Human Studies Consultation Core

Wake Forest University Health Sciences, Winston-Salem NC

Investigators

Linked publications & trials

Abstract

NORTH CAROLINA DIABETES RESEARCH CENTER (NCDRC): HUMAN STUDIES CONSULTATION CORE SUMMARY The context in which we do diabetes research is changing rapidly with increasing access to wearable technology and remote monitoring, and data for real world evidence generation from electronic medical records and claims data. New technologies bring immense new opportunities, but also limitations and logistical challenges different from more traditional approaches. While these tools can help overcome barriers to measurement, access to participants from underserved groups, and novel phenotyping, they are not readily available to those without prior expertise. The Human Studies Consultation Core (HSCC) of the North Carolina Diabetes Research Center (NCDRC) was planned specifically to bridge the translational gaps in the T2-T4 pipeline by overcoming the divide between clinicians and population researchers in determining the optimal implementation of these technologies to improve outcomes in people living with diabetes and for prevention in those at risk. During its first year the HSCC was successful at implementing multiple consultative service areas to meet these goals. In the next funding cycle the HSCC will refocus on the services most needed by the NCDRC membership by 1.Building strength for existing services, 2. Extending to complementary services, 3. Developing synergy with the new Bench to Bedside Consultative Core (B2C2) to ensure that translational steps are available across the full range of the scientific spectrum, and 4. Continuing to expand support for inclusion of under-represented groups as an overarching goal. To meet these goals the HSCC proposes the following specific aims: Aim 1: Strengthen existing consultation services to support A. Use of continuous glucose monitors in research, and B. Robust Real World Evidence generation, including electronic health record and claims data. Both service areas will include guidance on advanced study design and analytic methods, as well as practical concerns. Aim 2: Implement, expand, and integrate consultation services for A. Other wearable devices and remote monitoring options, B. Methods for machine learning, artificial intelligence, multisensory processing and other data science methods for research using claims, EHR, and wearable or remote monitoring technologies, and C. Connections between B2C2 and HSCC cores to provide a more seamless transition across the translational spectrum to help investigators bridge the gaps from T0 to T4. Aim 3: Track utilization and user satisfaction to evolve with needs of the NCDRC membership. An overarching goal across these aims is to foster opportunities for the appropriate inclusion of underrepresented populations in diabetes research. The HSCC will improve the robustness of research performed at the NCDRC and accelerate its translation into better treatments, cures, and preventive strategies for patients and populations with diabetes. Added value will be provided through free consultation and concierge services, amplified through cross-institutional collaborations facilitated by the three CTSAs.