NCT05540704Recruiting
Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
The goal of this clinical trial is to test whether a new intervention works to treat eating disorders in type 1 diabetes. Participants are assigned to one of the following: (1) Acceptance and Commitment Therapy (ACT), (2) Supportive Diabetes Counseling, or (3) a 6-month Waitlist Control. Participants in the ACT and Supportive Diabetes Counseling conditions complete 12 sessions over 12-16 weeks and use their mobile phone between sessions to increase engagement and reinforce learning. The main questions are: Does treatment improve glycemic levels, eating disorder symptoms, diabetes management and diabetes distress? Does one treatment do better than the other? How do the treatments work, if they work, and for whom? Participants complete assessments that include wearing a continuous glucose sensor and activity watch, and get a blood draw to determine HbA1c. They also complete diagnostic interviews, surveys and computer tests of attention and things like heart rate and reaction time. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 235 (estimated)
- First submitted
- 9 Sept 2022
- Start date
- 4 Apr 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- Duke University
- Diseases
- Type 1 diabetes
- NCT number
- NCT05540704
What you commit to
- Study type: Interventional
- Planned participants: 235
- From 4 Apr 2023 to the primary completion date, Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses
- Current substance abuse disorder or current or past psychotic disorder
Other
- Active suicidal ideation
- Hypoglycemic unawareness as assessed by the Gold Method and multiple severe episodes of hypoglycemia requiring 3rd party assistance in the last 2 years
- NonEnglish speaking
Who the study is looking for
- 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
- 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
Criteria the registry did not label
- Primary Cohort
Age in the registry: 16 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Brown University Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.