ABSTRACT Reducing adverse outcomes from Type 2 Diabetes Mellitus (T2DM) requires optimal self-management and appropriate clinical care.1 Combining an evidence-based intervention to improve diabetes self-management with individually-tailored patient navigation to improve appropriate clinical care holds great promise. Only one known randomized controlled trial has been tested that combines these two most essential components of diabetes control. That trial resulted in improvements to glycemic control, blood pressure, and diabetes self- management, but was implemented in a clinical setting.2 We aim to enhance this work by recruiting from and locating most research activities in community-based settings to insure involvement of the most vulnerable, hardest to reach populations who may not be receiving regular health care and by leveraging Community Health Workers and Patient Navigators, who are essential and sustainable outreach workers in health care professional shortage areas. We propose testing a refined intervention, “Community to Clinic Navigation” (CCN), shown to be promising, feasible, and acceptable in our pilot study. Given that Appalachian and rural residents maintain disproportionately high rates of T2DM and suffer tremendous burdens from diabetic complications,3 this setting provides a perfect opportunity to test the intervention with a hard to reach population while addressing health inequities. We will administer a 3 arm group randomized design including (1) Diabetes Self-management Program, DSMP only; (2) tailored Patient Navigation, PN only; and (3) the combined DSMP + PN: Community to Clinic Navigation program, CCN. Outcomes include biometrics (HbA1c, BMI, blood pressure, lipids, waist circumference); diabetes self-management and clinic attendance, as mediators of the primary outcomes; cost effectiveness and participant satisfaction. Persons with diabetes will be recruited through churches and other community venues. Our project leverages sustainable assets available in most health disparity communities-- faith organizations, community centers, federally qualified health clinics, strong social ties, and talented local lay people who can be trained to educate and navigate those diagnosed with T2DM. Our sustained involvement in Appalachian Kentucky positions our team to appropriately and efficiently test this promising program with strong potential for future dissemination to other traditionally underserved environments.

PROJECT NARRATIVE Since diabetes has reached epidemic proportions in the US, especially among low income and rural residents, we aim to test a refine and promising program called “Community to Clinic Navigation” (CCN) that combines diabetes self-management education with tailored patient navigation to improve clinical care. To our knowledge, no one has ever combined these two approaches which is surprising because these are the most important ways to manage and control diabetes. If this theory-based, culturally appropriate intervention shows improvement in physical and behavioral outcomes, then CCN can easily be applied to other communities with health disparities. 1