93
Participants
Start Date
June 27, 2022
Primary Completion Date
August 31, 2026
Study Completion Date
August 31, 2026
Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring
CBT-DD consists of approximately 10 individual sessions of CBT delivered virtually by trained protocol therapists, conducted over the course of approximately 12 weeks. The CBT-DD consists of 5 core modules targeting negative emotionality and aversive reactions to emotional experiences. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. The final module consists of relapse prevention. CBT-DD sessions will integrate a review of Continuous Glucose Monitoring (CGM) data and feedback will be provided by the therapist.
Continuous Glucose Monitoring (CGM)
Use of commercially available, FDA-approved continuous glucose monitoring (CGM) for 6 months post-randomization. Usual diabetes care will continue and participants can initiate a CGM review from their healthcare providers, as desired. In addition, a nurse practitioner with expertise in CGM will train each participant via video recordings in the proper placement of the device, and technical issues, and provide basic teaching at the beginning of the trial on interpretation of CGM data and self-titration of insulin/self-management. Written materials and online resources for recognizing and managing diabetes distress, along with self-management information and treatment options to discuss with providers will also be provided.
RECRUITING
Yeshiva University, New York
RECRUITING
Albert Einstein College of Medicine, The Bronx
Collaborators (1)
Juvenile Diabetes Research Foundation
OTHER
DexCom, Inc.
INDUSTRY
Albert Einstein College of Medicine
OTHER