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/NCT05988957</url>
    </required_header>
    <id_info>
      <org_study_id>A22-279</org_study_id>
      <nct_id>NCT05988957</nct_id>
    </id_info>
    <brief_title>Nutrition-Focused Approach During CGM Initiation: A Qualitative Study</brief_title>
    <official_title>Perspectives on Using a Nutrition-focused Approach When Initiating Continuous Glucose Monitoring in People With Type 2 Diabetes: a Qualitative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>HealthPartners Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Academy of Nutrition and Dietetics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>HealthPartners Institute</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 purpose of the qualitative research is to provide a deeper understanding of the&#xD;
        perspectives of people with type 2 diabetes (T2D) who received a nutrition-focused approach&#xD;
        (NFA) when initiating continuous glucose monitor (CGM).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of the qualitative research is to provide a deeper understanding of the&#xD;
        perspectives of people with T2D who received the NFA when initiating CGM.&#xD;
  &#xD;
        A single 30-minute semi-structured interview will be conducted in approximately 15 people who&#xD;
        have completed participation in the A21-292 study (also called the My Diabetes Study).&#xD;
  &#xD;
        The My Diabetes Study, is a randomized clinical trial to assess the impact of using a NFA or&#xD;
        a self-directed approach during CGM initiation. The NFA was developed specifically for the&#xD;
        randomized clinical trial study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Describe CGM data use</measure>
      <time_frame>Immediately following the study completion visit in the My Diabetes study.</time_frame>
      <description>Transcribed audio recordings and inductive thematic coding will be used to describe how participants in the My Diabetes Study used CGM data when making food-related decisions after receiving a NFA during CGM initiation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Describe overall experience of receiving a NFA during CGM initiation</measure>
      <time_frame>Immediately following the study completion visit in the My Diabetes study.</time_frame>
      <description>Transcribed audio recordings and inductive thematic coding will be used to describe how participants with T2D in the My Diabetes Study experienced the use of a NFA and its associated nutrition-focused CGM initiation materials.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Type 2 Diabetes</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Semi-structured interviews using an IRB-approved interview guide</intervention_name>
      <description>A single, semi-structured interview will be conducted using an IRB-approved interview guide. The interviews will be approximately 30 minutes total.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults who have met inclusion criteria for the My Diabetes study and who have completed the&#xD;
          nutrition-focused approach arm of the study may be eligible.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant was randomized to the nutrition-focused approach arm of the My Diabetes&#xD;
               study&#xD;
  &#xD;
            -  Participant completed all required study visits in the My Diabetes study; this&#xD;
               includes the baseline visit, the two intervention visits, and the study completion&#xD;
               visit&#xD;
  &#xD;
            -  Participant had at least 70% &quot;Time CGM Active&quot; on a 10-day Dexcom Clarity Report at&#xD;
               study completion visit&#xD;
  &#xD;
            -  Participant is willing to be recorded during the interview&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant was randomized to the self-directed approach study arm of the My Diabetes&#xD;
               study&#xD;
  &#xD;
            -  Participant is deemed unsuitable for participation due to any cause as determined by&#xD;
               the Investigator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Holly Willis, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>HealthPartners Institute; International Diabetes Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>HealthPartners Institute dba International Diabetes Center</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55416</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>HealthPartners Institute</investigator_affiliation>
      <investigator_full_name>Holly Willis</investigator_full_name>
      <investigator_title>PhD, RDN, CDCES</investigator_title>
    </responsible_party>
    <keyword>continuous glucose monitor</keyword>
    <keyword>CGM</keyword>
    <keyword>nutrition</keyword>
    <keyword>qualitative interview</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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/NCT05988957
  org study id: A22-279
  nct id: NCT05988957
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the qualitative research is to provide a deeper understanding of the
        perspectives of people with type 2 diabetes (T2D) who received a nutrition-focused approach
        (NFA) when initiating continuous glucose monitor (CGM).
  The purpose of the qualitative research is to provide a deeper understanding of the
        perspectives of people with T2D who received the NFA when initiating CGM.
  
        A single 30-minute semi-structured interview will be conducted in approximately 15 people who
        have completed participation in the A21-292 study (also called the My Diabetes Study).
  
        The My Diabetes Study, is a randomized clinical trial to assess the impact of using a NFA or
        a self-directed approach during CGM initiation. The NFA was developed specifically for the
        randomized clinical trial study.
  observational model: Other
  time perspective: Prospective
  measure: Describe CGM data use
  time frame: Immediately following the study completion visit in the My Diabetes study.
  description: Transcribed audio recordings and inductive thematic coding will be used to describe how participants in the My Diabetes Study used CGM data when making food-related decisions after receiving a NFA during CGM initiation
  measure: Describe overall experience of receiving a NFA during CGM initiation
  time frame: Immediately following the study completion visit in the My Diabetes study.
  description: Transcribed audio recordings and inductive thematic coding will be used to describe how participants with T2D in the My Diabetes Study experienced the use of a NFA and its associated nutrition-focused CGM initiation materials.
  intervention type: Other
  intervention name: Semi-structured interviews using an IRB-approved interview guide
  description: A single, semi-structured interview will be conducted using an IRB-approved interview guide. The interviews will be approximately 30 minutes total.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Holly Willis, PhD
  role: Principal Investigator
  affiliation: HealthPartners Institute; International Diabetes Center
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: HealthPartners Institute
  investigator full name: Holly Willis
  investigator title: PhD, RDN, CDCES
  mesh term: Diabetes Mellitus, Type 2