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The University of Alabama at Birmingham Department of Family and Community Medicine’s Vice Chair for Research Tapan Mehta, Ph.D., is partnering with investigators at the University of Mississippi Medical Center to lead a $3.6 million study to develop a sustainable and effective Type 2 diabetes management intervention in adults who have Type 2 diabetes and sub-optimal social determinants of health.

Mehta, an associate scientist in the UAB Comprehensive Diabetes Center, and Michael Hall, M.D., chair of the Department of Medicine at UMMC, will be leading the Food Delivery, Remote Monitoring and Coaching-Enhanced Education for Optimized Diabetes Management — FREEDOM — study. This study will use intervention components that target social determinants of health related to transportation barriers, health services access, quality of care and food insecurity.

The FREEDOM study is a pragmatic optimization trial supported by the National Institute on Minority Health and Health Disparities and the Forge AHEAD Center. This study will enroll patients to evaluate variables such as health coaching, food delivery and remote patient-monitoring, to see which will help patients manage diabetes and also be sustainable for health systems to implement.

States located in the Deep South, such as Alabama and Mississippi, have the highest rates of Type 2 diabetes and some of the worst outcomes due to diabetes-related cardiovascular disease and chronic kidney disease, Mehta says. These diseases disproportionately burden Black Americans because most of these racial health disparities can be attributed to social determinants of health, including reduced health care access, poverty, transportation barriers and food insecurity. Investigators say there is a need for effective and sustainable intervention packages that address outcomes related to diabetes.

“Our study will leverage multi-health care system and health care system-industry partnerships to promote health equity and to improve diabetes outcomes in socially vulnerable Black adults living in the Deep South,” Mehta said. “To our knowledge, this is the first optimization trial that brings three intervention components — health coaching, remote patient monitoring and food box delivery — together to identify the most sustainable intervention package. This study is important and will inform health systems as leaders consider population health management and value-based care and pilot some of these intervention components in isolation.”

Working with UAB, the University of Mississippi Medical Center, Cooper Green Mercy Health Systems and Pack Health, researchers will enroll 304 Black adult patients with Type 2 diabetes and related cardiovascular disease and chronic kidney disease.

All participants will be referred to diabetes self-management education and support programs. Participants also will receive some combination of three different interventions:

digital health coaching with an evidence-based curriculum, interactive group courses and one-on-one virtual support to help patients start and sustain positive health behaviors and self-manage their diabetes

Biweekly food boxes containing shelf-stable groceries that adhere to American Diabetes Association nutritional guidelines for those with Type 2 diabetes will be delivered directly to participants during the course of six months. The participants will also engage in remote patient-monitoring with instructions on how to monitor blood glucose levels four times daily using the glucometer, test strips and mobile devices provided. Nurses and pharmacists will review data summaries monthly.

The study will primarily track changes in patients’ HbA1C — measuring average blood sugar levels — at baseline, at the end of the six-month intervention period and 12 months after the study.
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