Clinical trial Recruiting at 2 sites Interventional Ages 16 to 50

Mobile health intervention for eating disorders in type 1 diabetes

Official title: Changing the T1DE (Type 1 Diabetes Eating Disorders): A Randomized Controlled Trial Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling and a Waitlist Control

Run by Duke University · NCT05540704 · Data updated 2026-11-12

This study is testing a new mobile health program to see if it can help young adults with type 1 diabetes who have binge-purge eating disorders feel better and manage their diabetes more effectively.

Quick facts

Study typeInterventional
Ages16 Years to 50 Years
SexAll
Enrollment235 (estimated)
SponsorDuke University
Academic / other
Locations2 sites (Durham, North Carolina and 1 other locations)
StatusRecruiting
StartedApril 4, 2023
Main results expectedJune 2027
Study endsSeptember 2027
Registry record updatedSeptember 8, 2026
Trial IDNCT05540704 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 16-50 with type 1 diabetes and binge-purge eating disorders who can independently manage their diabetes.

Probably not a fit

Patients with current suicidal ideation, anorexia nervosa, or those who are non-English speaking may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project is a randomized controlled trial evaluating a novel mobile health intervention (iACT) aimed at treating eating disorders in patients with type 1 diabetes. The study will involve 128 participants aged 16-45 who have binge-purge eating disorders, and they will be randomly assigned to receive either iACT or usual care. Assessments will be conducted at baseline and every three months over a nine-month period, focusing on glycemic control, eating disorder symptoms, and diabetes management. The study also aims to explore the biobehavioral mechanisms of change and predictors of treatment response.

Why it matters

Potential benefit: If successful, this intervention could significantly improve glycemic control and eating disorder symptoms in patients with type 1 diabetes.

How similar studies have gone: While this approach is innovative, similar interventions in related areas have shown promise, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Primary Cohort

Inclusion 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)

Expansion Cohort

Inclusion Criteria:

* 16-50 years of age
* Diagnosis of Type 1 diabetes
* DEPR-R score \>=20 but does not meet criteria for the primary cohort

Primary and Expansion Cohort

Exclusion Criteria:

* Active suicidal ideation
* Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses
* Hypoglycemic unawareness as assessed by the Gold Method and multiple severe episodes of hypoglycemia requiring 3rd party assistance in the last 2 years
* Current substance abuse disorder or current or past psychotic disorder
* NonEnglish speaking

Where it's running

  • Duke University
    Durham, North Carolina, United States
    Recruiting
  • Brown University
    Providence, Rhode Island, United States
    Recruiting

Study contacts

  • Principal investigator: Rhonda Merwin, PhD — Duke University faculty
  • Study coordinator: Dottie R Mayo, BA
  • Email: drm72@duke.edu
  • Phone: (919) 668-1935

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.