iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus; Eating Disorders
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      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.
    

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..
    

Intervention name(s): Therapy with Mobile App Enhancement
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Recovery Record; Acceptance and Commitment Therapy; ACT; Mobile Technology
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eating Disorders; Diabulimia; ED-T1DM; Type 1 Diabetes; Mobile Technology; Acceptance and Commitment Therapy