Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This project proposes to use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in adults with type 1 diabetes. The efficacy of CBT for diabetes distress (CBT-DD) will be tested in comparison to commercial FDA-approved CGM only in a randomized controlled clinical trial. The investigators' central hypothesis is that the addition of a CBT intervention that targets diabetes distress and self-management directly will yield clinically significant improvements in both diabetes distress and glycemic control relative to CGM alone. The investigators propose to recruit 93 adults (age 18-64) with type 1 diabetes from a national population for an entirely virtual 6-month study over four years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of HbA1c for glycemic control and validated patient-reported outcome (PRO) surveys, the investigators plan to innovatively integrate momentary psychological and behavioral data via smartphone-based ecological momentary assessment with CGM data to assess day-to-day changes in diabetes distress, affect, self-management, and glycemia over the course of the trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 18-64 years old

• HbA1c \>7.5%

• Diabetes Duration \>6 months

• Diabetes Distress level \>40

Locations
United States
New York
Yeshiva University
RECRUITING
New York
Albert Einstein College of Medicine
RECRUITING
The Bronx
Contact Information
Primary
Jeffrey Gonzalez, PhD
jeffrey.gonzalez@yu.edu
646-592-4376
Time Frame
Start Date: 2022-06-27
Estimated Completion Date: 2026-08
Participants
Target number of participants: 93
Treatments
Experimental: Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring
Participants randomized to this arm will receive Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD), enhanced by review of Continuous Glucose Monitoring (CGM) data. Participants will wear study-supplied CGM for the first 6 months of their participation in the trial.
Active_comparator: Continuous Glucose Monitoring (CGM) Only
Participants randomized to receive Continuous Glucose Monitoring (CGM) will continue to receive their usual care and will also wear CGM throughout the first 6 months of their participation in the trial.
Related Therapeutic Areas
Sponsors
Collaborators: Juvenile Diabetes Research Foundation, DexCom, Inc.
Leads: Albert Einstein College of Medicine

This content was sourced from clinicaltrials.gov