4-3-ADA-Standard-of-Care-for-DM-2020.pdf

STANDARDS OF CARE Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers American Diabetes Association outcomes within the group”; these outco...

STANDARDS OF CARE Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers American Diabetes Association outcomes within the group”; these outcomes can be The American Diabetes Association’s (ADA’s) Standards measured in terms of health outcomes (mortality, of Medical Care in Diabetes is updated and published an- morbidity, health, and functional status), disease nually in a supplement to the January issue of Diabetes Care. burden (incidence and prevalence), and behavioral The Standards are developed by the ADA’s multidisciplinary and metabolic factors (exercise, diet, A1C, etc.). Professional Practice Committee, which comprises physi- cians, diabetes educators, and other expert diabetes health Recommendations care professionals. The Standards include the most current 1.1 Ensure treatment decisions are timely, rely evidence-based recommendations for diagnosing and on evidence-based guidelines, and are made col- treating adults and children with all forms of diabetes. laboratively with patients based on individual ADA’s grading system uses A, B, C, or E to show the preferences, prognoses, and comorbidities. B evidence level that supports each recommendation. 1.2 Align approaches to diabetes management with A—Clear evidence from well-conducted, generalizable the Chronic Care Model (CCM). This model em- randomized controlled trials that are adequately phasizes person-centered team care, integrated powered long-term treatment approaches to diabetes and B—Supportive evidence from well-conducted cohort comorbidities, and ongoing collaborative commu- studies nication and goal setting between all team C—Supportive evidence from poorly controlled or members. A uncontrolled studies 1.3 Care systems should facilitate team-based care and E—Expert consensus or clinical experience utilization of patient registries, decision support tools, This is an abridged version of the current Standards and community involvement to meet patient needs. B containing the evidence-based recommendations 1.4 Assess diabetes health care maintenance using re- most pertinent to primary care. The recommendations, liable and relevant data metrics to improve processes tables, and figures included here retain the same num- of care and health outcomes, with simultaneous bering used in the complete 2020 Standards and so are emphasis on care costs. B not numbered sequentially in this abridged version. All of the recommendations included here are substantively the Six Core Elements same as in the complete Standards. The abridged version The CCM includes six core elements to optimize the care of does not include references. The complete 2020 Stan- patients with chronic disease: dards of Care, including all supporting references, is 1. Delivery system design (moving from a reactive to a available at professional.diabetes.org/standards. proactive care delivery system where planned visits are coordinated through a team-based approach) 1. IMPROVING CARE AND PROMOTING HEALTH 2. Self-management support IN POPULATIONS 3. Decision support (basing care on evidence-based, ef- fective care guidelines) Diabetes and Population Health 4. Clinical information systems (using registries that can Population health is defined as “the health outcomes of a provide patient-specific and population-based support group of individuals, including the distribution of health to the care team) This is an abridged version of the American Diabetes Association’s Standards of Medical Care in Diabetes—2020. Diabetes Care 2020;43(Suppl. 1): S1–S212. The complete 2020 Standards supplement, including all supporting references, is available at professional.diabetes.org/standards. https://doi.org/10.2337/cd20-as01 ©2019 by the American Diabetes Association. Readers may use this work as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://www.diabetesjournals.org/content/license for details. Readers may link to the version of record of this work on professional.diabetes.org/standards, but ADA permission is required to post this work on any third-party website or platform. Requests to reuse or repurpose; adapt or modify; or post, display, or distribute this work may be sent to [email protected]. 10 CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION 5. Community resources and policies (identifying or of food insecurity, homelessness, seasonal agricultural developing resources to support healthy lifestyles) work, and language barriers. 6. Health systems (to create a quality-oriented culture) A 5-year effectiveness study of the CCM in 53,436 primary care patients with type 2 diabetes suggested that 2. CLASSIFICATION AND DIAGNOSIS OF DIABETES the use of this model of care delivery reduced the cu- Classification mulative incidence of diabetes-related complications Diabetes can be classified into the following general and all-cause mortality. Patients who were enrolled in the categories: CCM experienced a reduction in cardiovascular disease 1. Type 1 diabetes (due to autoimmune b-cell destruction, (CVD) risk by 56.6%, microvascular complications by usually leading to absolute insulin deficiency) 11.9%, and mortality by 66.1%. The same study sug- 2. Type 2 diabetes (due to a progressive loss of b-cell gested that health care utilization was lower in the CCM insulin secretion frequently on the background of in- group, resulting in health care savings of $7,294 per sulin resistance) individual over the study period. 3. Gestational diabetes mellitus (GDM; diabetes diagnosed in the second or third trimester of Strategies for System-Level Improvement pregnancy that was not clearly overt diabetes prior to 1. Care teams gestation) 2. Telemedicine 4. Specific types of diabetes due to other causes, e.g., 3. Behaviors and well-being monogenic diabetes syndromes (such as neonatal 4. Cost considerations diabetes and maturity-onset diabetes of the 5. Access to care and quality improvement young), diseases of the exocrine pancreas (such as cystic fibrosis and pancreatitis), and drug- or chemical-induced diabetes (such as with Tailoring Treatment for Social Context glucocorticoid use, in the treatment of HIV/AIDS, or after organ transplantation) Recommendations It is important for providers to realize that classification 1.5 Providers should assess social context, including of diabetes type is not always straightforward at potential food insecurity, housing stability, and fi- presentation, and misdiagnosis may occur. The diagnosis nancial barriers, and apply that information to may become more obvious over time and should be treatment decisions. A reevaluated if there is concern. 1.6 Refer patients to local community resources when available. B 1.7 Provide patients with self-management support from Screening and Diagnostic Tests for Prediabetes lay health coaches, navigators, or community health and Type 2 Diabetes workers when available. A The diagnostic criteria for diabetes and prediabetes are Health inequities related to diabetes and its shown in Table 2.2/2.5. complications are well documented and are heavily influenced by social determinants of health (SDoH). Recommendations SDoH are defined as the economic, environmental, po- litical, and social conditions in which people live and are 2.6 Screening for prediabetes and type 2 diabetes with responsible for a major part of health inequality world- an informal assessment of risk factors or validated wide. The ADA recognizes the association between social tools should be considered in asymptomatic and environmental factors and the prevention and adults. B treatment of diabetes and has issued a call for research 2.7 Testing for prediabetes and/or type 2 diabetes in that seeks to better understand how these SDoH influence asymptomatic people should be considered in adults behaviors and how the relationships between these of any age with overweight or obesity (BMI $25 kg/m2 variables might be modified for the prevention and or $23 kg/m2 in Asian Americans) and who have one management of diabetes. or more additional risk factors for diabetes (Table 2.3). B The complete 2020 Standards of Care include a discussion 2.8 Testing for prediabetes and/or type 2 diabetes of assessment and treatment considerations in the context should be considered in women planning pregnancy VOLUME 38, NUMBER 1, WINTER 2020 11 ABRIDGED STANDARDS OF CARE 2020 with overweight or obesity and/or who have one should consider using an assay without interference one or more additional risk factor for diabetes or plasma blood glucose criteria for diagnosis. (See “6. (Table 2.3). C Glycemic Targets” in the complete 2020 Standards of 2.9 For all people, testing should begin at age 45 years. B Care for conditions causing discrepancies.) Unless there 2.10 If tests are normal, repeat testing carried out at a is a clear clinical diagnosis based on overt signs of hy- minimum of 3-year intervals is reasonable. C perglycemia, diagnosis requires two abnormal test re- 2.12 In patients with prediabetes and type 2 diabetes, sults from the same sample or in two separate test identify and treat other CVD risk factors. B samples. If using two separate test samples, it is rec- 2.13 Risk-based screening for prediabetes and/or type 2 ommended that the second test, which may either diabetes should be considered after the onset of be a repeat of the initial test or a different test, be puberty or after 10 years of age, whichever occurs performed without delay. If the patient has a test result earlier, in children and adolescents with overweight near the margins of the diagnostic threshold, the pro- vider should follow the patient closely and repeat the (BMI $85th percentile) or obesity (BMI $95th test in 3–6 months. percentile) and who have additional risk factors for diabetes. (See Table 2.4 for evidence grading of 3. PREVENTION OR DELAY OF TYPE 2 DIABETES risk factors.) Marked discrepancies between measured A1C and Recommendation plasma glucose levels should prompt consideration that 3.1 At least annual monitoring for the development of type the A1C assay may not be reliable for that individual, and 2 diabetes in those with prediabetes is suggested. E TABLE 2.2/2.5 Criteria for the screening and diagnosis of prediabetes and diabetes Prediabetes Diabetes A1C 5.7–6.4% (39–47 mmol/mol)* $6.5% (48 mmol/mol)† Fasting plasma glucose 100–125 mg/dL (5.6–6.9 mmol/L)* $126 mg/dL (7.0 mmol/L)† Oral glucose tolerance test 140–199 mg/dL (7.8–11.0 mmol/L)* $200 mg/dL (11.1 mmol/L)† Random plasma glucose $200 mg/dL (11.1 mmol/L)‡ Adapted from Tables 2.2 and 2.5 in the complete Standards of Care. *For all three tests, risk is continuous, extending below the lower limit of the range and becoming disproportionately greater at the higher end of the range. †In the absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results from the same sample or in two separate samples. ‡Only diagnostic in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis. TABLE 2.3 Criteria for testing for diabetes or prediabetes in asymptomatic adults 1. Testing should be considered in adults with overweight or obesity (BMI $25 kg/m2 or $23 kg/m2 in Asian Americans) who have one or more of the following risk factors: First-degree relative with diabetes High-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander) 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. Patients with prediabetes (A1C $5.7% [39 mmol/mol], impaired glucose tolerance, or impaired fasting glucose) should be tested yearly. 3. Women who were diagnosed with GDM should have lifelong testing at least every 3 years. 4. For all other patients, testing should begin at age 45 years. 5. 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 and risk status. 12 CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION Screening for prediabetes and type 2 diabetes risk through Study, and 34% reduction at 10 years and 27% reduction an informal assessment of risk factors (Table 2.3) or at 15 years in the U.S. Diabetes Prevention Program with an assessment tool such as the ADA risk test Outcomes Study. (diabetes.org/socrisktest) is recommended to guide providers on whether performing a diagnostic test for Pharmacologic Interventions prediabetes and previously undiagnosed type 2 Recommendation diabetes (Table 2.2/2.5) is appropriate. Those who 3.6 Metformin therapy for prevention of type 2 are determined to be at high risk for type 2 diabetes, diabetes should be considered in those with including people with an A1C of 5.7–6.4% (39–47 prediabetes, especially for those with BMI $35 mmol/mol), impaired glucose tolerance, or impaired kg/m2, those aged ,60 years, and women with prior fasting glucose, are ideal candidates for diabetes GDM. A prevention efforts. Although no drugs have been approved by the U.S. Lifestyle Interventions Food and Drug Administration (FDA) for diabetes pre- Recommendations vention, several have shown promise in research studies. Metformin has the strongest evidence base and dem- 3.2 Refer patients with prediabetes to an intensive onstrated long-term safety as pharmacologic therapy for behavioral lifestyle intervention program diabetes prevention. Cost, side effects, and durable modeled on the Diabetes Prevention Program efficacy require consideration when using other (DPP) to achieve and maintain 7% loss of initial body pharmacologic agents for diabetes prevention in those weight and increase moderate-intensity physical with prediabetes. activity (such as brisk walking) to at least 150 min/week. A Prevention of CVD 3.3 A variety of eating patterns are acceptable for persons with prediabetes. B Recommendation 3.4 Based on patient preference, technology-assisted 3.8 Prediabetes is associated with heightened cardio- diabetes prevention interventions may be effective in vascular (CV) risk; therefore, screening for and preventing type 2 diabetes and should be consid- treatment of modifiable risk factors for CVD are ered. B suggested. B 3.5 Given the cost-effectiveness of diabetes prevention, such intervention programs should be covered by third-party payers. B Diabetes Self-Management Education and Support The DPP trial demonstrated that an intensive lifestyle intervention could reduce the incidence of Recommendation type 2 diabetes by 58% over 3 years. Follow-up of 3.9 Diabetes self-management education and support three large studies of lifestyle intervention for (DSMES) programs may be appropriate venues for diabetes prevention has shown sustained reduction in people with prediabetes to receive education and the rate of conversion to type 2 diabetes: 39% reduction support to develop and maintain behaviors that can at 30 years in the Da Qing Diabetes Prevention Study, 43% prevent or delay the development of type 2 reduction at 7 years in the Finnish Diabetes Prevention diabetes. B TABLE 2.4 Risk-based screening for type 2 diabetes or prediabetes in asymptomatic children and adolescents in a clinical setting Testing should be considered in youth* with overweight ($85th percentile) or obesity ($95th percentile) A who have one or more additional risk factors based on the strength of their association with diabetes: Maternal history of diabetes or GDM during the child’s gestation A Family history of type 2 diabetes in first- or second-degree relative A Race/ethnicity (Native American, African American, Latino, Asian American, Pacific Islander) A Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational-age birth weight) B *After the onset of puberty or after 10 years of age, whichever occurs earlier. If tests are normal, repeat testing at a minimum of 3-year intervals, or more frequently if BMI is increasing, is recommended. Reports of type 2 diabetes before age 10 years exist, and this can be considered with numerous risk factors. VOLUME 38, NUMBER 1, WINTER 2020 13 ABRIDGED STANDARDS OF CARE 2020 4. COMPREHENSIVE MEDICAL EVALUATION AND quality of life. Treatment goals and plans for meeting ASSESSMENT OF COMORBIDITIES them should be created collaboratively with patients (Figure 4.1). Patient-Centered Collaborative Care Recommendations Comprehensive Medical Evaluation 4.1 A patient-centered communication style that uses Recommendations person-centered and strength-based language 4.3 A complete medical evaluation should be performed and active listening; elicits patient preferences at the initial visit to: and beliefs; and assesses literacy, numeracy, and Confirm the diagnosis and classify diabetes. B potential barriers to care should be used to Evaluate for diabetes complications and potential optimize patient health outcomes and health- comorbid conditions. B related quality of life. B Review previous treatment and risk factor control 4.2 Diabetes care should be managed by a multidisci- in patients with established diabetes. B plinary team that may draw from primary care Begin patient engagement in the formulation of a physicians, subspecialty physicians, nurse practi- care management plan. B tioners, physician assistants, nurses, dietitians, Develop a plan for continuing care. B exercise specialists, pharmacists, dentists, 4.4 A follow-up visit should include most components of podiatrists, and mental health professionals. E the initial comprehensive medical evaluation, in- Individuals with diabetes must assume an active role in cluding interval medical history, assessment of their care. The goals of treatment for diabetes are medication-taking behavior and intolerance/side to prevent or delay complications and maintain effects, physical examination, laboratory evaluation FIGURE 4.1 Decision cycle for patient-centered glycemic management in type 2 diabetes. HbA1c, glycated hemoglobin. Reprinted from Davies MJ, D’Alessio DA, Fradkin J, et al. Diabetes Care 2018;41:2669–2701. 14 CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION as appropriate to assess attainment of A1C and Comprehensive Medical Evaluation and Assessment of metabolic targets, and assessment of risk for com- Comorbidities” in the complete 2020 Standards of Care plications, diabetes self-management behaviors, for discussion on these topics. nutrition, psychosocial health, and the need for referrals, immunizations, or other routine health 5. FACILITATING BEHAVIOR CHANGE AND maintenance screening. B WELL-BEING TO IMPROVE HEALTH OUTCOMES 4.5 Ongoing management should be guided by the assessment of diabetes complications and shared Effective behavior management and psychological well- decision-making to set therapeutic goals. B being are foundational to achieving treatment goals for 4.6 The 10-year risk of a first atherosclerotic people with diabetes. Essential to achieving these goals cardiovascular disease (ASCVD) event should be are DSMES, medical nutrition therapy (MNT), routine assessed using the race- and sex-specific Pooled physical activity, smoking cessation counseling when Cohort Equations to better stratify ASCVD risk. B needed, and psychosocial care. DSMES Immunizations Recommendations Children and adults with diabetes should receive vacci- nations according to age-specific recommendations. 5.1 In accordance with the national standards for The Centers for Disease Control and Prevention DSMES, all people with diabetes should participate in provides vaccination schedules at www.cdc.gov/ diabetes self-management education (DSME) and vaccines/schedules. receive the support needed to facilitate the knowl- edge, decision-making, and skills mastery necessary Assessment of Comorbidities for diabetes self-care. A 5.2 There are four critical times to evaluate the need for Besides assessing diabetes-related complications, DSME to promote skills acquisition in support of clinicians and their patients need to be aware of regimen implementation, MNT, and well-being: at common comorbidities that may complicate diabetes diagnosis, annually, when complicating factors arise, management. and when transitions in care occur. E 5.3 Clinical outcomes, health status, and well-being are Autoimmune Diseases key goals of DSMES that should be measured as part Recommendations of routine care. C 5.4 DSMES should be patient centered, may be given in 4.12 Patients with type 1 diabetes should be screened for group or individual settings and/or use technology, autoimmune thyroid disease soon after diagnosis and should be communicated with the entire diabetes and periodically thereafter. B care team. A 4.13 Adult patients with type 1 diabetes should be screened for celiac disease in the presence of gas- Medical Nutrition Therapy trointestinal symptoms, signs, or laboratory mani- festations suggestive of celiac disease. B Evidence suggests that there is not an ideal percentage of calories from carbohydrate, protein, and fat for all people with Cancer diabetes. Therefore, macronutrient distribution should be based on an individualized assessment of current eating Patients with diabetes should be encouraged to undergo patterns, preferences, and metabolic goals. Consider personal recommended age- and sex-appropriate cancer screen- preferences (e.g., tradition, culture, religion, health beliefs, ings and to reduce their modifiable cancer risk factors and economics) as well as metabolic goals when working with (obesity, physical inactivity, and smoking). individuals to determine the best eating pattern for them. An individualized eating pattern considers the individual’s health Other Conditions status, skills, resources, food preferences, and health goals. Nonalcoholic fatty liver disease, hepatitis C infection, Referral to a registered dietitian nutritionist (RD/RDN) is pancreatitis, hearing impairment, HIV, cognitive essential to assess the overall nutrition status of, and to work impairment/dementia, hip fractures, low testosterone in collaboratively with, the patient to create a personalized meal men, obstructive sleep apnea, and periodontal disease are plan that coordinates and aligns with the overall treatment all more common in people with diabetes. See “4. plan, including physical activity and medication use. VOLUME 38, NUMBER 1, WINTER 2020 15 ABRIDGED STANDARDS OF CARE 2020 Physical Activity quality of life, available resources (financial, social, and emotional), and psychiatric history. E Recommendations 5.33 Providers should consider assessment for symptoms 5.24 Children and adolescents with type 1 or type 2 of diabetes distress, depression, anxiety, disordered diabetes or prediabetes should engage in 60 min/day eating, and cognitive capacities using appropriate or more of moderate- or vigorous-intensity aerobic standardized and validated tools at the initial visit, activity, with vigorous muscle-strengthening and at periodic intervals, and when there is a change in bone-strengthening activities at least 3 days/week. C disease, treatment, or life circumstance. Including 5.25 Most adults with type 1 C and type 2 B diabetes caregivers and family members in this assessment is should engage in 150 min or more of moderate- to recommended. B vigorous-intensity aerobic activity per week, spread 5.34 Consider screening older adults (aged $65 years) over at least 3 days/week, with no more than 2 with diabetes for cognitive impairment and de- consecutive days without activity. Shorter durations pression. B (minimum 75 min/week) of vigorous-intensity or 5.36 Consider screening for anxiety in people exhibiting interval training may be sufficient for younger anxiety or worries regarding diabetes complications, and more physically fit individuals. insulin administration, and taking medications, as 5.26 Adults with type 1 C and type 2 B diabetes should well as fear of hypoglycemia and/or hypoglycemia engage in 2–3 sessions/week of resistance exercise unawareness that interferes with self-management on nonconsecutive days. behaviors, and in those who express fear, dread, or 5.27 All adults, and particularly those with type 2 diabetes, irrational thoughts and/or show anxiety symptoms should decrease the amount of time spent in daily such as avoidance behaviors, excessive repetitive sedentary behavior. B Prolonged sitting should be behaviors, or social withdrawal. Refer for treatment if interrupted every 30 min for blood glucose benefits. C anxiety is present. B 5.28 Flexibility training and balance training are rec- 5.44 Annually screen people who are prescribed ommended 2–3 times/week for older adults with atypical antipsychotic medications for prediabetes diabetes. Yoga and tai chi may be included based on or diabetes. B individual preferences to increase flexibility, mus- Diabetes distress refers to significant negative psy- cular strength, and balance. C chological reactions to emotional burdens and worries The ADA position statement “Physical Activity/Exercise specific to an individual’s experience in having to and Diabetes” offers specific recommendations and manage a severe, complicated, and demanding chronic precautions related to type of diabetes, age, activity done, disease such as diabetes. Validated tools are available to and presence of diabetes-related health complications measure the level of distress and identify issues that including retinopathy, peripheral neuropathy, autonomic care team members may address. The ADA position neuropathy, and diabetic kidney disease (DKD). statement “Psychosocial Care for People With Diabetes” provides a list of assessment tools and additional Smoking Cessation: Tobacco and E-Cigarettes details. Recommendations 5.29 Advise all patients not to use cigarettes and other 6. GLYCEMIC TARGETS tobacco products A or e-cigarettes. A Assessment of Glycemic Control 5.30 After identification of tobacco or e-cigarette use, include smoking cessation counseling and other Glycemic management is primarily assessed with the A1C forms of treatment as a routine component of test, the primary measure studied in clinical trials diabetes care. A demonstrating the benefits of improved glycemic control. Self-monitoring of blood glucose (SMBG) may help with Psychosocial Issues self-management and medication adjustment, particu- larly in individuals taking insulin. Continuous glucose Recommendations monitoring (CGM) also has an important role in assessing 5.32 Psychosocial screening and follow-up may include, the effectiveness and safety of treatment in many patients but are not limited to, attitudes about diabetes, with type 1 diabetes, and limited data suggest it may also expectations for medical management and out- be helpful in selected patients with type 2 diabetes, such as comes, affect or mood, general and diabetes-related those on intensive insulin regimens. 16 CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION A1C Testing insulin. CGM has emerged as a complementary method for the assessment of glucose levels. The patient’s specific Recommendations needs and goals should dictate SMBG frequency and timing 6.1 Perform the A1C test at least two times a year in or the consideration of CGM use. patients who are meeting treatment goals (and who have stable glycemic control). E 6.2 Perform the A1C test quarterly in patients whose Glucose Assessment Using CGM therapy has changed or who are not meeting gly- CGM has evolved rapidly in both accuracy and affordability. cemic goals. E To make CGM metrics more actionable, standardized 6.3 Point-of-care testing for A1C provides the opportu- reports with visual cues such as the AGP (Figure 6.1) are nity for more timely treatment changes. E recommended and may help patients and providers in- terpret the data and use it to guide treatment decisions. Glucose Assessment Recommendations A1C Goals 6.4 Standardized, single-page glucose reports with visual Recommendations cues such as the Ambulatory Glucose Profile (AGP) 6.6 An A1C goal for many nonpregnant adults of ,7% should be considered as a standard printout for all (53 mmol/mol) is appropriate. A CGM devices. E 6.7 On the basis of provider judgment and 6.5 Time in range is associated with the risk of micro- patient preference, achievement of lower A1C levels vascular complications and should be an acceptable (such as ,6.5%) may be acceptable if this can be end point for clinical trials and can be used for as- achieved safely without significant hypoglycemia or sessment of glycemic control. Additionally, time other adverse effects of treatment. C below target (,70 and ,54 mg/dL [3.9 and 3.0 6.8 Less stringent A1C goals (such as ,8% [64 mmol/L]) and time above target (.180 mg/dL [10.0 mmol/mol]) may be appropriate for patients with a mmol/L]) are useful parameters for reevaluation of history of severe hypoglycemia, limited life expec- the treatment regimen. E tancy, advanced microvascular or macrovascular Glucose monitoring is key for the achievement of complications, extensive comorbid conditions, or glycemic targets for many people with diabetes. SMBG is an long-standing diabetes in whom the goal is difficult to integral component of effective therapy for patients taking achieve despite DSME, appropriate glucose FIGURE 6.1 Sample AGP report. Adapted from Battelino T, Danne T, Bergenstal RM, et al. Diabetes Care 2019;42:1593–1603. VOLUME 38, NUMBER 1, WINTER 2020 17 ABRIDGED STANDARDS OF CARE 2020 Hypoglycemia TABLE 6.3 Summary of glycemic recommendations for many nonpregnant adults with diabetes Table 6.4 summarizes the classification of hypoglycemia A1C ,7.0% (53 mmol/mol)* levels. Preprandial capillary 80–130 mg/dL* (4.4–7.2 mmol/L) Recommendations plasma glucose 6.10 Individuals at risk for hypoglycemia should be asked Peak postprandial capillary ,180 mg/dL* (10.0 mmol/L) about symptomatic and asymptomatic hypoglyce- plasma glucose† mia at each encounter. C *More or less stringent glycemic goals may be appropriate for individual 6.11 In patients taking medication that can lead to hy- patients. Goals should be individualized based on duration of diabetes, poglycemia, investigate, screen, and assess risk for age/life expectancy, comorbid conditions, known CVD or advanced or occurrence of unrecognized hypoglycemia, microvascular complications, hypoglycemia unawareness, and individual patient considerations. †Postprandial glucose may be targeted considering that patients may have hypoglycemia if A1C goals are not met despite reaching preprandial glucose goals. unawareness. C Postprandial glucose measurements should be made 1–2 h after the 6.12 Glucose (15–20 g) is the preferred treatment for the beginning of the meal, generally peak levels in patients with diabetes. conscious individual with blood glucose ,70 mg/dL [3.9 mmol/L]), although any form of carbohydrate that contains glucose may be used. Fifteen minutes monitoring, and effective doses of multiple glucose- after treatment, if SMBG shows continued hypo- lowering agents including insulin. B glycemia, the treatment should be repeated. Once 6.9 Reassess glycemic targets over time based on the SMBG returns to normal, the individual should criteria in Figure 6.2. E consume a meal or snack to prevent recurrence of See “6. Glycemic Targets,” “13. Children and Adolescents,” hypoglycemia. B and “14. Management of Diabetes in Pregnancy” in the 6.13 Glucagon should be prescribed for all individuals complete 2020 Standards of Care. Table 6.3 summarizes at increased risk of level 2 hypoglycemia, defined glycemic recommendations for many nonpregnant adults. as blood glucose ,54 mg/dL (3.0 mmol/L), so it FIGURE 6.2 Depicted are patient and disease factors used to determine optimal A1C targets. Characteristics and predicaments toward the left justify more stringent efforts to lower A1C; those toward the right suggest less stringent efforts. A1C 7% 5 53 mmol/mol. Adapted with permission from Inzucchi SE, Bergenstal RM, Buse JB, et al. Diabetes Care 2015;38:140–149. 18 CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION is available should it be needed. Caregivers, TABLE 6.4 Classification of hypoglycemia school personnel, or family members of these individuals should know where it is and when Glycemic criteria/description and how to administer it. Glucagon administration Level 1 Glucose ,70 mg/dL (3.9 mmol/L) and $54 mg/dL is not limited to health care professionals, partic- (3.0 mmol/L) ularly with the availability of intranasal and Level 2 Glucose ,54 mg/dL (3.0 mmol/L) stable soluble glucagon available in autoinjector pens. E Level 3 A severe event characterized by altered mental and/or physical status requiring assistance for treatment of 6.14 Hypoglycemia unawareness or one or more epi- hypoglycemia sodes of level 3 hypoglycemia should trigger hy- Reprinted from Agiostratidou G, Anhalt H, Ball D, et al. Diabetes Care poglycemia avoidance education and reevaluation 2017;40:1622–1630. of the treatment regimen. E 6.15 Insulin-treated patients with hypoglycemia un- awareness, one level 3 hypoglycemic event, or a pattern of unexplained level 2 hypoglycemia should TABLE 7.3 CGM devices be advised to raise their glycemic targets to strictly Real-time CGM CGM systems that measure glucose levels avoid hypoglycemia for at least several weeks in continuously and provide the user automated order to partially reverse hypoglycemia un- alarms and alerts at specific glucose levels and/or for changing glucose levels. awareness and reduce risk of future episodes. A 6.16 Ongoing assessment of cognitive function is sug- Intermittently scanned CGM systems that measure glucose levels CGM continuously but only display glucose values gested with increased vigilance for hypoglycemia by when swiped by a reader or a smart phone that the clinician, patient, and caregivers if low cognition reveals the glucose levels. or declining cognition is found. B Blinded (professional) CGM devices that measure glucose levels that CGM are not displayed to the patient in real time. 7. DIABETES TECHNOLOGY These devices are generally initiated in a clinic, using a reader that is owned by the clinic. They Diabetes technology describes the devices, software, and are removed after a period of time (generally hardware used to manage diabetes. It includes delivery 10–14 days) and analyzed by the patient and provider to assess glycemic patterns and systems such as insulin pumps, pens, and syringes as well trends. as CGM devices and glucose meters. Newer forms of diabetes technology include hybrid devices that both Unblinded CGM CGM devices that measure glucose levels that are displayed to the patient. deliver insulin and monitor glucose levels and software that provides diabetes self-management support. In- suspect low blood glucose, after treating low blood creased patient interest has increased the use of diabetes glucose until they are normoglycemic, and prior to technology in the primary care setting. and while performing critical tasks such as driving. B 7.3 When prescribed as part of a DSMES program, SMBG Recommendation may help to guide treatment decisions and/or self- 7.1 Use of technology should be individualized based on management for patients taking less frequent insulin a patient’s needs, desires, skill level, and availability injections. B of devices. Nonprofit websites can offer advice for providers and patients to determine the suitability of CGM various options. E Table 7.3 defines the types of available CGM devices. SMBG Recommendations Recommendations 7.11 When used properly, real-time and intermittently 7.2 Most patients using intensive insulin regimens scanned CGM in conjunction with insulin therapy (multiple daily injection [MDI] or continuous sub- are useful tools to lower A1C and/or reduce hy- cutaneous insulin infusion [CSII; insulin pump poglycemia in adults with type 2 diabetes who are therapy]) should be encouraged to assess glucose not meeting glycemic targets. B levels using SMBG (and/or CGM) prior to meals and The use of real-time CGM in adults with type 1 diabetes on snacks, at bedtime, prior to exercise, when they either CSII or MDI is supported by data showing reduction VOLUME 38, NUMBER 1, WINTER 2020 19 ABRIDGED STANDARDS OF CARE 2020 in both hypoglycemia and A1C. People with type 2 diabetes 8.7 As all energy-deficit food intake will result in weight on CSII or MDI have shown significant reduction in A1C in loss, eating plans should be individualized to meet multiple studies of real-time or intermittently scanned the patient’s protein, fat, and carbohydrate needs CGM but did not show a reduction in hypoglycemia. while still promoting weight loss. A 8.8 Food availability should be queried, as well as other 8. OBESITY MANAGEMENT FOR THE TREATMENT cultural circumstances that could affect dietary OF TYPE 2 DIABETES patterns. C 8.9 For patients who achieve short-term weight-loss There is strong evidence that treating obesity can delay the goals, long-term ($1 year) weight maintenance progression from prediabetes to type 2 diabetes. It also has programs are recommended when available. Such been shown to be beneficial in the treatment of type 2 programs should at minimum provide monthly diabetes. Modest and sustained weight loss has been contact, as well as encourage ongoing monitoring of shown to improve glycemic control and reduce the need body weight (weekly or more frequently) and other for glucose-lowering medications. Clinical benefits can be self-monitoring strategies, including participation seen with a minimum of 3–5% weight loss. in high levels of physical activity (200–300 min/week). A Assessment 8.10 To achieve weight loss of.5%, short-term Recommendations (3-month) interventions that use very low-calorie 8.1 Measure height and weight and calculate BMI at diets (#800 kcal/day) and meal replacements may annual visits or more frequently. E be prescribed for carefully selected patients by 8.2 Based on clinical considerations, such as the presence trained practitioners in medical care settings with of comorbid heart failure (HF) or significant un- close medical monitoring. To maintain weight loss, explained weight gain or loss, weight may need to such programs must incorporate long-term be monitored and evaluated more frequently. B If comprehensive weight-maintenance counseling. B deterioration of medical status is associated with significant weight gain or loss, inpatient evaluation Pharmacotherapy should be considered, specifically focused on the Recommendations association between medication use, food intake, and 8.11 When choosing glucose-lowering medications for glycemic status. E patients with type 2 diabetes and overweight or 8.3 For patients with a high level of weight-related obesity, consider a medication’s effect on weight. B distress, special accommodations should be made to 8.12 Whenever possible, minimize medications for ensure privacy during weighing. E comorbid conditions that are associated with weight gain. E Diet, Physical Activity, and Behavioral Therapy 8.13 Weight-loss medications are effective as adjuncts to Recommendations diet, physical activity, and behavioral counseling for 8.4 Diet, physical activity, and behavioral therapy selected patients with type 2 diabetes and designed to achieve and maintain $5% weight loss BMI $27 kg/m2. Potential benefits must be weighed is recommended for patients with type 2 diabetes against potential risks of medications. A who have overweight or obesity and are ready to 8.14 If a patient’s response to weight-loss medications is achieve weight loss. Greater benefits in control of ,5% weight loss after 3 months or if there are diabetes and CV factors may be gained from even significant safety or tolerability issues at any time, greater weight loss. B the medication should be discontinued and alter- 8.5 Such interventions should be high intensity native medications or treatment approaches should ($16 sessions in 6 months) and focus on be considered. A dietary changes, physical activity, and behavioral The FDA has approved medications for both short- and strategies to achieve a 500–750 kcal/day energy long-term weight management along with diet, exercise, deficit. A and behavioral therapy. Nearly all of these FDA-approved 8.6 Individual’s motivation, life circumstances, and will- medications have been found to improve glycemic control ingness to make lifestyle changes to achieve weight in patients with type 2 diabetes and delay progression to loss should be assessed along with medical status type 2 diabetes in patients at risk. Table 8.2 in the when weight loss interventions are undertaken. C complete 2020 Standards of Care provides a list of 20 CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION FDA-approved medications for the treatment of obesity, 9.2 Most individuals with type 1 diabetes should use along with their advantages and disadvantages. The rapid-acting insulin analogs to reduce hypoglycemia efficacy and safety of these medications should be risk. A assessed at least monthly for the first 3 months. 9.3 Patients with type 1 diabetes should be trained to match prandial insulin doses to carbohydrate intake, premeal blood glucose, and anticipated physical Metabolic Surgery activity. C Recommendations See “9. Pharmacologic Approaches to Glycemic 8.15 Metabolic surgery should be recommended as Treatment” in the complete 2020 Standards of Care for an option to treat type 2 diabetes in screened more detailed information on pharmacologic approaches surgical candidates with BMI $40 kg/m2 (BMI to type 1 diabetes management. $37.5 kg/m2 in Asian Americans) and in adults with BMI 35.0–39.9 kg/m2 (32.5–37.4 kg/m2 in Asian Americans) who do not achieve durable Pharmacologic Therapy for Type 2 Diabetes weight loss and improvement in comorbidities Figure 9.1, Figure 9.2, and Table 9.1 provide details for (including hyperglycemia) with nonsurgical informed decision-making on pharmacologic agents for methods. A type 2 diabetes. 8.16 Metabolic surgery may be considered as an option for adults with type 2 diabetes and BMI Recommendations 30.0–34.9 kg/m2 (27.5–32.4 kg/m2 in Asian 9.4 Metformin is the preferred initial pharmacologic Americans) who do not achieve durable weight loss agent for the treatment of type 2 diabetes. A and improvement in comorbidities (including hy- 9.5 Once initiated, metformin should be continued as perglycemia) with tested efficacious nonsurgical long as it is tolerated and not contraindicated; other methods. A agents, including insulin, should be added to 8.17 Metabolic surgery should be performed in high- metformin. A volume centers with multidisciplinary teams 9.6 Early combination therapy can be considered in knowledgeable about and experienced in the man- some patients at treatment initiation to extend the agement of diabetes and gastrointestinal surgery. E time to treatment failure. A 8.18 Long-term lifestyle support and routine monitoring 9.7 The early introduction of insulin should be con- of micronutrient and nutritional status must be sidered if there is evidence of ongoing catabolism provided to patients after surgery, according to (weight loss), if symptoms of hyperglycemia guidelines for postoperative management of met- are present, or when A1C levels (.10% [86 abolic surgery by national and international pro- mmol/mol]) or blood glucose levels ($300 mg/dL fessional societies. C [16.7 mmol/L]) are very high. E 8.19 People being considered for metabolic surgery 9.8 A patient-centered approach should be used to should be evaluated for comorbid psychological guide the choice of pharmacologic agents. Con- conditions and social and situational circumstances siderations include CV comorbidities, hypoglycemia that have the potential to interfere with surgery risk, impact on weight, cost, risk for side effects, and outcomes. B patient preferences (Figure 9.1). E 8.20 People who undergo metabolic surgery should 9.9 Among patients with type 2 diabetes who have routinely be evaluated to assess the need for on- established ASCVD or indicators of high-risk, going mental health services to help with the ad- established kidney disease, or HF, a sodium–glucose justment to medical and psychosocial changes after cotransporter 2 (SGLT2) inhibitor or glucagon-like surgery. C peptide 1 (GLP-1) receptor agonist with demon- strated CVD benefit (Table 9.1) is recommended as 9. PHARMACOLOGIC APPROACHES TO part of the glucose-lowering regimen independent of GLYCEMIC TREATMENT A1C and in consideration of patient-specific factors Pharmacologic Therapy for Type 1 Diabetes (Figure 9.1). A 9.10 In patients with type 2 diabetes who need greater Recommendations glucose lowering than can be obtained with oral 9.1 Most people with type 1 diabetes should be treated agents, GLP-1 receptor agonists are preferred to with MDI of prandial and basal insulin or CSII. A insulin when possible. B VOLUME 38, NUMBER 1, WINTER 2020 21 22 ABRIDGED STANDARDS OF CARE 2020 FIGURE 9.1 Glucose-lowering medication in type 2 diabetes: overall approach. For appropriate context, see Figure 4.1. CREDENCE, Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy. CVOTs, CV outcomes trials; DPP-4i, dipeptidyl peptidase 4 inhibitor; GLP-1 RA, GLP-1 receptor agonist; SGLT2i, SGLT2 inhibitor; SU, sulfonylurea; TZD, thiazolidinedione. Adapted from Davies MJ, D’Alessio DA, Fradkin J, et al. Diabetes Care 2018;41:2669–2701 and Buse JB, Wexler DJ, Tsapas A, et al. Diabetes Care 19 December 2019 [Epub ahead of print]. DOI: 10.2337/dci19-0066. CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION FIGURE 9.2 Intensifying to injectable therapies. FPG, fasting plasma glucose; FRC, fixed-ratio combination; GLP-1 RA, GLP-1 receptor agonist; iDegLira, insulin degludec/liraglutide; iGlarLixi, insulin glargine/lixisenatide; max, maximum; PPG, postprandial glucose; Table 9.3 appears in the complete 2020 Standards of Care. Adapted from Davies MJ, D’Alessio DA, Fradkin J, et al. Diabetes Care 2018;41: 2669–2701. VOLUME 38, NUMBER 1, WINTER 2020 23 24 TABLE 9.1 Drug-specific and patient factors to consider when selecting antihyperglycemic treatment in adults with type 2 diabetes ABRIDGED STANDARDS OF CARE 2020 *For agent-specific dosing recommendations, please refer to the manufacturers’ prescribing information. †FDA-approved for CVD benefit. ‡FDA-approved for HF indication. §FDA-approved for CKD indication. DPP-4, dipeptidyl peptidase 4; DKA, diabetic ketoacidosis; GLP-1 RAs, GLP-1 receptor agonists; NASH, nonalcoholic steatohepatitis; SQ, subcutaneous; T2DM, type 2 diabetes. CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION 9.11 Intensification of treatment for patients with type 2 Treatment Goals diabetes not meeting treatment goals should not be Recommendations delayed. B 10.3 For patients with diabetes and hypertension, blood 9.12 The medication regimen and medication-taking pressure targets should be individualized through a behavior should be reevaluated at regular shared decision-making process that addresses CV intervals (every 3–6 months) and adjusted risk, potential adverse effects of antihypertensive as needed to incorporate specific factors that impact medications, and patient preferences. C choice of treatment (Figure 4.1 and Table 9.1). E 10.4 For individuals with diabetes and hypertension at higher CV risk (existing ASCVD or 10-year ASCVD CV Outcomes Trials risk $15%), a blood pressure target of ,130/80 See “10. CVD and Risk Management” below for details. mmHg may be appropriate, if it can be safely attained. C 10. CVD AND RISK MANAGEMENT 10.5 For individuals with diabetes and hypertension at lower risk for CVD (10-year ASCVD risk ,15%), treat This section has received endorsement from the American to a blood pressure target of ,140/90 mmHg. A College of Cardiology. 10.6 In pregnant patients with diabetes and preexisting ASCVD—defined as coronary heart disease, cerebrovas- hypertension, a blood pressure target of #135/85 cular disease, or peripheral arterial disease (PAD) pre- mmHg is suggested in the interest of reducing the sumed to be of atherosclerotic origin—is the leading cause risk for accelerated maternal hypertension A and of morbidity and mortality for individuals with diabetes. HF minimizing impaired fetal growth. E is another major cause of morbidity and mortality from CVD. For prevention and management of both ASCVD and Individualization of Treatment Targets HF, CV risk factors should be systematically assessed at Patients and clinicians should engage in a shared decision- least annually in all patients with diabetes. These risk making process to determine individual blood pressure factors include obesity/overweight, hypertension, dysli- targets. Potential adverse effects of antihypertensive pidemia, smoking, a family history of premature coronary therapy (e.g., hypotension, syncope, falls, acute kidney disease, chronic kidney disease (CKD), and the presence of albuminuria. injury, and electrolyte abnormalities) should also be taken into account. Patients with older age, CKD, and frailty The Risk Calculator have been shown to be at higher risk of adverse effects of intensive blood pressure control. The American College of Cardiology/American Heart Association ASCVD risk calculator (Risk Estimator Plus) is Treatment Strategies a useful tool to estimate 10-year ASCVD risk (http:// tools.acc.org/ASCVD-Risk-Estimator-Plus). This calcula- Figure 10.1 provides an algorithm for the treatment of tor includes diabetes as a risk factor because diabetes itself confirmed hypertension in people with diabetes. confers increased risk for ASCVD. It should be ac- knowledged that this risk calculator does not account for Lifestyle Intervention duration of diabetes or the presence of diabetes com- Recommendation plications such as albuminuria. 10.7 For patients with blood pressure.120/80 mmHg, lifestyle intervention consists of weight loss if they Hypertension/Blood Pressure Control have overweight or obesity, a Dietary Approaches to Screening and Diagnosis Stop Hypertension (DASH)-style eating pattern Recommendations including reducing sodium and increasing potas- 10.1 Blood pressure should be measured at every routine sium intake, moderation of alcohol intake, and clinical visit. Patients found to have elevated blood increased physical activity. A pressure ($140/90 mmHg) should have blood Pharmacologic Interventions pressure confirmed using multiple readings, in- cluding measurements on a separate day, to di- Recommendations agnose hypertension. B 10.8 Patients with confirmed office-based blood 10.2 All hypertensive patients with diabetes should pressure $140/90 mmHg should, in addition to monitor their blood pressure at home. B lifestyle therapy, have prompt initiation and timely VOLUME 38, NUMBER 1, WINTER 2020 25 ABRIDGED STANDARDS OF CARE 2020 FIGURE 10.1 Recommendations for the treatment of confirmed hypertension in people with diabetes. *An ACE inhibitor (ACEi) or ARB is suggested to treat hypertension for patients with a UACR 30–299 mg/g Cr and strongly recommended for patients with a UACR $300 mg/g Cr. **Thiazide-like diuretic; long-acting agents shown to reduce CV events, such as chlorthalidone and indapamide, are preferred. ***Dihydropyridine CCB. BP, blood pressure. Adapted from de Boer IH, Bangalore S, Benetos A, et al. Diabetes Care 2017;40:1273–1284. titration of pharmacologic therapy to achieve blood lifestyle therapy, have prompt initiation and timely pressure goals. A titration of two drugs or a single-pill combination of 10.9 Patients with confirmed office-based blood drugs demonstrated to reduce CV events in patients pressure $160/100 mmHg should, in addition to with diabetes. A 26 CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION 10.10 Treatment for hypertension should include drug physical activity should be recommended to improve classes demonstrated to reduce CV events in pa- the lipid profile and reduce the risk of developing tients with diabetes (ACE inhibitors, angiotensin ASCVD in patients with diabetes. A receptor blockers [ARBs], thiazide-like diuretics, or 10.16 Intensify lifestyle therapy and optimize glycemic dihydropyridine calcium channel blockers control for patients with elevated triglyceride levels [CCBs]). A ($150 mg/dL [1.7 mmol/L]) and/or low HDL 10.11 Multiple-drug therapy is generally required to cholesterol (,40 mg/dL [1.0 mmol/L] for men, ,50 achieve blood pressure targets. However, mg/dL [1.3 mmol/L] for women). C combinations of ACE inhibitors and ARBs and combinations of ACE inhibitors or ARBs with direct Ongoing Therapy and Monitoring With Lipid Panel renin inhibitors should not be used. A 10.12 An ACE inhibitor or ARB, at the maximum Recommendations tolerated dose indicated for blood pressure 10.17 In adults not taking statins or other lipid-lowering treatment, is the recommended first-line treatment therapy, it is reasonable to obtain a lipid profile at the for hypertension in patients with diabetes and time of diabetes diagnosis, at an initial medical urinary albumin-to-creatinine ratio (UACR) $300 evaluation, and every 5 years thereafter if under the mg/g creatinine (Cr) A or 30–299 mg/g Cr. B If age of 40 years, or more frequently if indicated. E one class is not tolerated, the other should be 10.18 Obtain a lipid profile at initiation of statins or other substituted. B lipid-lowering therapy, 4–12 weeks after initiation 10.13 For patients treated with an ACE inhibitor, or a change in dose, and annually thereafter as it ARB, or diuretic, serum Cr/estimated glomerular may help to monitor the response to therapy and filtration rate (eGFR) and serum potassium levels inform medication adherence. E should be monitored at least annually. B Statin Treatment Resistant Hypertension Recommendations Recommendation 10.19 For patients with diabetes aged 40–75 years without ASCVD, use moderate-intensity statin 10.14 Patients with hypertension who are not therapy in addition to lifestyle therapy. A meeting blood pressure targets on three classes of 10.20 For patients with diabetes aged 20–39 years with antihypertensive medications (including a di- additional ASCVD risk factors, it may be reasonable uretic) should be considered for mineralocorticoid to initiate statin therapy in addition to lifestyle receptor antagonist therapy. B therapy. C Prior to diagnosing resistant hypertension, a 10.21 In patients with diabetes at higher risk, especially number of other conditions should be excluded, those with multiple ASCVD risk factors or aged including medication nonadherence, white coat 50–70 years, it is reasonable to use high-intensity hypertension, and secondary hypertension. Mineralo- statin therapy. B corticoid receptor antagonists are effective for 10.22 In adults with diabetes and 10-year ASCVD risk of management of resistant hypertension in patients with 20% or higher, it may be reasonable to add eze- type 2 diabetes when added to existing treatment with an timibe to maximally tolerated statin therapy to ACE inhibitor or ARB, thiazide-like diuretic, or dihy- reduce LDL cholesterol levels by 50% or more. C dropyridine CCB. Lipid Management Secondary Prevention 10.23 For patients of all ages with diabetes and ASCVD, Lifestyle Intervention high-intensity statin therapy should be added to Recommendations lifestyle therapy. A 10.15 Lifestyle modification focusing on weight loss (if 10.24 For patients with diabetes and ASCVD considered indicated); application of a Mediterranean-style or very high risk using specific criteria, if LDL cho- DASH eating pattern; reduction of saturated fat and lesterol is $70 mg/dL on maximally tolerated trans fat; increase of dietary n-3 fatty acids, viscous statin dose, consider adding additional LDL- fiber, and plant stanols/sterols intake; and increased lowering therapy (such as ezetimibe or PCSK9 VOLUME 38, NUMBER 1, WINTER 2020 27 ABRIDGED STANDARDS OF CARE 2020 inhibitor). A Ezetimibe may be preferred due to additional case of diabetes while simultaneously pre- lower cost. venting 5.4 vascular events among those 255 patients. 10.25 For patients who do not tolerate the intended intensity, the maximally tolerated statin dose Lipid-Lowering Agents and Cognitive Function should be used. E A concern that statins or other lipid-lowering agents 10.26 In adults with diabetes aged.75 years already on might cause cognitive dysfunction or dementia is not statin therapy, it is reasonable to continue statin currently supported by evidence and should not deter treatment. B their use in individuals with diabetes at high risk for 10.27 In adults with diabetes aged.75 years, it may be ASCVD. reasonable to initiate statin therapy after discus- sion of potential benefits and risks. C Antiplatelet Agents 10.28 Statin therapy is contraindicated in pregnancy. B Recommendations Treatment of Other Lipoprotein Fractions or Targets 10.34 Use aspirin therapy (75–162 mg/day) as a sec- Recommendations ondary prevention strategy in those with diabetes 10.29 For patients with fasting triglyceride levels $500 and a history of ASCVD. A 10.35 For patients with ASCVD and documented aspirin mg/dL, evaluate for secondary causes of hyper- triglyceridemia and consider medical therapy to allergy, clopidogrel (75 mg/day) should be used. B 10.36 Dual antiplatelet therapy (with low-dose aspirin reduce the risk of pancreatitis. C 10.30 In adults with moderate hypertriglyceridemia and a P2Y12 inhibitor) is reasonable for a year after (fasting or nonfasting triglycerides 175–499 an acute coronary syndrome A and may have mg/dL), clinicians should address and treat benefits beyond this period. B 10.37 Aspirin therapy (75–162 mg/day) may be considered lifestyle factors (obesity and metabolic syndrome), secondary factors (diabetes, chronic liver or as a primary prevention strategy in those with di- kidney disease and/or nephrotic syndrome, abetes who are at increased CV risk, after a com- hypothyroidism), and medications that raise prehensive discussion with the patient on the benefits triglycerides. C versus the comparable increased risk of bleeding. A 10.31 In patients with ASCVD or other CV risk factors on a statin with controlled LDL cholesterol but elevated Risk Reduction triglycerides (135–499 mg/dL), the addition of Aspirin has been shown to be effective in reducing CV icosapent ethyl can be considered to reduce CV morbidity and mortality in high-risk patients with pre- risk. A vious myocardial infarction or stroke (secondary pre- vention) and is strongly recommended. In primary Other Combination Therapy prevention, however, among patients with no previous CV Recommendations events, its net benefit is more controversial. Recom- 10.32 Statin plus fibrate combination therapy has mendations for using aspirin as primary prevention in- not been shown to improve ASCVD outcomes and is clude both men and women aged $50 years with diabetes generally not recommended. A and at least one additional major risk factor (family history 10.33 Statin plus niacin combination therapy has of premature ASCVD, hypertension, dyslipidemia, not been shown to provide additional CV smoking, or CKD/albuminuria) who are not at increased benefit above statin therapy alone, may increase risk of bleeding (e.g., older age, anemia, renal disease). the risk of stroke with additional side effects, and The main adverse effect is an increased risk of gastro- is generally not recommended. A intestinal bleeding. Diabetes Risk With Statin Use CVD Recommendations Several studies have reported a modestly increased risk of incident diabetes with statin use, which may be limited to Screening those with diabetes risk factors. A meta-analysis of 13 10.38 In asymptomatic patients, routine screening for randomized statin trials showed an odds ratio of 1.09 for a coronary artery disease is not recommended as it new diagnosis of diabetes, so that (on average) treatment does not improve outcomes as long as ASCVD risk of 255 patients with statins for 4 years resulted in one factors are treated. A 28 CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION 10.39 Consider investigations for coronary artery patients with established ASCVD, multiple risk factors for disease in the presence of any of the following: ASCVD, or DKD. atypical cardiac symptoms (e.g., unexplained dyspnea, chest discomfort); signs or symptoms of 11. MICROVASCULAR COMPLICATIONS AND associated vascular disease including carotid FOOT CARE bruits, transient ischemic attack, stroke, claudi- cation, or PAD; or electrocardiogram abnormalities CKD (e.g., Q waves). E Recommendations Screening Treatment 11.1 At least once a year, assess urinary albumin (e.g., 10.40 In patients with known ASCVD, consider ACE spot UACR) and eGFR in patients with type 1 inhibitor or ARB therapy to reduce the risk of CV diabetes with duration of $5 years and in all pa- events. B tients with type 2 diabetes regardless of treatment. B 10.41 In patients with prior myocardial infarction, Patients with urinary albumin.30 mg/g Cr and/or b-blockers should be continued for at least 2 years an eGFR ,60 mL/min/1.73 m2 should be monitored after the event. B twice annually to guide therapy. C 10.42 In patients with type 2 diabetes with stable HF, metformin may be continued for glucose lowering if eGFR remains.30 mL/min but should be Treatment avoided in unstable or hospitalized patients with 11.2 Optimize glucose control to reduce the risk or slow HF. B the progression of CKD. A 10.43 Among patients with type 2 diabetes who have 11.3 For patients with type 2 diabetes and DKD, consider established ASCVD or established kidney use of an SGLT2 inhibitor in patients with an disease, an SGLT2 inhibitor or GLP-1 receptor eGFR $30 mL/min/1.73 m2 and urinary albu- agonist with demonstrated CVD benefit is min.30 mg/g Cr, particularly in those with urinary recommended as part of the glucose-lowering albumin.300 mg/g Cr, to reduce risk of CKD regimen. A progression, CV events, or both. A In patients with 10.43a In patients with type 2 diabetes and established CKD who are at increased risk for CV events, use of a ASCVD, multiple ASCVD risk factors, or DKD, GLP-1 receptor agonist may reduce risk of pro- an SGLT2 inhibitor with demonstrated CV gression of albuminuria, CV events, or both benefit is recommended to reduce the risk of major (Table 9.1). C adverse CV events and HF hospitalization. A 11.4 Optimize blood pressure control to reduce the risk 10.43b In patients with type 2 diabetes and established or slow the progression of CKD. A ASCVD or multiple risk factors for ASCVD, a GLP-1 11.5 Do not discontinue renin-angiotensin system receptor agonist with demonstrated CV benefit is blockade for minor increases in serum Cr (,30%) recommended to reduce the risk of major adverse in the absence of volume depletion. B CV events. A 11.6 For people with nondialysis-dependent CKD, 10.43c In patients with type 2 diabetes and established dietary protein intake should be approximately HF, an SGLT2 inhibitor may be considered to 0.8 g/kg body weight per day (the recommended reduce risk of HF hospitalization. C daily allowance). A For patients on dialysis, Numerous large, randomized controlled trials have higher levels of dietary protein intake should reported statistically significant reductions in CV events be considered, since malnutrition is a major for three of the FDA-approved SGLT2 inhibitors problem in some dialysis patients. B (empagliflozin, canagliflozin, and dapagliflozin) and 11.7 In nonpregnant patients with diabetes and four FDA-approved GLP-1 receptor agonists (liraglutide, hypertension, either an ACE inhibitor or an albiglutide [although that agent was removed from the ARB is recommended for those with modestly market for business reasons], semaglutide [lower risk of elevated UACR (30–299 mg/g Cr) B and is strongly CV events in a moderate-sized clinical trial but one not recommended for those with UACR $300 mg/g powered as a CV outcomes trial], and dulaglutide). Cr and/or eGFR ,60 mL/min/1.73 m2. A SGLT2 inhibitors also appear to reduce risk of HF 11.8 Periodically monitor serum Cr and potassium levels hospitalization and progression of kidney disease in for the development of increased Cr or changes in VOLUME 38, NUMBER 1, WINTER 2020 29 ABRIDGED STANDARDS OF CARE 2020 FIGURE 11.1 Risk of CKD progression, frequency of visits, and referral to nephrology according to GFR and albuminuria. The GFR and albuminuria grid depicts the risk of progression, morbidity, and mortality by color, from best to worst (green, yellow, orange, red, dark red). The numbers in the boxes are a guide to the frequency of visits (number of times per year). Green can reflect CKD with normal eGFR and UACR only in the presence of other markers of kidney damage, such as imaging showing polycystic kidney disease or kidney biopsy abnormalities, with follow-up measurements annually; yellow requires caution and measurements at least once per year; orange requires measurements twice per year; red requires measurements three times per year; and dark red requires measurements four times per year. These are general parameters only, based on expert opinion, and underlying comorbid conditions and disease state as well as the likelihood of impacting a change in management for any individual patient must be taken into account. “Refer” indicates that nephrology services are recommended. *Referring clinicians may wish to discuss with their nephrology service, depending on local arrangements regarding treating or referring. Reprinted with permission from Vassalotti JA, Centor R, Turner BJ, Greer RC, Choi M, Sequist TD; National Kidney Foundation Kidney Disease Outcomes Quality Initiative. Am J Med 2016;129:153–162.e7. potassium when ACE inhibitors, ARBs, or diuretics with metformin should be reassessed for are used. B patients with an eGFR ,45 mL/min/1.73 m 2 11.9 An ACE inhibitor or ARB is not recommended and should be temporarily discontinued at the for the primary prevention of CKD in patients with time of or before iodinated contrast imaging diabetes who have normal blood pressure, normal procedures in patients with eGFR 30–60 mL/min/ UACR (,30 mg/g Cr), and normal eGFR. A 1.73 m 2. SGLT2 inhibitors and GLP-1 receptor 11.10 Patients should be referred for evaluation by a agonists should be considered for patients with nephrologist if they have an eGFR ,30 mL/min/ type 2 diabetes and CKD who require another 1.73 m2. A drug added to metformin to attain target A1C 11.11 Promptly refer to a physician experienced in the or cannot use or tolerate metformin. Agents care of kidney disease for uncertainty about the from these drug classes are suggested because etiology of kidney disease, difficult management they appear to reduce risks of CKD progression, issues, and rapidly progressing kidney disease. A CVD events, and hypoglycemia. Several large clinical trials have proven the effectiveness of both SGLT2 and GLP-1 receptor agonists in Epidemiology and Staging of CKD reducing the progression of albuminuria CKD is characterized by persistent albuminuria, low eGFR, and the risk of developing or worsening and other manifestations of kidney damage (Figure 11.1). nephropathy. A detailed summary of the clinical The degree of albuminuria is associated with CKD trials data can be found in “11. Microvascular progression, CVD, and mortality. CKD among people Complications and Foot Care” in the complete with diabetes markedly increases CVD risk and health 2020 Standards of Care. care costs. Two clinical trials studied the combinations of ACE in- hibitors and ARBs and found no benefits on CVD or Selection of Glucose-Lowering Medications for People CKD and a higher rate of adverse events (hyperkalemia With CKD and/or acute kidney injury) with the combination. Metformin is contraindicated for use in patients Therefore, the combined use of an ACE inhibitor and with an eGFR ,30 mL/min/1.73 m 2. Treatment an ARB should be avoided. 30 CLINICAL.DIABETESJOURNALS.ORG  AMERICAN DIABETES ASSOCIATION Diabetic Retinopathy to an ophthalmologist who is knowledgeable and experienced in the management of diabetic reti- Recommendations