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iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

NCT02980627 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-06-11

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Rhonda Merwin, PhD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-05-02
Completion
2019-05-02

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02980627 on ClinicalTrials.gov