Recommendations are detailed in new roadmaps (algorithms) outlining therapies and medications to help achieve optimal diabetes control and improved quality of life
The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have jointly produced and presented today at the EASD’s Annual Meeting in Berlin a new guidance document Management of Hyperglycemia in Type 2 Diabetes, 2018: A Consensus Report by the American Diabetes Association and the European Association for the Study of Diabetes (ADA-EASD Consensus Report). Produced by an international panel of diabetes care experts assembled by the ADA and the EASD, the ADA-EASD Consensus Report calls for a paradigm shift to patient-centered care and details the panel’s comprehensive review of the latest evidence. The ADA-EASD Consensus Report is simultaneously published today in Diabetes Care, the ADA’s flagship clinical research journal, and Diabetologia, the journal of the EASD.
The panel reviewed nearly 500 published manuscripts (n=479), with a particular focus on key cardiovascular outcomes trials (CVOTs) in the past four years, to provide guidance on optimizing blood glucose control, improving patient outcomes, and reducing the serious complications of type 2 diabetes including cardiovascular and chronic kidney disease. The ADA has endorsed the ADA-EASD Consensus Report and today incorporated the recommendations in the ADA’s Standards of Medical Care in Diabetes—2018 as a Living Standards Update.
To make the guidance as helpful for clinicians and health care providers as possible, the ADA-EASD Consensus Report features seven new graphic Figures that provide detailed health care roadmaps (algorithms) and two new Tables enumerating the multiple therapy and medication options for the care of adults with type 2 diabetes. The ADA-EASD Consensus Report recommends patient-centered care that accounts for each individual’s health history and status, weight, costs of care, and preferences. While the algorithms focus on the choice of diabetes medications, the report also highlights the critical importance of comprehensive lifestyle management and diabetes self-management education and support in the overall health of people with type 2 diabetes.
The report’s central theme is conveyed in Figure 1—a Decision Cycle for Patient-Centered Glycemic Management in Type 2 Diabetes—representing a continuum of care for adults with type 2 diabetes throughout their lifetime. The Goals of Care are at the core—prevent complications and optimize quality of life. The steps are 1) assess key patient characteristics; 2) consider specific factors that impact choice of treatment; 3) shared decision-making to create a management plan; 4) agree on a management plan; 5) implement management plan; 6) ongoing monitoring and support including mental health, medication tolerance and adherence, monitoring of blood glucose, weight, nutrition, physical fitness and exercise, and smoking cessation counseling; 7) review and agree on management plan; returning to step 1 and going through the full cycle at least twice each year, and as needed throughout each patient’s life. As the continuum of care evolves throughout each patient’s life, as graphically displayed in Figure 1, the patient remains at the center, and the intensification, deintensification or shift in the diabetes care plan requires meaningful consideration of the patient’s life and circumstances, especially the burdens of treatment and cost.
For the first time, the ADA-EASD Consensus Report includes specific pharmacologic recommendations based on a patient’s profile and health history (Figure 2), providing instructions in the context of ASCVD, heart failure, kidney disease, weight, risk for hypoglycemia, or a need for low-cost options. One thing that hasn’t changed is an emphasis on comprehensive lifestyle management and metformin, which remains the preferred first-line agent. There is a new guidance for glucagon-like peptide 1 (GLP-1) receptor agonists, which are now recommended as the first injectable medication prior to insulin for most adults with type 2 diabetes who need the greater blood glucose-lowering of an injectable medication. For patients with chronic kidney disease, the panel recommends consideration of a sodium-glucose cotransporter 2 (SGLT2) inhibitor with proven benefits. Individual medications in both the GLP-1 receptor agonist and SGLT2 inhibitor classes have been shown to have cardiovascular benefits.
The panel recommends the target HbA1c to increase microvascular benefits is 7 percent or less (53 mmol/mol) for most nonpregnant adults with sufficient life expectancy, with individualization based on patient preferences and goals; risk of adverse effects including hypoglycemia and weight gain; and patient characteristics including frailty and comorbid conditions. The cost, adherence and tolerability burdens have been added as factors to be considered for all medication therapy.
The report suggests that a patient’s medication-taking and self-management behavior (adherence) be specifically considered as part of the decision cycle, ensuring a good match between patient and care plan. Inconsistent medication-taking behavior affects almost half of people with diabetes, which leads to suboptimal blood glucose control and increased CVD risk. All patients should be offered access to ongoing Diabetes Self-Management Education and Support (DSMES) programs in order to help patients cope with the daily challenges of living with diabetes, which can increase adherence to the diabetes care plan. DSME/S programs provide essential information to increase patient’s ability to successfully and effectively manage their diabetes every day.
The comprehensive care plan must also include intensive lifestyle interventions including nutrition and physical activity to ensure healthy weight. Medical nutrition therapy, including healthy eating advice and strategies, should be offered to all patients. Increased and regular physical exercise is recommended for all people with type 2 diabetes. The panel also recommends metabolic surgery for adults with type 2 diabetes and either 1) BMI ≥40 (BMI ≥37 for people of Asian ancestry) or 2) BMI ≥35 but <40 (BMI ≥32.5 or <35 for people of Asian ancestry) who are not able to achieve sustainable weight loss through intensive, non-surgical programs. For BMI ≥30-35, metabolic surgery may be considered.
While the ADA-EASD Consensus Report panel makes bold recommendations that can improve outcomes, the panel also urges more targeted research to help further define and improve patient outcomes— “As the cost implications for these various approaches is enormous, evidence is desperately needed. Defining optimal cost-effective approaches to care, particularly in the management of patients—including those with multi-morbidity—is essential. Addressing these and other vital clinical questions will require additional investment in basic, translational, clinical and implementation research.”
“Over the past two decades, numerous advances and innovations have drastically improved outcomes and provided nearly comparable life expectancy for people with diabetes. However, given the complexity of diabetes, without the proper care and support systems, the complications of poor blood glucose control are progressive and can be devastating. We are proud to call for this paradigm shift as the most logical and appropriate next steps in care through this joint consensus report with EASD. The needs of our patients require that we consider the many individual life factors in order to improve quality and length of life for as many people as possible,” says the ADA’s chief scientific, medical, and mission Officer William T. Cefalu, MD. “We must also recommit to further research that will help us to continuously refine these recommendations. With the right care plan and supports, our patients can experience full lives with diabetes as we continue to understand the many facets of this sophisticated disease.”
The ADA-EASD Consensus Report was produced by co-chairs John B. Buse, MD, PhD, University of North Carolina School of Medicine, and Melanie J. Davies, MC ChB, MD, University of Leicester, UK; and additional authors David D’Alessio, MD, Duke University, Durham, NC; Judith E. Fradkin, MD, The National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health; Walter N. Kernan, MD, Yale School of Medicine, New Haven, CT; Chantal Mathieu, MD, PhD, Katholieke Universiteit Leuven, Leuven, Belgium; Geltrude Mingrone, MD, PhD, Catholic University of the Sacred Heart, Rome; Peter Rossing, MD, Steno Diabetes Center, Copenhagen; Apostolos Tsapas, MD, PhD, MSc, Artistotle University Thessaloniki, Greece; and Deborah J. Wexler, MD, MSc, Massachusetts General Hospital and Harvard Medical School, Boston. Author disclosures are noted in the manuscript, and the manuscript details the 36 distinguished professionals who served as peer-reviewers.