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NCT05000021 · ClinicalTrials.gov registry record · NA
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
A NA study of Type 1 Diabetes, sponsored by Albert Einstein College of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 93
- Enrollment target
- 2
- Study locations
NCT05000021 is a NA study of Type 1 Diabetes that is actively recruiting participants, run by Albert Einstein College of Medicine. The registered enrollment target is 93 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05000021, a NA study of Type 1 Diabetes, is actively recruiting participants, sponsored by Albert Einstein College of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 93 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring
- DEVICE Continuous Glucose Monitoring (CGM)
Study Locations (2)
New York
- Yeshiva University - New York
- Albert Einstein College of Medicine - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2022-06-27 |
| Est. Completion | 2026-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05000021
The ClinicalTrials.gov registry entry for NCT05000021 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (89% lower). The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring is the first listed.
NCT05000021 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05000021 about?
NCT05000021 is a clinical study titled "Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes". 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-a...
What is the current status of trial NCT05000021?
This trial is currently recruiting. It is a NA study. The enrollment target is 93 participants. The study started on 2022-06-27. Estimated completion is 2026-06.
What conditions does trial NCT05000021 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT05000021?
The interventions under investigation include: Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring (BEHAVIORAL), Continuous Glucose Monitoring (CGM) (DEVICE).
Who is sponsoring clinical trial NCT05000021?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05000021 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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