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/NCT06040463</url>
    </required_header>
    <id_info>
      <org_study_id>23-11</org_study_id>
      <nct_id>NCT06040463</nct_id>
    </id_info>
    <brief_title>Improving Diabetes Equity and Advancing Care Study</brief_title>
    <acronym>IDEA</acronym>
    <official_title>Improving Diabetes Equity and Advancing Care Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sinai Health System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sinai Health System</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 goal of this randomized trial is to determine the optimal combination and sequence of&#xD;
        three enhancements for a team-based care model for patients living with diabetes in Chicago.&#xD;
        The study aim is to determine optimization of intervention components. Participants will be&#xD;
        randomly assigned to diabetes self-management training or remote glucose monitoring. After 6&#xD;
        months, participants will be rerandomized to a subsequent study arm (including a CHW support&#xD;
        program) depending on a tailoring variable of change in A1c. Researchers will compare the&#xD;
        final 6 study arms to see which combination and sequence of enhancements produces the most&#xD;
        improvement in A1c.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sinai Health System is Illinois' largest private safety-net healthcare system, serving&#xD;
        predominantly low-income communities of color with large Medicaid-eligible populations in&#xD;
        Chicago. In response to high diabetes rates and community calls for coordinated,&#xD;
        multidisciplinary diabetes care, Sinai designed the Center for Diabetes and Endocrinology&#xD;
        (the Center) which launched in 2020. The Center uses a comprehensive model with streamlined&#xD;
        services to address the full spectrum of patient medical and non-medical needs. This study&#xD;
        seeks to determine the appropriateness and fidelity of three intervention components of a&#xD;
        team-based care model for patients served by the Center to define the ideal sequence for&#xD;
        improving patient outcomes. Grounded in qualitative methodology and guided by a sequential&#xD;
        multiple assignment randomized trial (SMART), we propose evaluating the appropriateness of&#xD;
        novel intervention components (Aim 1); measuring fidelity of new intervention components (Aim&#xD;
        2); comparing the effectiveness and determine optimization of intervention components (Aim&#xD;
        3). We will evaluate Aim 1 via key stakeholder interviews and focus groups. We will analyze&#xD;
        Aims 2 &amp; 3 by conducting descriptive statistics on all variables, giving special attention to&#xD;
        outlier values. We will also run bivariate and multivariate analyses across variables of&#xD;
        interest and time points to determine the optimal sequence of intervention activities.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 1, 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>Factorial Assignment</intervention_model>
      <intervention_model_description>Sequential Multiple Assignment Randomized Trial (SMART)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>No masking</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in A1c</measure>
      <time_frame>Baseline (time = 0); 6 months (time = 1); 12 months (time = 2)</time_frame>
      <description>Change in A1c from baseline to the 12-month study end point measured at the patient level. Measure will be collected every 6 months, at a minimum. The 6-month A1c will be used to determine their study condition at the rerandomization poiont.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Active Usage of RGM</measure>
      <time_frame>Data will be exported from the Glooko application monthly for the full 18 months of the trial period.</time_frame>
      <description>Active usage will be defined as at least one upload of data within a 30-day period and at least 16 blood glucose entries within a 30-day period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DSMT Attendance</measure>
      <time_frame>Attendance data will be collected throughout the entire study period (18 months)</time_frame>
      <description>We will collect # and proportion of attended DSMT classes by participant.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CHW Support Adherence</measure>
      <time_frame>After rerandomization period (starting at 6 months post enrollment)</time_frame>
      <description>Adherence to CHW engagement will include completing the initial education session with a CHW, competing a SDoH screener and at least three phone or in-person touchpoints over the 6-month intervention period.</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">270</enrollment>
    <condition>Diabetes</condition>
    <condition>Diabetes Mellitus</condition>
    <condition>Diabetes Mellitus, Type 1</condition>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Remote Glucose Monitoring &gt; Remote Glucose Monitoring (RGM-&gt;RGM)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will remain in the RGM group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Remote Glucose Monitoring &gt; Remote Glucose Monitoring+Community Health Worker (RGM-&gt;RGM+CHW)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a continuation of RGM, with the addition of a CHW to provide tailored support.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Remote Glucose Monitoring &gt; Diabetes Self-Management Training (RGM-&gt;DSMT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being diabetes self-management training (DSMT).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Diabetes Self-Management Training &gt; Standard of Care (DSMT-&gt;SOC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will be directed back to standard of care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Diabetes Self-Management Training &gt; Community Health Worker (DSMT-&gt;CHW)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a CHW to provide tailored support.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Diabetes Self-Management Training &gt; Remote Glucose Monitoring (DSMT-&gt;RGM)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being RGM.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Diabetes Self-Management Training (DSMT)</intervention_name>
      <description>The American Diabetes Association endorses the use of small-group diabetes self-management training (DSMT), for people living with diabetes to improve lifestyle, HbA1c levels, and overall quality of life. A certified diabetes care and education specialist will teach a four-part series of one-hour sessions providing culturally competent group education and discussion for groups of 5-8 patients: Session 1 - Living with diabetes - physiology of diabetes, integrating diabetes into your daily life, long term outcomes of diabetes; Session 2 - Culturally competent food education &amp; portion control; Session 3 - Tips &amp; Tricks for dining out and special occasions; Session 4 - Advanced tools and psychosocial implications of living with diabetes. While patients will be encouraged to move through the series together as a cohort, there will be make-up sessions and flexibility to ensure high-quality participation.</description>
      <arm_group_label>Diabetes Self-Management Training &gt; Community Health Worker (DSMT-&gt;CHW)</arm_group_label>
      <arm_group_label>Diabetes Self-Management Training &gt; Remote Glucose Monitoring (DSMT-&gt;RGM)</arm_group_label>
      <arm_group_label>Diabetes Self-Management Training &gt; Standard of Care (DSMT-&gt;SOC)</arm_group_label>
      <arm_group_label>Remote Glucose Monitoring &gt; Diabetes Self-Management Training (RGM-&gt;DSMT)</arm_group_label>
      <other_name>Diabetes Self-Management Education and Support (DSMES)</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Remote Glucose Monitoring (RGM)</intervention_name>
      <description>Remote Glucose Monitoring (RGM) is an automated process of transmitting glucose levels directly from a personal smartphone device to a healthcare provider using a remote data transmitter. Since 2020, Sinai has worked with Glooko Inc. to provide the RGM platform and technical assistance to patients and for Sinai providers to access data remotely. Via the app, patients can: document their glucose levels; sync data from a meter, insulin pump, pen or continuous glucose monitoring device; track their weight; log food and meals; access educational resources; track steps; and track blood pressure. Remotely uploading data provides patients with a direct line to their provider for regular feedback on progress and answers to questions between clinic visits. Patients also receive one one-hour education session on RGM and the Glooko application.</description>
      <arm_group_label>Diabetes Self-Management Training &gt; Remote Glucose Monitoring (DSMT-&gt;RGM)</arm_group_label>
      <arm_group_label>Remote Glucose Monitoring &gt; Diabetes Self-Management Training (RGM-&gt;DSMT)</arm_group_label>
      <arm_group_label>Remote Glucose Monitoring &gt; Remote Glucose Monitoring (RGM-&gt;RGM)</arm_group_label>
      <arm_group_label>Remote Glucose Monitoring &gt; Remote Glucose Monitoring+Community Health Worker (RGM-&gt;RGM+CHW)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Community Health Worker tailored support</intervention_name>
      <description>CHWs are frontline public health workers who are trusted members of and/or have an unusually close understanding of the community served. The Center has two bilingual (Spanish/English) CHWs; additional bilingual CHWs will be added to the team to support the proposed study. While approaches will differ slightly depending on the patient and study condition, all patients paired with a CHW will be screened for social needs utilizing a standard social determinants of health (SDoH) screening tool, receive referrals to resources to address unmet social/health needs, and aided in navigating health and social systems.</description>
      <arm_group_label>Diabetes Self-Management Training &gt; Community Health Worker (DSMT-&gt;CHW)</arm_group_label>
      <arm_group_label>Remote Glucose Monitoring &gt; Remote Glucose Monitoring+Community Health Worker (RGM-&gt;RGM+CHW)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A diagnosis of type 1 or type 2 diabetes&#xD;
  &#xD;
            -  18+ years of age&#xD;
  &#xD;
            -  Able to provide consent&#xD;
  &#xD;
            -  Identify as African American/Black or Latinx&#xD;
  &#xD;
            -  most recent HbA1c &gt; 7%,&#xD;
  &#xD;
            -  Have a smartphone compatible with the Glooko application&#xD;
  &#xD;
            -  Have completed at least one Center appointment (i.e. current patient)&#xD;
  &#xD;
            -  Completed at least 3 months of their assigned study condition&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Already an active user of RGM&#xD;
  &#xD;
            -  Actively working with a CHW&#xD;
  &#xD;
            -  Diagnosis of gestational diabetes (without type 1 or type 2)&#xD;
  &#xD;
            -  Has a Power of Attorney&#xD;
  &#xD;
            -  Be suffering from Stage-V renal disease or undergoing dialysis.&#xD;
  &#xD;
            -  Be suffering from a severe form of cardiovascular disease (NYHA Class III and IV)&#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_contact>
      <last_name>Jackie Jacobs, MPH</last_name>
      <phone>7732572553</phone>
      <email>jackie.jacobs@sinai.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Helen Margellos-Anast, MPH</last_name>
      <phone>7732575259</phone>
      <email>helen.margellos@sinai.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mount Sinai Hospital</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60608</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>implementation science</keyword>
    <keyword>optimization study</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 2</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 1</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/NCT06040463
  org study id: 23-11
  nct id: NCT06040463
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized trial is to determine the optimal combination and sequence of
        three enhancements for a team-based care model for patients living with diabetes in Chicago.
        The study aim is to determine optimization of intervention components. Participants will be
        randomly assigned to diabetes self-management training or remote glucose monitoring. After 6
        months, participants will be rerandomized to a subsequent study arm (including a CHW support
        program) depending on a tailoring variable of change in A1c. Researchers will compare the
        final 6 study arms to see which combination and sequence of enhancements produces the most
        improvement in A1c.
  Sinai Health System is Illinois' largest private safety-net healthcare system, serving
        predominantly low-income communities of color with large Medicaid-eligible populations in
        Chicago. In response to high diabetes rates and community calls for coordinated,
        multidisciplinary diabetes care, Sinai designed the Center for Diabetes and Endocrinology
        (the Center) which launched in 2020. The Center uses a comprehensive model with streamlined
        services to address the full spectrum of patient medical and non-medical needs. This study
        seeks to determine the appropriateness and fidelity of three intervention components of a
        team-based care model for patients served by the Center to define the ideal sequence for
        improving patient outcomes. Grounded in qualitative methodology and guided by a sequential
        multiple assignment randomized trial (SMART), we propose evaluating the appropriateness of
        novel intervention components (Aim 1); measuring fidelity of new intervention components (Aim
        2); comparing the effectiveness and determine optimization of intervention components (Aim
        3). We will evaluate Aim 1 via key stakeholder interviews and focus groups. We will analyze
        Aims 2 & 3 by conducting descriptive statistics on all variables, giving special attention to
        outlier values. We will also run bivariate and multivariate analyses across variables of
        interest and time points to determine the optimal sequence of intervention activities.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: Sequential Multiple Assignment Randomized Trial (SMART)
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: No masking
  measure: Change in A1c
  time frame: Baseline (time = 0); 6 months (time = 1); 12 months (time = 2)
  description: Change in A1c from baseline to the 12-month study end point measured at the patient level. Measure will be collected every 6 months, at a minimum. The 6-month A1c will be used to determine their study condition at the rerandomization poiont.
  measure: Active Usage of RGM
  time frame: Data will be exported from the Glooko application monthly for the full 18 months of the trial period.
  description: Active usage will be defined as at least one upload of data within a 30-day period and at least 16 blood glucose entries within a 30-day period.
  measure: DSMT Attendance
  time frame: Attendance data will be collected throughout the entire study period (18 months)
  description: We will collect # and proportion of attended DSMT classes by participant.
  measure: CHW Support Adherence
  time frame: After rerandomization period (starting at 6 months post enrollment)
  description: Adherence to CHW engagement will include completing the initial education session with a CHW, competing a SDoH screener and at least three phone or in-person touchpoints over the 6-month intervention period.
  arm group label: Remote Glucose Monitoring > Remote Glucose Monitoring (RGM->RGM)
  arm group type: Experimental
  description: Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will remain in the RGM group.
  arm group label: Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW)
  arm group type: Experimental
  description: Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a continuation of RGM, with the addition of a CHW to provide tailored support.
  arm group label: Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT)
  arm group type: Experimental
  description: Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being diabetes self-management training (DSMT).
  arm group label: Diabetes Self-Management Training > Standard of Care (DSMT->SOC)
  arm group type: Experimental
  description: Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will be directed back to standard of care.
  arm group label: Diabetes Self-Management Training > Community Health Worker (DSMT->CHW)
  arm group type: Experimental
  description: Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a CHW to provide tailored support.
  arm group label: Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM)
  arm group type: Experimental
  description: Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being RGM.
  intervention type: Behavioral
  intervention name: Diabetes Self-Management Training (DSMT)
  description: The American Diabetes Association endorses the use of small-group diabetes self-management training (DSMT), for people living with diabetes to improve lifestyle, HbA1c levels, and overall quality of life. A certified diabetes care and education specialist will teach a four-part series of one-hour sessions providing culturally competent group education and discussion for groups of 5-8 patients: Session 1 - Living with diabetes - physiology of diabetes, integrating diabetes into your daily life, long term outcomes of diabetes; Session 2 - Culturally competent food education & portion control; Session 3 - Tips & Tricks for dining out and special occasions; Session 4 - Advanced tools and psychosocial implications of living with diabetes. While patients will be encouraged to move through the series together as a cohort, there will be make-up sessions and flexibility to ensure high-quality participation.
  arm group label: Diabetes Self-Management Training > Community Health Worker (DSMT->CHW)
  arm group label: Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM)
  arm group label: Diabetes Self-Management Training > Standard of Care (DSMT->SOC)
  arm group label: Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT)
  other name: Diabetes Self-Management Education and Support (DSMES)
  intervention type: Behavioral
  intervention name: Remote Glucose Monitoring (RGM)
  description: Remote Glucose Monitoring (RGM) is an automated process of transmitting glucose levels directly from a personal smartphone device to a healthcare provider using a remote data transmitter. Since 2020, Sinai has worked with Glooko Inc. to provide the RGM platform and technical assistance to patients and for Sinai providers to access data remotely. Via the app, patients can: document their glucose levels; sync data from a meter, insulin pump, pen or continuous glucose monitoring device; track their weight; log food and meals; access educational resources; track steps; and track blood pressure. Remotely uploading data provides patients with a direct line to their provider for regular feedback on progress and answers to questions between clinic visits. Patients also receive one one-hour education session on RGM and the Glooko application.
  arm group label: Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM)
  arm group label: Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT)
  arm group label: Remote Glucose Monitoring > Remote Glucose Monitoring (RGM->RGM)
  arm group label: Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW)
  intervention type: Behavioral
  intervention name: Community Health Worker tailored support
  description: CHWs are frontline public health workers who are trusted members of and/or have an unusually close understanding of the community served. The Center has two bilingual (Spanish/English) CHWs; additional bilingual CHWs will be added to the team to support the proposed study. While approaches will differ slightly depending on the patient and study condition, all patients paired with a CHW will be screened for social needs utilizing a standard social determinants of health (SDoH) screening tool, receive referrals to resources to address unmet social/health needs, and aided in navigating health and social systems.
  arm group label: Diabetes Self-Management Training > Community Health Worker (DSMT->CHW)
  arm group label: Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jackie Jacobs, MPH
  phone: 7732572553
  email: jackie.jacobs@sinai.org
  last name: Helen Margellos-Anast, MPH
  phone: 7732575259
  email: helen.margellos@sinai.org
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: Undecided