During the ninth annual Diabetes Care Symposium at the Scientific Sessions, a panel of world-renowned clinicians and researchers emphasized the need to consider all aspects of diabetes over long periods of time rather than relying on short-term clinical studies, single clinical assessments of individual patients, and short-term therapeutic goals.
The symposium, Long-Term Perspectives on Study and Care of Diabetes, can be viewed by registered attendees at ADA2020.org through September 10, 2020. If you haven’t registered for the Virtual 80th Scientific Sessions, register today to access all of the valuable meeting content.
Diabetes Care Editor in Chief Matthew C. Riddle, MD, Professor of Medicine in the Division of Endocrinology, Diabetes, and Clinical Nutrition at the Oregon Health & Science University, moderated the symposium. In the first presentation, Amanda Adler, MD, PhD, discussed the evolution of diabetes clinical trial design.
“It’s been said that it’s ironic that we take the same clinical trial approach to evaluate all manner of potentially amazing transformative experimental therapies, and yet we don’t experiment with the design of the clinical trial itself,” said Dr. Adler, Professor of Diabetic Medicine and Health Policy, and Director of the Diabetes Trial Unit at the University of Oxford.
Despite the perceived lack of change, diabetes clinical trial design has evolved since the University Group Diabetes Program trial, which began in the early 1960s.
“Since that time, among the key drivers in the evolution of clinical trials in diabetes include, but are not limited to: how we use associations from observational studies to identify modifiable risk factors for trials, how regulatory agencies around the world have harmonized requirements, and how transparency in reporting trials has improved,” Dr. Adler said. “It also includes the development of statistics used by data safety monitoring committees to stop trials for benefit, for harm, or for futility.”
In looking to the future, Dr. Adler questioned whether the final evolution is that clinical trials are overtaken by observational data and become extinct.
“Will we continue to have trials?” she asked. “I am going to say yes, trials are here to stay. Randomization isn’t perfect, but doing better is harder than you think.”
Lars Rydén, MD, PhD, Senior Professor in Cardiology at the Karolinska Institute in Stockholm, Sweden, explored the overlap of diabetes and cardiovascular disease, beginning with a simple question: Is coronary artery disease inevitable in type 2 diabetes?
“The longstanding paradigm was that if one just lowered the hallmark of diabetes—high glucose—then cardiovascular complications would be much less,” Dr. Rydén said. “This was perhaps true, in part, at the time when no other risk factors, such as hypertension and dyslipidemia, could be treated with modern drugs like statins.”
As type 2 diabetes became better understood as a multifactorial disease and new cardioprotective drugs with glucose-lowering capacity were introduced, Dr. Rydén said the medical community began to move from a “gluco-centric” approach to a more holistic view of patient management.
But more needs to be done. Dr. Rydén believes that if screening and guideline adherence improve, cardiovascular complications of dysglycemia could be considerably reduced. Moving forward, he said interdisciplinary collaboration and multifactorial treatment are crucial to improving long-term outcomes.
“We need to build bridges aimed at improved collaboration between cardiology and diabetology and primary care with the patient in focus,” Dr. Rydén said. “We need better education, better referrals, and better communication with patients about the benefits of lifestyle modifications. So I don’t think coronary artery disease is inevitable; not if people are well managed.”
In the final presentation, Steven E. Kahn, MB, ChB, discussed the development and progression of type 2 diabetes in youth and middle age, and the threat posed by increased early-onset type 2 diabetes.
“The risk of progression to impaired glucose tolerance, or prediabetes, and progression of prediabetes to type 2 diabetes is based on a progressive loss of β-cell function resulting in impaired insulin secretion,” said Dr. Kahn, Professor of Medicine and the Leonard L. Wright & Marjorie C. Wright Term Chair at the University of Washington and VA Puget Sound Health Care System.
Despite advances in the understanding of the pathophysiology of hyperglycemia, Dr. Kahn said effective approaches that slow or prevent the progression of the disease process are still needed.
“The challenge now facing all of us in the development of approaches to treat patients with diabetes or prevent diabetes is determining what the optimal medication is, because clearly lifestyle is not always sustainable and many people with diabetes need more than lifestyle,” he said. “It’s time to start thinking about drugs that are a little different and are not so β-cell-centric in terms of stimulating insulin secretion, but rather improve insulin sensitivity.”