iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

Status:	Active, not recruiting
Conditions:	Diabetes, Diabetes, Eating Disorder
Therapuetic Areas:	Endocrinology, Psychiatry / Psychology
Healthy:	No
Age Range:	18 - 55
Updated:	9/14/2018
Start Date:	March 2016
End Date:	June 2019

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.

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..

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

We found this trial at

sites

Duke University Health System

Durham, North Carolina

Principal Investigator: Rhonda M Merwin, PhD

Phone: 919-684-0149

from

Durham, NC