The American Diabetes Association’s (ADA’s) Standards of Medical Care in Diabetes are published each year in a supplement to the January issue of Diabetes Care. The ADA’s Professional Practice Committee develops the Standards and updates them annually, or more frequently online should it determine that new evidence or regulatory changes (e.g., drug approvals, label changes) merit immediate incorporation. The Standards include the most current evidence-based recommendations for diagnosing and treating adults and children with diabetes. ADA’s grading system uses A, B, C, or E to show the evidence level that supports each recommendation. A—Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered B—Supportive evidence from well-conducted cohort studies C—Supportive evidence from poorly controlled or uncontrolled studies E—Expert consensus or clinical experience This is an abridged version of the Standards containing the evidence-based recommendations most pertinent to primary care. The tables and figures have been renumbered from the original document to match this version. All of the recommendations (bulleted text) are precisely the same as in the full Standards of Care. The complete 2018 Standards of Care document, including all supporting references, is available at professional.diabetes.org/standards. IMPROVING CARE AND PROMOTING HEALTH IN POPULATIONS Over the past 10 years, the proportion of patients with diabetes who achieve recommended A1C, blood pressure, and LDL cholesterol levels has increased. The mean A1C nationally among people with diabetes has declined from 7.6% (60 mmol/mol) in 1999–2002 to 7.2% (55 mmol/mol) in 2007–2010 based on the National Health and Nutrition Examination Survey, with younger adults less likely to meet treatment targets than older adults. This has been accompanied by improvements in cardiovascular outcomes and has led to substantial reductions in end-stage microvascular complications. Nevertheless, 33–49% of patients still do not meet targets for glycemic, blood pressure, or cholesterol control, and only 14% meet targets for all three measures while also avoiding smoking. Optimal diabetes management requires an organized, systematic approach and the involvement of a coordinated team of dedicated health care professionals working in an environment where patient-centered high-quality care is a priority. Recommendations Ensure treatment decisions are timely, rely on evidence-based guidelines, and are made collaboratively with patients based on individual preferences, prognoses, and comorbidities. B Align approaches to diabetes management with the Chronic Care Model, emphasizing productive interactions between a prepared proactive care team and an informed activated patient. A Care systems should facilitate team-based care, patient registries, decision support tools, and community involvement to meet patient needs. B Efforts to assess the quality of diabetes care and create quality improvement strategies should incorporate reliable data metrics, to promote improved processes of care and health outcomes, with simultaneous emphasis on costs. E Tailoring Treatment for Social Context Health inequities related to diabetes and its complications are well documented and are heavily influenced by social determinants of health. Social determinants of health are defined as the economic, environmental, political, and social conditions in which people live and are responsible for a major part of health inequality worldwide. The ADA recognizes the association between social and environmental factors and risk for diabetes and its complications. Recommendations Providers should assess social context, including potential food insecurity, housing stability, and financial barriers, and apply that information to treatment decisions. A Refer patients to local community resources when available. B Provide patients with self-management support from lay health coaches, navigators, or community health workers when available. A CLASSIFICATION AND DIAGNOSIS OF DIABETES Diabetes can be classified into the following general categories: Type 1 diabetes (due to autoimmune β-cell destruction, usually leading to absolute insulin deficiency) Type 2 diabetes (due to a progressive loss of β-cell insulin secretion frequently on the background of insulin resistance) Gestational diabetes mellitus (GDM) (diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation) Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young), diseases of the exocrine pancreas (such as cystic fibrosis and pancreatitis), and drug- or chemical-induced diabetes (such as with glucocorticoid use, in the treatment of HIV/AIDS, or after organ transplantation) Diagnostic Tests for Diabetes Diabetes and prediabetes may be screened based on plasma glucose criteria, either the fasting plasma glucose (FPG) or the 2-h plasma glucose (2-h PG) value during a 75-g oral glucose tolerance test (OGTT), or A1C criteria (Table 1). TABLE 1. Criteria for the Screening and Diagnosis of Diabetes Prediabetes Diabetes A1C 5.7–6.4%* ≥6.5%† FPG 100–125 mg/dL (5.6–6.9 mmol/L)* ≥126 mg/dL (7.0 mmol/L)† OGTT 140–199 mg/dL (7.8–11.0 mmol/L)* ≥200 mg/dL (11.1 mmol/L)† RPG — ≥200 mg/dL (11.1 mmol/L)‡ * For all three tests, risk is continuous, extending below the lower limit of the range and becoming disproportionately greater at the higher end of the range. † In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing. ‡ Only diagnostic in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis. RPG, random plasma glucose. There is incomplete concordance between A1C, FPG, and 2-h PG, and the 2-h PG diagnoses more people with diabetes than the FPG or A1C. Marked discrepancies between measured A1C and plasma glucose levels should prompt consideration that the A1C assay may not be reliable for that individual, since a relatively small percentage of patients have conditions such as sickle cell trait or hemoglobinopathies that skew A1C results. See the full 2018 Standards of Care for conditions causing discrepancies. Unless there is a clear clinical diagnosis based on overt signs of hyperglycemia, a second test is required for confirmation, either repeating the same test used initially or a different test. If patients have test results near the margins of the diagnostic threshold, the health care professional should follow the patient closely and repeat the test in 3–6 months. Categories of Increased Risk for Diabetes (Prediabetes) “Prediabetes” is the term used for individuals whose glucose levels do not meet the criteria for diabetes but are too high to be considered normal (see Table 1). Prediabetes should not be viewed as a clinical entity in its own right but rather as an increased risk for diabetes and cardiovascular disease (CVD). Recommendations Screening for prediabetes and risk for future diabetes with an informal assessment of risk factors or validated tools should be considered in asymptomatic adults. B Testing for prediabetes and risk for future diabetes in asymptomatic people should be considered in adults of any age who are overweight or obese (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans) and who have one or more additional risk factors for diabetes (Table 2). B For all people, testing should begin at age 45 years. B If tests are normal, repeat testing carried out at a minimum of 3-year intervals is reasonable. C To test for prediabetes, FPG, 2-h PG during 75-g OGTT tolerance test, and A1C are equally appropriate. B In patients with prediabetes, identify and, if appropriate, treat other CVD risk factors. B Testing for prediabetes should be considered in children and adolescents who are overweight or obese (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal for height) and who have additional risk factors for diabetes (Table 3). E TABLE 2. Criteria for Testing for Diabetes or Prediabetes in Asymptomatic Adults 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 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) Patients with prediabetes (A1C ≥5.7% [39 mmol/mol], IGT, or IFG) should be tested yearly. Women who were diagnosed with GDM should have lifelong testing at least every 3 years. For all other patients, testing should begin at age 45 years. 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. TABLE 3. Risk-Based Screening for Type 2 Diabetes or Prediabetes in Asymptomatic Children and Adolescents in a Clinical Setting* Criteria ● Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal for height) A ● Plus one or more additional risk factors based on the strength of their association with diabetes as indicated by evidence grades: ● 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 * Persons aged 5% weight loss should be prescribed for overweight and obese patients with type 2 diabetes ready to achieve weight loss. A Such interventions should be high intensity (≥16 sessions in 6 months) and focus on diet, physical activity, and behavioral strategies to achieve a 500–750 kcal/day energy deficit. A Diets should be individualized, as those that provide the same caloric restriction but differ in protein, carbohydrate, and fat content are equally effective in achieving weight loss. A For patients who achieve short-term weight-loss goals, long-term (≥1 year) comprehensive weight maintenance programs should be prescribed. Such programs should provide at least monthly contact and encourage ongoing monitoring of body weight (weekly or more frequently), continued consumption of a reduced-calorie diet, and participation in high levels of physical activity (200–300 min/week). A Pharmacotherapy Recommendations When choosing glucose-lowering medications for overweight or obese patients with type 2 diabetes, consider their effect on weight. E Whenever possible, minimize the medications for comorbid conditions that are associated with weight gain. E Weight loss medications may be effective as adjuncts to diet, physical activity, and behavioral counseling for selected patients with type 2 diabetes and BMI ≥27 kg/m2. Potential benefits must be weighed against the potential risks of the medications. A If a patient’s response to weight loss medications is 120/80 mmHg, lifestyle intervention consists of weight loss if overweight or obese; a Dietary Approaches to Stop Hypertension–style dietary pattern including reducing sodium and increasing potassium intake; moderation of alcohol intake; and increased physical activity. B Patients with confirmed office-based blood pressure ≥140/90 mmHg should, in addition to lifestyle therapy, have prompt initiation and timely titration of pharmacologic therapy to achieve blood pressure goals. A Patients with confirmed office-based blood pressure ≥160/100 mmHg should, in addition to lifestyle therapy, have prompt initiation and timely titration of two drugs or a single-pill combination of drugs demonstrated to reduce cardiovascular events in patients with diabetes. A Treatment for hypertension should include drug classes demonstrated to reduce cardiovascular events in patients with diabetes (ACE inhibitors, angiotensin receptor blockers [ARBs], thiazide-like diuretics, or dihydropyridine calcium channel blockers). A Multiple-drug therapy is generally required to achieve blood pressure targets. However, combinations of ACE inhibitors and ARBs and combinations of ACE inhibitors or ARBs with direct renin inhibitors should not be used. A An ACE inhibitor or ARB, at the maximumly tolerated dose indicated for blood pressure treatment, is the recommended first-line treatment for hypertension in patients with diabetes and urinary albumin–to–creatinine ratio (UACR) ≥300 mg/g creatinine (Cr) A or 30–299 mg/g Cr. B If one class is not tolerated, the other should be substituted. B For patients treated with an ACE inhibitor, ARB, or diuretic, serum creatinine/estimated glomerular filtration rate (eGFR) and serum potassium levels should be monitored at least annually. B Figure 9.1 in the full 2018 Standards of Care summarizes recommendations for the treatment of confirmed hypertension in people with diabetes. Based on current evidence, ADA recommends hypertension diagnosis and treatment as outlined, emphasizing individualization of blood pressure targets. ADA is aware of hypertension recommendations from other organizations. The ADA Professional Practice Committee continuously reviews and considers all studies, particularly high-quality trials including people with diabetes, for potential incorporation in future recommendations. Lipid Management Recommendations Lifestyle modification focusing on weight loss (if indicated); the reduction of saturated fat, trans fat, and cholesterol intake; increase of dietary ω-3 fatty acids, viscous fiber, and plant stanols/sterols intake; and increased physical activity should be recommended to improve the lipid profile in patients with diabetes. A Intensify lifestyle therapy and optimize glycemic control for patients with elevated triglyceride levels (≥150 mg/dL [1.7 mmol/L]) and/or low HDL cholesterol ( 75 years B without ASCVD, use moderate-intensity statin in addition to lifestyle therapy. In clinical practice, providers may need to adjust the intensity of statin therapy based on individual patient response to medication (e.g., side effects, tolerability, LDL cholesterol levels, or percent LDL reduction on statin therapy). For patients who do not tolerate the intended intensity of the statin, the maximally tolerated statin dose should be used. E For patients with diabetes and ASCVD, if LDL cholesterol is ≥70 mg/dL (3.9 mmol/L) on maximally tolerated statin dose, consider adding additional LDL-lowering therapy (such as ezetimibe or PCSK9 inhibitor) after evaluating the potential for further ASCVD risk reduction, drug-specific adverse effects, and patient preferences. Ezetimibe may be preferred due to lower cost. A Statin therapy is contraindicated in pregnancy. B For patients with fasting triglyceride levels ≥500 mg/dL (5.7 mmol/L), evaluate for secondary causes of hypertriglyceridemia and consider medical therapy to reduce the risk of pancreatitis. C Combination therapy (statin/fibrate) has not been shown to improve ASCVD outcomes and is generally not recommended. A Combination therapy (statin/niacin) has not been shown to provide additional cardiovascular benefit above statin therapy alone, may increase the risk of stroke with additional side effects, and is generally not recommended. A Table 8 and Table 9 provide recommendations on high-intensity and moderate-intensity statin therapy. TABLE 8. Recommendations for Statin and Combination Treatment in Adults With Diabetes Age ASCVD Recommended statin intensity^ and combination treatment* 30 mL/min but should be avoided in unstable or hospitalized patients with congestive heart failure. B In patients with type 2 diabetes and established ASCVD, antihyperglycemic therapy should begin with lifestyle management and metformin and subsequently incorporate an agent proven to reduce major adverse cardiovascular events and cardiovascular mortality (currently empagliflozin and liraglutide), after considering drug-specific and patient factors (see Table 7). A In patients with type 2 diabetes and established ASCVD, after lifestyle management and metformin, the antihyperglycemic agent canagliflozin may be considered to reduce major adverse cardiovascular events, based on drug-specific and patient factors (see Table 7). C MICROVASCULAR COMPLICATIONS AND FOOT CARE Diabetic Kidney Disease Diabetic kidney disease (DKD) is a clinical diagnosis usually made based on the presence of albuminuria and/or reduced eGFR in the absence of signs or symptoms of other primary causes of kidney damage. CKD is diagnosed by the persistent presence of elevated urinary albumin excretion (albuminuria), low eGFR, or other manifestations of kidney damage (Table 10). DKD, or CKD attributed to diabetes, occurs in 20–40% of patients with diabetes. DKD typically develops after diabetes duration of 10 years in type 1 diabetes, but may be present at diagnosis of type 2 diabetes. DKD can progress to end-stage renal disease (ESRD) requiring dialysis or kidney transplantation and is the leading cause of ESRD in the United States. In addition, among people with type 1 or type 2 diabetes, the presence of CKD markedly increases cardiovascular risk. TABLE 10. CKD Stages and Corresponding Focus of Kidney-Related Care CKD Stage† Focus of Kidney-Related Care Stage eGFR (ml/min/1.73 m2) Evidence of Kidney Damage* Diagnose Cause of Kidney Injury Evaluate and Treat Risk Factors for CKD Progression** Evaluate and Treat CKD Complications*** Prepare for Renal Replacement Therapy No clinical evidence of CKD ≥60 — 1 ≥90 + ✓ ✓ 2 60–89 + ✓ ✓ 3 30–59 +/– ✓ ✓ ✓ 4 15–29 +/– ✓ ✓ ✓ 5 85th %) or obese (BMI >95th %) and who have one or more additional risk factors for diabetes (see Table 4). A If tests are normal, repeat testing at a minimum of 3-year intervals E, or more frequently if BMI is increasing. C Pharmacologic Management Initiate pharmacologic therapy, in addition to lifestyle therapy, at diagnosis of type 2 diabetes. A In metabolically stable patients (A1C 30 mL/min/ 1.73 m2. A Youth with marked hyperglycemia (blood glucose ≥250 mg/dL [13.9 mmol/L], A1C ≥8.5% [69 mmol/mol]) without ketoacidosis at diagnosis who are symptomatic with polyuria, polydipsia, nocturia, and/or weight loss should be treated initially with basal insulin while metformin is initiated and titrated to maximally tolerated dose to achieve A1C goal. E When the A1C target is no longer met with metformin monotherapy, or if contraindications or intolerable side effects of metformin develop, basal insulin therapy should be initiated. E In patients initially treated with basal insulin and metformin who are meeting glucose targets based on home blood glucose monitoring, basal insulin can be tapered over 2–6 weeks by decreasing the insulin dose by 10–30% every few days. A MANAGEMENT OF DIABETES IN PREGNANCY The majority of diabetes in pregnancy is GDM, with the remainder primarily preexisting type 1 diabetes and type 2 diabetes. Good preconception care for women with existing diabetes has been shown to dramatically improve outcomes for both mother and child. Preconception Counseling Recommendations Starting at puberty, preconception counseling should be incorporated into routine diabetes care for all girls of childbearing potential. A Family planning should be discussed and effective contraception should be prescribed and used until a woman is prepared and ready to become pregnant. A Preconception counseling should address the importance of glycemic control as close to normal as is safely possible, ideally A1C 140 mg/dL) admitted to the hospital if not performed in the prior 3 months. B Considerations on Admission Diabetes self-management should be assessed on admission in addition to A1C. Physician Order Entry Best practice care can often be ensured by the use of structured order sets consistent with quality assurance standards. Recommendation Insulin should be administered using validated written or computerized protocols that allow for predefined adjustments in the insulin dosage based on glycemic fluctuations. E Glycemic Targets in Hospitalized Patients Recommendations Insulin therapy should be initiated for treatment of persistent hyperglycemia starting at a threshold ≥180 mg/dL (10.0 mmol/L). Once insulin therapy is started, a target glucose range of 140–180 mg/dL (7.8–10.0 mmol/L) is recommended for the majority of critically ill patients and noncritically ill patients. A More stringent goals, such as 110–140 mg/dL (6.1–7.8 mmol/L), may be appropriate for selected patients, if this can be achieved without significant hypoglycemia. C Hyperglycemia in hospitalized patients is defined as blood glucose levels >140 mg/dL (7.8 mmol/L). The hypoglycemia alert value in hospitalized patients is defined as blood glucose ≤70 mg/dL (3.9 mmol/L) and clinically significant hypoglycemia as glucose values <54 mg/dL (3.0 mmol/L). Bedside Blood Glucose Monitoring In the patient who is eating meals, glucose monitoring should be performed before meals. In the patient who is not eating, glucose monitoring is advised every 4–6 h. Testing every 30 min to 2 h is required for intravenous insulin infusion. Glucose results from a POC meter that do not correlate with the patient’s clinical status should be confirmed with conventional laboratory measures. Several inpatient studies have shown that CGM use did not improve glucose control but detected a greater number of hypoglycemic events than POC testing. However, a recent review has recommended against using CGM in adults in a hospital setting until more safety and efficacy data become available. Antihyperglycemic Agents in Hospitalized Patients Recommendations A basal plus bolus correction insulin regimen, with the addition of nutritional insulin in patients who have good nutritional intake, is the preferred treatment for noncritically ill patients. A Sole use of sliding scale insulin in the inpatient hospital setting is strongly discouraged. A In most instances in the hospital setting, insulin is the preferred treatment for glycemic control. However, in certain circumstances, it may be appropriate to continue home regimens including oral antihyperglycemic medications. Insulin Therapy In the critical care setting, continuous intravenous insulin infusion has been shown to be the best method for achieving glycemic targets. Outside of critical care units, scheduled insulin regimens as described above are recommended. If the patient is eating, insulin injections should align with meals. In such instances, POC glucose testing should be performed immediately before meals. Type 1 diabetes patients should have basal-bolus plus nutritional insulin if the patient is eating. A transition protocol from insulin infusion to subcutaneous insulin is recommended. Noninsulin Therapies The safety and efficacy of noninsulin antihyperglycemic therapies in the hospital setting is an area of active research. See the full 2018 Standards of Care for a comprehensive review of the inpatient use of these medications. Hypoglycemia Recommendations A hypoglycemia management protocol should be adopted and implemented by each hospital or hospital system. A plan for preventing and treating hypoglycemia should be established for each patient. Episodes of hypoglycemia in the hospital should be documented in the medical record and tracked. E The treatment regimen should be reviewed and changed as necessary to prevent further hypoglycemia when a blood glucose value is ≤70 mg/dL (3.9 mmol/L). C While hypoglycemia is associated with increased mortality, hypoglycemia may be a marker of underlying disease rather than the cause of increased mortality. However, until it is proven not to be causal, it is prudent to avoid hypoglycemia. Iatrogenic triggers should be considered. Studies of “bundled” preventative therapies including proactive surveillance of glycemic outliers and an interdisciplinary data-driven approach to glycemic management showed that hypoglycemic episodes in the hospital could be prevented. MNT in the Hospital The goals of MNT are to optimize glycemic control, provide adequate calories to meet metabolic demands, and address personal food preferences. The ADA does not endorse any single meal plan. A registered dietitian can serve as an inpatient team member. Self-Management in the Hospital Diabetes self-management in the hospital may be appropriate for select youth and adult patients. Sufficient cognitive and physical skills, adequate oral intake, proficiency in carbohydrate estimation, and knowledge of sick-day management are some of the requirements. See the full 2018 Standards of Care regarding self-administered insulin with an MDI or CSII (insulin pump) regimen. A protocol should exist for these situations. Standards for Special Situations See the full 2018 Standards of Care for guidance on enteral/parenteral feedings, diabetic ketoacidosis and hyperosmolar hyperglycemic state, perioperative care, and glucocorticoid therapy. Transition From the Acute Care Setting Recommendation There should be a structured discharge plan tailored to the individual patient with diabetes. B Tailor a structured discharge plan beginning at admission and update as patient needs change. It is important that patients be provided with appropriate durable medical equipment, medication reconciliation, supplies, and prescriptions, along with appropriate education at the time of discharge. An outpatient follow-up visit within 1 month of discharge is advised for all patients who have hyperglycemia in the hospital. Continuing contact may also be needed. Clear communication with outpatient providers either directly or via structured hospital discharge summaries facilitates safe transitions to outpatient care. If oral medications are held in the hospital, there should be protocols for resuming them 1–2 days before discharge. Refer to the full 2018 Standards of Care for a complete discussion of readmission prevention. Diabetes Advocacy For a list of ADA advocacy position statements, including “Diabetes and Driving” and “Diabetes and Employment,” see the Diabetes Advocacy section of the full 2018 Standards of Care.
