New diabetes study will examine coordinated care with cardiologists, endocrinologists

The Duke Clinical Research Institute will lead a new clinical study at cardiology clinics throughout the United States to evaluate the benefits of a multidisciplinary approach to care for people with type 2 diabetes and cardiovascular disease, according to a press release from Boehringer Ingelheim and Eli Lilly.

The research program, COORDINATE-Diabetes (COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs), is designed to examine the impact of multifaceted interventions involving guideline-based therapies among cardiologists, endocrinologists, primary care providers and patients. Guidelines include the American Diabetes Association’s 2018 Standards of Medical Care in Diabetes and the American College of Cardiology Expert Consensus Decision Pathway on novel therapies for CV risk reduction in adults with type 2 diabetes and atherosclerotic CVD.

"The public health impact of type 2 diabetes and cardiovascular disease in the U.S. is immense," Christopher Granger, MD, professor of medicine in the division of cardiology at Duke University, said in the release. "While highly effective evidence-based treatments have been developed, these treatments are not consistently used, and thus preventable death and disability are occurring. Our goal with COORDINATE-Diabetes is to better understand the effectiveness of specific interventions at cardiology clinics to achieve best practices for improving patient health."

The trial will include 46 cardiology clinics in the U.S. and aims to enroll 30 patients at each site. Researchers will randomly assign clinics to a basic education arm utilizing guideline-based therapies, or, an intensive intervention arm focusing on coordinating care between cardiologists and endocrinologists to develop and implement an integrated, multidisciplinary care pathway.

The care teams at the intervention sites will be encouraged to communicate with patients' primary care physicians to facilitate a well-rounded, multidisciplinary approach to patient care, according to the release. The trial will measure the impact of the intervention on the sites' use of guideline-recommended therapies after 12 months.

"We are pleased to support evidence-based research to understand how to best manage risks and optimize care for patients with type 2 diabetes and

cardiovascular disease in a real-world, clinical setting," Thomas Seck, MD, senior vice president of medicine and regulatory affairs for Boehringer Ingelheim Pharmaceuticals, said in the release. "Although there are treatments with proven cardiovascular benefits recommended by the ADA and other organizations, many health care providers are not prescribing them to all their patients who may benefit. We look forward to learning more about how health care providers can work together to improve adherence to these treatment guidelines in the quest to reduce patients' cardiovascular risk."

The trial will also leverage the power of electronic health record data from a consortium of health systems across the U.S. that have curated their data to support research and improve outcomes, according to the release. Researchers will begin enrolling clinics and patients for the study in 2019 with the goal of sharing the main results by 2021.

"Few rigorous studies have tested the effectiveness of a multidisciplinary approach to improving care among this vulnerable patient population," Sherry Martin, MD, vice president of medical affairs for Eli Lilly, said in the release. "Given the serious cardiovascular complications associated with type 2 diabetes, it is important for cardiologists and endocrinologists to work collaboratively to help improve care for people with type 2 diabetes and cardiovascular disease."

Boehringer Ingelheim and Eli Lilly and Company are funding COORDINATE-Diabetes.