iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus, Eating Disorders

In brief

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.

Key facts

Study ID

NCT02980627

Run by

Duke University

People needed

27

Starts

2016-03-01

Expected to finish

2019-05-02

Last updated by the study team

2019-06-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult aged 18 or older
• Diagnosed with T1D
• Positive for insulin misuse for weight control
• HbA1c ≥ 7.5
• Approved for participation by their physician
• Agrees to continue care with their current physician with consent to contact
• Access to a Smartphone

You may not qualify if…

• Non-English speaking
• Cognitive impairments that preclude independent management of T1D

Where it is running

• Duke University Health System — Durham, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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