NCT05000021Active, not recruiting
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 26 Jul 2021
- Start date
- 27 Jun 2022
- Primary completion date
- Oct 2026
- Lead sponsor
- Albert Einstein College of Medicine
- Diseases
- Type 1 diabetes
- NCT number
- NCT05000021
What you commit to
- Study type: Interventional
- Participants enrolled: 96
- From 27 Jun 2022 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of non-insulin medications or recent medical procedures that would impact glycemic control or use of CGM over the study
Other illness
- Comorbid psychiatric condition, including depression, anxiety, or suicidality, which may be independently associated with the main outcomes of DD or glycemic control. Comorbid psychiatric conditions listed above are being excluded because CBT-DD currently centers on mitigating specifically diabetes distress to improve glycemic outcomes
- In treatment for a psychological condition within the last 6 months or on a non-stable dose of psychiatric medication over the last 2 months
Other
- Developmental or sensory disability interfering with participation
- Current pregnancy, as self-management and glycemic goals differ
- Participation in another behavioral intervention study
- Minors
- Subjects who do have the capacity to consent
Who the study is looking for
- Type 1 Diabetes (T1D) duration ≥6 months
- English or Spanish speaking
- At least moderate Diabetes Distress (DD) (score of ≥2 on T1D-Diabetes Distress Scale)
- Stable insulin treatment regimen (insulin prescription, use of pump, etc.) for at least 3 months prior to study enrollment
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yeshiva University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Albert Einstein College of Medicine Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.