More than 400 million people have diabetes mellitus, and clinical laboratory testing is critical in screening, diagnosis, and monitoring of treatment in diabetes. As the evidence—and testing technology—advances, so too must laboratorians’ approach. Attendees to today’s session, “Guidelines for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus: 2021 Revision,” will get a preview of the latest update of the American Diabetes Association (ADA) guidelines from three of its authors, who will discuss the main revisions since its most recent version in 2011.

The first iteration of the ADA guidelines was published in 2002 and introduced an evidence-based rating system to score the strength of the supporting evidence for each of the recommendations. As more research data accumulates, the recommendations, and/or the strength of the recommendations, are updated in each revision. The ADA continues to support these guidelines for laboratory testing in diabetes. These guidelines have implications on the diagnosis and care of patients worldwide

David Sacks, MB ChB, FACP, FRCPath, will highlight some of the changes in the upcoming guidelines and explain how the areas with the most  technological and research developments in diabetes are  continuous glucose monitoring (CGM), genetic analysis, and autoimmune markers. The guidelines also cover testing for diabetic kidney disease, diagnosing of gestational diabetes, and specimen handling for the measurement of blood glucose.

Sue Kirkman, MD, will discuss recent evidence and best practices for the use of CGM in her talk, “Continuous Glucose Monitoring: State of the Art in 2021.” Manufacturers of continuous glucose monitoring devices have made improvements in device accuracy. Many are FDA approved for use in blood glucose management without verifying the result with a blood glucose meter. Kirkman will explore how ‘hybrid closed-loop’ systems have come to market, in which an algorithm analyzes CGM trends and regulates insulin delivery through an insulin pump. These systems can be life-changing for people with type 1 diabetes.

Another game changer is how patients and clinicians can interpret and use large amounts of data obtained from continuous glucose monitoring systems to make treatment decisions. Kirkman will also discuss the new information gained from randomized studies comparing CGM to meter blood glucose monitoring in additional patient populations from studies pre-2011. These newer studies include CGM use in teens and young adults to older adults with type 1 diabetes, as well as more studies in patients with type 2 diabetes.

Åke Lernmark, MD, PhD, will cover the state of autoimmune markers in diabetes, another fast-developing focus area. Since the 2011 version of the guidelines, there has been a vast amount of research on the role of autoimmune markers for the diagnosis and management of diabetes mellitus. These markers have a particular role in the differential diagnosis of type 1 and type 2 diabetes mellitus in newborns. Attendees will learn about the different autoimmune markers used in diabetes care and the evidence surrounding their use.