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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: Recruiting NA study of Type 1 Diabetes, sponsored by Albert Einstein College of Medicine.
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 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Diabetes distress will be assessed using the Problem Areas in Diabetes (PAID) scale. The PAID scale will be administered to each participant via the REDCap database. The PAID scale is a 20 item, self-report questionnaire that describes negative emotions related to diabetes commonly experienced by people with diabetes. For each item, participants are asked to provide a response describing the extent the item is currently a diabetes issue for them using a 5-point Likert scale ranging from 0 ("Not
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 |
What NCT05000021 shows while recruiting
NCT05000021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05000021's enrollment target sits among peer trials
93 61st of 198 higher than 138 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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