Clinical trial NCT02980627: iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes
Official title: iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Eating Disorders
Keywords: Eating Disorders
Diabulimia
ED-T1DM
Type 1 Diabetes
Mobile Technology
Acceptance and Commitment Therapy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-12-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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..

Eligibility 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

Primary outcomes:
measure: Metabolic Control (Change in HbA1c)
timeFrame: Baseline, 3-months, 6-months and 9-months
Secondary outcomes:
measure: Mobile Technology Engagement (Frequency of Use)
timeFrame: Daily monitoring for 3 months
measure: Adequate Insulin Dosing (Frequency)
timeFrame: Baseline, 3-months, 6-months and 9-months
measure: Medical Utilization: Total Number of Primary Care Visits
timeFrame: Baseline, 3-months, 6-months, and 9-months
measure: Medical Utilization: Total Number of Emergency Department Care Visits
timeFrame: Baseline, 3-months, 6-months, and 9-months
measure: Participant Engagement in Treatment as evidenced by attendance/treatment completion
timeFrame: 3 months
measure: Improvement in Metabolic Control; CGM Continuous Glucose Monitoring
timeFrame: Baseline, 3-months
measure: Decrease in Diabetes-Specific Eating Disorder symptomatology
timeFrame: Baseline, 3-months, 6-months, and 9-months
measure: Decrease in Overall Eating Disorder symptomatology
timeFrame: Baseline, 3-months, 6-months, and 9-months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Rhonda Merwin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merwin RM, Dmitrieva NO, Honeycutt LK, Moskovich AA, Lane JD, Zucker NL, Surwit RS, Feinglos M, Kuo J. Momentary Predictors of Insulin Restriction Among Adults With Type 1 Diabetes and Eating Disorder Symptomatology. Diabetes Care. 2015 Nov;38(11):2025-32. doi: 10.2337/dc15-0753. Epub 2015 Sep 17.
citation: Merwin RM, Moskovich AA, Dmitrieva NO, Pieper CF, Honeycutt LK, Zucker NL, Surwit RS, Buhi L. Disinhibited eating and weight-related insulin mismanagement among individuals with type 1 diabetes. Appetite. 2014 Oct;81:123-30. doi: 10.1016/j.appet.2014.05.028. Epub 2014 May 29.
citation: Merwin RM, Moskovich AA, Babyak M, Feinglos M, Honeycutt LK, Mooney J, Freeman SP, Batchelder H, Sangvai D. An open trial of app-assisted acceptance and commitment therapy (iACT) for eating disorders in type 1 diabetes. J Eat Disord. 2021 Jan 6;9(1):6. doi: 10.1186/s40337-020-00357-6.