Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

Completed

• Conditions: Type 1 Diabetes; Eating Disorder

• Registration Number: NCT01513746
• Lead Sponsor: Duke University

Brief Summary

The purpose of the study is to investigate how people with type 1 diabetes experience and manage their diabetes, eating, and weight. Summary of the Study: If you choose to participate, you will complete a set of questionnaires and a structured interview. You will then wear a continuous glucose monitor and use your cell phone to answer study questions for a period of 3 days. The questions come in the form of regular phone calls between the hours of 8:00 a.m. and 10:00 p.m. Each call takes only a minute or two to complete. You will also be asked to call in and answer study questions at other times during the day, especially after eating. The study involves a minimum of 2 clinic visits to Duke. Participants who live greater than 1.5 hours from Duke can be approved to take part in the study by phone/Skype. Participants will receive and return study materials through the mail.

Detailed Description

Eating disorders (ED) are far more prevalent among individuals with type 1 diabetes (T1D) than the general population. Yet what accounts for the increased prevalence of ED in T1D, and how to effectively treat these patients is unknown. ED in T1D is dangerous. T1D patients with ED not only engage in behaviors common among non-diabetic ED patients (like binge eating), but also might omit insulin to prevent weight gain. The goal of this study is to understand the psychophysiological precipitants to ED behavior among T1D patients.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-20
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

1. Adult (aged 18-65)
2. Diagnosed with type 1 diabetes
3. Clinically significant eating disorder symptoms
4. Currently monitored by a physician

Exclusion:

1. Severe hypoglycemic unawareness
2. Pregnancy
3. Current or history of psychosis or mania
4. Current substance abuse
5. Non-English speaking
6. Significant deficits in intellectual functioning

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Glucose Values	72 Hours

Secondary Outcome Measures

Name	Time	Method
Ecological Momentary Assessment of Emotional and Behavioral Outcomes	72 hours

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States