Type 1 Diabetes Mellitus Clinical Trial
Official title:
iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes
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.. ;
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