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/NCT05975242</url>
    </required_header>
    <id_info>
      <org_study_id>IIS-000011</org_study_id>
      <nct_id>NCT05975242</nct_id>
    </id_info>
    <brief_title>Acceptability &amp; Impact of a Diabetes Management Smartphone App (mySugr) for Spanish-literate Adults With Type 2 Diabetes</brief_title>
    <acronym>mySugr</acronym>
    <official_title>Acceptability and Impact of the Proactive Use of a Diabetes Management Smartphone Application (mySugr) for Spanish-literate Adults With Poorly Controlled Non-intensively Treated Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sansum Diabetes Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Roche Pharma AG</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Sansum Diabetes Research 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 goal of this clinical trial is to compare those using a diabetes management smartphone&#xD;
        application (mySugr) to those not using the application. This smartphone application is for&#xD;
        Spanish-literate adults with poorly controlled, non-intensively treated type 2 diabetes.&#xD;
  &#xD;
        The main question[s] that it aims to answer are:&#xD;
  &#xD;
          -  What is the impact of the use of mySugr (a smartphone-based application or app) with&#xD;
             structured blood glucose monitoring on diabetes self-management among Hispanic/Latino&#xD;
             adults with poorly controlled, non-intensively treated T2D?&#xD;
  &#xD;
          -  Will diabetes self-management be more effective for those using mySugr (the Active&#xD;
             group) compared to those not using mySugr (the Control group) over a 12-week study&#xD;
             period? Participants will be screened and enrolled if they are eligible; they will have&#xD;
             the study explained to them in Spanish or English and have time to ask questions and&#xD;
             then sign an informed consent form. Clinical measurements (including height, weight, and&#xD;
             blood pressure) and hemoglobin A1c will be done. All subjects will be given a blood&#xD;
             glucose meter, lancing device, and blood glucose strips for the meter, and they will&#xD;
             also receive an electronic scale. Several questionnaires will be answered.&#xD;
  &#xD;
        If a subject is randomly assigned to the Active group, they will download the mySugr Pro app&#xD;
        in Spanish to their smartphone and be trained in its use. They will receive education focused&#xD;
        on paired (before and 2 hours after a meal) blood glucose testing, which participants will&#xD;
        conduct twice a day for 6 days and once a month for 3 months. Participants will continue&#xD;
        structured blood glucose testing with the mySugr PRO app for 12 weeks, and they will have 3&#xD;
        virtual visits in Spanish with mySugr PRO coaches who will review the blood glucose records&#xD;
        and advise the subjects.&#xD;
  &#xD;
        Subjects in the Control group will not receive the mySugr PRO app or coaching. They will&#xD;
        continue with their usual diabetes management.&#xD;
  &#xD;
        All subjects will return after 12 weeks to return the scale and have a close-out visit with&#xD;
        clinical measurements and questionnaires. Subjects will also receive a disturbance allowance&#xD;
        for their time and participation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this pilot observation trial is to determine feasibility, acceptability, and&#xD;
        impact of the combination of mySugr and structured SMBG for Spanish-literate Hispanic/Latino&#xD;
        adults with poorly controlled T2D. The study will be single site (Sansum Diabetes Research&#xD;
        Institute - SDRI), prospective data collection, with pre- and post-intervention comparison. A&#xD;
        total of 30 people with T2D will be randomly allocated (2:1 randomization) to the&#xD;
        interventional group (n = 20) that will use the digital self-management application during&#xD;
        the 12-week study period or the control group (n = 10) without the app. Pre- and&#xD;
        post-intervention assessments will measure diabetes distress as well as self-efficacy to&#xD;
        manage diabetes, HbA1c, weight, and blood glucose. MySugr app perceived usefulness, ease of&#xD;
        use, content, efficacy, and usability will be measured post-intervention. To maximize&#xD;
        retention, both participant groups will receive a disturbance allowance as they progress&#xD;
        through the study.&#xD;
  &#xD;
        Spanish-literate Hispanic/Latino adults with T2D and HbA1c 7.5% - 10% and who reside in the&#xD;
        Central Coast of California and currently use a compatible smartphone will be enrolled.&#xD;
  &#xD;
        Study interaction and procedures will be conducted in Spanish by an existing, trusted&#xD;
        bilingual Hispanic/Latino Certified Diabetes Educator (CDE) and SDRI Community Scientists.&#xD;
        Following informed consent, participants will be randomly assigned to the interventional&#xD;
        group that will use the digital self-management application during the 12-week study period&#xD;
        or the control group that will not use the app. The interventional group will be trained in&#xD;
        the use of the mySugr app and receive education focusing on SMBG based on paired (before and&#xD;
        2 hours after a meal) BG testing, which participants will conduct twice daily for 6 days once&#xD;
        monthly for 3 months. Participants will continue structured SMBG with mySugr PRO for 12 weeks&#xD;
        and will have access to mySugr proactive coaching consisting of 3 virtual engagements focused&#xD;
        on reviewing and reacting to participant-derived structured SMBG data.&#xD;
  &#xD;
        At Visit 1, vital signs health measurements (height, weight, waist circumference and resting&#xD;
        blood pressure) will be conducted by trained clinical staff, and fingerstick HbA1c will be&#xD;
        measured using the Abbott Afinion 2 Point of Care (POC) Analyzer or FDA-approved equivalent.&#xD;
        Several questionnaires will be completed. Subjects will measure their blood glucose at home&#xD;
        using the Accu Check Guide Me blood glucose meter and their weight at home using a smartphone&#xD;
        connected weight scale.&#xD;
  &#xD;
        If subjects are randomized to the Active or intervention group, they will download and be&#xD;
        trained in the use of the mySugr app. Active group participants will be asked to use the&#xD;
        mobile application throughout the duration of the study. The app will be used to collect data&#xD;
        from glucometers in their mobile phones and to have access to mySugr proactive coaching. The&#xD;
        coach visits will be conducted in Spanish with a duration of 30-minutes each month and&#xD;
        focusing on reviewing and reacting to participant derived structured SMBG data. In the&#xD;
        control group, people with diabetes will neither have access to the mySugr Pro app nor&#xD;
        coaching during the 12-week Intervention Period; they will continue with their usual,&#xD;
        discretionary mode of therapy, data documentation, and glucose monitoring.&#xD;
  &#xD;
        After 12 weeks, subjects will complete a second and final visit with vital signs, HbA1c, and&#xD;
        questionnaires repeated. A disturbance allowance will be given to each subject for their time&#xD;
        and participation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 4, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">April 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>The study will be single site, prospective data collection, with pre- and post-intervention comparison. A total of 30 people with T2D will be randomly allocated (2:1 randomization) to the interventional group (n = 20) that will use the digital self-management application during the 12-week study period or the control group (n = 10) without the app.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Spanish-language Diabetes Self-Efficacy Scale (DSES-S)</measure>
      <time_frame>Visit 1, week 1 and Visit 2, week 12</time_frame>
      <description>A scale of 8 Likert-type 10-point items to measure self-efficacy of diabetes self-management</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin A1c</measure>
      <time_frame>Visit 1, week 1 and Visit 2, week 12</time_frame>
      <description>A measure of glycosylated hemoglobin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Problem areas in diabetes (PAID) scale</measure>
      <time_frame>Visit 1, week 1 and Visit 2, week 12</time_frame>
      <description>The Problem Areas in Diabetes (PAID) instrument was developed to measure emotional distress in people with diabetes. It is a 20-item scale consisting of emotional problems commonly reported in type 1 and type 2 diabetes mellitus, and has been found to be a valid and reliable scale in Western populations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood glucose measurements</measure>
      <time_frame>Week 1, Week 4, Week 8</time_frame>
      <description>Blood glucose measurements made with the assigned glucose meter at specific times</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>Visit 1, week 1 and Visit 2, week 12</time_frame>
      <description>Body weight in kilograms</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Health Information Technology Usability Evaluation Scale (Health-ITUES)</measure>
      <time_frame>Visit 1, week 1 and Visit 2, week 12</time_frame>
      <description>The measurement scale is used to assess perceived usefulness and perceived ease of use.</description>
    </other_outcome>
    <other_outcome>
      <measure>Mobile App Rating Scale (MARS)</measure>
      <time_frame>Visit 1, week 1 and Visit 2, week 12</time_frame>
      <description>The measurement scale is used to assess the content, efficacy and usability of a smartphone application.</description>
    </other_outcome>
    <other_outcome>
      <measure>Mobile Device Proficiency Questionnaire (MDPQ)</measure>
      <time_frame>Visit 1, week 1 and Visit 2, week 12</time_frame>
      <description>A questionnaire to assess digital literacy.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Interventional group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The interventional group will use the digital self-management smartphone application during the 12-week study period and will have access to 3 coaching sessions. The interventional group will be trained in the use of the app and receive education focused on self-monitoring blood glucose based on paired (before and 2 hours after a meal) blood glucose testing, which participants will conduct twice daily for 6 days once monthly for 3 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group will not have use of the digital self-management smartphone application during the 12-week study period and will not have access to 3 coaching sessions. No structured self-monitoring blood glucose testing will be done.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Smartphone diabetes management application</intervention_name>
      <description>The intervention is a smartphone diabetes management application that is combined with structured blood glucose testing.</description>
      <arm_group_label>Interventional group</arm_group_label>
      <other_name>mySugr</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults ≥ 18 years of age at enrollment&#xD;
  &#xD;
            2. Self-reported Hispanic/Latino ethnicity&#xD;
  &#xD;
            3. Spanish-literate with Spanish as preferred language&#xD;
  &#xD;
            4. Diagnosis of T2D for at least 6 months&#xD;
  &#xD;
            5. HbA1c 7.5% - 10%&#xD;
  &#xD;
            6. mySugr-compatible smartphone&#xD;
  &#xD;
            7. Any glucose lowering therapy except rapid-acting mealtime insulin&#xD;
  &#xD;
            8. Residence in Central Coast of California -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. Type 1 diabetes 2. Use of rapid-acting mealtime insulin 3. Pregnancy 4. Any active&#xD;
          clinically significant disease or disorder which in the investigator's opinion could&#xD;
          interfere with participation in the study.&#xD;
  &#xD;
          -&#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>Ashley Thorsell, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sansum Diabetes Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Karla Gonzalez, RN</last_name>
      <phone>8053350416</phone>
      <email>kgonzalez@sansum.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wendy Bevier, PhD</last_name>
      <phone>8056801521</phone>
      <email>wbevier@sansum.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sansum Diabetes Research Institute</name>
        <address>
          <city>Santa Barbara</city>
          <state>California</state>
          <zip>93105</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Karla Gonzalez, RN</last_name>
        <phone>805-335-0416</phone>
        <email>kgonzalez@sansum.org</email>
      </contact>
      <contact_backup>
        <last_name>Wendy C Bevier, PhD</last_name>
        <phone>8056801521</phone>
        <email>wbevier@sansum.org</email>
      </contact_backup>
      <investigator>
        <last_name>Ashley Thorsell, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hispanic/Latino</keyword>
    <keyword>smartphone application</keyword>
    <keyword>self-monitoring blood glucose</keyword>
    <keyword>Spanish</keyword>
    <keyword>mySugr PRO</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>
    </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/NCT05975242
  org study id: IIS-000011
  nct id: NCT05975242
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare those using a diabetes management smartphone
        application (mySugr) to those not using the application. This smartphone application is for
        Spanish-literate adults with poorly controlled, non-intensively treated type 2 diabetes.
  
        The main question[s] that it aims to answer are:
  
          -  What is the impact of the use of mySugr (a smartphone-based application or app) with
             structured blood glucose monitoring on diabetes self-management among Hispanic/Latino
             adults with poorly controlled, non-intensively treated T2D?
  
          -  Will diabetes self-management be more effective for those using mySugr (the Active
             group) compared to those not using mySugr (the Control group) over a 12-week study
             period? Participants will be screened and enrolled if they are eligible; they will have
             the study explained to them in Spanish or English and have time to ask questions and
             then sign an informed consent form. Clinical measurements (including height, weight, and
             blood pressure) and hemoglobin A1c will be done. All subjects will be given a blood
             glucose meter, lancing device, and blood glucose strips for the meter, and they will
             also receive an electronic scale. Several questionnaires will be answered.
  
        If a subject is randomly assigned to the Active group, they will download the mySugr Pro app
        in Spanish to their smartphone and be trained in its use. They will receive education focused
        on paired (before and 2 hours after a meal) blood glucose testing, which participants will
        conduct twice a day for 6 days and once a month for 3 months. Participants will continue
        structured blood glucose testing with the mySugr PRO app for 12 weeks, and they will have 3
        virtual visits in Spanish with mySugr PRO coaches who will review the blood glucose records
        and advise the subjects.
  
        Subjects in the Control group will not receive the mySugr PRO app or coaching. They will
        continue with their usual diabetes management.
  
        All subjects will return after 12 weeks to return the scale and have a close-out visit with
        clinical measurements and questionnaires. Subjects will also receive a disturbance allowance
        for their time and participation.
  The aim of this pilot observation trial is to determine feasibility, acceptability, and
        impact of the combination of mySugr and structured SMBG for Spanish-literate Hispanic/Latino
        adults with poorly controlled T2D. The study will be single site (Sansum Diabetes Research
        Institute - SDRI), prospective data collection, with pre- and post-intervention comparison. A
        total of 30 people with T2D will be randomly allocated (2:1 randomization) to the
        interventional group (n = 20) that will use the digital self-management application during
        the 12-week study period or the control group (n = 10) without the app. Pre- and
        post-intervention assessments will measure diabetes distress as well as self-efficacy to
        manage diabetes, HbA1c, weight, and blood glucose. MySugr app perceived usefulness, ease of
        use, content, efficacy, and usability will be measured post-intervention. To maximize
        retention, both participant groups will receive a disturbance allowance as they progress
        through the study.
  
        Spanish-literate Hispanic/Latino adults with T2D and HbA1c 7.5% - 10% and who reside in the
        Central Coast of California and currently use a compatible smartphone will be enrolled.
  
        Study interaction and procedures will be conducted in Spanish by an existing, trusted
        bilingual Hispanic/Latino Certified Diabetes Educator (CDE) and SDRI Community Scientists.
        Following informed consent, participants will be randomly assigned to the interventional
        group that will use the digital self-management application during the 12-week study period
        or the control group that will not use the app. The interventional group will be trained in
        the use of the mySugr app and receive education focusing on SMBG based on paired (before and
        2 hours after a meal) BG testing, which participants will conduct twice daily for 6 days once
        monthly for 3 months. Participants will continue structured SMBG with mySugr PRO for 12 weeks
        and will have access to mySugr proactive coaching consisting of 3 virtual engagements focused
        on reviewing and reacting to participant-derived structured SMBG data.
  
        At Visit 1, vital signs health measurements (height, weight, waist circumference and resting
        blood pressure) will be conducted by trained clinical staff, and fingerstick HbA1c will be
        measured using the Abbott Afinion 2 Point of Care (POC) Analyzer or FDA-approved equivalent.
        Several questionnaires will be completed. Subjects will measure their blood glucose at home
        using the Accu Check Guide Me blood glucose meter and their weight at home using a smartphone
        connected weight scale.
  
        If subjects are randomized to the Active or intervention group, they will download and be
        trained in the use of the mySugr app. Active group participants will be asked to use the
        mobile application throughout the duration of the study. The app will be used to collect data
        from glucometers in their mobile phones and to have access to mySugr proactive coaching. The
        coach visits will be conducted in Spanish with a duration of 30-minutes each month and
        focusing on reviewing and reacting to participant derived structured SMBG data. In the
        control group, people with diabetes will neither have access to the mySugr Pro app nor
        coaching during the 12-week Intervention Period; they will continue with their usual,
        discretionary mode of therapy, data documentation, and glucose monitoring.
  
        After 12 weeks, subjects will complete a second and final visit with vital signs, HbA1c, and
        questionnaires repeated. A disturbance allowance will be given to each subject for their time
        and participation.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study will be single site, prospective data collection, with pre- and post-intervention comparison. A total of 30 people with T2D will be randomly allocated (2:1 randomization) to the interventional group (n = 20) that will use the digital self-management application during the 12-week study period or the control group (n = 10) without the app.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Spanish-language Diabetes Self-Efficacy Scale (DSES-S)
  time frame: Visit 1, week 1 and Visit 2, week 12
  description: A scale of 8 Likert-type 10-point items to measure self-efficacy of diabetes self-management
  measure: Hemoglobin A1c
  time frame: Visit 1, week 1 and Visit 2, week 12
  description: A measure of glycosylated hemoglobin
  measure: Problem areas in diabetes (PAID) scale
  time frame: Visit 1, week 1 and Visit 2, week 12
  description: The Problem Areas in Diabetes (PAID) instrument was developed to measure emotional distress in people with diabetes. It is a 20-item scale consisting of emotional problems commonly reported in type 1 and type 2 diabetes mellitus, and has been found to be a valid and reliable scale in Western populations.
  measure: Blood glucose measurements
  time frame: Week 1, Week 4, Week 8
  description: Blood glucose measurements made with the assigned glucose meter at specific times
  measure: Weight
  time frame: Visit 1, week 1 and Visit 2, week 12
  description: Body weight in kilograms
  measure: Health Information Technology Usability Evaluation Scale (Health-ITUES)
  time frame: Visit 1, week 1 and Visit 2, week 12
  description: The measurement scale is used to assess perceived usefulness and perceived ease of use.
  measure: Mobile App Rating Scale (MARS)
  time frame: Visit 1, week 1 and Visit 2, week 12
  description: The measurement scale is used to assess the content, efficacy and usability of a smartphone application.
  measure: Mobile Device Proficiency Questionnaire (MDPQ)
  time frame: Visit 1, week 1 and Visit 2, week 12
  description: A questionnaire to assess digital literacy.
  arm group label: Interventional group
  arm group type: Experimental
  description: The interventional group will use the digital self-management smartphone application during the 12-week study period and will have access to 3 coaching sessions. The interventional group will be trained in the use of the app and receive education focused on self-monitoring blood glucose based on paired (before and 2 hours after a meal) blood glucose testing, which participants will conduct twice daily for 6 days once monthly for 3 months.
  arm group label: Control group
  arm group type: No Intervention
  description: The control group will not have use of the digital self-management smartphone application during the 12-week study period and will not have access to 3 coaching sessions. No structured self-monitoring blood glucose testing will be done.
  intervention type: Behavioral
  intervention name: Smartphone diabetes management application
  description: The intervention is a smartphone diabetes management application that is combined with structured blood glucose testing.
  arm group label: Interventional group
  other name: mySugr
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ashley Thorsell, MD
  role: Principal Investigator
  affiliation: Sansum Diabetes Research Institute
  last name: Karla Gonzalez, RN
  phone: 8053350416
  email: kgonzalez@sansum.org
  last name: Wendy Bevier, PhD
  phone: 8056801521
  email: wbevier@sansum.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2