Synopsis of the 2017 U.S. Department of Veterans Affairs/U.S. Department of Defense Clinical Practice Guideline: Management of Type 2 Diabetes Mellitus

Diabetes is the leading cause of major complications, such as end-stage renal disease and lower extremity amputations, and is a significant contributor to ischemic heart disease, stroke, peripheral vascular disease, and vision loss (1). There has been increasing acceptance of the importance of individualizing glycemic management and assessment of risk for adverse events, especially hypoglycemia (26). This is of great importance for all patients, especially older adults (aged 65 years) with comorbid conditions. In 2013, 12.0 million older adults in the United States had diabetes, comprising 40% of the 30.2 million persons with the disease (7). Older adults account for an estimated 60% to 70% of the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) diabetic population (largely retirees) (VA/DoD. Unpublished data). These considerations make safe and effective diabetes management a policy priority for health care providers (physicians, nurses, dietitians, and pharmacists) and policymakers in both the VA and the DoD. The 2017 VA/DoD Clinical Practice Guideline (CPG) for the Management of Type 2 Diabetes Mellitus in Primary Care offers health care providers an evidence-based framework to evaluate, treat, and manage persons with type 2 diabetes mellitus in the context of their individual needs and preferences (8). The current article is a summary of key CPG recommendations, which was developed with multiple stakeholders to ensure representation by a broad spectrum of clinicians. It provides practice recommendations for the care of patients with diabetes, with an emphasis on shared decision making. Guideline Development and Review Process These recommendations were developed using methods established by the VA/DoD Evidence-Based Practice Work Group (EBPWG) (9), which are aligned with standards for trustworthy guidelines (10). The EBPWG and the U.S. Army Medical Command selected guideline panel cochairs (1 each from the VA and the DoD). The cochairs then selected a multidisciplinary panel of practicing clinician stakeholders, including primary care physicians (family and internal medicine), endocrinologists, medical nutritionists, pharmacists, diabetes educators, and nurse practitioners. At the start of the CPG development process and at other key points throughout, all members were required to submit disclosure statements for potential conflicts of interest in the previous 24 months. Verbal affirmations of no conflicts were used during meetings throughout the development process. The project team was also subject to random Web-based surveillance (for example, ProPublica). The VA/DoD contracted with The Lewin Group, a third party with expertise in clinical practice guideline development, to facilitate meetings. The guideline panel, in collaboration with the ECRI Institute, developed 9 key questions using the PICOTS (population, intervention, comparator, outcomes, timing of outcomes measurement, and setting) format. A systematic search of the peer-reviewed literature from January 2009 through March 2016 was conducted to find evidence relevant to the key questions that focused on randomized trials, systematic reviews, and meta-analyses of fair or better quality. One key question was updated through 14 June 2016. The search methods and results are detailed in the full guideline (8). The guideline panel rated recommendations by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method (11). The guideline panel focused on developing new and updated recommendations using the evidence review for the key questions. The panel also considered, without a complete review of the relevant evidence, the current applicability of recommendations that were included in the 2010 CPG. As part of the development process, a patient focus group was also convened to better understand the perspectives of patients receiving diabetes treatment in the VA and the DoD. Five patients were included, consistent with the requirements of the federal Paperwork Reduction Act. All patients had type 2 diabetes and were veterans receiving care in the VA. The focus group explored knowledge of treatment options, views on the delivery of care, patients' needs and preferences, and the effect of diabetes on their lives. Important concepts that emerged from the focus group were shared with the panel and informed guideline development. It was acknowledged that this convenience sample may not be representative of all VA and DoD patients receiving treatment for type 2 diabetes. The draft guideline was sent to more than 15 expert reviewers inside and outside the federal sector. Comments were reviewed and, where appropriate, were incorporated into the final guideline based on panel consensus. The VA/DoD EBPWG approved the final document on 3 April 2017 and released it on 17 April 2017. Recommendations are presented in the Table, and an algorithm for establishing a personalized glycemic goal and treatment plan is presented in the Figure. Key recommendations are reviewed in this article. Table. Summary of Recommendations From the 2017 VA/DoD CPG on the Management of Type 2 Diabetes Mellitus Figure. Algorithmic approach to evaluating glycemic control risk factors, setting a personalized glycemic control target range, providing self-management (including lifestyle and nutrition) education, and initiating or reevaluating medication therapy. Recommendations Provide Patient-Centered Care and Incorporate Shared Decision Making The CPG strongly encourages clinicians to incorporate shared decision making and partner with their patients. Shared decision making is the process by which the patient and family, in conjunction with the care provider, reach an agreement about a plan of care and treatment. Key principles include readiness of the patient and family, tools with understandable information about the benefits and harms of all options, and strategies to identify and incorporate patient preferences. Patients cannot effectively participate in care and shared decision making unless they understand diabetes and how they can be involved in planning and carrying out the jointly developed care plan. Shared decision making reinforces a trusted therapeutic relationship and increases patient satisfaction and treatment buy-in with regard to the methods used to reach a particular goal or treatment plan (1214). It should be used not only for patients with stable glycemic control but also to assist those who are not able or willing to make lifestyle changes and decisions that affect their diabetes at any time during the course of treatment. At a minimum, shared decision making should be included at the time of diagnosis, during difficulties with management, and at times of transition or development of complications (14). Benefits include greater knowledge of medications (13) and understanding of risks (14). In addition, patient-centered care and shared decision making together may decrease patient anxiety, increase trust in clinicians (15), and improve treatment adherence (16). Family involvement should be considered if appropriate, especially in older adults (17). Patient information should be culturally appropriate; understandable and actionable by people with limited literacy skills; and accessible to those with physical, sensory, or learning needs (18). As part of the patient-centered care approach to diabetes management, clinicians should explore with the patient the outcomes of previous opportunities for shared decision making, their ability to self-manage, prior efforts to change health behaviors, past treatment experiences (including reasons for discontinuing treatment), and relevant clinical outcomes. In actively sharing decisions, they should involve the patient in prioritizing problems to be addressed and setting specific goals regardless of the setting or level of care. Assess Patient Characteristics and Nonglycemic Factors When Interpreting Results of Hemoglobin A1c, Fructosamine, and Other Glycemic Biomarker Testing Many factors affect measurement of hemoglobin A1c (HbA1c) besides the level of glycemia (19). Because HbA1c level depends on the duration of erythrocyte exposure to glucose, conditions that alter erythrocyte life span affect the measured level of HbA1c (20, 21). Iron deficiency anemia, which prolongs erythrocyte life span and exposes the cell to glucose for a longer period, is associated with falsely elevated HbA1c levels (22). In contrast, conditions that shorten erythrocyte life span (such as hemolytic anemia) may result in falsely low HbA1c levels. Various other conditions, such as chronic kidney disease, may alter HbA1c measurement. Hemoglobin variants can result in falsely elevated or falsely lowered HbA1c levels, depending on the assay used (2325). In addition, oral hypoglycemic agents (metformin or sulfonylureas) may alter the relationship between blood glucose and HbA1c levels, although the clinical significance is unclear (26). There are also racial/ethnic differences in HbA1c levels for a given level of glycemia. A previous study found that African Americans with prediabetes (27) had HbA1c values that were 0.4% higher than among white persons; those who were within 3 years of diagnosis (28) also had higher HbA1c values than white persons for any measure of glycemia. This difference cannot be explained by measured differences in glycemia, clinical factors known to affect HbA1c measurement, or sociodemographic factors (27, 28). Therefore, it is recommended that a new diagnosis of diabetes be based on a confirmatory fasting blood glucose level of at least 7.0 mmol/L (126 mg/dL) if the initial HbA1c value is 6.5% to 6.9%. How and where the HbA1c level is measured can also affect results because of intralaboratory variation (variation in test accuracy and precision) and interlaboratory variation (variation related to use of different test methods). A single HbA1c measurement, even from a high-qualit