Disclosures Jay Shubrook's latest update on the 2018 ADA Standards of Care is now available here. Every year with the January issue of Diabetes Care, the American Diabetes Association (ADA) releases the Standards of Medical Care in Diabetes. This document is the output of the ADA’s multidisciplinary Professional Practice Committee that systematically searches MEDLINE to revise or clarify recommendations. Feedback from the larger clinical community also is incorporated. While most of the recommendations in the Standards are reaffirmed year after year, there are always a few key changes made that reflect new advances in improving the care of people with diabetes. I will focus on key 2017 updates. You can download the Standards of Care here. What is new and different in the Standards of Care for 2017? This year’s Standards of Care includes new recommendations for global assessment and management, prediabetes, hypoglycemia, and pregnancy, as well as some tweaks to diabetes nomenclature and updates to medication advice to reflect the latest clinical trial findings. 1. Global assessment, lifestyle management and psychosocial care The 2017 Standards of Care discuss a more global assessment of the person with diabetes, balancing individualization of treatment with population health. This includes a discussion of care systems and a focus on the environmental and system factors contributing to diabetes. Health literacy, numeracy, and social determinants of health are all important factors to assess. Lifestyle management: The Standards of Care have been reorganized to highlight the importance of lifestyle management of diabetes. This section discusses the goals of nutrition therapy, weight management, physical activity, psychosocial care, and sleep. Diabetes self-management education (DSME) and diabetes self-management support (DSMS) are recommended for all people with diabetes throughout the progression of the disease. Key times for DSME and DSMS include: time of diagnosis; annually for assessment of ongoing needs; when new complicating factors arise such as a change in health; and when transitions in care occur. Based on new evidence of glycemic benefits, the Standards of Care now recommend that prolonged sitting be interrupted every 30 minutes with short bouts of physical activity. A recommendation has been added to highlight the importance of balance and flexibility training in older adults. Psychosocial care: In late 2016 the ADA published a new position statement on psychosocial care for people with diabetes, which is reflected in this year’s Standards of Care. Highlights include adding key mental health conditions (depression, anxiety, bipolar disorder) to the list of important co-morbid illnesses that should be assessed and addressed in people with diabetes. There are also new recommendations for when to refer to a mental health professional. Table 1 [4.2 in the SOC 2017]: Situations that warrant referral of a person with diabetes to a mental health provider for evaluation and treatment • If self-care remains impaired in a person with diabetes distress after tailored diabetes education • If a person has a positive screen on a validated screening tool for depressive symptoms • In the presence of symptoms or suspicions of disordered eating behavior, an eating disorder, or disrupted patterns of eating • If intentional omission of insulin or oral medication to cause weight loss is identified • If a person has a positive screen for anxiety or fear of hypoglycemia • If a serious mental illness is suspected • In youth and families with behavioral self-care difficulties, repeated hospitalizations for diabetic ketoacidosis, or significant distress • If a person screens positive for cognitive impairment • Declining or impaired ability to perform diabetes self-care behaviors • Before undergoing bariatric or metabolic surgery and after surgery if assessment reveals an ongoing need for adjustment support Finally it is recommended that people should be monitored for diabetes distress, especially when treatment targets are not met and at the onset of any complication. Sleep in glucose metabolism and control: The Standards of Care now suggest that health care providers consider the assessment of sleep pattern and duration as part of the comprehensive medical evaluation for people with diabetes. This is based on emerging evidence that poor sleep quality, short sleep, and long sleep are associated with suboptimal glycemic control. 2. Prediabetes Recommendations on screening for prediabetes: To help providers identify those patients who would benefit from prevention efforts, new text has been added emphasizing the importance of screening for prediabetes using an assessment tool (available here) or informal assessment of risk factors and performing a diagnostic test when appropriate. (Tables 2 and 3) Table 2 [2.3 in SOC 2017] - Criteria for testing for diabetes or prediabetes in asymptomatic adults 1. Testing should be considered in overweight or obese (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans) adults who have one or more of the following risk factors: • A1C ≥5.7% (39 mmol/mol), IGT, or IFG on previous testing • first-degree relative with diabetes • high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander) • women who were diagnosed with GDM • history of CVD • hypertension (≥140/90 mmHg or on therapy for hypertension) • HDL cholesterol level <35 mg/dL (0.90 mmol/L) and/or a triglyceride level >250 mg/dL (2.82 mmol/L) • women with polycystic ovary syndrome • physical inactivity • other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans). 2. For all patients, testing should begin at age 45 years. 3. If results are normal, testing should be repeated at a minimum of 3-year intervals, with consideration of more frequent testing depending on initial results (e.g., those with prediabetes should be tested yearly) and risk status. Table 3 [2.5 in SOC 2017] - Testing criteria for type 2 diabetes or prediabetes in asymptomatic children (persons aged ≤18 years) • Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal for height) Plus any two of the following risk factors: • Family history of type 2 diabetes in first- or second-degree relative • Race/ethnicity (Native American, African American, Latino, Asian American, Pacific Islander) • Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational-age birth weight) • Maternal history of diabetes or GDM during the child’s gestation Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a younger age Frequency: every 3 years 3. Hypoglycemia New definition of hypoglycemia: The definition of hypoglycemia has been adjusted based on recommendations from the International Hypoglycemia Study Group. Serious clinically significant hypoglycemia is now defined as blood glucose < 54 mg/dL (3.0 mmol/L), while the blood glucose alert value is defined as < 70 mg/dL (3.9 mmol/L). (Table 4) Table 4 [6.3 in SOC 2017] - Classification of hypoglycemia Level Glycemic criteria Description Glucose alert value (level 1) ≤70 mg/dL (3.9 mmol/L) Sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy Clinically significant hypoglycemia (level 2) <54 mg/dL (3.0 mmol/L) Sufficiently low to indicate serious, clinically important hypoglycemia Severe hypoglycemia (level 3) No specific glucose threshold Hypoglycemia associated with severe cognitive impairment requiring external assistance for recovery 4. Pregnancy-related changes There are a number of key recommendations changed or highlighted regarding the care of pregnant women with diabetes. Use insulin to treat hyperglycemia in pregnancy: There is an emphasis on insulin as a treatment of choice in pregnancy over metformin and glyburide. While individual randomized controlled trials support the efficacy and short-term safety of metformin and glyburide, both agents cross the placenta. Long-term safety data are not available for any oral agent. Change in recommendation of when postpartum glucose testing should occur: The ADA now recommends testing women with gestational diabetes for persistent diabetes at 4–12 weeks postpartum. This allows the test to be scheduled just before the standard 6-week postpartum obstetrical checkup so that the results can be discussed with the patient at the time of that visit. If the patient was not tested, this allows the test to be rescheduled at the visit. 5. Diabetes classification and nomenclature Staging of type 1 diabetes: Various genetic and environmental factors can result in the progressive loss of β-cell mass and/or function that manifests clinically as hyperglycemia. Three distinct stages of type 1 diabetes can be identified and serve as a framework for future research and regulatory decision making. (Table 5) Table 5 [2.1 in SOC 2017] - Staging of type 1 diabetes Stage 1 Stage 2 Stage 3 Stage • Autoimmunity • Normoglycemia • Presymptomatic • Autoimmunity • Dysglycemia • Presymptomatic • New-onset hyperglycemia • Symptomatic Diagnostic criteria • Multiple autoantibodies • No IGT or IFG • Multiple autoantibodies • Dysglycemia: IFG and/or IGT • FPG 100–125 mg/dL (5.6–6.9 mmol/L) • 2-h PG 140–199 mg/dL (7.8–11.0 mmol/L) • A1C 5.7–6.4% (39–47 mmol/mol) or ≥10% increase in A1C • Clinical symptoms • Diabetes by standard criteria Greater details on monogenic forms of diabetes: Additional detail has been added to the section on monogenic diabetes syndromes and a new table has been added (Table 6) describing the most common forms of monogenic diabetes. Table 6 [2.7 in SOC 2017] - Most common causes of monogenic diabetes Gene Inheritance Clinical features MODY GCK AD GCK-MODY: stable, nonprogressive elevated fasting blood glucose; typically does not require treatment; microvascular complications are rare; small rise in 2-h PG level on OGTT (<54 mg/dL [3 mmol/L]) HNF1A AD HNF1A-MODY: progressive insulin secretory defect with presentation in adolescence or early adulthood; lowered renal threshold for glucosuria; large rise in 2-h PG level on OGTT (>90 mg/dL [5 mmol/L]); sensitive to sulfonylureas HNF4A AD HNF4A-MODY: progressive insulin secretory defect with presentation in adolescence or early adulthood; may have large birth weight and transient neonatal hypoglycemia; sensitive to sulfonylureas HNF1B AD HNF1B-MODY: developmental renal disease (typically cystic); genitourinary abnormalities; atrophy of the pancreas; hyperuricemia; gout Neonatal diabetes KCNJ11 AD Permanent or transient: IUGR; possible developmental delay and seizures; responsive to sulfonylureas INS AD Permanent: IUGR; insulin requiring ABCC8 AD Transient or permanent: IUGR; rarely developmental delay; responsive to sulfonylureas 6q24 (PLAGL1, HYMA1) AD for paternal duplications Transient: IUGR; macroglossia; umbilical hernia; mechanisms include UPD6, paternal duplication or maternal methylation defect; may be treatable with medications other than insulin GATA6 AD Permanent: pancreatic hypoplasia; cardiac malformations; pancreatic exocrine insufficiency; insulin requiring EIF2AK3 AR Permanent: Wolcott-Rallison syndrome: epiphyseal dysplasia; pancreatic exocrine insufficiency; insulin requiring FOXP3 x-linked Permanent: immunodysregulation, polyendocrinopathy, enteropathy X-linked (IPEX) syndrome: autoimmune diabetes; autoimmune thyroid disease; exfoliative dermatitis; insulin requiring 6. Changes to medication-related recommendations B12 supplementation in those taking metformin: To reflect new evidence showing that long-term metformin may lead to vitamin B12 deficiency, a recommendation has been added to consider periodic measurement of B12 levels and supplementation as needed. Additional recommendation based on EMPA-REG OUTCOME and LEADER trials: Based on the results of two large clinical trials, a recommendation has been added to consider empagliflozin or liraglutide in patients with cardiovascular disease to reduce cardiovascular and all-cause mortality. Other pharmacologic updates: Combination injectable therapy recommendations for type 2 diabetes (Figure 1) have been changed to reflect studies demonstrating the noninferiority of basal insulin plus GLP-1 receptor agonist to basal insulin plus rapid-acting insulin or to two daily injections of premixed insulin, as well as studies demonstrating the noninferiority of a premixed analog insulin three times daily regimen versus basal-bolus therapy. × Due to concerns about the affordability of antihyperglycemic agents, new tables have been added showing estimates of the median costs of non-insulin agents and insulin. Jay H Shubrook, DO, is chair of the American Diabetes Association’s Primary Care Advisory Group. This group is responsible for producing the ADA’s abridged Standards of Medical Care, published in Clinical Diabetes, that highlights key recommendations for primary care providers.