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Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
NCT06405373 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06405373
The ClinicalTrials.gov registry entry for NCT06405373 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 725 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06405373 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06405373?
The interventions under investigation include: ReCharge (BEHAVIORAL), TakeCharge (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06405373?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 725 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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