POSITION STATEMENT

Standards of Medical Care in Diabetes—2019 Abridged for Primary Care Providers American Diabetes Association

he American Diabetes Associa- 1. IMPROVING CARE AND tion’s (ADA’s) Standards of Med- PROMOTING HEALTH IN Tical Care in Diabetes is updated POPULATIONS and published annually in a supple- Diabetes and Population Health ment to the January issue of Diabetes Care. The ADA’s Professional Practice Recommendations Committee, which includes physi- • Ensure treatment decisions are cians, diabetes educators, registered timely, rely on evidence-based dietitians (RDs), and public health guidelines, and are made collab- experts, develops the Standards. The oratively with patients based on Standards include the most current individual preferences, prognoses, evidence-based recommendations for and comorbidities. B diagnosing and treating adults and • Align approaches to diabetes children with all forms of diabetes. management with the Chronic ADA’s grading system uses A, B, C, Care Model, emphasizing pro- or E to show the evidence level that ductive interactions between a supports each recommendation. prepared proactive care team and A • A—Clear evidence from well- an informed activated patient. • Care systems should facilitate conducted, generalizable ran- team-based care, patient regis- domized controlled trials that are tries, decision support tools, and adequately powered community involvement to meet • B—Supportive evidence from patient needs. B well-conducted cohort studies • C—Supportive evidence from Population health is defined as poorly controlled or uncontrolled “the health outcomes of a group of studies individuals, including the distribution • E—Expert consensus or clinical of health outcomes within the group”; experience these outcomes can be measured in This is an abridged version of the American terms of health outcomes (mortality, Diabetes Association’s Standards of Medical This is an abridged version of morbidity, health, and functional sta- Care in Diabetes—2019. Diabetes Care the 2019 Standards containing the 2018;42(Suppl. 1):S1–S194. tus), disease burden (incidence and evidence-based recommendations The complete 2019 Standards supplement, prevalence), and behavioral and meta- including all supporting references, is most pertinent to primary care. The bolic factors (exercise, diet, A1C, etc.). available at professional.diabetes.org/ tables and figures have been renum- Clinical practice recommendations standards. bered from the original document for health care providers are tools that https://doi.org/10.2337/cd18-0105 to match this version. The complete can ultimately improve health across

©2018 by the American Diabetes Association. 2019 Standards of Care document, populations; however, for optimal Readers may use this article as long as the work is including all supporting references, outcomes, diabetes care must also be properly cited, the use is educational and not for profit, and the work is not altered. See www. is available at professional.diabetes. individualized for each patient. Thus, diabetesjournals.org/content/license for details. org/standards. efforts to improve population health

CLINICAL DIABETES 1 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT will require a combination of system-​ Tailoring Treatment for Social 2. CLASSIFICATION AND level and patient-level approaches. Context DIAGNOSIS OF DIABETES Diabetes can be classified into the The proportion of patients with Recommendations diabetes who achieve recommended following general categories: • Providers should assess social A1C, blood pressure, and LDL cho- 1. Type 1 diabetes (due to auto- context, including potential food lesterol levels has increased in recent immune β-cell destruction, insecurity, housing stability, and years. Nevertheless, a 2013 report usually leading to absolute insulin financial barriers, and apply that found that 33–49% of patients still deficiency) information to treatment deci- did not meet general targets for gly- 2. Type 2 diabetes (due to a progres- sions. A cemic, blood pressure, or cholesterol sive loss of β-cell insulin secretion control, and only 14% met targets for • Refer patients to local community frequently on the background of B all three measures while also avoiding resources when available. insulin resistance) smoking. • Provide patients with self- 3. Gestational diabetes mellitus Diabetes poses a significant management support from lay (GDM) (diabetes diagnosed in the financial burden to individuals and health coaches, navigators, or second or third trimester of preg- society. After adjusting for inflation, community health workers when nancy that was not clearly overt A economic costs of diabetes increased available. diabetes prior to gestation) 4. Specific types of diabetes due to by 26% from 2012 to 2017. This is Health inequities related to other causes, e.g., monogenic dia- attributed to the increased prevalence diabetes and its complications are betes syndromes (such as neonatal of diabetes and the increased cost per well documented and are heavily diabetes and maturity-onset diabe- person with diabetes. influenced by social determinants tes of the young), diseases of the The Chronic Care Model (CCM) of health. Social determinants of exocrine pancreas (such as cystic is an effective framework for improv- health are defined as the economic, ing the quality of diabetes care and fibrosis and pancreatitis), and drug- environmental, political, and social or chemical-induced diabetes (such includes six core elements: conditions in which people live and 1. as with glucocorticoid use, in the Delivery system design (moving are responsible for a major part of from a reactive to a proactive care treatment of HIV/AIDS, or after health inequality worldwide. delivery system where planned organ transplantation) Food insecurity (FI) is the unre- visits are coordinated through a liable availability of nutritious food Diagnostic Tests for Diabetes team-based approach) and the inability to consistently 2. Self-management support Recommendations obtain food without resorting to 3. Decision support (basing care • Testing for prediabetes and type socially unacceptable practices. FI on evidence-based, effective care 2 diabetes in asymptomatic peo- affects more than 14% of the U.S. guidelines) ple should be considered in adults population, with higher rates in 4. Clinical information systems of any age who are overweight or some racial/ethnic minority groups, 2 (using registries that can provide obese (BMI ≥25 kg/m or ≥23 patient-specific and population- in low-income households, and in kg/m2 in Asian Americans) and based support to the care team) homes headed by a single mother. who have one or more additional FI is associated with increased 5. Community resources and pol- risk factors for diabetes (Table 1). B icies (identifying or developing risk for type 2 diabetes, subopti- • For all people, testing should begin resources to support healthy mal glycemic control, psychosocial at age 45 years. B lifestyles) conditions, and low treatment • If tests are normal, repeat testing 6. Health systems (to create a quality- adherence. carried out at a minimum of 3-year oriented culture) Community health workers intervals is reasonable. C (CHWs), peer supporters, and lay • In patients with prediabetes and Redefining the roles of the health leaders may assist in the delivery of type 2 diabetes, identify and, if care delivery team and empow- diabetes self-management education appropriate, treat other cardiovas- ering patient self-management and support (DSMES) services, cular disease risk factors. B are fundamental to the success- particularly in underserved com- • Risk-based screening for prediabe- ful implementation of the CCM. munities. CHWs can be part of a tes and/or type 2 diabetes should Collaborative, multidisciplinary cost-effective, evidence-based strat- be considered after the onset of teams are best suited to provide care egy to improve the management of puberty or after 10 years of age, for people with chronic conditions diabetes and cardiovascular risk whichever occurs earlier, in chil- such as diabetes and to facilitate factors in underserved communi- dren and adolescents who are patients’ self-management. ties and health care systems. overweight (BMI ≥85th percentile)

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TABLE 1. 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: • 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], IGT, or IFG) 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. IFG, impaired fasting glucose; IGT, impaired glucose tolerance.

TABLE 2. Risk-Based Screening for Type 2 Diabetes or Prediabetes in Asymptomatic Children and Adolescents in a Clinical Setting Testing should be considered in youth* who are overweight (≥85% percentile) or obese (≥95 percentile) A and 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. or obese (BMI ≥95th percentile) centage of patients have conditions overt signs of hyperglycemia, diagno- and who have additional risk fac- such as sickle cell trait or hemoglob- sis requires two abnormal test results tors for diabetes. See Table 2 for inopathies that skew A1C results. See from the same sample or in two sepa- evidence grading of risk factors. “6. Glycemic Targets” in the complete rate test samples. If using two separate 2019 Standards of Care for conditions test samples, it is recommended that Diabetes and prediabetes may be causing discrepancies. Unless there is the second test, which may either be a screened based on plasma glucose cri- a clear clinical diagnosis based on repeat of the initial test or a different teria, either the fasting plasma glucose (FPG) or the 2-h plasma glucose (2-h TABLE 3. Criteria for the Screening and Diagnosis of Diabetes PG) value during a 75-g oral glucose Prediabetes Diabetes tolerance test (OGTT), or A1C crite- ria (Table 3). A1C 5.7– 6.4%* ≥6.5%† There is incomplete concordance FPG 100–125 mg/dL (5.6–6.9 mmol/L)* ≥126 mg/dL (7.0 mmol/L)† between A1C, FPG, and 2-h PG, OGTT 140–199 mg/dL (7.8–11.0 mmol/L)* ≥200 mg/dL (11.1 mmol/L)† and the 2-h PG value diagnoses more RPG ≥200 mg/dL (11.1 mmol/L)‡ people with prediabetes and diabe- *For all three tests, risk is continuous, extending below the lower limit of the tes than the FPG or A1C cut points. range and becoming disproportionately greater at the higher end of the Marked discrepancies between mea- range. †In the absence of unequivocal hyperglycemia, diagnosis requires sured A1C and plasma glucose levels two abnormal test results from the same sample or in two separate samples. should prompt consideration that the ‡Only diagnostic in a patient with classic symptoms of hyperglycemia or A1C assay may not be reliable for that hyperglycemic crisis. RPG, random plasma glucose. individual, since a relatively small per-

CLINICAL DIABETES 3 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT test, be performed without delay. If incidence of type 2 diabetes. In the Medicare reimbursement coverage patients have test results near the mar- DPP, diabetes incidence was reduced for the Centers for Disease Control gins of the diagnostic threshold, the by 58% over 3 years. Follow-up in and Prevention (CDC)-coordinated health care professional should follow the Diabetes Prevention Program National DPP lifestyle intervention to the patient closely and repeat the test Outcomes Study has shown sustained CDC-recognized organizations that in 3–6 months. reduction in the rate of conversion to become Medicare suppliers for this type 2 diabetes of 34% at 10 years 3. PREVENTION OR DELAY OF service. and 27% at 15 years. TYPE 2 DIABETES The DPP’s 7% weight loss goal Pharmacologic Interventions Recommendation was selected because it was feasible Recommendation • At least annual monitoring for the to achieve and maintain and likely to • Metformin therapy for prevention development of type 2 diabetes lessen the risk of developing diabetes. of type 2 diabetes should be con- in those with prediabetes is sug- Nutrition sidered in those with prediabetes, gested. E Structured behavioral weight loss ther- especially for those with BMI ≥35 2 apy, including a reduced calorie meal kg/m , those aged <60 years, and “Prediabetes” is the term used for women with prior GDM. A individuals whose glucose levels do plan and physical activity, is of para- mount importance for those at high not meet the criteria for diabetes but Several pharmacologic agents have are too high to be considered normal. risk for developing type 2 diabetes who have overweight or obesity. Based on been shown to decrease the incidence (See Table 3.) Prediabetes should not of diabetes, although none are ap- be viewed as a clinical entity in its intervention trials, the eating patterns that may be helpful for those with proved by the U.S. Food and Drug own right but rather as an increased Administration (FDA) specifically risk for diabetes and cardiovascular prediabetes include a Mediterranean eating plan and a low-calorie, low- for diabetes prevention. Metformin disease (CVD). fat eating plan. Additional research is has the strongest evidence base and Screening for prediabetes and type needed regarding whether a low-car- demonstrated long-term safety as 2 diabetes risk through an informal bohydrate eating plan is beneficial for pharmacologic therapy for diabetes assessment of risk factors or with an persons with prediabetes. In addition, prevention. For other drugs, cost, side assessment tool such as the ADA risk evidence suggests that the overall qual- effects, and durable efficacy require test is recommended to guide provid- ity of food consumed (as measured by consideration. ers on whether to perform a diagnostic the Alternative Healthy Eating Index), test for prediabetes (Table 3) and pre- Prevention of Cardiovascular with an emphasis on whole grains, le- viously undiagnosed type 2 diabetes. Disease gumes, nuts, fruits, and vegetables and Lifestyle Interventions minimal refined and processed foods, Recommendation is also important. • Prediabetes is associated with Recommendations Whereas overall healthy low- heightened cardiovascular risk; • Refer patients with prediabetes to calorie eating patterns should be therefore, screening for and treat- an intensive behavioral lifestyle encouraged, there is also some evidence ment of modifiable risk factors intervention program modeled on that particular dietary components for cardiovascular disease is sug- the Diabetes Prevention Program impact diabetes risk in observational gested. B to achieve and maintain 7% loss studies. Higher intakes of nuts, berries, of initial body weight and increase yogurt, coffee, and tea are associated People with prediabetes often moderate-intensity physical activ- with reduced diabetes risk. Conversely, have other cardiovascular risk fac- ity (such as brisk walking) to at red meats and sugar-sweetened bever- tors, including hypertension and least 150 min/week. A ages are associated with an increased dyslipidemia, and are at increased • Based on patient preference, risk of type 2 diabetes. risk for CVD. Although treatment technology-assisted diabetes pre- goals for people with prediabetes are vention interventions may be Cost-Effectiveness the same as for the general popula- effective in preventing type 2 dia- A cost-effectiveness model suggested tion, increased vigilance is warranted betes and should be considered. B that the lifestyle intervention used in to identify and treat these and other the DPP was cost-effective. The use cardiovascular risk factors. Several major randomized con- of CHWs to support DPP efforts trolled trials, including the Diabetes has been shown to be effective with 4. COMPREHENSIVE Prevention Program (DPP), have cost savings. MEDICAL EVALUATION demonstrated that an intensive life- The Centers for Medicare & AND ASSESSMENT OF style intervention can reduce the Medicaid Services has expanded COMORBIDITIES

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■ FIGURE 1. Decision cycle for patient-centered glycemic management in type 2 diabetes. Adapted from Davies MJ, D’Alessio DA, Fradkin J, et al. Diabetes Care 2018;41:2669–2701.

Patient-Centered Collaborative and plans for meeting them should be history, assessment of medication- Care created collaboratively with patients taking behavior and intolerance/ Recommendations (Figure 1). side effects, physical examination, • A patient-centered communication Comprehensive Medical laboratory evaluation as appropri- style that uses person-centered and Evaluation ate to assess attainment of A1C strength-based language and active and metabolic targets, and assess- Recommendations listening, elicits patient preferences ment of risk for complications, and beliefs, and assesses literacy, • A complete medical evaluation diabetes self-management behav- numeracy, and potential barriers should be performed at the initial iors, nutrition, psychosocial health, to care should be used to opti- visit to: and the need for referrals, immu- mize patient health outcomes and ❍❍ Confirm the diagnosis and clas- nizations, or other routine health B health-related quality of life. B sify diabetes. maintenance screening. B • Diabetes care should be managed ❍❍ Evaluate for diabetes complica- The risk assessment of acute and by a multidisciplinary team that tions and potential comorbid chronic diabetes complications and may draw from primary care phy- conditions. B ❍❍ treatment planning are key com- sicians, subspecialty physicians, Review previous treatment and nurse practitioners, physician assis- risk factor control in patients ponents of initial and follow-up tants, nurses, dietitians, exercise with established diabetes. B visits. The risk of atherosclerotic CVD specialists, pharmacists, dentists, ❍❍ Begin patient engagement in (ASCVD) and heart failure, chronic podiatrists, and mental health the formulation of a care man- kidney disease (CKD) staging, and professionals. E agement plan. B treatment-associated hypoglycemia ❍❍ Develop a plan for continuing should be used to individualize tar- Individuals with diabetes must assume care. B gets for glycemia, blood pressure, an active role in their care. The goals • A follow-up visit should include and lipids and to select specific of treatment for diabetes are to pre- most components of the initial glucose-lowering medication, anti- vent or delay complications and main- comprehensive medical evalua- hypertension medication, or statin tain quality of life. Treatment goals tion including: interval medical treatment intensity.

CLINICAL DIABETES 5 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT

Immunizations See Sec. 5 “Lifestyle Management” should be communicated with the Children and adults with diabetes and Sec. 12 “Older Adults” below for entire diabetes care team. A should receive vaccinations accord- more discussion of this topic. Nutrition Therapy ing to age-specific recommendations. Other Conditions See the CDC website for current For many individuals with diabetes, Nonalcoholic fatty liver disease, hepa- recommendations. the most challenging part of the treat- tocellular carcinoma, hearing impair- ment plan is determining what to eat Assessment of Comorbidities ment, psychosocial/emotional disor- and following a meal plan. Each per- Besides assessing diabetes-related ders, hip fractures, low testosterone son with diabetes should be actively complications, clinicians and their in men, obstructive sleep apnea, and engaged in developing an individual- patients need to be aware of common periodontal disease are all more com- ized eating plan. All individuals with comorbidities that may complicate mon in persons with diabetes. See “4. diabetes should be offered a referral for diabetes management. Comprehensive Medical Evaluation individualized MNT provided by an Autoimmune Diseases and Assessment of Comorbidities” in RD who is knowledgeable and skilled the complete 2019 Standards of Care in providing diabetes-specific MNT. Recommendation for discussion on these topics. Eating Patterns, Macronutrient • Consider screening patients with 5. LIFESTYLE MANAGEMENT type 1 diabetes for autoimmune Distribution, and Meal Planning Lifestyle management is a funda- thyroid disease and celiac disease Evidence suggests that there is not mental aspect of diabetes care and soon after diagnosis. B an ideal percentage of calories from includes DSMES, medical nutrition carbohydrate, protein, and fat for Cancer therapy (MNT), physical activity, all people with diabetes. Therefore, Diabetes is associated with increased smoking cessation counseling, and macronutrient distribution should be risk of cancers of the liver, pancreas, psychosocial care. Patients and pro- based on an individualized assessment endometrium, colon/rectum, breast, viders should focus together on how of current eating patterns, personal and bladder. The association may re- to optimize lifestyle from the time preferences (e.g., tradition, culture, sult from shared risk factors between of the initial comprehensive medical religion, health beliefs and goals, eco- type 2 diabetes and cancer (older age, evaluation, throughout all subsequent nomics), and metabolic goals. obesity, and physical inactivity) but evaluations and follow-up, and during The Mediterranean, Dietary may also be due to diabetes-related the assessment of complications and Approaches to Stop Hypertension factors, such as underlying disease management of comorbid conditions (DASH), and plant-based eating plans physiology or diabetes treatments. in order to enhance diabetes care. Patients with diabetes should be en- are examples of healthful eating pat- Diabetes Self-Management terns that have shown positive results couraged to undergo recommend- Education and Support ed age- and sex-appropriate cancer in research. In addition, research indi- screenings and to reduce their mod- Recommendations cates that low-carbohydrate eating ifiable cancer risk factors (obesity, • In accordance with the national plans may result in improved glyce- physical inactivity, and smoking). standards for DSMES, all people mia and have the potential to reduce New onset of atypical diabetes (lean with diabetes should participate antihyperglycemic medications for body type, negative family history) in in diabetes self-management edu- individuals with type 2 diabetes. a middle-aged or older patient may cation to facilitate the knowledge, There is inadequate research in type precede the diagnosis of pancreatic skills, and ability necessary for 1 diabetes to support one eating plan adenocarcinoma. However, in the ab- diabetes self-care. Diabetes self- over another at this time. sence of other symptoms (e.g., weight management support is addition- A simple approach to glycemia and loss, abdominal pain), routine screen- ally recommended to assist with weight management emphasizing por- ing of all such patients is not currently implementing and sustaining skills tion control and healthy food choices, recommended. and behaviors needed for ongoing such as the diabetes plate method, B should be considered for those with Cognitive Impairment/Dementia self-management. • There are four critical times to type 2 diabetes who are not taking Recommendation evaluate the need for DSMES: at insulin, who have limited health liter- • In people with a history of cog- diagnosis, annually, when com- acy or numeracy, or who are older and nitive impairment/dementia, plicating factors arise, and when prone to hypoglycemia. This visual intensive glucose control cannot transitions in care occur. E guide shows how to control calories be expected to remediate deficits. • DSMES should be patient centered, (by featuring a smaller plate) and car- Treatment should be tailored to may be given in group or individual bohydrates (by limiting them to what avoid significant hypoglycemia.B settings or using technology, and fits in one-quarter of the plate) and

6 CLINICAL.DIABETESJOURNALS.ORG Clinical Diabetes Online Ahead of Print, published online December 17, 2018 a b r i d g e d s ta n d a r d s o f c a r e 2019 puts an emphasis on low-carbohydrate ate-to-vigorous intensity aerobic (DKD), and there appears to be no (or nonstarchy) vegetables. activity per week, spread over at need for specific exercise restrictions Alcohol least 3 days/week, with no more for people with DKD in general. than 2 consecutive days without Moderate alcohol intake does not have Neuropathy activity. Shorter durations (min- major detrimental effects on long-term imum 75 min/week) of vigorous Decreased pain sensation and a high- blood glucose control in people with intensity or interval training may er pain threshold in the extremities diabetes. Risks associated with alcohol be sufficient for younger and more result in an increased risk of skin consumption include hypoglycemia physically fit individuals. breakdown, infection, and Charcot (particularly for those using insulin or • Adults with type 1 C and type 2 joint destruction with some forms of insulin secretagogue therapies), weight B diabetes should engage in 2–3 exercise, so assessment is key, although gain, and hyperglycemia (for those sessions/week of resistance exercise moderate-intensity walking with consuming excessive amounts). People on nonconsecutive days. proper footwear may not increase risk. with diabetes can follow the same • All adults, and particularly those Smoking Cessation: Tobacco guidelines as those without diabetes if with type 2 diabetes, should and E-Cigarettes they choose to drink. For women, no decrease the amount of time spent more than one drink per day, and two in daily sedentary behavior. B Recommendations for men, is recommended. (One drink Prolonged sitting should be inter- • Advise all patients not to use ciga- is equal to a 12-oz beer, a 5-oz glass rupted every 30 min for blood rettes and other tobacco products of wine, or 1.5 oz of distilled spirits.) glucose benefits, particularly in A or e-cigarettes. B Nonnutritive Sweeteners adults with type 2 diabetes. C • Include smoking cessation coun- For some people with diabetes who • Flexibility training and balance seling and other forms of treatment are accustomed to sugar-sweetened training are recommended 2–3 as a routine component of diabetes products, nonnutritive sweeteners times/week for older adults with care. A (containing few or no calories) may be diabetes. Yoga and tai chi may Psychosocial Issues an acceptable substitute for nutritive be included based on individual sweeteners when consumed in mod- preferences to increase flexibility, Recommendations eration. While use of nonnutritive muscular strength, and balance. C • Psychosocial care should be sweeteners does not appear to have a integrated with a collaborative, significant effect on glycemic control, The ADA position statement Physical“ patient-centered approach and pro- they can reduce overall calorie and Activity/Exercise and Diabetes” re- vided to all people with diabetes, carbohydrate intake. Most systematic views the evidence for the benefits with the goals of optimizing health reviews and meta-analyses show ben- of exercise in people with type 1 and outcomes and health-related qual- efits for nonnutritive sweetener use in type 2 diabetes and offers specific ity of life. A weight loss; however, some research recommendations. • Psychosocial screening and follow- suggests an association with weight Exercise in the Presence of up may include, but are not lim- gain. Overall, people are encouraged Microvascular Complications ited to, attitudes about diabetes, to decrease both sweetened and non- expectations for medical man- Retinopathy nutritive-sweetened beverages and use agement and outcomes, affect or other alternatives, with an emphasis If proliferative diabetic retinopathy mood, general and diabetes-related on water intake. or severe nonproliferative diabetic quality of life, available resources retinopathy is present, then vigorous- (financial, social, and emotional), Physical Activity intensity aerobic or resistance exercise and psychiatric history. E Recommendations may be contraindicated because of the • Providers should consider assess- • Children and adolescents with risk of triggering vitreous hemorrhage ment for symptoms of diabetes type 1 or type 2 diabetes or predia- or retinal detachment. Consultation distress, depression, anxiety, dis- with an ophthalmologist prior to en- betes should engage in 60 min/day ordered eating, and cognitive gaging in an intense exercise regimen or more of moderate- or vigorous- capacities using patient-appropriate may be appropriate. intensity aerobic activity, with vig- standardized and validated tools at orous muscle-strengthening and Diabetic Kidney Disease the initial visit, at periodic inter- bone-strengthening activities at Physical activity can acutely increase vals, and when there is a change in least 3 days/week. C urinary albumin excretion. However, disease, treatment, or life circum- • Most adults with type 1 C and there is no evidence that vigorous- stance. Including caregivers and type 2 B diabetes should engage intensity exercise increases the rate of family members in this assessment in 150 min or more of moder- progression of diabetic kidney disease is recommended. B

CLINICAL DIABETES 7 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT

• Consider screening older adults problem or deterioration in metabol- tool for guiding MNT and physical (aged ≥65 years) with diabetes ic or psychological status to occur. activity, preventing hypoglycemia, and for cognitive impairment and The ADA provides an online Mental adjusting medications (particularly depression. B Health Provider Directory of mental prandial insulin doses). The patient’s health providers who have received specific needs and goals should dictate The ADA position statement additional education in diabetes. SMBG frequency and timing or the “Psychosocial Care for People With 6. GLYCEMIC TARGETS consideration of CGM use. See “7. Diabetes” provides a list of assessment Diabetes Technology” in the complete tools and additional details. Assessment of Glycemic Control Standards of Care for more discussion Diabetes Distress Glycemic management is primar- of the use of SMBG and CGM. ily assessed with the A1C test, the A1C Goals Recommendation primary measure studied in clin- • Routinely monitor people with ical trials demonstrating the ben- Recommendations diabetes for diabetes distress, par- efits of improved glycemic con- • A reasonable A1C goal for many ticularly when treatment targets trol. Self-monitoring of blood nonpregnant adults is <7% (53 are not met and/or at the onset of glucose (SMBG) may help with self- mmol/mol). A B diabetes complications. management and medication adjust- • Providers might reasonably suggest Diabetes distress (DD) is very common ment, particularly in individuals tak- more stringent A1C goals (such as < and is distinct from other psychologi- ing insulin. Continuous glucose mon- 6.5% [48 mmol/mol]) for selected cal disorders. DD refers to significant itoring (CGM) also has an important individual patients if this can be negative psychological reactions relat- role in assessing the effectiveness and achieved without significant hypo- ed to emotional burdens and worries safety of treatment in many patients glycemia or other adverse effects specific to an individual’s experience with type 1 diabetes, and limited data of treatment (i.e., polypharmacy). in having to manage a severe, compli- suggest it may also be helpful in select- Appropriate patients might include cated, and demanding chronic disease ed patients with type 2 diabetes, such those with short duration of dia- such as diabetes. The constant behav- as those on intensive insulin regimens. betes, type 2 diabetes treated with lifestyle or metformin only, long ioral demands (medication dosing, A1C Testing frequency, and titration; monitoring life expectancy, or no significant blood glucose, food intake, eating pat- Recommendations cardiovascular disease. C terns, and physical activity) of diabetes • Perform the A1C test at least two • Less stringent A1C goals (such self-management and the potential or times a year in patients who are as <8% [64 mmol/mol]) may be actuality of disease progression are di- meeting treatment goals (and who appropriate for patients with a rectly associated with reports of DD. have stable glycemic control). E history of level 3 hypoglycemia The prevalence of DD is reported to be • Perform the A1C test quarterly (altered mental and/or physical 18–45% with an incidence of 38–48% in patients whose therapy has state requiring assistance), lim- over 18 months. High levels of DD changed or who are not meeting ited life expectancy, advanced significantly impact medication-tak- glycemic goals. E microvascular or macrovascular ing behaviors and are linked to higher • Point-of-care testing for A1C pro- complications, extensive comorbid A1C, lower self-efficacy, and poorer -di vides the opportunity for more conditions, or long-standing dia- etary and exercise behaviors. DSMES timely treatment changes. E betes in whom the goal is difficult has been shown to reduce DD. to achieve despite diabetes self- Glucose Assessment management education, appro- Referral to a Mental Health Glucose monitoring is key for the priate glucose monitoring, and Specialist achievement of glycemic targets for effective doses of multiple glu- Indications for referral to a mental most people with diabetes. SMBG cose-lowering agents including health specialist familiar with diabe- is an integral component of effective insulin. B tes management may include positive therapy of patients taking insulin. • Reassess glycemic targets over time screening for overall stress related to CGM has emerged as a complemen- based on the criteria in Figure 2 or, work-life balance, DD, diabetes man- tary method for the assessment of glu- in older adults, Table 12.1 [in the agement difficulties, depression, anx- cose levels. Glucose monitoring allows complete Standards of Care]. E iety, disordered eating, and cognitive patients to evaluate their individual dysfunction, among other issues. It is response to therapy and assess wheth- See “6. Glycemic Targets” in the preferable to incorporate psychosocial er glycemic targets are being safely complete 2019 Standards of Care for assessment and treatment into routine achieved. Integrating results into di- the justification for current glycemic care rather than waiting for a specific abetes management can be a useful control recommendations. See Sec.

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13 “Children and Adolescents” and Sec. 14 “Management of Diabetes in Pregnancy” below for A1C goals for these populations. Table 4 summa- rizes glycemic recommendations for many nonpregnant adults. Figure 2 depicts factors used to determine A1C targets for individual patients. Hypoglycemia Level 1 hypoglycemia is defined as a measurable glucose concentration <70 mg/dL (3.9 mmol/L). Level 2 hypoglycemia (defined as a blood glu- cose concentration <54 mg/dL [3.0 mmol/L]) is the threshold at which neuroglycopenic symptoms begin to occur and requires immediate action to resolve the hypoglycemic event. Level 3 hypoglycemia is defined as a severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery. ■ FIGURE 2. Depicted are patient and disease factors used to determine optimal Recommendations 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% = • Individuals at risk for hypogly- 53 mmol/mol. Adapted with permission from Inzucchi SE, Bergenstal RM, Buse JB, cemia should be asked about et al. Diabetes Care 2015;38:140–149. symptomatic and asymptomatic hypoglycemia at each encounter. C • Hypoglycemia unawareness or plications, reduce the burden of living • Glucose (15–20 g) is the one or more episodes of level with diabetes, and improve quality of preferred treatment for the con- 3 hypoglycemia should trigger life. Historically, diabetes technolo- scious individual with blood reevaluation of the treatment gy has been divided into two main glucose <70 mg/dL (3.9 mmol/L), regimen. E categories: insulin administered by although any form of carbohydrate • Insulin-treated patients with syringe, pen, or pump, and blood that contains glucose may be used. hypoglycemia unawareness or an glucose monitoring as assessed with a Fifteen minutes after treatment, if episode of level 2 hypoglycemia meter or CGM system. More recent- SMBG shows continued hypogly- should be advised to raise their ly, diabetes technology has expanded cemia, the treatment should be glycemic targets to strictly avoid to include hybrid devices that both repeated. Once SMBG returns to hypoglycemia for at least several monitor glucose and deliver insulin, normal, the individual should con- weeks in order to partially reverse some automatically, as well as soft- sume a meal or snack to prevent hypoglycemia unawareness and ware that serves as a medical device, recurrence of hypoglycemia. E reduce risk of future episodes. A providing diabetes self-management • Glucagon should be prescribed • Ongoing assessment of cogni- support. Diabetes technology, when for all individuals at increased risk tive function is suggested with applied appropriately, can improve of level 2 hypoglycemia, defined increased vigilance for hypogly- the lives and health of people with di- as blood glucose <54 mg/dL (3.0 cemia by the clinician, patient, abetes; however, the complexity and mmol/L), so it is available should and caregivers if low cognition or rapid change of the diabetes technol- B it be needed. Caregivers, school declining cognition is found. ogy landscape can also be a barrier to personnel, or family members of 7. DIABETES TECHNOLOGY patient and provider implementation. these individuals should know “Diabetes technology” is the term Patient interest will certainly be a driv- where it is and when and how to used to describe the hardware, de- er for more widespread use of diabetes administer it. Glucagon adminis- vices, and software that people with technology, and this may include pri- tration is not limited to health care diabetes use to help manage blood mary care practices caring for those professionals. E glucose levels, stave off diabetes com- with diabetes.

CLINICAL DIABETES 9 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT

TABLE 4. Summary of Glycemic Recommendations for Many • Such interventions should be Nonpregnant Adults With Diabetes high intensity (≥16 sessions in 6 months) and focus on diet, A1C <7.0% (53 mmol/mol)* physical activity, and behavioral Preprandial capillary plasma glucose 80–130 mg/dL* (4.4–7.2 mmol/L) strategies to achieve a 500–750 Peak postprandial capillary plasma <180 mg/dL* (10.0 mmol/L) kcal/day energy deficit. A glucose† • Diets should be individualized, as *More or less stringent glycemic goals may be appropriate for individual those that provide the same caloric patients. Goals should be individualized based on duration of diabetes, restriction but differ in protein, age/life expectancy, comorbid conditions, known CVD or advanced carbohydrate, and fat content microvascular complications, hypoglycemia unawareness, and individual are equally effective in achieving patient considerations. †Postprandial glucose may be targeted if A1C goals weight loss. A are not met despite reaching preprandial glucose goals. Postprandial • For patients who achieve short- glucose measurements should be made 1–2 h after the beginning of the term weight-loss goals, long-term meal, generally peak levels in patients with diabetes. (≥1 year) comprehensive weight maintenance programs should be prescribed. Such programs should SMBG 8. OBESITY MANAGEMENT provide at least monthly contact FOR THE TREATMENT OF TYPE Recommendation and encourage ongoing moni- 2 DIABETES • When prescribed as part of a broad toring of body weight (weekly educational program, SMBG There is strong and consistent evidence or more frequently) and/or other may help to guide treatment deci- that obesity management is beneficial self-monitoring strategies, such sions and/or self-management for in the treatment of type 2 diabetes. as tracking intake, steps, etc.; patients taking less frequent insulin In patients with type 2 diabetes who continued consumption of a injections. B are overweight or obese, modest and reduced-calorie diet; and partic- sustained weight loss has been shown ipation in high levels of physical In people with type 2 diabetes not to improve glycemic control and to activity (200–300 min/week). A using insulin, routine glucose mon- reduce the need for glucose-lowering • To achieve weight loss of >5%, itoring may be of limited additional medications. short-term (3-month) interven- clinical benefit. For some individu- Assessment tions that use very low-calorie diets als, glucose monitoring can provide (≤800 kcal/day) and total meal insight into the impact of diet, physical Recommendation replacements may be prescribed activity, and medication management • At each patient encounter, BMI for carefully selected patients by on glucose levels. Glucose monitor- should be calculated and docu- trained practitioners in medical ing may also be useful in assessing mented in the medical record. B care settings with close medical hypoglycemia, glucose levels during monitoring. To maintain weight intercurrent illness, or discrepancies Providers should advise patients who loss, such programs must incor- between measured A1C and glucose are overweight or obese that, in gen- porate long-term comprehensive levels when there is concern that an eral, higher BMIs increase the risk of weight-maintenance counseling. B CVD and all-cause mortality. Providers A1C result may not be reliable in Pharmacotherapy specific individuals. However, sev- should assess each patient’s readiness to eral randomized trials have called achieve weight loss and jointly deter- Recommendations into question the clinical utility and mine weight-loss goals and interven- • When choosing glucose-lowering cost-effectiveness of routine SMBG in tion strategies. medications for overweight or noninsulin-treated patients. The ongo- Diet, Physical Activity, and obese patients with type 2 diabetes, E ing need for and frequency of SMBG Behavioral Therapy consider their effect on weight. should be reevaluated at each routine • Whenever possible, minimize visit to avoid overuse, particularly if Recommendations medications for comorbid con- SMBG is not being used effectively • Diet, physical activity, and behav- ditions that are associated with for self-management. ioral therapy designed to achieve weight gain. E Due to the newness and complexity and maintain >5% weight loss • Weight-loss medications are effec- of this topic, readers are referred to the should be prescribed for patients tive as adjuncts to diet, physical discussion in “7. Diabetes Technology” with type 2 diabetes who are activity, and behavioral counsel- in the complete 2019 Standards overweight or obese and ready to ing for selected patients with type of Care. achieve weight loss. A 2 diabetes and BMI ≥27 kg/m2.

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Potential benefits must be weighed • Long-term lifestyle support and typical doses ranging from 0.4 to 1.0 against the potential risks of the routine monitoring of micronutri- units/kg/day. Higher amounts are re- medications. A ent and nutritional status must be quired during puberty, pregnancy, and • If a patient’s response to weight- provided to patients after surgery, illness. A typical starting dose is 0.5 loss medications is <5% weight loss according to guidelines for postop- units/kg/day in patients with type 1 after 3 months or if there are signif- erative management of metabolic diabetes who are metabolically stable, icant safety or tolerability issues at surgery by national and interna- with half administered as prandial in- any time, the medication should be tional professional societies. C sulin given to control blood glucose discontinued and alternative med- • People presenting for metabolic after meals and the other half as basal ications or treatment approaches surgery should receive a com- insulin to control glycemia in the pe- should be considered. A prehensive readiness and mental riods between meal absorption. health assessment. B Physiologic insulin secretion varies The FDA has approved medications • People who undergo metabolic with glycemia, meal size, and tissue for both short-term and long-term surgery should be evaluated to demands for glucose. To approach weight management as adjuncts to assess the need for ongoing men- this variability in people using insu- diet, exercise, and behavioral therapy. tal health services to help them lin treatment, strategies have evolved Nearly all FDA-approved medications adjust to medical and psychosocial to adjust prandial doses based on for weight loss have been shown to changes after surgery. C predicted needs. Thus, education of improve glycemic control in patients patients on how to adjust prandial with type 2 diabetes and delay pro- A substantial body of evidence has insulin to account for carbohydrate gression to type 2 diabetes in patients now been accumulated, including intake, premeal glucose levels, and at risk. Table 8.2 in the complete data from numerous randomized con- anticipated activity can be effective 2019 Standards of Care lists the cur- trolled clinical trials, demonstrating and should be considered. rently available obesity drugs. that metabolic surgery achieves supe- Postprandial glucose excursions rior glycemic control and reduction of may be better controlled by adjusting Metabolic Surgery cardiovascular risk factors in patients the timing of prandial insulin dose Recommendations with type 2 diabetes and obesity com- administration. The optimal time to pared with various lifestyle/medical • Metabolic surgery should be rec- administer prandial insulin varies, interventions. ommended as an option to treat based on the type of insulin used type 2 diabetes in appropriate sur- 9. PHARMACOLOGIC (regular, rapid-acting analog, inhaled, gical candidates with BMI ≥40 APPROACHES TO GLYCEMIC etc.), measured blood glucose level, kg/m2 (BMI ≥37.5 k g/m 2 in Asian TREATMENT timing of meals, and carbohydrate consumption. Recommendations for Americans) and in adults with Pharmacologic Therapy for prandial insulin dose administration BMI 35.0–39.9 kg/m2 (32.5 –37.4 Type 1 Diabetes should therefore be individualized. kg/m2 in Asian Americans) who Insulin pumps and CGM systems do not achieve durable weight loss Recommendations • Most people with type 1 diabetes may provide advantages in reducing and improvement in comorbidities hypoglycemia. (including hyperglycemia) with should be treated with multiple reasonable nonsurgical methods. A daily injections of prandial and Pharmacologic Therapy for • Metabolic surgery may be consid- basal insulin, or continuous sub- Type 2 Diabetes cutaneous insulin infusion. A ered as an option for adults with Recommendations • Most individuals with type 1 type 2 diabetes and BMI 30.0– • Metformin is the preferred initial 34.9 kg/m2 (27.5–32.4 kg/m2 in diabetes should use rapid-acting insulin analogs to reduce hypo- pharmacologic agent for the treat- Asian Americans) who do not ment of type 2 diabetes. A glycemia risk. A achieve durable weight loss and • Once initiated, metformin should • Consider educating individuals improvement in comorbidities be continued as long as it is tol- with type 1 diabetes on matching (including hyperglycemia) with erated and not contraindicated; prandial insulin doses to carbo- reasonable nonsurgical methods. A other agents, including insulin, hydrate intake, premeal blood • Metabolic surgery should be per- should be added to metformin. A glucose levels, and anticipated formed in high-volume centers • Long-term use of metformin physical activity. E with multidisciplinary teams that may be associated with biochem- understand and are experienced in Insulin Therapy ical vitamin B12 deficiency, and the management of diabetes and Generally, insulin requirements can periodic measurement of vitamin gastrointestinal surgery. C be estimated based on weight, with B12 levels should be considered

CLINICAL DIABETES 11 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT

in metformin-treated patients, (every 3–6 months) and adjusted • All hypertensive patients with dia- especially in those with anemia or as needed to incorporate new betes should monitor their blood peripheral neuropathy. B patient factors (Table 5). E pressure at home. B • The early introduction of insu- Treatment Goals lin should be considered if there Table 5 highlights considerations • For patients with diabetes and is evidence of ongoing catabo- for a patient-centered approach to hypertension, blood pressure tar- lism (weight loss), if symptoms choosing appropriate pharmacologic gets should be individualized of hyperglycemia are present, treatment of blood glucose. Figures 3 through a shared decision-making or when A1C levels (>10% [86 and 4 outline monotherapy and com- process that addresses cardiovascu- mmol/mol]) or blood glucose levels bination therapy, including initiating lar risk, potential adverse effects of (≥300 mg/dL [16.7 mmol/L]) are and intensifying injectable therapies, antihypertensive medications, and very high. E emphasizing drugs commonly used in patient preferences. C • Consider initiating dual therapy the United States and/or Europe. • For individuals with diabetes and in patients with newly diagnosed 10. CARDIOVASCULAR hypertension at higher cardiovas- type 2 diabetes who have A1C DISEASE AND RISK cular risk (existing ASCVD or ≥1.5% (12.5 mmol/mol) above MANAGEMENT 10-year ASCVD risk >15%), a their glycemic target. E ASCVD—defined as coronary heart blood pressure target of <130/80 • A patient-centered approach disease, cerebrovascular disease, or mmHg may be appropriate, if it should be used to guide the peripheral arterial disease (PAD) can be safely attained. C choice of pharmacologic agents. presumed to be of atherosclerotic or- • For individuals with diabetes and Considerations include comorbidi- igin—is the leading cause of morbid- hypertension at lower risk for ties (ASCVD, heart failure, CKD), ity and mortality for individuals with cardiovascular disease (10-year hypoglycemia risk, impact on diabetes. Heart failure is another ma- ASCVD risk <15%), treat to a weight, cost, risk for side effects, jor cause of morbidity and mortality blood pressure target of <140/90 and patient preferences. E from CVD. mmHg. A • Among patients with type 2 For prevention and management diabetes who have established of both ASCVD and heart failure, Treatment Strategies ASCVD, sodium–glucose cardiovascular risk factors should be • For patients with blood pressure cotransporter 2 (SGLT2) inhib- systematically assessed at least annu- >120/80 mmHg, lifestyle inter- itors or glucagon-like peptide 1 ally in all patients with diabetes. vention consists of weight loss if (GLP-1) receptor agonists with These risk factors include obesity/ overweight or obese, a DASH-style demonstrated CVD benefit (Table overweight, hypertension, dyslipid- dietary pattern including reducing 5) are recommended as part of the emia, smoking, a family history of sodium and increasing potassium A antihyperglycemic regimen. premature coronary disease, CKD, intake, moderation of alcohol • Among patients with ASCVD and the presence of albuminuria. The intake, and increased physical B at high risk of heart failure or American College of Cardiology/ activity. in whom heart failure coexists, American Heart Association ASCVD • Patients with confirmed office- C ≥ SGLT2 inhibitors are preferred. risk calculator (Risk Estimator Plus) based blood pressure 140/90 • For patients with type 2 diabe- is generally a useful tool to estimate mmHg should, in addition to tes and CKD, consider use of an 10-year ASCVD risk. lifestyle therapy, have prompt SGLT2 inhibitor or GLP-1 recep- initiation and timely titration of tor agonist shown to reduce risk of Hypertension/Blood Pressure pharmacologic therapy to achieve DKD progression, cardiovascular Control blood pressure goals. A C events, or both. Recommendations • Patients with confirmed office- • In most patients who need the based blood pressure ≥160/100 greater glucose-lowering effect of Screening and Diagnosis mmHg should, in addition to an injectable medication, GLP-1 • Blood pressure should be mea- lifestyle therapy, have prompt ini- receptor agonists are preferred to sured at every routine clinical visit. tiation and timely titration of two insulin. B Patients found to have elevated drugs or a single-pill combination • Intensification of treatment for blood pressure (≥140/90 mmHg) of drugs demonstrated to reduce patients with type 2 diabetes not should have blood pressure con- cardiovascular events in patients meeting treatment goals should firmed using multiple readings, with diabetes. A not be delayed. B including measurements on a • Treatment for hypertension should • The medication regimen should separate day, to diagnose hyper- include drug classes demonstrated be reevaluated at regular intervals tension. B to reduce cardiovascular events in

12 CLINICAL.DIABETESJOURNALS.ORG Clinical Diabetes Online Ahead of Print, published online December 17, 2018 a b r i d g e d s ta n d a r d s o f c a r e 2019 subcutaneous; T2DM, type 2 diabetes. type T2DM, subcutaneous; SQ, steatohepatitis; GLP1 NASH, GLP1 ketoacidosis; nonalcoholic RAs, agonists; diabetic receptor 4; DKA, peptidase failure; CV, DPP4, dipeptidyl cardiovascular; *For agentspecificdosing recommendations, please refer to the manufacturers’ prescribing information. †FDAapproved for CVDbenefit. CHF, congestive heart TABLE 5 . Drug-Specific and Patient Factors to Consider When Selecting Antihyperglycemic Treatment in Adults With Type 2 Diabetes

CLINICAL DIABETES 13 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT - , glycated hemoglobin; HF, heart failure; SGLT2i, SGLT2 inhibitor; SU, sulfo SGLT2 SGLT2i, heart failure; hemoglobin; HF, , glycated 1c . Glucose-lowering medication in type 2 diabetes: overall approach. For appropriate context, see Figure 1. CV, cardiovascular; CVOTs, cardiovascular outcomes cardiovascular CVOTs, cardiovascular; 1. CV, context, see Figure appropriate For approach. medication in type 2 diabetes: overall . Glucose-lowering FIGURE 3 2018;41:2669–2701. J, et al. Diabetes Care MJ, D’Alessio DA, Fradkin Davies from Adapted TZD, thiazolidinedione. nylurea; ■ agonist; HbA trials; DPP-4i, dipeptidyl peptidase 4 inhibitor; GLP-1 RA, receptor

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3

■ FIGURE 4. Intensifying to injectable therapies. FRC, fixed-ratio combination; GLP-1 RA, GLP-1 receptor agonist; Hba1c, glycated hemoglobin; iDegLira, insulin degludec/liraglutide; iGlarLixi; insulin glargine/lixsenatide; max, maximum; PPG, postprandial glucose. Adapted from Davies MJ, D’Alessio DA, Fradkin J, et al. Diabetes Care 2018;41:2669–2701.

CLINICAL DIABETES 15 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT

patients with diabetes (ACE inhib- with elevated triglyceride levels A Ezetimibe may be preferred due itors, angiotensin receptor blockers (≥150 mg/dL [1.7 mmol/L]) and/or to lower cost. < [ARBs], thiazide-like diuretics, or low HDL cholesterol ( 40 mg/dL Treatment of Other Lipoprotein < dihydropyridine calcium channel [1.0 mmol/L] for men, 50 mg/dL Fractions or Targets blockers). A [1.3 mmol/L] for women). C • For patients with fasting tri- • Multiple-drug therapy is generally Ongoing Therapy and Monitoring glyceride levels ≥500 mg/dL (5.7 required to achieve blood pressure With Lipid Panel targets. However, combinations mmol/L), evaluate for secondary of ACE inhibitors with ARBs and • In adults not taking statins or causes of hypertriglyceridemia and combinations of ACE inhibitors or other lipid-lowering therapy, it is consider medical therapy to reduce C ARBs with direct renin inhibitors reasonable to obtain a lipid profile the risk of pancreatitis. should not be used. A at the time of diabetes diagnosis, at • In adults with moderate hypertri- • An ACE inhibitor or ARB, at the an initial medical evaluation, and glyceridemia (fasting or nonfasting maximum tolerated dose indicated every 5 years thereafter if under triglycerides 175–499 mg/dL), cli- for blood pressure treatment, is the the age of 40 years, or more fre- nicians should address and treat recommended first-line treatment quently if indicated. E lifestyle factors (obesity and meta- for hypertension in patients with • Obtain a lipid profile at initiation bolic syndrome), secondary factors diabetes and urinary albumin- of statins or other lipid-lowering (diabetes, chronic liver or kidney to-creatinine ratio ≥300 mg/g therapy, 4–12 weeks after initiation disease and/or nephrotic syndrome, creatinine A or 30–299 mg/g creat- or a change in dose, and annually hypothyroidism), and medications inine. B If one class is not tolerated, thereafter as it may help to monitor that raise triglycerides. C the other should be substituted. B the response to therapy and inform Other Combination Therapy medication adherence. E • For patients treated with an ACE • Combination therapy (statin/ inhibitor, ARB, or diuretic, serum Statin Treatment fibrate) has not been shown to creatinine/estimated glomerular • For patients of all ages with dia- improve ASCVD outcomes and filtration rate (eGFR) and serum betes and ASCVD or 10-year is generally not recommended. A potassium levels should be moni- ASCVD risk >20%, high-intensity • Combination therapy (statin/ tored at least annually. B statin therapy should be added to niacin) has not been shown to • Patients with hypertension who lifestyle therapy. A provide additional cardiovascular are not meeting blood pressure • For patients with diabetes aged <40 benefit above statin therapy alone, targets on three classes of antihy- years with additional ASCVD risk may increase the risk of stroke pertensive medications (including factors, the patient and provider with additional side effects, and is a diuretic) should be considered for should consider using moderate- generally not recommended. A mineralocorticoid receptor antago- intensity statin in addition to life- Antiplatelet Agents nist therapy. B style therapy. C Lipid Management • For patients with diabetes aged Recommendations 40–75 years A and >75 years B • Use aspirin therapy (75–162 Recommendations without ASCVD, use moderate- mg/day) as a secondary prevention Lifestyle Intervention intensity statin in addition to life- strategy in those with diabetes and • Lifestyle modification focusing on style therapy. a history of ASCVD. A weight loss (if indicated); applica- • In patients with diabetes who have • For patients with ASCVD and doc- tion of a Mediterranean eating multiple ASCVD risk factors, it umented aspirin allergy, clopidogrel plan or DASH dietary pattern; is reasonable to consider high- (75 mg/day) should be used. B the reduction of saturated fat intensity statin therapy. C • Dual antiplatelet therapy (with and trans fat; increase of dietary • For patients who do not tolerate low-dose aspirin and a P2Y12 n-3 fatty acids, viscous fiber, and the intended intensity, the maxi- inhibitor) is reasonable for a year plant stanols/sterols intake; and mally tolerated statin dose should after an acute coronary syndrome increased physical activity should be used. E A and may have benefits beyond be recommended to improve the • For patients with diabetes and this period. B lipid profile and reduce the risk ASCVD, if LDL cholesterol is • Aspirin therapy (75–162 mg/day) of developing ASCVD in patients ≥70 mg/dL on maximally tolerated may be considered as a primary with diabetes. A statin dose, consider adding addi- prevention strategy in those with • Intensify lifestyle therapy and opti- tional LDL-lowering therapy (such diabetes who are at increased car- mize glycemic control for patients as ezetimibe or PCSK9 inhibitor). diovascular risk, after a discussion

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with the patient on the benefits cemic treatment in adults with type creatinine or changes in potassium versus increased risk of bleeding. C 2 diabetes. when ACE inhibitors, ARBs, or B Cardiovascular Disease 11. MICROVASCULAR diuretics are used. COMPLICATIONS AND FOOT • An ACE inhibitor or ARB is not Recommendations CARE recommended for the primary pre- Screening vention of CKD in patients with Chronic Kidney Disease diabetes who have normal blood • In asymptomatic patients, routine pressure, normal urinary albu- screening for coronary artery dis- Recommendations < ease is not recommended as it does min-to-creatinine ratio ( 30 mg/g Screening B not improve outcomes as long as creatinine), and normal eGFR. • At least once a year, assess uri- < ASCVD risk factors are treated. A • When eGFR is 60 mL/min/1.73 nary albumin (e.g., spot urinary 2 • Consider investigations for m , evaluate and manage potential albumin-to-creatinine ratio) and E coronary artery disease in the complications of CKD. presence of any of the follow- eGFR in patients with type 1 dia- • Patients should be referred for ≥ ing: atypical cardiac symptoms betes with duration of 5 years, in evaluation for renal replacement (e.g., unexplained dyspnea, chest all patients with type 2 diabetes, treatment if they have an eGFR < 2 A discomfort); signs or symptoms and in all patients with comorbid 30 mL/min/1.73 m . B of associated vascular disease hypertension. • Promptly refer to a physician including carotid bruits, transient Treatment experienced in the care of kidney disease for uncertainty about the ischemic attack, stroke, claudica- • Optimize glucose control to reduce etiology of kidney disease, difficult tion, or peripheral arterial disease; the risk or slow the progression of management issues, and rapidly or electrocardiogram abnormalities CKD. A progressing kidney disease. B (e.g., Q waves). E • For patients with type 2 dia- Treatment betes and CKD, consider use Epidemiology of Diabetes and • In patients with known ASCVD, of an SGLT2 inhibitor or a Chronic Kidney Disease consider ACE inhibitor or ARB GLP-1 receptor agonist shown to CKD is diagnosed by the persistent therapy to reduce the risk of car- reduce risk of CKD progression, presence of elevated urinary albumin diovascular events. B cardiovascular events, or both excretion (albuminuria), low eGFR, C • In patients with prior myocardial (Table 5). or other manifestations of kidney infarction, β-blockers should be • Optimize blood pressure control to damage. At any eGFR, the degree of continued for at least 2 years after reduce the risk or slow the progres- albuminuria is associated with risk of the event. B sion of CKD. A CKD progression, CVD, and mor- • In patients with type 2 diabetes • For people with nondialysis- tality. Among people with type 1 or with stable congestive heart fail- dependent CKD, dietary protein type 2 diabetes, the presence of CKD ure, metformin may be used if intake should be approximately 0.8 markedly increases cardiovascular risk eGFR remains >30 mL/min but g/kg body weight per day (the rec- and health care costs. Table 6 summa- should be avoided in unstable or ommended daily allowance). For rizes the staging of CKD. hospitalized patients with conges- patients on dialysis, higher levels Interventions tive heart failure. B of dietary protein intake should be • Among patients with type 2 diabe- considered. B Selection of Glucose-Lowering tes who have established ASCVD, • In nonpregnant patients with dia- Medications for Patients With SGLT2 inhibitors or GLP-1 recep- betes and hypertension, either an Chronic Kidney Disease tor agonists with demonstrated ACE inhibitor or an ARB is recom- The FDA revised its guidance for cardiovascular disease benefit mended for those with modestly the use metformin in CKD in 2016, (Table 5) are recommended as elevated urinary albumin-to-creati- stating that metformin is contraindi- part of the antihyperglycemic reg- nine ratio (30–299 mg/g creatinine) cated in patients with an eGFR <30 2 imen. A B and is strongly recommended for mL/min/1.73 m , eGFR should be • Among patients with ASCVD those with urinary albumin-to- monitored while taking metformin, at high risk of heart failure or creatinine ratio ≥300 mg/g cre- the benefits and risks of continuing in whom heart failure coexists, atinine and/or eGFR <60 mL/ treatment should be reassessed when 2 2 SGLT2 inhibitors are preferred. C min/1.73 m . A eGFR falls to <45 mL/min/1.73 m , • Periodically monitor serum cre- metformin should not be initiated See Figure 3 for additional atinine and potassium levels for for patients with an eGFR <45 mL/ recommendations on antihypergly- the development of increased min/1.73 m2, and metformin should

CLINICAL DIABETES 17 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT be temporarily discontinued at the an ophthalmologist or optometrist Neuropathy time of or before iodinated contrast at the time of the diabetes diag- Recommendations imaging procedures in patients with nosis. B eGFR 30–60 mL/min/1.73 m2. • If there is no evidence of retinop- Screening See Sec. 9 “Pharmacologic athy for one or more annual eye • All patients should be assessed Approaches to Glycemic Treatment” exam and glycemia is well con- for diabetic peripheral neuropa- above for considerations regarding trolled, then exams every 1–2 thy starting at diagnosis of type 2 appropriate pharmacologic therapy years may be considered. If any diabetes and 5 years after the diag- for patients with type 2 diabetes and level of diabetic retinopathy is nosis of type 1 diabetes and at least CKD. present, subsequent dilated retinal annually thereafter. B Two clinical trials studied the examinations should be repeated at • Assessment for distal symmetric combinations of ACE inhibitors and least annually by an ophthalmolo- polyneuropathy should include ARBs and found no benefits on CVD gist or optometrist. If retinopathy a careful history and assessment or CKD, and the drug combination is progressing or sight-threatening, of either temperature or pinprick had higher adverse event rates (hyper- then examinations will be required sensation (small-fiber function) kalemia and/or acute kidney injury). more frequently. B and vibration sensation using a Therefore, the combined use of ACE • Telemedicine programs that use 128-Hz tuning fork (for large- inhibitors and ARBs should be avoided. validated retinal photography with fiber function). All patients should Referral to a Nephrologist remote reading by an ophthalmol- have annual 10-g monofilament Consider referral to a physician ex- ogist or optometrist and timely testing to identify feet at risk for perienced in the care of CKD when referral for a comprehensive eye ulceration and amputation. B examination when indicated can there is uncertainty about the etiology • Symptoms and signs of autonomic be an appropriate screening strat- of CKD, difficult management issues neuropathy should be assessed in egy for diabetic retinopathy. B (anemia, secondary hyperparathyroid- patients with microvascular com- • Women with preexisting type 1 or ism, metabolic bone disease, resistant plications. E hypertension, or electrolyte distur- type 2 diabetes who are planning bances), or stage 4 CKD (eGFR <30 pregnancy or who are pregnant Treatment mL/min/1.73 m2) requiring discussion should be counseled on the risk of • Optimize glucose control to pre- of renal replacement therapy for end- development and/or progression of vent or delay the development of stage renal disease. Consultation with diabetic retinopathy. B neuropathy in patients with type a nephrologist when stage 4 CKD de- • Eye examinations should occur 1 diabetes A and to slow the pro- velops (eGFR <30 mL/min/1.73 m2) before pregnancy or in the first tri- gression of neuropathy in patients has been found to reduce cost, improve mester in patients with preexisting with type 2 diabetes. B quality of care, and delay dialysis. type 1 or type 2 diabetes, and then • Assess and treat patients to reduce patients should be monitored every Diabetic Retinopathy pain related to diabetic periph- trimester and for 1-year postpar- eral neuropathy B and symptoms Recommendations tum as indicated by the degree of of autonomic neuropathy and to • Optimize glycemic control to retinopathy. B improve quality of life. E reduce the risk or slow the pro- Treatment • Pregabalin, duloxetine, or gab- gression of diabetic retinopathy. A • Promptly refer patients with any apentin are recommended as • Optimize blood pressure and level of macular edema, severe initial pharmacologic treatments serum lipid control to reduce the nonproliferative diabetic retinop- for neuropathic pain in diabetes. A risk or slow the progression of dia- athy (a precursor of proliferative A betic retinopathy. diabetic retinopathy), or any pro- Diabetic neuropathies are a het- Screening liferative diabetic retinopathy to erogeneous group of disorders with • Adults with type 1 diabetes should an ophthalmologist who is knowl- diverse clinical manifestations. The have an initial dilated and com- edgeable and experienced in the early recognition and appropriate prehensive eye examination by an management of diabetic retinop- management of neuropathy in the ophthalmologist or optometrist athy. A patient with diabetes is important. within 5 years after the onset of • The presence of retinopathy is not 1. Diabetic neuropathy is a diag- diabetes. B a contraindication to aspirin ther- nosis of exclusion. Nondiabetic • Patients with type 2 diabetes apy for cardioprotection, as aspirin neuropathies may be present in should have an initial dilated and does not increase the risk of retinal patients with diabetes and may be comprehensive eye examination by hemorrhage. A treatable.

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TABLE 6. CKD Stages and Corresponding Focus of Kidney-Related Care CKD Stage† Focus of Kidney-Related Care Stage eGFR Evidence Diagnose Evaluate and treat Evaluate and Prepare for renal (mL/min/ of kidney cause of kidney risk factors for treat CKD replacement 1.73 m2) damage* injury CKD progression** complications*** therapy No clinical ≥60 − evidence of CKD 1 ≥90 + ✓ ✓ 2 60–89 + ✓ ✓ 3 30–59 +/− ✓ ✓ ✓ 4 15–29 +/− ✓ ✓ ✓ 5 <15 +/− ✓ ✓ †CKD stages 1 and 2 are defined by evidence of kidney damage (+), while CKD stages 3–5 are defined by reduced eGFR with or without evidence of kidney damage (+/−). At any stage of CKD, the degree of albuminuria, observed history of eGFR loss, and cause of kidney damage (including possible causes other than diabetes) may also be used to characterize CKD, gauge prognosis, and guide treatment decisions. *Kidney damage is most often manifest as albuminuria (urine albumin-to-creatinine ratio ≥30 mg/g Cr) but can also include glomerular hematuria, other abnormalities of the urinary sediment, radiographic abnormalities, and other presentations. **Risk factors for CKD progression include elevated blood pressure, hyperglycemia, and albuminuria. ***See Table 11.2 in the complete Standards of Care.

2. Numerous treatment options Foot Care further vascular assessment as C exist for symptomatic diabetic Recommendations appropriate. neuropathy. • A multidisciplinary approach is • Perform a comprehensive foot 3. Up to 50% of diabetic periph- recommended for individuals evaluation at least annually to eral neuropathy (DPN) may be with foot ulcers and high-risk feet identify risk factors for ulcers and asymptomatic. If not recognized (e.g., dialysis patients and those amputations. B and if preventive foot care is not with Charcot foot or prior ulcers • Patients with evidence of sen- implemented, patients are at risk or amputation). B sory loss or prior ulceration or for injuries to their insensate feet. • Refer patients who smoke or amputation should have their feet 4. Recognition and treatment of auto- who have histories of prior lower- inspected at every visit. C nomic neuropathy may improve extremity complications, loss of • Obtain a prior history of ulcer- symptoms, reduce sequelae, and protective sensation, structural improve quality of life. ation, amputation, Charcot foot, abnormalities, or peripheral arte- angioplasty or vascular surgery, rial disease to foot care specialists Specific treatment for the under- cigarette smoking, retinopathy, for ongoing preventive care and lying nerve damage, other than and renal disease and assess cur- lifelong surveillance. C improved glycemic control, is cur- rent symptoms of neuropathy • Provide general preventive foot rently not available. Therapeutic (pain, burning, numbness) and self-care education to all patients strategies (pharmacologic and non- vascular disease (leg fatigue, clau- with diabetes. B pharmacologic) for the relief of painful dication). B DPN and symptoms of autonomic • The use of specialized therapeu- • The examination should include tic footwear is recommended for neuropathy can potentially reduce inspection of the skin, assessment pain and improve quality of life. high-risk patients with diabe- of foot deformities, neurological tes including those with severe Neuropathic Pain assessment (10-g monofilament neuropathy, foot deformities, or Neuropathic pain can be severe and testing with at least one other history of amputation. B can impact quality of life, limit mobil- assessment: pinprick, temperature, ity, and contribute to depression and vibration), and vascular assessment Foot ulcers and amputation, which social dysfunction. No compelling including pulses in the legs and are consequences of diabetic neurop- evidence exists in support of glyce- feet. B athy and/or PAD, are common and mic control or lifestyle management • Patients with symptoms of clau- represent major causes of morbidity as therapies for neuropathic pain in dication or decreased or absent and mortality in people with diabe- diabetes or prediabetes, which leaves pedal pulses should be referred tes. Early recognition and treatment only pharmaceutical interventions. for ankle-brachial index and for of patients with diabetes and feet at

CLINICAL DIABETES 19 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT risk for ulcers and amputations can diabetes self-management and be training, should be encouraged delay or prevent adverse outcomes. related to health-related quality of in all older adults who can safely Clinicians are encouraged to life. C engage in such activities. B review ADA screening recom- • Screening for early detection of • In older adults at increased risk of mendations in “11. Microvascular mild cognitive impairment or hypoglycemia, medication classes Complications and Foot Care” in the dementia and depression is indi- with low risk of hypoglycemia are complete Standards of Care for fur- cated for adults 65 years of age or preferred. B ther details and practical descriptions older at the initial visit and annu- • Overtreatment of diabetes is com- of how to perform components of the ally as appropriate. B mon in older adults and should be comprehensive foot examination. • Hypoglycemia should be avoided avoided. B in older adults with diabetes. It • Deintensification (or simplifi- Treatment should be assessed and managed cation) of complex regimens is People with neuropathy or evidence by adjusting glycemic targets and recommended to reduce the risk of of increased plantar pressures (e.g., pharmacologic interventions. B hypoglycemia, if it can be achieved erythema, warmth, or calluses) may • Older adults who are other- within the individualized A1C be adequately managed with well- wise healthy with few coexisting target. B fitted walking shoes or athletic shoes chronic illnesses and intact cogni- that cushion the feet and redistribute tive function and functional status Older adults are at higher risk pressure. People with bony deformi- should have lower glycemic goals of hypoglycemia for many reasons, ties (e.g., hammertoes, prominent (such as A1C <7.5% [58 mmol/ including insulin deficiency necessi- metatarsal heads, bunions) may need mol]), while those with multiple tating insulin therapy and progressive extra wide or deep shoes, and some coexisting chronic illnesses, cog- renal insufficiency. Hypoglycemic will require custom-molded shoes. nitive impairment, or functional events should be diligently monitored Use of custom therapeutic footwear dependence should have less strin- and avoided, whereas glycemic targets can help reduce the risk of future foot gent glycemic goals (such as A1C and pharmacologic interventions may ulcers in high-risk patients. <8.0–8.5% [64–69 mmol/mol]). C need to be adjusted to accommodate for the changing needs of the older 12. OLDER ADULTS • Glycemic goals for some older adult. It is important to prevent Diabetes is an important health con- adults might reasonably be relaxed as part of individualized care, hypoglycemia to reduce the risk of dition for the aging population as cognitive decline and other major approximately one-quarter of people but hyperglycemia leading to symptoms or risk of acute hyper- adverse outcomes. over the age of 65 years have diabe- The care of older adults with dia- tes and one-half of older adults have glycemia complications should be avoided in all patients. C betes is complicated by their clinical, prediabetes. Older individuals with cognitive, and functional hetero- diabetes have higher rates of prema- • Screening for diabetes complica- tions should be individualized in geneity. Providers caring for older ture death, functional disability, and adults with diabetes should prioritize coexisting illnesses. They also have older adults. Particular attention should be paid to complications treatment goals. For patients with higher incidences of all-cause demen- complications and reduced func- tia, Alzheimer’s disease, and vascular that would lead to functional impairment. C tionality, it is reasonable to set less dementia than people with normal intensive glycemic goals. Patients with glucose tolerance. • Treatment of hypertension to indi- vidualized target levels is indicated good cognitive and physical func- Recommendations in most older adults. C tion may benefit from interventions • Consider the assessment of med- • Treatment of other cardiovascular and goals similar to younger adults. ical, psychological, functional risk factors should be individual- DSMES is vital to diabetes care for (self-management abilities), and ized in older adults considering older adults and their caregivers. social geriatric domains in older the time frame of benefit. Lipid- Pharmacologic Therapy adults to provide a framework to lowering therapy and aspirin Special care is required in prescrib- determine targets and therapeutic therapy may benefit those with life ing and monitoring pharmacologic approaches for diabetes manage- expectancies at least equal to the therapies in older adults. See Figure 3 ment. C time frame of primary prevention for general recommendations regard- • Screening for geriatric syndromes or secondary intervention trials. E ing antihyperglycemia treatment for may be appropriate in older adults • Optimal nutrition and protein adults with type 2 diabetes and Table experiencing limitations in their intake is recommended for older 5 for patient- and drug-specific factors basic and instrumental activities adults; regular exercise, includ- to consider when selecting antihyper- of daily living as they may affect ing aerobic activity and resistance glycemia agents. Metformin is the

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first-line agent for older adults with • An A1C target of <7.5% (58 Management type 2 diabetes. mmol/mol) should be considered Recommendations The patient’s living situation in children and adolescents with must be considered because it may type 1 diabetes but should be Glycemic Targets affect diabetes management and individualized based on the needs • A reasonable A1C target for most support. Cost may be an important and situation of the patient and children and adolescents with type consideration. Deintensification of family. E 2 diabetes treated with oral agents regimens in patients taking nonin- alone is <7% (53 mmol/mol). sulin glucose-lowering medications A multidisciplinary team of spe- More stringent A1C targets (such can be achieved by either lower- cialists trained in pediatric diabetes as <6.5%) may be appropriate for ing the dose or discontinuing some management and sensitive to the selected individual patients if this medications, so long as the individ- challenges of children and adoles- can be achieved without signifi- ualized A1C target is maintained. cents with type 1 diabetes and their cant hypoglycemia or other adverse Simplification of insulin regimens families should provide care for this effects of treatment. Appropriate may also be appropriate. population. patients might include those with Older adults with diabetes are See “13. Children and Adolescents” short duration of diabetes and likely to benefit from control of other in the complete 2019 Standards of lesser degrees of β-cell dysfunction cardiovascular risk factors. Evidence Care regarding the use of insulin and patients treated with lifestyle is strong for treatment of hyper- pumps, blood glucose monitoring, or metformin only who achieve tension. There is less evidence for and CGM in pediatric patients with significant weight improvement. E lipid-lowering and aspirin therapy, type 1 diabetes. Pharmacologic Management although the benefits of these inter- ventions are likely to apply to older Type 2 Diabetes • Initiate pharmacologic therapy, adults whose life expectancies equal in addition to lifestyle therapy, at Screening and Diagnosis A or exceed the time frames of clinical diagnosis of type 2 diabetes. prevention trials. Recommendations • In incidentally diagnosed or met- abolically stable patients (A1C • Risk-based screening for prediabe- Treatment in Skilled Nursing <8.5% [69 mmol/mol] and asymp- tes and/or type 2 diabetes should Facilities and Nursing Homes tomatic), metformin is the initial be considered in children and ado- Management of diabetes is unique pharmacologic treatment of choice lescents after the onset of puberty in the long-term care (LTC) setting if renal function is normal. A ≥ (i.e., nursing homes and skilled nurs- or 10 years of age, whichever • If the A1C target is no longer met ing facilities). Individualization of occurs earlier, who are overweight with metformin monotherapy, or health care is important for all pa- (BMI ≥85th percentile) or obese if contraindications or intolerable tients. Practical guidance is needed (BMI ≥95th percentile) and who side effects of metformin develop, for medical providers as well as the have one or more additional risk basal insulin therapy should be LTC staff and caregivers. For patients factors for diabetes (see Table 2 initiated. B in the LTC setting, special attention for evidence grading of other risk • Patients treated with basal insulin should be given to nutritional consid- factors). up to 1.5 units/kg/day who do not erations, end-of-life care, and changes • If tests are normal, repeat testing meet A1C target should be moved in diabetes management with respect at a minimum of 3-year intervals to multiple daily injections with to advanced disease. In some circum- E, or more frequently if BMI is basal and premeal bolus insulins. E stances, withdrawal of medications increasing. C • Use of medications not approved may be appropriate. • Fasting plasma glucose, 2-h plasma by the FDA for youth with type 2 13. CHILDREN AND glucose during a 75-g oral glucose diabetes is not recommended out- ADOLESCENTS tolerance test, and A1C can be used side of research trials. B to test for prediabetes or diabetes in Type 1 Diabetes children and adolescents. B See “13. Children and Adolescents” in the complete 2019 Standards of Care Recommendations • Children and adolescents with regarding the comprehensive treat- • The majority of children and overweight/obesity in whom the ment of children with type 2 diabetes. adolescents with type 1 diabetes diagnosis of type 2 diabetes is should be treated with intensive being considered should have a 14. DIABETES IN PREGNANCY insulin regimens, either via multi- panel of pancreatic autoantibod- The prevalence of diabetes in pregnan- ple daily injections or continuous ies tested to exclude the possibility cy has been increasing in the United subcutaneous insulin infusion. A of autoimmune type 1 diabetes. B States. The majority is GDM with the

CLINICAL DIABETES 21 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT remainder primarily preexisting type 1 recommended in both GDM and Management of Preexisting diabetes and type 2 diabetes. The rise preexisting diabetes in pregnancy Type 1 Diabetes and Type 2 in GDM and type 2 diabetes in par- to achieve glycemic control. Some Diabetes in Pregnancy allel with obesity both in the United women with preexisting diabetes Insulin Use States and worldwide is of particular should also test blood glucose pre- concern. prandially. B Recommendation Preconception Counseling • Due to increased red blood cell • Insulin is the preferred agent turnover, A1C is slightly lower in for management of both type 1 Recommendations normal pregnancy than in nor- diabetes and type 2 diabetes in • Starting at puberty and continu- mal nonpregnant women. Ideally, pregnancy because it does not ing in all women with reproductive the A1C target in pregnancy is cross the placenta and because oral potential, preconception counsel- <6% (42 mmol/mol) if this can agents are generally insufficient to ing should be incorporated into be achieved without significant overcome the insulin resistance in routine diabetes care. A hypoglycemia, but the target may type 2 diabetes and are ineffective • Family planning should be dis- be relaxed to <7% (53 mmol/mol) in type 1 diabetes. E cussed and effective contraception if necessary to prevent hypoglyce- should be prescribed and used mia. B Due to the continuous change in in- until a woman is prepared and sulin requirements during pregnancy, ready to become pregnant. A Similar to the targets recommend- regular monitoring of blood glucose • Preconception counseling should ed by the American College of and insulin adjustments are necessary. address the importance of glycemic Obstetricians and Gynecologists (the Toward the end of the third trimester, management as close to normal same as for GDM; described below), it is common for there to be a greater as is safely possible, ideally A1C the ADA recommended targets for need for prandial insulin (>50%) than <6.5% (48 mmol/mol), to reduce women with type 1 or type 2 diabetes for basal insulin (<50%). Referral to the risk of congenital anomalies, are as follows: a specialized care team experienced in preeclampsia, macrosomia, and • Fasting <95 mg/dL (5.3 mmol/L) managing pregnancy in women with other complications. B and either preexisting diabetes is recommended • One-hour postprandial <140 if this resource is available. None of Preconception Care mg/dL (7.8 mmol/L) or the available human insulins have Recommendations • Two-hour postprandial <120 been found to cross the placenta. Use • Women with preexisting type 1 or mg/dL (6.7 mmol/L) of a basal/bolus regimen versus con- type 2 diabetes who are planning Management of GDM tinuous subcutaneous insulin infusion pregnancy or who have become (insulin pump therapy) is to be indi- pregnant should be counseled on Recommendations vidualized to patients’ needs. the risk of development and/or • Lifestyle change is an essen- Preeclampsia and Aspirin progression of diabetic retinopathy. tial component of management Dilated eye examinations should of GDM and may suffice for Recommendation occur ideally before pregnancy the treatment of many women. • Women with type 1 or type 2 or in the first trimester, and then Medications should be added if diabetes should be prescribed low- patients should be monitored every needed to achieve glycemic tar- dose aspirin 60–150 mg/day (usual trimester and for 1-year postpar- gets. A dose 81 mg/day) from the end of tum as indicated by the degree of • Insulin is the preferred medica- the first trimester until the baby is retinopathy and as recommended tion for treating hyperglycemia born in order to lower the risk of by the eye care provider. B in GDM as it does not cross the preeclampsia. A • Women with preexisting diabetes placenta to a measurable extent. Pregnancy and Drug should ideally be managed in a Metformin and glyburide should Considerations multidisciplinary clinic including not be used as first-line agents, an endocrinologist, maternal-fetal as both cross the placenta to the Recommendations medicine specialist, dietitian, and fetus. All oral agents lack long-term • In pregnant patients with diabetes diabetes educator, when available. B safety data. A and chronic hypertension, blood Glycemic Targets in Pregnancy • Metformin, when used to treat pressure targets of 120–160/80–105 polycystic ovary syndrome and mmHg are suggested in the interest Recommendations induce ovulation, should be dis- of optimizing long-term maternal • Fasting and postprandial self- continued once pregnancy has health and minimizing impaired monitoring of blood glucose are been confirmed. A fetal growth. E

22 CLINICAL.DIABETESJOURNALS.ORG Clinical Diabetes Online Ahead of Print, published online December 17, 2018 a b r i d g e d s ta n d a r d s o f c a r e 2019

• Potentially teratogenic medications mmol/L]) admitted to the hospi- 30 min to every 2 h is required for (i.e., ACE inhibitors, ARBs, statins) tal if not performed in the prior 3 intravenous insulin infusion. should be avoided in sexually active months. B Several inpatient studies have women of childbearing age who are Considerations on Admission shown that CGM use did not improve not using reliable contraception. B glucose control but detected a greater Initial orders should state the type of Postpartum Care diabetes. For best practice, hospitals number of hypoglycemic events than point-of-care (POC) glucose testing. Postpartum care should include psy- should establish protocols for struc- However, a recent review has recom- chosocial assessment and support for tured patient care and structured or- mended against using CGM in adults self-care. der sets, which include computerized Because GDM may represent pre- physician order entry. in a hospital setting until more safety and efficacy data become available. existing undiagnosed type 2 or even Recommendation Antihyperglycemic Agents in type 1 diabetes, women with GDM • Insulin should be administered should be tested for persistent dia- using validated written or com- Hospitalized Patients betes or prediabetes at 4–12 weeks puterized protocols that allow Recommendations postpartum with a 75-g OGTT using for predefined adjustments in the nonpregnancy criteria (Table 3). • Basal insulin or a basal plus bolus insulin dosage based on glycemic correction insulin regimen is Women should also be tested fluctuations.E every 1–3 years thereafter if the 4- to the preferred treatment for non- 12-week postpartum 75-g OGTT Glycemic Targets in critically ill hospitalized patients is normal, with frequency of test- Hospitalized Patients with poor oral intake or those who ing depending on other risk factors are taking nothing by mouth. An Recommendations insulin regimen with basal, pran- including family history, prepregnancy • Insulin therapy should be initiated BMI, and need for insulin or oral dial, and correction components for treatment of persistent hyper- is the preferred treatment for non- glucose-lowering medication during glycemia starting at a threshold pregnancy. Ongoing evaluation may critically ill hospitalized patients ≥180 mg/dL (10.0 mmol/L). A be performed with any recommended with good nutritional intake. Once insulin therapy is started, a • Sole use of sliding scale insulin glycemic test (e.g., A1C, FPG, or 75-g target glucose range of 140–180 OGTT using nonpregnant thresholds). in the inpatient hospital setting is mg/dL (7.8–10.0 mmol/L) is strongly discouraged. A In women taking insulin, partic- recommended for the majority ular attention should be directed to of critically ill patients and non-​ In most instances in the hospital hypoglycemia prevention in the set- critically ill patients. A setting, insulin is the preferred treat- ting of breastfeeding and erratic sleep • More stringent goals, such as ment for glycemic control. and eating schedules. 110–140 mg/dL (6.1–7.8 mmol/L), Insulin Therapy All women with diabetes of child- maybe appropriate for selected bearing potential should have family patients, if this can be achieved In the critical care setting, continu- planning options reviewed at regular without significant hypogly- ous intravenous insulin infusion has intervals. cemia. C been shown to be the best method for achieving glycemic targets. Outside 15. DIABETES CARE IN THE of critical care units, scheduled insu- HOSPITAL Hyperglycemia in hospitalized lin regimens as described above are Hospitals should promote the short- patients is defined as blood glucose > recommended. est safe hospital stay, providing an ef- levels 140 mg/dL (7.8 mmol/L). An admission A1C value ≥6.5% (48 If the patient is eating, insulin fective transition out of the hospital injections should align with meals. that prevents acute complications and mmol/mol) suggests that diabetes pre- ceded hospitalization. Hypoglycemia In such instances, POC glucose readmission. Prevention of hypogly- in the hospital is classified the same as testing should be performed imme- cemia and hyperglycemia should be in any setting. (See Sec. 6 “Glycemic diately before meals. Patients with goals, since adverse outcomes are as- Targets” above.) type 1 diabetes should have basal- sociated with both. bolus insulin plus nutritional insu- Bedside Blood Glucose Hospital Care Delivery lin if they are eating. A transition Monitoring Standards protocol from insulin infusion to sub- In the patient who is eating meals, cutaneous insulin is recommended. Recommendation glucose monitoring should be per- • Perform an A1C on all patients formed before meals. In the patient Noninsulin Therapies with diabetes or hyperglycemia who is not eating, glucose monitoring The safety and efficacy of noninsulin (blood glucose >140 mg/dL [7.8 is advised every 4–6 h. Testing every antihyperglycemic therapies in the

CLINICAL DIABETES 23 Clinical Diabetes Online Ahead of Print, published online December 17, 2018 POSITION STATEMENT hospital setting is an area of active mic control, and address personal food onciliation and structured discharge research. See “15. Diabetes Care in preferences. The ADA does not en- communication. Discharge planning the Hospital” in the complete 2019 dorse any single meal plan. An RD can should begin at admission and be Standards of Care for a comprehen- serve as an inpatient team member. updated as patient needs change. An sive review of the inpatient use of Self-Management in the outpatient follow-up visit 1 month these medications. Hospital after discharge is recommended. Hypoglycemia Diabetes self-management in the 16. DIABETES ADVOCACY Recommendations hospital may be appropriate for select For a list of ADA advocacy position • A hypoglycemia management youth and adult patients. Sufficient statements, including “Diabetes protocol should be adopted and cognitive and physical skills, adequate and Driving” and “Diabetes and implemented by each hospital or oral intake, proficiency in carbohy- Employment,” see “16. Diabetes hospital system. A plan for pre- drate estimation, and knowledge of Advocacy” in the complete Standards venting and treating hypoglycemia sick-day management are some of the of Care. should be established for each requirements. Self-administered in- patient. Episodes of hypoglycemia sulin with a multiple daily injection Acknowledgments regimen or insulin pump therapy may in the hospital should be docu- This abridged version of the Standards of mented in the medical record and be considered. A protocol should exist Medical Care in Diabetes—2019 was created E for these situations. by the ADA’s Primary Care Advisory Group tracked. (PCAG), with special thanks to PCAG chair • The treatment regimen should be Standards for Special Situations Eric L. Johnson, MD, of Grand Forks, ND; reviewed and changed as necessary See “15. Diabetes Care in the vice-chair Hope Feldman, CRNP, FNP-BC, to prevent further hypoglycemia of Philadelphia, PA; Amy Butts, PA-C, Hospital” in the complete 2019 MPAS, CDE, of Weirton, WV; CDR Billy when a blood glucose value is <70 Standards of Care for guidance on St. John Collins, DHSc, MS, of Bethesda, mg/dL (3.9 mmol/L). C enteral/parenteral feedings, diabetic MD; Joy Dugan, MPH, DHS(c), PA-C, of Vallejo, CA; Sandra Leal, PharmD, MPH, ketoacidosis and hyperosmolar hyper- Patients with or without diabetes FAPhA, CDE, of Tucson, AZ; Andrew may experience hypoglycemia in the glycemic state, perioperative care, and S. Rhinehart, MD, FACP, FACE, CDE, glucocorticoid therapy. BC-ADM, CDTC, of Marco Island, FL; hospital setting. While hypoglycemia Jay H. Shubrook, DO, of Vallejo, CA; and is associated with increased mortality, Transition From the Acute Care Jennifer Trujillo, PharmD, FCCP, BCPS, CDE, BC-ADM, of Aurora, CO; with ADA it may be a marker of underlying dis- Setting staff support from Sarah Bradley. ease rather than the cause of increased Recommendation The complete Standards of Medical Care in mortality. However, until it is proven Diabetes—2019 was developed by the ADA’s not to be causal, it is prudent to avoid • There should be a structured Professional Practice Committee: Joshua J. hypoglycemia. Studies of “bundled” discharge plan tailored to the indi- Neumiller, PharmD, CDE, FASCP (Chair); vidual patient with diabetes. B Christopher Cannon, MD; Ian de Boer, MD, preventive therapies including proac- MS; Jill Crandall, MD; David D’Alessio, tive surveillance of glycemic outliers Transition from the acute care MD; Mary de Groot, PhD; Judith Fradkin, and an interdisciplinary data-driven MD; Kathryn Kreider, DNP, APRN, setting is a risky time for all patients FNP-BC, BC-ADM; David Maahs, MD, approach to glycemic management A structured discharge plan tailored PhD; Nisa Maruthur, MD, MHS; Melinda showed that hypoglycemic episodes to the individual patient may reduce Maryniuk, MEd, RD, CDE; Medha N. in the hospital could be prevented. Munshi, MD; Maria Jose Rdondo, MD, length of hospital stay and read- PhD, MPH; Guillermo E. Umpierrez, MD, MNT in the Hospital mission rates and increase patient CDE; and Jennifer Wyckoff, MD. ADA staff satisfaction. A structured discharge support includes Erika Berg, PhD; William The goals of MNT in the hospital are T. Cefalu, MD; Matt Petersen; Shamera to provide adequate calories to meet plan should be tailored to each patient Robinson, MPH, RDN; Mindy Saraco, metabolic demands, optimize glyce- and should include medication rec- MHA; and Sacha Uelmen, RDN, CDE.

24 CLINICAL.DIABETESJOURNALS.ORG Clinical Diabetes Online Ahead of Print, published online December 17, 2018