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NCT06405373 · ClinicalTrials.gov registry record · NA
Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
A NA study of Diabetes Mellitus and Diabetes Mellitus, Type 1, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06405373: Recruiting NA study of Diabetes Mellitus and Diabetes Mellitus, Type 1, sponsored by University of North Carolina, Chapel Hill.
NCT06405373 is a NA study of Diabetes Mellitus and Diabetes Mellitus, Type 1 that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 200 participants, below the 1,866-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06405373, a NA study of Diabetes Mellitus and Diabetes Mellitus, Type 1, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.
Primary Outcome
Self-reported total diabetes distress will be measured using the 28-item Type 1 Diabetes Distress Scale (T1-DDS Total Score). The scale yields an overall distress score that is the average of all responses rated on a 6-point Likert scale for all 28 items (range 1-6). A score \>= 2.0 is considered clinically significant diabetes distress. The primary efficacy outcomes of this study is the change in the T1D-DDS score and the proportion of individuals with a change in the T1D-DDS score at least as
Conditions Studied
Interventions
- BEHAVIORAL ReCharge
- BEHAVIORAL TakeCharge
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2027-09-15 |
| Phase | NA |
What NCT06405373 shows while recruiting
NCT06405373 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,866-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (89% lower).
The record links to 5 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which ReCharge is the first listed.
NCT06405373 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06405373 about?
NCT06405373 is a clinical study titled "Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART". This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in...
What is the current status of trial NCT06405373?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-10-01. Estimated completion is 2027-09-15.
What conditions does trial NCT06405373 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1, Distress, Emotional, Diabetes type1, Diabetes, Autoimmune.
What interventions are being tested in trial NCT06405373?
The interventions under investigation include: ReCharge (BEHAVIORAL), TakeCharge (BEHAVIORAL).
Who is sponsoring clinical trial NCT06405373?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06405373 being conducted?
This trial has 1 study location across North Carolina. 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 NCT06405373's enrollment target sits among peer trials
200 88th of 208 higher than 119 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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