Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Device: Continuous Glucose Monitoring (CGM)Behavioral: Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring
- Registration Number
- NCT05000021
- Lead Sponsor
- Albert Einstein College of Medicine
- Brief 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.
- Detailed 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 ecological momentary assessment (EMA) 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.
We will also collect qualitative information from people with Type 1 Diabetes (T1D) ages 35-64 to solicit suggestions and inform future study decisions. We will create 2-4 focus groups to ask their impressions about our current study and explore key factors like establishing adult care and attending medical appointments, disease self-management, and adjusting to chronic disease. We will compare interview responses from participant groups who have high vs. low social needs and poor vs. good glycemic control.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 93
- 18-64 years old
- HbA1c >7.5%
- Diabetes Duration >6 months
- Diabetes Distress level >40
- Comorbid psychiatric condition (e.g. depression, anxiety, or suicidality).
- In treatment for a psychological condition within the last 6 months
- On a non-stable dose of psychiatric medication over the past 2 months
- Developmental or sensory disability interfering with participation
- Current pregnancy, as self-management and glycemic goals differ
- Participations in another behavioral intervention study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous Glucose Monitoring (CGM) Only Continuous Glucose Monitoring (CGM) 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. Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring 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. Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring Continuous Glucose Monitoring (CGM) 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.
- Primary Outcome Measures
Name Time Method Diabetes Distress Levels 3 month mark (post-intervention) The Problem Areas in Diabetes (PAID) scale will be administered
- Secondary Outcome Measures
Name Time Method Hemoglobin A1c 3 month mark (post-intervention) Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory.
Time Below Range (TBR) calculated from Continuous Glucose Monitoring (CGM) 3 month mark (post-intervention) Percent of time with glucose values below 70 mg/dl will be calculated from CGM wear in the 3 months after randomization.
Time Above Range (TAR) calculated from Continuous Glucose Monitoring (CGM) 3 month mark (post-intervention) Percent of time with glucose values above 180 mg/dl will be calculated from CGM wear in the 3 months after randomization.
Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM) 3 month mark (post-intervention) Percent of time with glucose values between 70-180 mg/dl will be calculated from CGM wear in the 3 months after randomization.
Coefficient of Variation (CV) calculated from Continuous Glucose Monitoring (CGM) 3 month mark (post-intervention) The CV is the standard deviation of glucose changes divided by the mean glucose value
Trial Locations
- Locations (2)
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Yeshiva University
🇺🇸New York, New York, United States