Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT05540704
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT05540704
Study Brief:
Protocol Section:
NCT05540704