Eating Disorders, Type 1 Diabetes Mellitus
Conditions
Keywords
Eating Disorders, Diabulimia, ED-T1DM, Type 1 Diabetes, Mobile Technology, Acceptance and Commitment Therapy
Brief 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..
Interventions
BEHAVIORALTherapy 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic Control (Change in HbA1c) | Baseline, 3-months, 6-months and 9-months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adequate Insulin Dosing (Frequency) | 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 | 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 | — |
| Mobile Technology Engagement (Frequency of Use) | 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 |
| 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 | — |
| Participant Engagement in Treatment as evidenced by attendance/treatment completion | 3 months | Attrition will be \< 20% |
Countries
United States
Outcome results
None listed