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

Type 1 Diabetes Clinical Trial

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

Status Recruiting

Clinical Trial Summary

This project proposes to use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in young 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 150 young adults (age 18-35) 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.

Clinical Trial Description

The investigators propose a randomized controlled trial (RCT) of CBT-DD, enhanced by CGM feedback. The study period will last for 6 months, with the first 3 months on CGM and consisting of a 2-week run-in period prior to randomization, in which EMA (ecological momentary assessment) data will be collected daily, followed by an 8-week CBT intervention period in which EMA data will be collected weekly surrounding CBT sessions, with a subsequent 2-week period post-intervention in which EMA data will again be collected daily. Both intervention and control groups will be doing the same EMA and CGM procedures to enable matching data for comparison. Follow-up virtual study data collection will occur at 3, 6, 9, and 12 months to assess the primary outcome of HbA1c and durability of intervention effect on diabetes distress and HbA1c. Participants in both arms will be provided a sufficient supply of CGM sensors to track their blood glucose daily, throughout the first 6 months of the study. If participants already have personal CGM, they will replace with study-supplied CGM. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

• NCT number: NCT05000021
• Study type: Interventional
• Source: Albert Einstein College of Medicine
• Contact: Shivani Agarwal, MD, MPH
• Phone: 844-556-6683
• Email: Shivani.agarwal@einsteinmed.org
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2022
• Completion date: March 31, 2025