iACT for Eating Disorders in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

A Randomized Controlled Trial of iACT, a Novel mHealth Intervention for Eating Disorders in Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540704
• Other study ID #: Pro00111401
• Secondary ID: 4-SRA-2022-1226-
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: Dottie R Mayo, BA
• Phone: (919) 668-1935
• Email: drm72[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is a randomized controlled trial of iACT, a novel mHealth intervention for eating disorders in type 1 diabetes (ED-T1DM). Participants will be 128 T1DM patients between the ages of 16-45 with binge-purge EDs, including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Participants will be randomized to either iACT or Usual Care, and complete assessments at baseline and every 3 months for 9 months. The primary outcome of interest is glycemic control as assessed by continuous glucose monitoring. Other outcomes include HbA1c, eating disorder symptoms, diabetes self-management and diabetes distress. In addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. Process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. The primary site is Duke University Medical Center. The Miriam Hospital is a secondary site.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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)

Exclusion Criteria:

• Current suicidal ideation or self-harming behavior

• Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses

• Hypoglycemic unawareness as assessed by the Gold Method

• Current substance abuse disorder or current or past psychotic disorder

• NonEnglish speaking

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Eating Disorders
• Feeding and Eating Disorders
• Type 1 Diabetes

Intervention

Behavioral:
• iACT
Treatment is based on Acceptance and Commitment Therapy (ACT), a contemporary cognitive behavioral therapy (CBT) that improves human functioning and adaptability by increasing psychological flexibility. Individual therapy sessions are paired with mobile phone delivered interventions.

Other:
• Usual Care
Usual care for problems in Type 1 diabetes management

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycemic control as indexed by continuous glucose monitoring (CGM)	CGM indices of time in range, frequency of Level 1 and 2 hyperglycemia and blood glucose variability	baseline, 6 weeks, 12 weeks, 36 weeks
Primary	Change in glycemic control as indexed by hemoglobin A1c (HbA1c)	Glycated hemoglobin (percentage of red blood cells that are glycated providing an estimate of average blood glucose over 3 months)	baseline, 12 weeks, 24 weeks, 36 weeks
Primary	Change in eating disorder symptoms as indexed by the Eating Disorder Examination Global score	Severity of eating and body image concerns, frequency of engagement in maladaptive eating and weight control behaviors. Global scores range from 0-6, with higher scores indicating greater symptom severity (worse outcome).	baseline, 12 weeks, 36 weeks
Primary	Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey	Severity of eating and body image concerns, frequency of engagement in maladaptive eating and weight control behaviors, specifically in the context of diabetes. Scores range from 0-80, with higher scores indicating greater symptom severity (worse outcome).	baseline, 12 weeks, 24 weeks, 36 weeks
Primary	Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire	Engagement in activities necessary to manage diabetes, including checking blood sugar and administering insulin. Scores range from 0-10 with higher scores indicating better self-management.	baseline, 12 weeks, 24 weeks, 36 weeks
Primary	Acceptability as measured by meeting the recruitment target for the study	recruitment of n=128	36 months from start of enrollment
Primary	Feasibility as measured by participant attrition less than 20%	Less than n=26 individuals dropping out of treatment prematurely	39 months from start of enrollment
Secondary	Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale	Feelings of stress or overwhelm with the burden of living with diabetes and diabetes management. Scores range from 1-6, with higher scores indicating greater distress (worse outcome)	baseline, 12 weeks, 24 weeks, 36 weeks
Secondary	Change in NIH PROMIS Scale - Depression	8 items assessing depressive affect, scored 1-5 and t-score normed (mean of 50, standard deviation of 10). Higher scores indicating greater symptoms (worse outcome).	baseline, 12 weeks, 36 weeks
Secondary	Change in NIH PROMIS Scale - Anxiety	8 items assessing anxious affect, scored 1-5 and t-score normed (mean of 50, standard deviation of 10). Higher scores indicating greater symptoms (worse outcome).	baseline, 12 weeks, 36 weeks