Changing the T1DE - Clinical Trial

¿Cuál es el Propósito de este estudio?

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.

¿Cuál es la Condición que se está estudiando?

Type 1 Diabetes and Disordered Eating

¿Quién puede participar en el Estudio?

Adultos de 16 a 50 años que:

  • 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, or 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 in the description of the study.

Grupo etario
Adultos, Niños

¿Qué Implica?

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

The study assessments can include:

  • Diagnostic interviews
  • Encuestas
  • 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

Detalles del Estudio

Título Completo
Changing the T1DE: A randomized controlled trial comparing ACT to supportive diabetes counseling
Investigador Principal
Rhonda M. Merwin, PhD
Especialista en psicología clínica
Número de Protocolo
IRB: PRO00111401
NCT: NCT05540704
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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