<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/NCT03799796</url>
  </required_header>
  <id_info>
    <org_study_id>ADC-SRR-IIS-18-23</org_study_id>
    <nct_id>NCT03799796</nct_id>
  </id_info>
  <brief_title>Combining Flash Glucose Monitoring and Online Peer Support to Improve Outcomes in Hispanics With Type 2 Diabetes</brief_title>
  <official_title>Combining Flash Glucose Monitoring and Online Peer Support to Improve Outcomes in Hispanic Spanish-Speaking People With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>La Trobe University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate&#xD;
      diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management,&#xD;
      including healthy eating and being physically active in Hispanic Spanish-speaking&#xD;
      individuals. Use of diabetes technology is on the rise, however, many technologies do not&#xD;
      provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in&#xD;
      both English and Spanish. Research suggests that use of FGM results in improved clinical&#xD;
      outcomes. Furthermore, increased number of FGM scans are associated with improved clinical&#xD;
      outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work&#xD;
      indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it&#xD;
      supports Spanish language and (2) in English-speaking populations, but not specific to the&#xD;
      Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work,&#xD;
      and the work of others, indicate Hispanic individuals desire for peer interactions to relate&#xD;
      and understand the variables that impact T2D. Interaction with online peer support&#xD;
      communities is associated with increased knowledge, receipt of emotional support, and&#xD;
      improved glycemic levels. These results suggest that education and support to increase use&#xD;
      and understanding of FGM will lead to improved clinical and behavioral outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate&#xD;
      diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management,&#xD;
      including healthy eating and being physically active in Hispanic Spanish-speaking&#xD;
      individuals. Use of diabetes technology is on the rise, however, many technologies do not&#xD;
      provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in&#xD;
      both English and Spanish. FGM involves wearing an interstitial glucose sensor that is placed&#xD;
      on the upper arm and a reader. When an individual wants to check their glucose level, they&#xD;
      waive or scan the reader over their sensor and a glucose history, current glucose level, and&#xD;
      projected glucose trend is displayed. Research suggests that use of FGM results in improved&#xD;
      clinical outcomes. Furthermore, increased number of FGM scans are associated with improved&#xD;
      clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary&#xD;
      work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it&#xD;
      supports Spanish language and (2) in English-speaking populations, but not specific to the&#xD;
      Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work,&#xD;
      and the work of others, indicate Hispanic individuals desire for peer interactions to relate&#xD;
      and understand the variables that impact T2D. Interaction with online peer support&#xD;
      communities is associated with increased knowledge, receipt of emotional support, and&#xD;
      improved glycemic levels. These results suggest that education and support to increase use&#xD;
      and understanding of FGM will lead to improved clinical and behavioral outcomes.&#xD;
&#xD;
      Little is known about the uses, benefits, and limitations of online peer support in the&#xD;
      context of learning how to use diabetes technology, such as FGM. Hispanic, Spanish speaking&#xD;
      individuals are at high risk for T2D and associated morbidity and mortality. Hispanics are&#xD;
      more likely to die from diabetes compared to Caucasian counterparts. The investigators&#xD;
      propose to address gaps in diabetes care for Hispanic individuals by conducting a pilot trial&#xD;
      of an online peer support intervention using an online peer facilitator to augment the use of&#xD;
      FGM. The online peer facilitator will be Hispanic and bilingual in English and Spanish with&#xD;
      substantial knowledge of diabetes and FGM. Our intervention is culturally appropriate to&#xD;
      address the biobehavioral and biopsychosocial needs of Hispanic individuals. The&#xD;
      investigators anticipate the additional support provided by the online peer facilitator will&#xD;
      encourage healthy eating habits and physical activity behaviors in Hispanic individuals with&#xD;
      T2D. Our research team is experienced with community-based participatory research in both&#xD;
      diabetes online peer support communities and Hispanic populations using technology to support&#xD;
      T2D.&#xD;
&#xD;
      Examining online peer support communities to augment diabetes care in Hispanic Spanish&#xD;
      speaking individuals is a promising, exciting, and innovative area of research that has not&#xD;
      yet been explored. This proposed study contains several novel components. First, using online&#xD;
      peer support communities is low-cost and easily accessible, making this intervention more&#xD;
      translatable in the clinical setting while adding to the toolkit that already exists for&#xD;
      diabetes care. Second, using FGM in a population not using insulin is forward thinking.&#xD;
      Empowering people with their own glucose data, early in the course of their diabetes, may&#xD;
      change the trajectory of diabetes management. The research team received PCORI&#xD;
      pipeline-to-proposal funding (tiers I-III) to develop a research question via a community&#xD;
      advisory board (CAB) in partnership with the diabetes online peer support community. The CAB&#xD;
      included researchers, clinicians, and people with diabetes, both English and Spanish&#xD;
      speaking. This study will address important questions identified by people affected by&#xD;
      diabetes.&#xD;
&#xD;
      Aim 1 Explore the relationship between engagement in an online peer support intervention with&#xD;
      clinical and behavioral outcomes in Hispanic, Spanish speaking individuals with T2D using&#xD;
      flash glucose monitoring for 12 weeks&#xD;
&#xD;
      Method. A one group, pre-post evaluation of Hispanic, Spanish speaking individuals (N=43)&#xD;
      recruited from a health center in Utah.&#xD;
&#xD;
      Primary outcome: Time-in-range (average glucose level and number of minutes in&#xD;
      70mg/dl-180mg/dl in last 10 days of the study minus average glucose level and number of&#xD;
      minutes in 70mg/dl-180mg/dl for 10 days baseline) between baseline and 12 weeks.&#xD;
&#xD;
      Secondary outcomes: Change in A1C from baseline to 12 weeks. Online peer support engagement&#xD;
      (measured by survey and Facebook activity), Frequency of FGM scans. Change in self-reported&#xD;
      self-management behaviors, self-efficacy and quality of life between baseline and 12 weeks.&#xD;
&#xD;
      Hypothesis. Increased engagement in the online peer support intervention will be associated&#xD;
      with improved clinical, behavioral and psychosocial outcomes after 12 weeks of FGM.&#xD;
&#xD;
      Aim 2. Evaluate the acceptability and feasibility of an online peer support intervention for&#xD;
      Hispanic Spanish speaking individuals with T2D to learn how to use flash glucose monitoring&#xD;
      to make changes to meal and activity choices.&#xD;
&#xD;
      Method. Qualitative and quantitative analysis for measures of use of and satisfaction with&#xD;
      flash glucose sensors, eligible participant acceptance of flash glucose sensors, and dropout&#xD;
      rates, including causes for drop out, and online peer support engagement through platform&#xD;
      analytics. A semi-structured interview will be conducted with participants at the end of the&#xD;
      intervention explore their experiences during engagement with the online peer support&#xD;
      community.&#xD;
&#xD;
      Hypothesis. Online peer support engagement will be associated with satisfaction with FGM and&#xD;
      number of daily scans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2019</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 27, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time-in-Range</measure>
    <time_frame>12 weeks</time_frame>
    <description>Average glucose level and number of minutes spent between 70-180 mg/dL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A1C</measure>
    <time_frame>12 weeks</time_frame>
    <description>Glycosylated hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Online peer support engagement</measure>
    <time_frame>12 weeks</time_frame>
    <description>Survey, Activity in online peer support group</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Flash Glucose Monitoring with Online Peer Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-Test-Post-Test</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Flash Glucose Monitoring with Online Peer Support</intervention_name>
    <description>Hispanic Adults who are Spanish-Speaking with type 2 diabetes who are not using insulin will be asked to use flash glucose monitoring and to sign up for an moderated online peer support group where they can ask questions and share progress.</description>
    <arm_group_label>Flash Glucose Monitoring with Online Peer Support</arm_group_label>
    <other_name>Abbott Freestyle Libre</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥21 years&#xD;
&#xD;
          -  Self-report as Hispanic&#xD;
&#xD;
          -  Able to communicate in Spanish&#xD;
&#xD;
          -  Clinical diagnosis of T2D and HbA1c ≥8% per clinic records&#xD;
&#xD;
          -  Willing to wear a flash glucose monitor for 12 weeks&#xD;
&#xD;
          -  Access to the internet and willing to engage in an online peer support community&#xD;
&#xD;
          -  Willing to avoid Vitamin C 500 mg and Aspirin 325 mg or greater daily&#xD;
&#xD;
          -  Not using insulin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-Spanish speaking&#xD;
&#xD;
          -  Using insulin&#xD;
&#xD;
          -  Already using a continuous glucose monitor or flash glucose monitor in previous 6&#xD;
             months&#xD;
&#xD;
          -  Participation in other diabetes clinical trials&#xD;
&#xD;
          -  Alcohol or drug abuse/dependency&#xD;
&#xD;
          -  Severe illness (physical or mental health), cognitive impairment, high dose steroids,&#xD;
             hospitalized more than 2 times in past 12 months or other impairment that would, in&#xD;
             the opinion of the investigators, interfere with ability to complete the study&#xD;
&#xD;
          -  Uncorrected hearing or vision impairment&#xD;
&#xD;
          -  Life expectancy &lt;6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle L Litchman, PhD, FNP-BC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah College of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah College of Nursing</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>841112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Michelle Litchman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>flash glucose monitoring</keyword>
  <keyword>online peer support</keyword>
  <keyword>Hispanic</keyword>
  <keyword>Spanish-Speaking</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data can be shared upon request.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03799796
org study id: ADC-SRR-IIS-18-23
nct id: NCT03799796
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Currently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate
      diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management,
      including healthy eating and being physically active in Hispanic Spanish-speaking
      individuals. Use of diabetes technology is on the rise, however, many technologies do not
      provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in
      both English and Spanish. Research suggests that use of FGM results in improved clinical
      outcomes. Furthermore, increased number of FGM scans are associated with improved clinical
      outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work
      indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it
      supports Spanish language and (2) in English-speaking populations, but not specific to the
      Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work,
      and the work of others, indicate Hispanic individuals desire for peer interactions to relate
      and understand the variables that impact T2D. Interaction with online peer support
      communities is associated with increased knowledge, receipt of emotional support, and
      improved glycemic levels. These results suggest that education and support to increase use
      and understanding of FGM will lead to improved clinical and behavioral outcomes.
Currently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate
      diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management,
      including healthy eating and being physically active in Hispanic Spanish-speaking
      individuals. Use of diabetes technology is on the rise, however, many technologies do not
      provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in
      both English and Spanish. FGM involves wearing an interstitial glucose sensor that is placed
      on the upper arm and a reader. When an individual wants to check their glucose level, they
      waive or scan the reader over their sensor and a glucose history, current glucose level, and
      projected glucose trend is displayed. Research suggests that use of FGM results in improved
      clinical outcomes. Furthermore, increased number of FGM scans are associated with improved
      clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary
      work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it
      supports Spanish language and (2) in English-speaking populations, but not specific to the
      Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work,
      and the work of others, indicate Hispanic individuals desire for peer interactions to relate
      and understand the variables that impact T2D. Interaction with online peer support
      communities is associated with increased knowledge, receipt of emotional support, and
      improved glycemic levels. These results suggest that education and support to increase use
      and understanding of FGM will lead to improved clinical and behavioral outcomes.

      Little is known about the uses, benefits, and limitations of online peer support in the
      context of learning how to use diabetes technology, such as FGM. Hispanic, Spanish speaking
      individuals are at high risk for T2D and associated morbidity and mortality. Hispanics are
      more likely to die from diabetes compared to Caucasian counterparts. The investigators
      propose to address gaps in diabetes care for Hispanic individuals by conducting a pilot trial
      of an online peer support intervention using an online peer facilitator to augment the use of
      FGM. The online peer facilitator will be Hispanic and bilingual in English and Spanish with
      substantial knowledge of diabetes and FGM. Our intervention is culturally appropriate to
      address the biobehavioral and biopsychosocial needs of Hispanic individuals. The
      investigators anticipate the additional support provided by the online peer facilitator will
      encourage healthy eating habits and physical activity behaviors in Hispanic individuals with
      T2D. Our research team is experienced with community-based participatory research in both
      diabetes online peer support communities and Hispanic populations using technology to support
      T2D.

      Examining online peer support communities to augment diabetes care in Hispanic Spanish
      speaking individuals is a promising, exciting, and innovative area of research that has not
      yet been explored. This proposed study contains several novel components. First, using online
      peer support communities is low-cost and easily accessible, making this intervention more
      translatable in the clinical setting while adding to the toolkit that already exists for
      diabetes care. Second, using FGM in a population not using insulin is forward thinking.
      Empowering people with their own glucose data, early in the course of their diabetes, may
      change the trajectory of diabetes management. The research team received PCORI
      pipeline-to-proposal funding (tiers I-III) to develop a research question via a community
      advisory board (CAB) in partnership with the diabetes online peer support community. The CAB
      included researchers, clinicians, and people with diabetes, both English and Spanish
      speaking. This study will address important questions identified by people affected by
      diabetes.

      Aim 1 Explore the relationship between engagement in an online peer support intervention with
      clinical and behavioral outcomes in Hispanic, Spanish speaking individuals with T2D using
      flash glucose monitoring for 12 weeks

      Method. A one group, pre-post evaluation of Hispanic, Spanish speaking individuals (N=43)
      recruited from a health center in Utah.

      Primary outcome: Time-in-range (average glucose level and number of minutes in
      70mg/dl-180mg/dl in last 10 days of the study minus average glucose level and number of
      minutes in 70mg/dl-180mg/dl for 10 days baseline) between baseline and 12 weeks.

      Secondary outcomes: Change in A1C from baseline to 12 weeks. Online peer support engagement
      (measured by survey and Facebook activity), Frequency of FGM scans. Change in self-reported
      self-management behaviors, self-efficacy and quality of life between baseline and 12 weeks.

      Hypothesis. Increased engagement in the online peer support intervention will be associated
      with improved clinical, behavioral and psychosocial outcomes after 12 weeks of FGM.

      Aim 2. Evaluate the acceptability and feasibility of an online peer support intervention for
      Hispanic Spanish speaking individuals with T2D to learn how to use flash glucose monitoring
      to make changes to meal and activity choices.

      Method. Qualitative and quantitative analysis for measures of use of and satisfaction with
      flash glucose sensors, eligible participant acceptance of flash glucose sensors, and dropout
      rates, including causes for drop out, and online peer support engagement through platform
      analytics. A semi-structured interview will be conducted with participants at the end of the
      intervention explore their experiences during engagement with the online peer support
      community.

      Hypothesis. Online peer support engagement will be associated with satisfaction with FGM and
      number of daily scans.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Time-in-Range
time frame: 12 weeks
description: Average glucose level and number of minutes spent between 70-180 mg/dL
measure: A1C
time frame: 12 weeks
description: Glycosylated hemoglobin
measure: Online peer support engagement
time frame: 12 weeks
description: Survey, Activity in online peer support group
arm group label: Flash Glucose Monitoring with Online Peer Support
arm group type: Experimental
description: Pre-Test-Post-Test
intervention type: Behavioral
intervention name: Flash Glucose Monitoring with Online Peer Support
description: Hispanic Adults who are Spanish-Speaking with type 2 diabetes who are not using insulin will be asked to use flash glucose monitoring and to sign up for an moderated online peer support group where they can ask questions and share progress.
arm group label: Flash Glucose Monitoring with Online Peer Support
other name: Abbott Freestyle Libre
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Michelle L Litchman, PhD, FNP-BC
role: Principal Investigator
affiliation: University of Utah College of Nursing
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Michelle Litchman
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided
ipd description: Data can be shared upon request.