ACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: Diagnosed diabetes (self-reported) and with an HbA1c ≥ 6.0 (using point-of-care device) at least 18 years of age or older able to speak English able to provide informed consent and participate in the study reliable access to a personal smartphone device 6) zip code is associated with a rural area. Exclusion Criteria: Reported suicidal ideation at the initial visit has evidence of acute psychosis that precludes informed consent appears to be cognitively impaired to the extent that precludes informed consent uses a heavy amount of alcohol or other substances is deemed by the multidisciplinary study team has too medically complex for a more conservative treatment approach has a pacemaker or other implanted electrical medical device Pregnant (management of diabetes while pregnant may require additional medical oversight). Under 18 years old (protocol was validated for adults) Non-English-speaking individuals (protocol has not been translated and validated in other languages)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Acceptance and Commitment Therapy + Continuous Glucose Monitoring + Lifestyle Education (ACT+CGM+LE)
Continuous Glucose Monitoring + Lifestyle Education (CGM+LE)
Lifestyle Education (LE)
Participants assigned to ACT+CGM+LE will have both of the above modules in addition to three ACT modules based on Gregg et al.8 and traditional ACT therapy19. Two facilitators will lead the ACT sessions: Dr. Marek or Dr. Ratcliff and one trained doctoral-level clinical psychology student under their direct supervision (i.e., one licensed provider paired with a student). We will run all sessions in a group format. Participants will be given breaks between modules and one long lunch break.
Participants assigned to CGM+LE will attend the group LE workshop. CGM training will occur after the 5 hour lifestyle education delineated above (same content, but less informal discussion). This will include training on using blood glucose monitoring devices, setting up the App on the smartphone (including activating the hypoglycemic alarm) and how to apply the glucose sensors on the arm. If a sensor does fall off a participant, a member of the study team will provide a spare sensor to the participant. The glucose range for participants will be set at between 70 and 140 mg/dL, unless the study physician (Dr. Olaiya) determines otherwise. The CGM device will allow us to calculate the percentage of 'time in range' per day, peak glucose, nocturnal glucose and number of hypoglycemic events. The CGM training will be managed by Dr. Olaiya and/or Dr. Kelly, and a medical/dietetic students.
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.