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NCT Number: NCT02980627

iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabulimia Eating Disorders Endocrine System Diseases Feeding and Eating Disorders Glucose Metabolism Disorders Immune System Diseases Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System, Durham, North Carolina, United States

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About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult aged 18 or older
  • Diagnosed with T1D
  • Positive for insulin misuse for weight control
  • HbA1c ≥ 7.5
  • Approved for participation by their physician
  • Agrees to continue care with their current physician with consent to contact
  • Access to a Smartphone

Exclusion criteria

  • Non-English speaking
  • Cognitive impairments that preclude independent management of T1D

Treatment and study plan

Therapy with Mobile App Enhancement

Behavioral

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

Primary outcomes

  1. Metabolic Control (Change in HbA1c)

    Time frame: Baseline, 3-months, 6-months and 9-months

Secondary outcomes

  1. 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

  2. Adequate Insulin Dosing (Frequency)

    Time frame: Baseline, 3-months, 6-months and 9-months

    Participants will report less frequent under-dosing of insulin

  3. Medical Utilization: Total Number of Primary Care Visits

    Time frame: Baseline, 3-months, 6-months, and 9-months

  4. Medical Utilization: Total Number of Emergency Department Care Visits

    Time frame: Baseline, 3-months, 6-months, and 9-months

  5. Participant Engagement in Treatment as evidenced by attendance/treatment completion

    Time frame: 3 months

    Attrition will be < 20%

  6. Improvement in Metabolic Control; CGM Continuous Glucose Monitoring

    Time frame: Baseline, 3-months

  7. Decrease in Diabetes-Specific Eating Disorder symptomatology

    Time frame: Baseline, 3-months, 6-months, and 9-months

  8. Decrease in Overall Eating Disorder symptomatology

    Time frame: Baseline, 3-months, 6-months, and 9-months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: iOmit

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2016
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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