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NCT05540704 · ClinicalTrials.gov registry record · NA
Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes
A NA study of Type 1 Diabetes and Binge-Eating Disorder, sponsored by Duke University.
- Recruiting
- Registry status
- NA
- Development phase
- 235
- Enrollment target
- 2
- Study locations
NCT05540704: Recruiting NA study of Type 1 Diabetes and Binge-Eating Disorder, sponsored by Duke University.
NCT05540704 is a NA study of Type 1 Diabetes and Binge-Eating Disorder that is actively recruiting participants, run by Duke University. The registered enrollment target is 235 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05540704, a NA study of Type 1 Diabetes and Binge-Eating Disorder, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- NA
- Development phase
- 235 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
CGM indices of time in target glycemic range, mean blood sugar, frequency of Level 1 and 2 hyperglycemia and blood glucose variability
Conditions Studied
Interventions
- BEHAVIORAL ACT
- BEHAVIORAL Supportive Diabetes Counseling
Study Locations (2)
North Carolina
- Duke University - Durham
Rhode Island
- Brown University - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2027-09 |
| Phase | NA |
What NCT05540704 shows while recruiting
NCT05540704 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (69% lower).
The record links to 5 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which ACT is the first listed.
NCT05540704 reports a single indexed study location in North Carolina, Rhode Island.
Frequently Asked Questions
What is clinical trial NCT05540704 about?
NCT05540704 is a clinical study titled "Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes". 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. Participant...
What is the current status of trial NCT05540704?
This trial is currently recruiting. It is a NA study. The enrollment target is 235 participants. The study started on 2023-04-04. Estimated completion is 2027-09.
What conditions does trial NCT05540704 study?
This clinical trial studies the following conditions: Type 1 Diabetes, Binge-Eating Disorder, Eating Disorders, Purging (Eating Disorders), Disordered Eating Behaviors.
What interventions are being tested in trial NCT05540704?
The interventions under investigation include: ACT (BEHAVIORAL), Supportive Diabetes Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT05540704?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05540704 being conducted?
This trial has 2 study locations across North Carolina, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05540704's enrollment target sits among peer trials
235 27th of 198 higher than 172 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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