No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
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At a Glance
Age
16 – 50
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
235 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for people between 16 and 50 with type 1 diabetes and certain eating disorders. Participants will receive therapy sessions or counseling and will complete various assessments to help improve their health.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 16 and 50 years old
I have been diagnosed with type 1 diabetes
I have an eating disorder with binge eating or problematic weight control
I manage my diabetes without help from a caregiver
You may not be able to join if
I have active suicidal thoughts
I have been diagnosed with Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa
I have hypoglycemic unawareness or severe hypoglycemia needing assistance
I currently abuse substances or have a past psychotic disorder
I do not speak English
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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City
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Status
Eligibility 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 …
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
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