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iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes (iOmit)

This study is currently recruiting participants.
Verified May 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980627
First Posted: December 2, 2016
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus Eating Disorders Behavioral: Therapy with Mobile App Enhancement Device: Recovery Record (RR) Mobile app

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Metabolic Control (Change in HbA1c) [ Time Frame: Baseline, 3-months, 6-months and 9-months ]

Secondary Outcome Measures:
  • Mobile Technology Engagement (Frequency of Use) [ Time Frame: Daily monitoring for 3 months ]
    Improvements in metabolic control will correspond with treatment engagement as reflected in frequency of app use from 0-3 months

  • Adequate Insulin Dosing (Frequency) [ Time Frame: Baseline, 3-months, 6-months and 9-months ]
    Participants will report less frequent under-dosing of insulin

  • Medical Utilization: Total Number of Primary Care Visits [ Time Frame: Baseline, 3-months, 6-months, and 9-months ]
  • Medical Utilization: Total Number of Emergency Department Care Visits [ Time Frame: Baseline, 3-months, 6-months, and 9-months ]
  • Participant Engagement in Treatment as evidenced by attendance/treatment completion [ Time Frame: 3 months ]
    Attrition will be < 20%

  • Improvement in Metabolic Control; CGM Continuous Glucose Monitoring [ Time Frame: Baseline, 3-months ]
  • Decrease in Diabetes-Specific Eating Disorder symptomatology [ Time Frame: Baseline, 3-months, 6-months, and 9-months ]
  • Decrease in Overall Eating Disorder symptomatology [ Time Frame: Baseline, 3-months, 6-months, and 9-months ]

Estimated Enrollment: 60
Actual Study Start Date: March 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapy with Mobile App Enhancement
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.
Behavioral: Therapy with Mobile App Enhancement
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.
Other Names:
  • Recovery Record
  • Acceptance and Commitment Therapy
  • ACT
  • Mobile Technology
Device: Recovery Record (RR) Mobile app
Treatment includes the use of a mobile application originally designed for eating disorders and adapted to include components specific to Type 1 Diabetes and Acceptance and Commitment Therapy (ACT). Participants will access this app outside of therapy and receive prompts from their therapist related to their current treatment goals.

Detailed Description:
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..
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult aged 18 or older
  2. Diagnosed with T1D
  3. Positive for insulin misuse for weight control
  4. HbA1c ≥ 7.5
  5. Approved for participation by their physician
  6. Agrees to continue care with their current physician with consent to contact
  7. Access to a Smartphone

Exclusion Criteria:

  1. Non-English speaking
  2. Cognitive impairments that preclude independent management of T1D
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980627


Contacts
Contact: Rhonda M Merwin, PhD 9196817231 Rhonda.Merwin@duke.edu
Contact: Lisa K Honeycutt, MA, LPCS 9196840353 lisa.honeycutt@duke.edu

Locations
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Lisa K Honeycutt, MA, LPC    919-684-0149    lisa.honeycutt@duke.edu   
Principal Investigator: Rhonda M Merwin, PhD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27713
Contact: Rhonda Merwin, PhD    919-681-7231    rhonda.merwin@duke.edu   
Contact: Lisa Honeycutt, MA    919-684-0353    lisa.honeycutt@duke.edu   
Principal Investigator: Rhonda Merwin, PhD         
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Rhonda Merwin, PhD Duke University
  More Information

Additional Information:
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02980627     History of Changes
Other Study ID Numbers: Pro00068040
1R21DK106603-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2016
First Posted: December 2, 2016
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Duke University:
Eating Disorders
Diabulimia
ED-T1DM
Type 1 Diabetes
Mobile Technology
Acceptance and Commitment Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Feeding and Eating Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Mental Disorders