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/NCT05998460</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00006573</org_study_id>
      <nct_id>NCT05998460</nct_id>
    </id_info>
    <brief_title>Glucose-Guided Eating Pilot</brief_title>
    <acronym>GET CHARGED</acronym>
    <official_title>Glucose-Guided Eating to Reduce Chronic Disease Risk: a Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Georgetown University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Georgetown University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This is a single center, parallel-arm randomized controlled pilot study that aims to examine&#xD;
        the feasibility and acceptability of the glucose-guided eating (GGE) mobile app and&#xD;
        intervention in two populations at risk of chronic disease (postmenopausal women with&#xD;
        prediabetes and AYA cancer survivors).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary objectives of the study are to (1) test the feasibility and acceptability of the&#xD;
        GGE intervention and companion GGE mobile app and (2) quantify the preliminary effect of GGE&#xD;
        on 12-week changes in insulin resistance (IR) and body weight.&#xD;
  &#xD;
        The secondary objectives of the study are to (1) collect preliminary data on hypothesized&#xD;
        mechanisms linking GGE to IR and (2) explore the durability of intervention effects on&#xD;
        24-week changes in body weight.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Population-specific accrual</measure>
      <time_frame>Week 0</time_frame>
      <description>Population-specific accrual will reflect rates of study enrollment and will be defined as number of participants consented to the number of individuals who are determined to be eligible.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Population-specific retention rates</measure>
      <time_frame>Week 12</time_frame>
      <description>Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>GGE app usability</measure>
      <time_frame>Week 12</time_frame>
      <description>The app usability will be assessed using the 10-item System Usability Scale. SUS scores have a range of 0 to 100 with 100 representing greatest usability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>GGE intervention acceptability</measure>
      <time_frame>Week 12</time_frame>
      <description>GGE intervention acceptability will be assessed with a study specific survey (collected from participants randomized to the GGE intervention only).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>GGE adherence</measure>
      <time_frame>Weeks 1-4</time_frame>
      <description>GGE adherence will be quantified as percent of reported eating events occurring at or below personalized glucose thresholds/personalized average fasting glucose levels that is collected using the GGE app (collected from participants randomized to the GGE intervention only-during use of the GGE app only).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in body weight</measure>
      <time_frame>Weeks 0-12 and Weeks 12-24</time_frame>
      <description>Changes in body weight will be measured using calibrated digital scales (measured in kilograms).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in insulin resistance (HOMA-IR)</measure>
      <time_frame>Weeks 1-12</time_frame>
      <description>Changes in insulin resistance will be measured as homeostatic model assessment for insulin resistance (HOMA-IR). It will be computed from fasting insulin and fasting glucose (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in glycemic variability</measure>
      <time_frame>Weeks 1-12</time_frame>
      <description>Changes in glycemic variability will be assessed from CGM data using the freely accessible EasyGV software available from the University of Oxford (https://www.phc.ox.ac.uk/research/resources/easygv).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in oxidative stress</measure>
      <time_frame>Weeks 1-12</time_frame>
      <description>Changes in oxidative stress will be measured as 8-isoprostane from spot urine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the soluble receptor for advanced glycation end-products (sRAGE)</measure>
      <time_frame>Weeks 1-12</time_frame>
      <description>Changes the sRAGE was measured in serum by ELISA.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Postmenopausal</condition>
    <condition>Prediabetes</condition>
    <condition>Adolescent and Young Adult (AYA) Cancer Survivors</condition>
    <arm_group>
      <arm_group_label>GGE with CGM</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to the Glucose-Guided Intervention will be trained to align their mealtimes with a personalized glucose threshold monitored using continuous glucose monitoring (CGM) and the GGE study app.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CGM only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants randomized to the control arm will only wear a CGM.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Glucose-Guided Eating with CGM</intervention_name>
      <description>The GGE intervention consist of up to four weeks of training to learn to eat when glucose levels are at or below their usual fasting level. Specifically, participants following GGE will self-monitor their glucose levels with an unblinded CGM while using a mobile app (GGE app) that will provide feedback on whether or not to eat. At desired mealtimes participants will enter their current glucose level, rate their perceived hunger, and label the type of hunger they are experiencing (physical, emotional, sensory and practical). Participants following GGE will be instructed by the app to eat when two conditions are met: (a) the desire to eat arises and (b) their glucose levels are at or below a personalized threshold. During the training period, participants are meant to associate feelings of perceived hunger with fasting glucose levels (i.e., physical hunger). After the training period, participants continue to follow GGE without CGM or use of the app.</description>
      <arm_group_label>GGE with CGM</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CGM only</intervention_name>
      <description>Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.</description>
      <arm_group_label>CGM only</arm_group_label>
      <arm_group_label>GGE with CGM</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All:&#xD;
  &#xD;
            1. Self-reported height and weight that is consistent with a BMI ≥ 27 kg/m2&#xD;
  &#xD;
            2. Willing to use a continuous glucose monitor&#xD;
  &#xD;
            3. Own smartphone that is compatible with Dexcom CGM.&#xD;
  &#xD;
            4. Willingness to commute to GUMC for in-person study visits&#xD;
  &#xD;
            5. No active cancer (except for nonmelanoma skin cancer)&#xD;
  &#xD;
            6. Less than 5 lbs. weight change in previous 3 months&#xD;
  &#xD;
            7. Proficient in speaking and reading English&#xD;
  &#xD;
               Postmenopausal women with pre-diabetes:&#xD;
  &#xD;
            8. Age 18 years and older&#xD;
  &#xD;
            9. Diagnosed as having prediabetes.&#xD;
  &#xD;
           10. HbA1c (within 3 months) between 5.7% and 6.4%&#xD;
  &#xD;
           11. Postmenopausal (defined as reporting no menstrual period for ≥1 year or a reported&#xD;
               history of a total abdominal hysterectomy with oophorectomy)&#xD;
  &#xD;
               AYA cancer survivors:&#xD;
  &#xD;
           12. Current age 21-39 years&#xD;
  &#xD;
           13. Previously diagnosed with cancer, with all cancer-related diagnosis chemotherapy&#xD;
               and/or radiation completed at least 6 months previously&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Unable or unwilling to provide informed consent&#xD;
  &#xD;
            2. Clinical history of type 1 or type 2 diabetes&#xD;
  &#xD;
            3. Currently receiving anti-diabetics (e.g., insulin, GLP1), oral hypoglycemic agent&#xD;
               (e.g., metformin), oral corticosteroids, oral glucocorticoids, beta blockers,&#xD;
               hydroxyurea, atypical antipsychotic agents (i.e., Olanzapine, Aripiprazole) or&#xD;
               systemic progestin-only contraceptives&#xD;
  &#xD;
            4. Current or past history of an eating disorder&#xD;
  &#xD;
            5. Self-identify as an overnight eater (defined as eating main meals between 9pm-5am)&#xD;
  &#xD;
            6. Have any contraindications for CGM, including: severe allergy to surgical adhesive,&#xD;
               being on dialysis, receiving diathermy treatment, or scheduled CT scan or MRI during&#xD;
               wear period&#xD;
  &#xD;
            7. Growth hormone deficiency, hypoadrenal function, or hypopituitary function&#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>Susan M Schembre</last_name>
      <role>Principal Investigator</role>
      <affiliation>Georgetown's Lombardi Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nina Kadan-Lottick</last_name>
      <role>Principal Investigator</role>
      <affiliation>Georgetown's Lombardi Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Princess M Georges</last_name>
      <phone>2026872117</phone>
      <email>pg763@georgetown.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Megan Roy</last_name>
      <email>mr1839@georgetown.edu</email>
    </overall_contact_backup>
    <reference>
      <citation>Schembre SM, Jospe MR, Giles ED, Sears DD, Liao Y, Basen-Engquist KM, Thomson CA. A Low-Glucose Eating Pattern Improves Biomarkers of Postmenopausal Breast Cancer Risk: An Exploratory Secondary Analysis of a Randomized Feasibility Trial. Nutrients. 2021 Dec 16;13(12):4508. doi: 10.3390/nu13124508.</citation>
      <PMID>34960058</PMID>
    </reference>
    <reference>
      <citation>Schembre SM, Jospe MR, Bedrick EJ, Li L, Brewster AM, Levy E, Dirba DD, Campbell M, Taylor RW, Basen-Engquist KM. Hunger Training as a Self-regulation Strategy in a Comprehensive Weight Loss Program for Breast Cancer Prevention: A Randomized Feasibility Study. Cancer Prev Res (Phila). 2022 Mar 1;15(3):193-201. doi: 10.1158/1940-6207.CAPR-21-0298.</citation>
      <PMID>34893531</PMID>
    </reference>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Prediabetic State</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The investigators intend to publish the protocol in a manuscript and share the IPD through an appropriate free access data repository.</ipd_description>
      <ipd_time_frame>Within 1 year of study completion.</ipd_time_frame>
      <ipd_access_criteria>Shared IPD will be available via freely accessible data registry.</ipd_access_criteria>
    </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/NCT05998460
  org study id: STUDY00006573
  nct id: NCT05998460
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a single center, parallel-arm randomized controlled pilot study that aims to examine
        the feasibility and acceptability of the glucose-guided eating (GGE) mobile app and
        intervention in two populations at risk of chronic disease (postmenopausal women with
        prediabetes and AYA cancer survivors).
  The primary objectives of the study are to (1) test the feasibility and acceptability of the
        GGE intervention and companion GGE mobile app and (2) quantify the preliminary effect of GGE
        on 12-week changes in insulin resistance (IR) and body weight.
  
        The secondary objectives of the study are to (1) collect preliminary data on hypothesized
        mechanisms linking GGE to IR and (2) explore the durability of intervention effects on
        24-week changes in body weight.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Population-specific accrual
  time frame: Week 0
  description: Population-specific accrual will reflect rates of study enrollment and will be defined as number of participants consented to the number of individuals who are determined to be eligible.
  measure: Population-specific retention rates
  time frame: Week 12
  description: Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.
  measure: GGE app usability
  time frame: Week 12
  description: The app usability will be assessed using the 10-item System Usability Scale. SUS scores have a range of 0 to 100 with 100 representing greatest usability.
  measure: GGE intervention acceptability
  time frame: Week 12
  description: GGE intervention acceptability will be assessed with a study specific survey (collected from participants randomized to the GGE intervention only).
  measure: GGE adherence
  time frame: Weeks 1-4
  description: GGE adherence will be quantified as percent of reported eating events occurring at or below personalized glucose thresholds/personalized average fasting glucose levels that is collected using the GGE app (collected from participants randomized to the GGE intervention only-during use of the GGE app only).
  measure: Changes in body weight
  time frame: Weeks 0-12 and Weeks 12-24
  description: Changes in body weight will be measured using calibrated digital scales (measured in kilograms).
  measure: Changes in insulin resistance (HOMA-IR)
  time frame: Weeks 1-12
  description: Changes in insulin resistance will be measured as homeostatic model assessment for insulin resistance (HOMA-IR). It will be computed from fasting insulin and fasting glucose (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5).
  measure: Changes in glycemic variability
  time frame: Weeks 1-12
  description: Changes in glycemic variability will be assessed from CGM data using the freely accessible EasyGV software available from the University of Oxford (https://www.phc.ox.ac.uk/research/resources/easygv).
  measure: Changes in oxidative stress
  time frame: Weeks 1-12
  description: Changes in oxidative stress will be measured as 8-isoprostane from spot urine.
  measure: Changes in the soluble receptor for advanced glycation end-products (sRAGE)
  time frame: Weeks 1-12
  description: Changes the sRAGE was measured in serum by ELISA.
  arm group label: GGE with CGM
  arm group type: Experimental
  description: Participants randomized to the Glucose-Guided Intervention will be trained to align their mealtimes with a personalized glucose threshold monitored using continuous glucose monitoring (CGM) and the GGE study app.
  arm group label: CGM only
  arm group type: Active Comparator
  description: Participants randomized to the control arm will only wear a CGM.
  intervention type: Behavioral
  intervention name: Glucose-Guided Eating with CGM
  description: The GGE intervention consist of up to four weeks of training to learn to eat when glucose levels are at or below their usual fasting level. Specifically, participants following GGE will self-monitor their glucose levels with an unblinded CGM while using a mobile app (GGE app) that will provide feedback on whether or not to eat. At desired mealtimes participants will enter their current glucose level, rate their perceived hunger, and label the type of hunger they are experiencing (physical, emotional, sensory and practical). Participants following GGE will be instructed by the app to eat when two conditions are met: (a) the desire to eat arises and (b) their glucose levels are at or below a personalized threshold. During the training period, participants are meant to associate feelings of perceived hunger with fasting glucose levels (i.e., physical hunger). After the training period, participants continue to follow GGE without CGM or use of the app.
  arm group label: GGE with CGM
  intervention type: Other
  intervention name: CGM only
  description: Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.
  arm group label: CGM only
  arm group label: GGE with CGM
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Susan M Schembre
  role: Principal Investigator
  affiliation: Georgetown's Lombardi Comprehensive Cancer Center
  last name: Nina Kadan-Lottick
  role: Principal Investigator
  affiliation: Georgetown's Lombardi Comprehensive Cancer Center
  last name: Princess M Georges
  phone: 2026872117
  email: pg763@georgetown.edu
  last name: Megan Roy
  email: mr1839@georgetown.edu
  citation: Schembre SM, Jospe MR, Giles ED, Sears DD, Liao Y, Basen-Engquist KM, Thomson CA. A Low-Glucose Eating Pattern Improves Biomarkers of Postmenopausal Breast Cancer Risk: An Exploratory Secondary Analysis of a Randomized Feasibility Trial. Nutrients. 2021 Dec 16;13(12):4508. doi: 10.3390/nu13124508.
  PMID: 34960058
  citation: Schembre SM, Jospe MR, Bedrick EJ, Li L, Brewster AM, Levy E, Dirba DD, Campbell M, Taylor RW, Basen-Engquist KM. Hunger Training as a Self-regulation Strategy in a Comprehensive Weight Loss Program for Breast Cancer Prevention: A Randomized Feasibility Study. Cancer Prev Res (Phila). 2022 Mar 1;15(3):193-201. doi: 10.1158/1940-6207.CAPR-21-0298.
  PMID: 34893531
  responsible party type: Sponsor
  mesh term: Prediabetic State
  sharing ipd: Yes
  ipd description: The investigators intend to publish the protocol in a manuscript and share the IPD through an appropriate free access data repository.
  ipd time frame: Within 1 year of study completion.
  ipd access criteria: Shared IPD will be available via freely accessible data registry.