NCT06028503 ACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community
| NCT ID | NCT06028503 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sam Houston State University |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-04-01 with a primary completion date of 2026-08-31.
⚠ 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
The purpose of this project is to examine the feasibility/acceptability of a one-day Acceptance and Commitment Therapy + Lifestyle Education group intervention paired with 12-weeks of Continuous Glucose Monitoring for patients with type 2 diabetes (T2D) living in rural communities. This study is being designed as a randomized control trial (RCT) comparing ACT+LE+CGM to LE+CGM to LE. The ultimate goal of this line of research is that a community-wide intervention of Acceptance and Commitment Therapy (ACT) with Continuous Glucose Monitoring (CGM) and Lifestyle Education (LE) will improve T2D outcomes in rural communities compared to CGM and LE, or LE alone. Our goal is to develop a scalable and sustainable program for diabetes management in rural areas that enables individual self-management and does not require extensive healthcare resources in an existing medical desert.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosed diabetes (self-reported) and with an HbA1c ≥ 6.0 (using point-of-care device) 2. at least 18 years of age or older 3. able to speak English 4. able to provide informed consent and participate in the study 5. reliable access to a personal smartphone device 6) zip code is associated with a rural area. Exclusion Criteria: 1. Reported suicidal ideation at the initial visit 2. has evidence of acute psychosis that precludes informed consent 3. appears to be cognitively impaired to the extent that precludes informed consent 4. uses a heavy amount of alcohol or other substances 5. is deemed by the multidisciplinary study team has too medically complex for a more conservative treatment approach 6. has a pacemaker or other implanted electrical medical device 7. Pregnant (management of diabetes while pregnant may require additional medical oversight). 8. Under 18 years old (protocol was validated for adults) 9. Non-English-speaking individuals (protocol has not been translated and validated in other languages)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06028503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06028503 currently recruiting?
Yes, NCT06028503 is actively recruiting participants. Contact the research team at rxm147@shsu.edu for enrollment information.
Where is the NCT06028503 trial being conducted?
This trial is being conducted at Conroe, United States.
Who is sponsoring the NCT06028503 clinical trial?
NCT06028503 is sponsored by Sam Houston State University. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.