iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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..

Official Title
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iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus, Eating Disorders

Intervention / Treatment
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* Behavioral: Therapy with Mobile App Enhancement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy with Mobile App Enhancement<br>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<br>* 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.<br>* Other names: Mobile Technology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Control (Change in HbA1c) |  | Baseline, 3-months, 6-months and 9-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobile Technology Engagement (Frequency of Use) | Improvements in metabolic control will correspond with treatment engagement as reflected in frequency of app use from 0-3 months | Daily monitoring for 3 months | 
| Adequate Insulin Dosing (Frequency) | Participants will report less frequent under-dosing of insulin | Baseline, 3-months, 6-months and 9-months | 
| Medical Utilization: Total Number of Primary Care Visits |  | Baseline, 3-months, 6-months, and 9-months | 
| Medical Utilization: Total Number of Emergency Department Care Visits |  | Baseline, 3-months, 6-months, and 9-months | 
| Participant Engagement in Treatment as evidenced by attendance/treatment completion | Attrition will be < 20% | 3 months | 
| Improvement in Metabolic Control; CGM Continuous Glucose Monitoring |  | Baseline, 3-months | 
| Decrease in Diabetes-Specific Eating Disorder symptomatology |  | Baseline, 3-months, 6-months, and 9-months | 
| Decrease in Overall Eating Disorder symptomatology |  | Baseline, 3-months, 6-months, and 9-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Eating Disorders, Diabulimia, ED-T1DM, Mobile Technology, Acceptance and Commitment Therapy