iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— iOmit  

Official title:

iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980627
• Other study ID #: Pro00068040
• Secondary ID: 1R21DK106603-01A
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: May 2, 2019

Study information

• Verified date: April 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2, 2019
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Eating Disorders
• Feeding and Eating Disorders
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Therapy 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.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Control (Change in HbA1c)		Baseline, 3-months, 6-months and 9-months
Secondary	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
Secondary	Adequate Insulin Dosing (Frequency)	Participants will report less frequent under-dosing of insulin	Baseline, 3-months, 6-months and 9-months
Secondary	Medical Utilization: Total Number of Primary Care Visits		Baseline, 3-months, 6-months, and 9-months
Secondary	Medical Utilization: Total Number of Emergency Department Care Visits		Baseline, 3-months, 6-months, and 9-months
Secondary	Participant Engagement in Treatment as evidenced by attendance/treatment completion	Attrition will be < 20%	3 months
Secondary	Improvement in Metabolic Control; CGM Continuous Glucose Monitoring		Baseline, 3-months
Secondary	Decrease in Diabetes-Specific Eating Disorder symptomatology		Baseline, 3-months, 6-months, and 9-months
Secondary	Decrease in Overall Eating Disorder symptomatology		Baseline, 3-months, 6-months, and 9-months

External Links

•   Acceptance and Commitment Therapy at Duke University Medical Center