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Behavioral Intervention

ACT Intervention for Type 2 Diabetes

N/A

Recruiting

Research Sponsored by Sam Houston State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to provide informed consent and participate in the study

At least 18 years of age or older

Must not have

Under 18 years old (protocol was validated for adults)

Appears to be cognitively impaired to the extent that precludes informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the effectiveness of a one-day therapy session combined with continuous glucose monitoring and lifestyle education for patients with type 2 diabetes in rural areas. The study will compare this intervention to just

Who is the study for?

This trial is for adults over 18 with type 2 diabetes, an HbA1c level of at least 6.0, and who live in rural areas. Participants must speak English, be able to give informed consent, and have access to a smartphone.

What is being tested?

The study tests if Acceptance and Commitment Therapy (ACT) plus Lifestyle Education (LE), combined with Continuous Glucose Monitoring (CGM), can help manage type 2 diabetes better than just CGM and LE or LE alone in rural communities.

What are the potential side effects?

Potential side effects are not specified for ACT or LE; however, the use of Abbott FreeStyle® Libre® 3 may cause skin irritation or allergic reactions where the sensor is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and agree to participate in the study.

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I am 18 years old or older.

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I have diabetes with an HbA1c level of 6.0 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am 18 years old or older.

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I am able to understand and give consent for my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in Hemoglobin A1C

Secondary study objectives

Adherence

Body Composition

Body Mass Index

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Continuous Glucose Monitoring + Lifestyle Education (CGM+LE)Experimental Treatment2 Interventions

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.

Group II: Acceptance and Commitment Therapy + Continuous Glucose Monitoring + Lifestyle Education (ACT+CGM+LE)Experimental Treatment3 Interventions

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.

Group III: Lifestyle Education (LE)Active Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance and Commitment Therapy

2010

Completed Phase 1

~1490

0 / 5Eligibility criteria met