RECRUITINGINTERVENTIONAL

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

Effectiveness of a Community-Based Intervention of Acceptance and Commitment Therapy for Type 2 Diabetes Management in a Rural and Underserved Community

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form and participate in the study 5. reliable access to a personal smartphone device 6) zip code is associated with a rural area. Who Should NOT Join This Trial: 1. Reported suicidal ideation at the initial visit 2. has evidence of acute psychosis that precludes willing to sign a consent form 3. appears to be cognitively impaired to the extent that precludes willing to sign a consent form 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

BEHAVIORAL

Acceptance and Commitment Therapy

Approximately 3 hours of ACT will be administered based on Gregg et al.;s (2007) protocol: 1. What is ACT? 2. Coping and Stress Management 3. Acceptance and Action

DEVICE

Abbott FreeStyle® Libre® 3

The Abbott FreeStyle® Libre® 3 (FDA approved) consists of a single use disposable electrochemical sensing unit which is placed on the upper arm and an App for smart phones where the participant can view their glucose data, including their current glucose reading, their 'trend arrow' so participants can see how glucose is changing, and their glucose history. The FreeStyle system does not require user calibration. A sensor log will be maintained for accountability of all sensors received as well as used sensors (including the lot/serial number, expiration date, and the date). Sensors will be stored at manufacturers recommendations.

OTHER

Generic Education

Participants will be given information about how lifestyle choices, including daily dietary choices, affect blood sugar for people with T2D, and best practices related to checking blood sugar and carbohydrate counting if participants are on insulin therapy. These sessions will also include education on diabetes nutrition guidelines and improving self-management through better food and lifestyle choices.

Locations (1)

Sam Houston State University College of Osteopathic Medicine

Conroe, Texas, United States