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ACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community

RecruitingNAAges 18 Years - anyAllSam Houston State University
NCT06028503 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Acceptance and Commitment Therapy
  • Abbott FreeStyle® Libre® 3
  • Generic Education
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Where

1 site
Sam Houston State University College of Osteopathic Medicine
Conroe, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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