of life between intervention and control over 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare cost as measured by cost of consultations, lab tests, medications, admission</measure>
      <time_frame>6 months</time_frame>
      <description>Healthcare cost over 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare cost as measured by WPAI</measure>
      <time_frame>6 months</time_frame>
      <description>Healthcare cost over 6 months</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Continuous glucose monitoring and health coaching</intervention_name>
      <description>Each CGM device will work for 14 days. The participants will use the CGM devices for the first two-week period in the first three months of the trial, and the first two-week period of the second three months of the trial.&#xD;
  Participants will interact with health coach throughout the study duration.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>EMPOWER mobile app</intervention_name>
      <description>Nudges will be delivered through the EMPOWER mobile app. Participants will log lifestyle information such as diet and physical activity, and clinical information such as medication and HbA1c levels through the EMPOWER mobile app. .</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 21 years and above&#xD;
  &#xD;
            -  Have diagnosis of type 2 diabetes mellitus&#xD;
  &#xD;
            -  Provided informed consent&#xD;
  &#xD;
            -  Have near-field communication (NFC) compatible phones&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Significant cognitive impairment&#xD;
  &#xD;
            -  Other conditions that may preclude participants from wearing CGM devices&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lian Leng Low</last_name>
      <phone>63265872</phone>
      <email>low.lian.leng@singhealth.com.sg</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</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/NCT06028139
  org study id: 202208-00017
  nct id: NCT06028139
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Lifestyle change is key to diabetes management but there are limited resources and time to
        support patients in improving lifestyle behaviour in the current healthcare system.
        Currently, health coaching for behavioural chance guided by continuous glucose data, wearable
        and lifestyle data is not available in primary and tertiary care management of diabetes. This
        parallel-group randomised controlled trial (RCT) aims to investigate the effectiveness of a
        novel multi-component model of care comprising interventions including the mobile app EMPOWER
        and smartwatch, health coaching, and continuous glucose monitoring (CGM).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: HbA1c
  time frame: 6 months
  description: HbA1c over 6 months
  measure: Physical activity as measured by number of steps
  time frame: 6 months
  description: Physical activity over 6 months
  measure: Physical activity as measured by moderate to vigorous active minutes
  time frame: 6 months
  description: Physical activity over 6 months
  measure: Physical activity as measured by GPAQ
  time frame: 6 months
  description: Physical activity over 6 months
  measure: Diet as measured by DASH
  time frame: 6 months
  description: Diet quality over 6 months
  measure: Sugar sweetened beverages intake
  time frame: 6 months
  description: Sugar sweetened beverages intake over 6 months
  measure: Patient activation score as measured by patient activation measure
  time frame: 6 months
  description: Difference in patient activation score between intervention and control over 6 months
  measure: Medication adherence as measured by DOSE-Nonadherence scale
  time frame: 6 months
  description: Difference in medication adherence between intervention and control over 6 months
  measure: Quality of life as measured by EQ-5D-5L
  time frame: 6 months
  description: Difference in quality of life between intervention and control over 6 months
  measure: Healthcare cost as measured by cost of consultations, lab tests, medications, admission
  time frame: 6 months
  description: Healthcare cost over 6 months
  measure: Healthcare cost as measured by WPAI
  time frame: 6 months
  description: Healthcare cost over 6 months
  arm group label: Intervention
  arm group type: Experimental
  arm group label: Control
  arm group type: Other
  intervention type: Behavioral
  intervention name: Continuous glucose monitoring and health coaching
  description: Each CGM device will work for 14 days. The participants will use the CGM devices for the first two-week period in the first three months of the trial, and the first two-week period of the second three months of the trial.
  Participants will interact with health coach throughout the study duration.
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: EMPOWER mobile app
  description: Nudges will be delivered through the EMPOWER mobile app. Participants will log lifestyle information such as diet and physical activity, and clinical information such as medication and HbA1c levels through the EMPOWER mobile app. .
  arm group label: Control
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Lian Leng Low
  phone: 63265872
  email: low.lian.leng@singhealth.com.sg
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2