NCT04933851 ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
| NCT ID | NCT04933851 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Scripps Whittier Diabetes Institute |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2021-10-25 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 250 participants in total. It began in 2021-10-25 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Spanish or English-speaking * Type 1 diabetes * Glycosylated Hemoglobin (HbA1c) 7.0% - 12.5% in last 90 days * Screen positive for diabetes distress Exclusion Criteria: * Severe medical or psychological conditions that would interfere with participation based on the opinion of a provider * Plans to move out of the San Diego area in the next 12 months * Lack of technology capability required to complete online surveys and telemedicine visit
Contact & Investigator
Addie Fortmann, PhD
PRINCIPAL INVESTIGATOR
Scripps Whittier Diabetes Institute
Frequently Asked Questions
Who can join the NCT04933851 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04933851 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04933851 currently recruiting?
Yes, NCT04933851 is actively recruiting participants. Contact the research team at sandoval.haley@scrippshealth.org for enrollment information.
Where is the NCT04933851 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT04933851 clinical trial?
NCT04933851 is sponsored by Scripps Whittier Diabetes Institute. The principal investigator is Addie Fortmann, PhD at Scripps Whittier Diabetes Institute. The trial plans to enroll 250 participants.
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