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NCT04933851 · ClinicalTrials.gov registry record · Phase 2
ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
A Phase 2 study of Type 1 Diabetes, sponsored by Scripps Whittier Diabetes Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT04933851: Recruiting Phase 2 study of Type 1 Diabetes, sponsored by Scripps Whittier Diabetes Institute.
NCT04933851 is a Phase 2 study of Type 1 Diabetes that is actively recruiting participants, run by Scripps Whittier Diabetes Institute. The registered enrollment target is 250 participants, below the 765-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04933851, a Phase 2 study of Type 1 Diabetes, is actively recruiting participants, sponsored by Scripps Whittier Diabetes Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.
Primary Outcome
HbA1c (%) reflects average glucose over the past 2-3 months, with higher values indicating greater risk for developing diabetes-related complications. HbA1c for up to 5 data points (0, 3, 6, 9, 12 months) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine HbA1c changes. Analyses will include the between-subjects factor of group and the within-subjects factor of time. Month 0 will be the referent time-point with post-intervention
Conditions Studied
Interventions
- BEHAVIORAL ACT1VATE
- BEHAVIORAL DSME/S
Study Locations (1)
California
- Scripps Whittier Diabetes Institute - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
What NCT04933851 shows while recruiting
NCT04933851 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 765-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which ACT1VATE is the first listed.
NCT04933851 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04933851 about?
NCT04933851 is a clinical study titled "ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes". This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing s...
What is the current status of trial NCT04933851?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2021-10-25. Estimated completion is 2027-03-31.
What conditions does trial NCT04933851 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT04933851?
The interventions under investigation include: ACT1VATE (BEHAVIORAL), DSME/S (BEHAVIORAL).
Who is sponsoring clinical trial NCT04933851?
This trial is sponsored by Scripps Whittier Diabetes Institute, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04933851 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
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 NCT04933851's enrollment target sits among peer trials
250 25th of 198 higher than 173 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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