Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

NCT01513746 | Completed DMC

• 1 other identifier: Pro00031840
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Eating Disorder

Keywords

Type 1 Diabetes; Type 1 Diabetes Mellitus; Eating Disorders; Insulin Omission

Outcome Measures

Primary Outcomes (1)

• Blood Glucose Values

  72 Hours

Secondary Outcomes (1)

• Ecological Momentary Assessment of Emotional and Behavioral Outcomes

  72 hours

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UNC and Duke Endocrine Clinics Community of the Durham, Chapel Hill and Raleigh area

You may qualify if:

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

You may not qualify if:

• Severe hypoglycemic unawareness
• Pregnancy
• Current or history of psychosis or mania
• Current substance abuse
• Non-English speaking
• Significant deficits in intellectual functioning

Sponsors & Collaborators

• Duke University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Rhonda Merwin, PhD

  Site Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 20, 2012
• Study Start: December 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

US (1)