iACT for eating disorders in Type 1 Diabetes - Clinical Trial

What is the Purpose of this Study?

Treatment

We are doing this study to test a new intervention for people with type 1 diabetes who also have disordered eating. We hope the strategy we are testing in this study can improve diabetes management and decrease eating disorder symptoms and emotional distress.

What is the Condition Being Studied?
Objective

Type 1 Diabetes and Disordered Eating

Who Can Participate in the Study?

Key Eligibility

Adults ages 16-50 who:
- Are diagnosed with type 1 diabetes
- Independently manage their T1D
- Experience signs/symptoms of disordered eating, including any of the following:
-- Overeating or binge eating
-- Skipping doses of insulin
-- Emotional distress about body weight or body image

For more information about this study, please contact the study team at act-at-duke@duke.edu or 919-668-1935. You can also fill out the survey linked above.

Age Group
Adults, Children

What is Involved?

Description

If you choose to join the study, we will randomly assign you (like a coin flip) to either receive standard diabetes education along with your usual care or to receive the experimental study intervention.

No matter your assignment, during the course of the study you will:
- Be enrolled for 3 months of active study treatment with 6 months of follow-up
- Complete individual counseling sessions with a health care provider (typically once a week for the first 3 months)
- Complete assessments at the beginning of the study, 6 weeks, end of the study, 3 months after the end of the study, and 6 months after the end of the study. These assessments can include:
-- Diagnostic interviews
-- Surveys
-- Brief computer tests of attention, memory, and heart rate variability
-- Blood draws to check hemoglobin A1c
-- Use of continuous glucose monitoring (using the Dexcom G6 Pro system)
-- Actigraphy (an ActiLife watch that tracks activity and sleep)

You can find out more about the study and see if you are eligible online: https://redcap.duke.edu/redcap/surveys/?s=9PXFYMHXD38PM7EP

Study Details

Full Title
A randomized controlled trial of iACT, a novel mHealth intervention for eating disorders in type 1 diabetes
Principal Investigator
Clinical Psychologist
Protocol Number
IRB: PRO00111401
NCT: NCT05540704
ClinicalTrials.gov
Enrollment Status
Open for Enrollment