<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/NCT02980627</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00068040</org_study_id>
    <secondary_id>1R21DK106603-01A1</secondary_id>
    <nct_id>NCT02980627</nct_id>
  </id_info>
  <brief_title>iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes</brief_title>
  <acronym>iOmit</acronym>
  <official_title>iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke 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>
      Individuals with type 1 diabetes who intentionally omit insulin to lose weight are at high&#xD;
      risk for diabetes-related medical complications and premature death. Conventional eating&#xD;
      disorder (ED) treatments are not as effective for these patients, suggesting that they need a&#xD;
      more tailored treatment approach and one that includes intervention at the time and place&#xD;
      when they are making decisions about their diabetes self-management. The goal of treatment&#xD;
      development project is to modify an existing mobile application (app) for EDs (Recovery&#xD;
      Record; RR) to address the unique needs of adults with type 1 diabetes (T1D) who&#xD;
      intentionally omit their insulin for weight control, and test whether app-supported&#xD;
      individual treatment decreases eating disorder (ED) symptoms and improves metabolic control.&#xD;
      The investigator will also gather preliminary data on the impact of the intervention on&#xD;
      health care utilization and costs and calculate attrition to assess feasibility.&#xD;
&#xD;
      The investigators hypothesize that (1) participants will evidence significant decreases in&#xD;
      mean blood glucose, (2) participation in routine medical care will increase and emergency&#xD;
      visits will decrease, (3) the percentage of time participants are hyperglycemic will&#xD;
      decrease, (4) participant scores on the DEPS-R will decrease and (5) participant scores on&#xD;
      the EDE will decrease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intentional insulin omission for weight control is a significant problem in the clinical&#xD;
      management of type 1 diabetes (T1D); despite this, there are no effective treatments.&#xD;
      Combining the use of mobile technology with individual therapy may help individuals with T1D&#xD;
      identify their triggers for insulin omission in their natural environment and cope more&#xD;
      effectively. In the current study, the investigators examine whether pairing a mobile&#xD;
      application, Recovery Record, with individual therapy helps reduce intentional insulin&#xD;
      omission for weight control among individuals with T1D. In Phase 1, the investigators build&#xD;
      T1D-specific content into the Recovery Record app based on our empirical evidence of triggers&#xD;
      for insulin omission and qualitative feedback from T1D patients. The fully functional app is&#xD;
      beta tested with 10 T1D patients who intentionally omit insulin. In Phase 2, 25 T1D patients&#xD;
      that misuse insulin complete 3 months of app-supported individual treatment and 6 months of&#xD;
      follow-up. The investigators test whether treatment is associated with decreases in mean&#xD;
      blood glucose, eating disorder symptoms and emergency care utilization. The investigators&#xD;
      also test whether frequency of app use in months 0-3 corresponds with outcomes, and calculate&#xD;
      attrition..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">May 2, 2019</completion_date>
  <primary_completion_date type="Actual">May 2, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolic Control (Change in HbA1c)</measure>
    <time_frame>Baseline, 3-months, 6-months and 9-months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mobile Technology Engagement (Frequency of Use)</measure>
    <time_frame>Daily monitoring for 3 months</time_frame>
    <description>Improvements in metabolic control will correspond with treatment engagement as reflected in frequency of app use from 0-3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate Insulin Dosing (Frequency)</measure>
    <time_frame>Baseline, 3-months, 6-months and 9-months</time_frame>
    <description>Participants will report less frequent under-dosing of insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Utilization: Total Number of Primary Care Visits</measure>
    <time_frame>Baseline, 3-months, 6-months, and 9-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Utilization: Total Number of Emergency Department Care Visits</measure>
    <time_frame>Baseline, 3-months, 6-months, and 9-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Engagement in Treatment as evidenced by attendance/treatment completion</measure>
    <time_frame>3 months</time_frame>
    <description>Attrition will be &lt; 20%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Metabolic Control; CGM Continuous Glucose Monitoring</measure>
    <time_frame>Baseline, 3-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in Diabetes-Specific Eating Disorder symptomatology</measure>
    <time_frame>Baseline, 3-months, 6-months, and 9-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in Overall Eating Disorder symptomatology</measure>
    <time_frame>Baseline, 3-months, 6-months, and 9-months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <condition>Eating Disorders</condition>
  <arm_group>
    <arm_group_label>Therapy with Mobile App Enhancement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete initial assessments and then take part in a 3-month intervention consisting of 12 weekly individual therapy sessions with daily RR app use between sessions. At the end of the 3-month intervention period, an exit interview will be conducted and participants will complete a second assessment consisting of questionnaires and an ED diagnostic interview, a blood specimen for HbA1c, and 3-days of blinded CGM monitoring. Participants will then enter a 6-month follow-up period during which time they may continue to use the app, but will no longer attend individual sessions. Participants will be return to the clinic at 6 and 9 months for follow-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapy with Mobile App Enhancement</intervention_name>
    <description>Treatment includes 12 weekly therapy sessions with daily RR app use between sessions. Intervention is CBT-based and specifically draws from ACT. ACT is a contextual behavior therapy that emphasizes the function of behavior (e.g., affect regulation) and helps individuals accept (or &quot;tolerate&quot;) emotional discomfort for a broader purpose (i.e., personal values). Broadly, treatment will focus on improving diabetes management by increasing patients' capacity to effectively cope with psychological barriers to self-care using acceptance and mindfulness strategies.</description>
    <arm_group_label>Therapy with Mobile App Enhancement</arm_group_label>
    <other_name>Recovery Record</other_name>
    <other_name>Acceptance and Commitment Therapy</other_name>
    <other_name>ACT</other_name>
    <other_name>Mobile Technology</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult aged 18 or older&#xD;
&#xD;
          2. Diagnosed with T1D&#xD;
&#xD;
          3. Positive for insulin misuse for weight control&#xD;
&#xD;
          4. HbA1c ≥ 7.5&#xD;
&#xD;
          5. Approved for participation by their physician&#xD;
&#xD;
          6. Agrees to continue care with their current physician with consent to contact&#xD;
&#xD;
          7. Access to a Smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-English speaking&#xD;
&#xD;
          2. Cognitive impairments that preclude independent management of T1D&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rhonda Merwin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Health System</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ACTatDuke.org</url>
    <description>Acceptance and Commitment Therapy at Duke University Medical Center</description>
  </link>
  <reference>
    <citation>Merwin RM, Dmitrieva NO, Honeycutt LK, Moskovich AA, Lane JD, Zucker NL, Surwit RS, Feinglos M, Kuo J. Momentary Predictors of Insulin Restriction Among Adults With Type 1 Diabetes and Eating Disorder Symptomatology. Diabetes Care. 2015 Nov;38(11):2025-32. doi: 10.2337/dc15-0753. Epub 2015 Sep 17.</citation>
    <PMID>26384389</PMID>
  </reference>
  <reference>
    <citation>Merwin RM, Moskovich AA, Dmitrieva NO, Pieper CF, Honeycutt LK, Zucker NL, Surwit RS, Buhi L. Disinhibited eating and weight-related insulin mismanagement among individuals with type 1 diabetes. Appetite. 2014 Oct;81:123-30. doi: 10.1016/j.appet.2014.05.028. Epub 2014 May 29.</citation>
    <PMID>24882448</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>June 7, 2019</last_update_submitted>
  <last_update_submitted_qc>June 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Eating Disorders</keyword>
  <keyword>Diabulimia</keyword>
  <keyword>ED-T1DM</keyword>
  <keyword>Type 1 Diabetes</keyword>
  <keyword>Mobile Technology</keyword>
  <keyword>Acceptance and Commitment Therapy</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 1</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02980627
org study id: Pro00068040
secondary id: 1R21DK106603-01A1
nct id: NCT02980627
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Individuals with type 1 diabetes who intentionally omit insulin to lose weight are at high
      risk for diabetes-related medical complications and premature death. Conventional eating
      disorder (ED) treatments are not as effective for these patients, suggesting that they need a
      more tailored treatment approach and one that includes intervention at the time and place
      when they are making decisions about their diabetes self-management. The goal of treatment
      development project is to modify an existing mobile application (app) for EDs (Recovery
      Record; RR) to address the unique needs of adults with type 1 diabetes (T1D) who
      intentionally omit their insulin for weight control, and test whether app-supported
      individual treatment decreases eating disorder (ED) symptoms and improves metabolic control.
      The investigator will also gather preliminary data on the impact of the intervention on
      health care utilization and costs and calculate attrition to assess feasibility.

      The investigators hypothesize that (1) participants will evidence significant decreases in
      mean blood glucose, (2) participation in routine medical care will increase and emergency
      visits will decrease, (3) the percentage of time participants are hyperglycemic will
      decrease, (4) participant scores on the DEPS-R will decrease and (5) participant scores on
      the EDE will decrease.
Intentional insulin omission for weight control is a significant problem in the clinical
      management of type 1 diabetes (T1D); despite this, there are no effective treatments.
      Combining the use of mobile technology with individual therapy may help individuals with T1D
      identify their triggers for insulin omission in their natural environment and cope more
      effectively. In the current study, the investigators examine whether pairing a mobile
      application, Recovery Record, with individual therapy helps reduce intentional insulin
      omission for weight control among individuals with T1D. In Phase 1, the investigators build
      T1D-specific content into the Recovery Record app based on our empirical evidence of triggers
      for insulin omission and qualitative feedback from T1D patients. The fully functional app is
      beta tested with 10 T1D patients who intentionally omit insulin. In Phase 2, 25 T1D patients
      that misuse insulin complete 3 months of app-supported individual treatment and 6 months of
      follow-up. The investigators test whether treatment is associated with decreases in mean
      blood glucose, eating disorder symptoms and emergency care utilization. The investigators
      also test whether frequency of app use in months 0-3 corresponds with outcomes, and calculate
      attrition..
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Metabolic Control (Change in HbA1c)
time frame: Baseline, 3-months, 6-months and 9-months
measure: Mobile Technology Engagement (Frequency of Use)
time frame: Daily monitoring for 3 months
description: Improvements in metabolic control will correspond with treatment engagement as reflected in frequency of app use from 0-3 months
measure: Adequate Insulin Dosing (Frequency)
time frame: Baseline, 3-months, 6-months and 9-months
description: Participants will report less frequent under-dosing of insulin
measure: Medical Utilization: Total Number of Primary Care Visits
time frame: Baseline, 3-months, 6-months, and 9-months
measure: Medical Utilization: Total Number of Emergency Department Care Visits
time frame: Baseline, 3-months, 6-months, and 9-months
measure: Participant Engagement in Treatment as evidenced by attendance/treatment completion
time frame: 3 months
description: Attrition will be < 20%
measure: Improvement in Metabolic Control; CGM Continuous Glucose Monitoring
time frame: Baseline, 3-months
measure: Decrease in Diabetes-Specific Eating Disorder symptomatology
time frame: Baseline, 3-months, 6-months, and 9-months
measure: Decrease in Overall Eating Disorder symptomatology
time frame: Baseline, 3-months, 6-months, and 9-months
arm group label: Therapy with Mobile App Enhancement
arm group type: Experimental
description: Participants will complete initial assessments and then take part in a 3-month intervention consisting of 12 weekly individual therapy sessions with daily RR app use between sessions. At the end of the 3-month intervention period, an exit interview will be conducted and participants will complete a second assessment consisting of questionnaires and an ED diagnostic interview, a blood specimen for HbA1c, and 3-days of blinded CGM monitoring. Participants will then enter a 6-month follow-up period during which time they may continue to use the app, but will no longer attend individual sessions. Participants will be return to the clinic at 6 and 9 months for follow-up.
intervention type: Behavioral
intervention name: Therapy with Mobile App Enhancement
description: Treatment includes 12 weekly therapy sessions with daily RR app use between sessions. Intervention is CBT-based and specifically draws from ACT. ACT is a contextual behavior therapy that emphasizes the function of behavior (e.g., affect regulation) and helps individuals accept (or "tolerate") emotional discomfort for a broader purpose (i.e., personal values). Broadly, treatment will focus on improving diabetes management by increasing patients' capacity to effectively cope with psychological barriers to self-care using acceptance and mindfulness strategies.
arm group label: Therapy with Mobile App Enhancement
other name: Recovery Record
other name: Acceptance and Commitment Therapy
other name: ACT
other name: Mobile Technology
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Rhonda Merwin, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
country: United States
url: http://www.ACTatDuke.org
description: Acceptance and Commitment Therapy at Duke University Medical Center
citation: Merwin RM, Dmitrieva NO, Honeycutt LK, Moskovich AA, Lane JD, Zucker NL, Surwit RS, Feinglos M, Kuo J. Momentary Predictors of Insulin Restriction Among Adults With Type 1 Diabetes and Eating Disorder Symptomatology. Diabetes Care. 2015 Nov;38(11):2025-32. doi: 10.2337/dc15-0753. Epub 2015 Sep 17.
PMID: 26384389
citation: Merwin RM, Moskovich AA, Dmitrieva NO, Pieper CF, Honeycutt LK, Zucker NL, Surwit RS, Buhi L. Disinhibited eating and weight-related insulin mismanagement among individuals with type 1 diabetes. Appetite. 2014 Oct;81:123-30. doi: 10.1016/j.appet.2014.05.028. Epub 2014 May 29.
PMID: 24882448
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Feeding and Eating Disorders
sharing ipd: No