iACT for Eating Disorders in Type 1 Diabetes

Description

This project is a randomized controlled trial of iACT, a novel mHealth intervention for eating disorders in type 1 diabetes (ED-T1DM). Participants will be 128 T1DM patients between the ages of 16-45 with binge-purge EDs, including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Participants will be randomized to either iACT or Usual Care, and complete assessments at baseline and every 3 months for 9 months. The primary outcome of interest is glycemic control as assessed by continuous glucose monitoring. Other outcomes include HbA1c, eating disorder symptoms, diabetes self-management and diabetes distress. In addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. Process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. The primary site is Duke University Medical Center. The Miriam Hospital is a secondary site.

Conditions

Type 1 Diabetes, Eating Disorders

Study Overview

Study Details

Study overview

This project is a randomized controlled trial of iACT, a novel mHealth intervention for eating disorders in type 1 diabetes (ED-T1DM). Participants will be 128 T1DM patients between the ages of 16-45 with binge-purge EDs, including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Participants will be randomized to either iACT or Usual Care, and complete assessments at baseline and every 3 months for 9 months. The primary outcome of interest is glycemic control as assessed by continuous glucose monitoring. Other outcomes include HbA1c, eating disorder symptoms, diabetes self-management and diabetes distress. In addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. Process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. The primary site is Duke University Medical Center. The Miriam Hospital is a secondary site.

A Randomized Controlled Trial of iACT, a Novel mHealth Intervention for Eating Disorders in Type 1 Diabetes

iACT for Eating Disorders in Type 1 Diabetes

Condition
Type 1 Diabetes
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University, Durham, North Carolina, United States, 27705

Providence

Brown University, Providence, Rhode Island, United States, 02903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 16-50 years of age
  • * Diagnosis of Type 1 diabetes
  • * Eating disorder characterized by binge eating and/or problematic weight control behaviors, including withholding insulin (Bulimia Nervosa, Binge Eating and Purging Disorder spectrum diagnoses)
  • * Independently manages diabetes (not reliant on a caregiver)
  • * Current suicidal ideation or self-harming behavior
  • * Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses
  • * Hypoglycemic unawareness as assessed by the Gold Method
  • * Current substance abuse disorder or current or past psychotic disorder
  • * NonEnglish speaking

Ages Eligible for Study

16 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Rhonda Merwin, PhD, PRINCIPAL_INVESTIGATOR, Duke University faculty

Study Record Dates

2026-06-01