Join a Trial Studying the Impact of Virtual Therapy on Type 1 Diabetes
If you are an adult under 65 with type 1 diabetes, you may be eligible to join a trial studying the use of therapy to improve your diabetes management and quality of life.
Clinical Trials Identifier: NCT05000021
Trial Name: Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Adults With Type 1 Diabetes (ReDUCe)
Diabetes Type: Type 1 diabetes
Trial Sponsor: Albert Einstein College of Medicine
What is the aim of the trial?
This study will look at the effectiveness of using cognitive behavioral therapy, a type of problem-focused psychotherapy, for diabetes distress, emotional well-being, and blood glucose control in adults living with type 1 diabetes.
Investigators are hoping to demonstrate that adding a telemedicine-delivered cognitive behavioral therapy intervention targeting diabetes distress will result in clinically significant improvements in both diabetes distress and blood glucose management when compared to CGM use alone.
There are currently limited ways to treat diabetes distress. If the addition of cognitive behavioral therapy for diabetes distress (CBT-DD) results in significant improvements in both diabetes distress and blood glucose management metrics when compared to CGM use alone, CBT-DD may be used to treat diabetes distress in the future.
How does the trial work?
This nationwide virtual study will recruit close to 100 adults with type 1 diabetes. Participants will be randomly chosen to receive either the combination of telemedicine-delivered CBT-DD as well as an FDA-approved CGM (for the intervention arm) or an FDA-approved continuous glucose monitor (CGM) alone (for the control group).
Researchers will observe outcome measures at various points throughout the process. This will include diabetes distress levels based on the Problem Areas in Diabetes (PAID) scale. It will also include metrics such as A1C, time in range (TIR), time above range (TAR), time below range (TBR), and coefficient of variation (CV) as calculated from CGM use.
The study will be entirely virtual and will last for 6 months. There will be a 2-week phase before the trial begins where participants will be given assessments daily. Following this, there will be an 8-week period of telemedicine-delivered CBT-DD therapy in which participants will be given assessments weekly. A 2-week period following this 8-week phase will involve daily assessments again. Both groups will be following the same procedures. Researchers will collect data at the 3, 6, 9, and 12 month intervals; this will include A1C as well as CGM and qualitative information.
Are you interested in participating?
You may be eligible if you:
- Are between 18 and 64 years of age
- Have an A1C of 7.5 or above
- Have had a diagnosis of type 1 diabetes for at least 6 months
- Have reported severe diabetes distress (a score of greater than 40 on the PAID scale)
People who are have been treated for a psychological condition within the last 6 months, are at risk of suicidality, are currently pregnant, are participating in another behavioral intervention study, or who have a developmental or sensory disability that may interfere with participation in the study are not eligible. See a full list of inclusion and exclusion criteria here.
This study is currently recruiting anyone who resides in the United States and meets inclusion criteria. To enroll in this trial, begin the screening process by taking an online survey. If you have further questions or would like to speak with study staff prior to the screening process, you can schedule an informational call first.
Read more about other trials and research findings on diabetes distress: