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The American Diabetes Association’s (ADA’s) Standards of Medical Care in Diabetes is updated and published annually in a supplement to the January issue of Diabetes Care. Formerly called Clinical Practice Recommendations, the Standards includes the most current evidence-based recommendations for diagnosing and treating adults and children with all forms of diabetes. ADA’s grading system uses A, B, C, or E to show the evidence level that supports each recommendation.
This is an abridged version of the current 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. The complete 2016 Standards of Care document, including all supporting references, is available at professional.diabetes.org/standards.
The CCM has been shown to be an effective framework for improving the quality of diabetes care. Collaborative, multidisciplinary teams are best equipped to provide care for people with chronic conditions such as diabetes. The CCM also facilitates patients’ self-management.
Several strategies have been shown to improve patient outcomes. Providers should focus on treatment intensification, which has been associated with improvement in A1C, hypertension, and hyperlipidemia.
Patient adherence should be addressed. Barriers may include patient factors (e.g., remembering to obtain or take medications, fears, depression, and health beliefs), medication factors (e.g., complexity, multiple daily dosing, cost, and side effects), and system factors (e.g., inadequate follow-up and support). Simplifying a complex treatment regimen may improve adherence.
Ethnic, cultural, religious, and sex differences and socioeconomic status may affect diabetes prevalence and outcomes. Diabetes management requires individualized, patient-centered, and culturally appropriate strategies. Strong social support leads to improved clinical outcomes, reduced psychosocial symptomatology, and adoption of healthier lifestyles. Structured interventions that are tailored to ethnic populations and integrate culture, language, religion, and literacy skills have a positive impact on patient outcomes.
FI is the unreliable availability of nutritious food and the inability to consistently obtain food without resorting to socially unacceptable practices. Hyperglycemia and hypoglycemia are more common in those with diabetes and FI.
Dementia is the most severe form of cognitive dysfunction. In those with type 2 diabetes, both degree and duration of hyperglycemia are related to dementia. More rapid cognitive decline is associated with increased A1C and longer duration of diabetes. In type 2 diabetes, severe hypoglycemia is associated with reduced cognitive function, and those with poor cognitive function have more severe hypoglycemia. Data do not support an adverse effect of statins on cognition.
The prevalence of type 2 diabetes is two to three times higher in people with schizophrenia, bipolar disorder, or schizoaffective disorder than in the general population. Diabetes medications are effective regardless of mental health status. Treatments for depression are effective in patients with diabetes, and treating depression may improve short-term glycemic control. Awareness of an individual’s medication profile, especially if the individual takes psychotropic medications, is key to effective management.
Diabetes can be classified into the following general categories:
Diabetes may be diagnosed based on plasma glucose criteria—either the fasting plasma glucose (FPG) or the 2-h plasma glucose value after a 75-g oral glucose tolerance test (OGTT)—or A1C criteria (Table 1). The same tests are used to screen for and diagnose diabetes and to detect individuals with prediabetes (Table 2).
The modified recommendations of the ADA consensus report “Type 2 Diabetes in Children and Adolescents” are summarized in Table 3.
It is necessary to take into account all aspects of a patient’s life circumstances. A team approach to care and a comprehensive clinical assessment should incorporate behavioral, dietary, lifestyle, and pharmaceutical intervention to manage this chronic condition (Table 4). Using the CCM may help improve the quality of diabetes care.
There are four critical time points for DSME/S delivery: at diagnosis; annually for assessment of education, nutrition, and emotional needs; when new complicating factors arise that influence self-management; and when transitions in care occur.
There is no one-size-fits-all eating pattern for individuals with diabetes. There are basic guidelines that can support the team in engaging the patient in more healthful eating patterns (Table 5).
The goals of medical nutrition therapy (MNT) are to promote and support healthful eating patterns, emphasizing a variety of nutrient-dense foods in appropriate portion sizes to achieve/maintain body weight goals; attain glycemic, lipid, and blood pressure goals; and delay/prevent complications of diabetes. MNT addresses individual nutrition needs based on personal and cultural preferences, health literacy, and access to healthful foods. It maintains the pleasure of eating by providing nonjudgmental messages about food choices and offers practical tools for developing healthy patterns.
All individuals should be encouraged to replace refined carbohydrates and added sugars with whole grains, legumes, vegetables, and fruit. Individuals who take mealtime insulin should be offered intensive education on coupling insulin administration with carbohydrate intake.
Weight loss is discussed in more detail below.
Physical activity is a general term that includes all movement that increases energy use and is an important part of the diabetes management plan. Exercise is a more specific form of physical activity that is structured and designed to improve physical fitness.
There is no routine pre-exercise testing recommended. However, providers should assess patients for conditions that might contraindicate certain types of exercise or predispose to injury and customize the exercise regimen to the individual’s needs.
Key opportunities for screening occur at multiple times during the management of diabetes: when medical status changes (e.g., at the end of the honeymoon period), when the need for intensified treatment is evident, and when complications are discovered. Optimizing the patient-provider relationship as a foundation may increase the likelihood of the patient accepting referral for other services.
A complete medical evaluation should be performed at the initial visit to:
Intensive lifestyle modification programs have been shown to be very effective (~58% risk reduction after 3 years).
In addition, pharmacological agents such as metformin, α-glucosidase inhibitors, orlistat, and thiazolidinediones have been shown to decrease incident diabetes to various degrees. Metformin has demonstrated long-term safety as pharmacological therapy for diabetes prevention.
SMBG frequency and timing should be dictated by the patient’s specific needs and goals. SMBG is especially important for patients treated with insulin to monitor for and prevent asymptomatic hypoglycemia and hyperglycemia. For patients on nonintensive insulin regimens such as those with type 2 diabetes using basal insulin, when to prescribe SMBG and at what testing frequency are less established.
SMBG allows patients to evaluate their individual response to therapy and assess whether glycemic targets are being achieved. Results of SMBG can be useful in preventing hypoglycemia and adjusting medications (particularly prandial insulin doses), MNT, and physical activity. Evidence also supports a correlation between SMBG frequency and lower A1C.
SMBG accuracy is instrument- and user-dependent. Evaluate each patient’s monitoring technique, both initially and at regular intervals thereafter. The ongoing need for and frequency of SMBG should be reevaluated at each routine visit.
For patients in whom A1C and measured blood glucose appear discrepant, clinicians should consider the possibilities of hemoglobinopathy or altered red blood cell turnover and the options of more frequent and/or different timing of SMBG or CGM use. Other measures of chronic glycemia such as fructosamine are available, but their linkage to average glucose and their prognostic significance are not as clear as for A1C.
See pages 18–20 for glycemic goals for children and pregnant women. The complete 2016 Standards includes additional goals for children and pregnant women.
Glycemic control achieved using A1C targets of <7% (53 mmol/mol) has been shown to reduce microvascular complications of diabetes, and, in type 1, mortality. If implemented soon after the diagnosis of diabetes, this target is associated with long-term reduction in macrovascular disease.
See Figure 1 for patient-specific and disease factors used to determine optimal A1C targets. Recommended glycemic targets are provided in Table 6. The recommendations are based on those for A1C values, with blood glucose levels that appear to correlate with achievement of an A1C of <7% (53 mmol/mol).
There is strong and consistent evidence that obesity management can delay progression from prediabetes to type 2 diabetes and benefits type 2 diabetes treatment. In overweight and obese patients with type 2 diabetes, modest weight loss, defined as sustained reduction of 5% of initial body weight, has been shown to improve glycemic control and triglycerides and to reduce the need for glucose-lowering medication. Sustained weight loss of ≥7% is optimal.
In Asian Americans, the cutoff points to define overweight and obesity are lower: normal (<23 BMI kg/m2), overweight (BMI 23.0–27.4 kg/m2), obese (BMI 27.5–37.4 kg/m2), and extremely obese (BMI ≥37.5 kg/m2). Providers should advise overweight and obese patients that higher BMIs increase the risk of CVD and all-cause mortality. Providers should assess each patient’s readiness to achieve weight loss and jointly determine weight loss goals and intervention strategies. Strategies include diet, physical activity, behavioral therapy, pharmacological therapy, and bariatric surgery. The latter two strategies may be prescribed for carefully selected patients as adjuncts to diet, physical activity, and behavioral therapy.
Younger age, shorter duration of type 2 diabetes, lower A1C, higher serum insulin levels, and nonuse of insulin have all been associated with higher diabetes remission rates after bariatric surgery.
For patients with frequent nocturnal hypoglycemia and/or hypoglycemia unawareness, a sensor-augmented pump with a low glucose threshold feature may be considered.
Figure 2 emphasizes drugs commonly used in the United States and/or Europe.
A comprehensive list of the properties of available glucose-lowering agents in the United States and Europe that may guide individualized treatment choices in patients with type 2 diabetes is available in the complete 2016 Standards.
Many patients with type 2 diabetes eventually require and benefit from insulin therapy. The progressive nature of type 2 diabetes and its therapies should be regularly and objectively explained to patients. Providers should avoid using insulin as a threat or describing it as a failure or punishment. Equipping patients with an algorithm for self-titration of insulin doses based on SMBG results improves glycemic control in patients with type 2 diabetes who are initiating insulin.
Atherosclerotic CVD (ASCVD)—defined as acute coronary syndromes, a history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease (PAD) presumed to be of atherosclerotic origin—is the leading cause of morbidity and mortality for individuals with diabetes and is the largest contributor to the direct and indirect costs of diabetes. In all patients with diabetes, cardiovascular risk factors should be systematically assessed at least annually. These risk factors include dyslipidemia, hypertension, smoking, a family history of premature coronary disease, and the presence of albuminuria.
Numerous studies have shown the efficacy of controlling individual cardiovascular risk factors in preventing or slowing ASCVD in people with diabetes. Large benefits are seen when multiple risk factors are addressed simultaneously. There is evidence that measures of 10-year coronary heart disease risk among U.S. adults with diabetes have improved significantly over the past decade, and ASCVD morbidity and mortality have decreased.
Intensive diabetes management with the goal of achieving near-normoglycemia has been shown in large, prospective, randomized studies to delay the onset and progression of microvascular complications.
Complications of kidney disease correlate with level of kidney function.
Screening can be performed by assessing UACR in a random spot urine collection; timed or 24-h collections are more burdensome and add little to prediction or accuracy. Two of three specimens collected within a 3- to 6-month period should be abnormal before considering a patient to have albuminuria.
Blood pressure levels <140/90 mmHg in diabetes are recommended to reduce the risk or slow the progression of DKD. ACE inhibitors have been shown to reduce major CVD events in patients with diabetes, supporting their use in those with albuminuria (a CVD risk factor).
Combined use of ACE inhibitors plus ARBs showed no benefit on CVD or DKD and higher adverse event rates. Thus, combination therapy should be avoided
Recommendations for the management of chronic kidney disease (CKD) in people with diabetes are summarized in Table 9.
Clinical tests to detect DPN include pinprick sensation, vibration perception with a 128-Hz tuning fork, and 10-g monofilament.
DPN can be debilitating and may be treated with pregabalin, duloxetine, and tapentadol. For severe, persistent pain, amitriptyline, venlafaxine, gabapentin, and opioids may be used. A tailored and stepwise approach is recommended to achieve pain reduction.
The symptoms and signs of autonomic dysfunction include hypoglycemia unawareness, resting tachycardia, orthostatic hypotension, gastroparesis, constipation, diarrhea, fecal incontinence, neurogenic bladder, and sudomotor dysfunction. In men, diabetic autonomic neuropathy may cause erectile dysfunction and/or retrograde ejaculation.
Gastrointestinal neuropathies may involve any portion of the gastrointestinal tract. Gastroparesis should be suspected in individuals with erratic glucose control or with upper gastrointestinal symptoms. Constipation is the most common lower-gastrointestinal symptom but can alternate with episodes of diarrhea.
Recurrent urinary tract infections, pyelonephritis, incontinence, or a palpable bladder should evoke evaluation for bladder dysfunction.
Patients with prior amputation, foot deformities, PAD, poor glycemic control, visual impairment, peripheral neuropathy, or cigarette smoking are high risk.
A complete foot examination should include inspection of skin integrity, identification of musculoskeletal deformities, and assessment of pedal pulses.
Examination should seek to identify loss of protective sensation (LOPS). Absent monofilament sensation suggests LOPS, whereas at least two normal tests (and no abnormal test) rules out LOPS.
Screening for PAD should include a history of claudication and an assessment of pedal pulses. Ankle-brachial index evaluation should be performed in patients at 50 years of age and older and should be considered in patients <50 years of age who have other PAD risk factors (e.g., smoking, hypertension, dyslipidemia, or duration of diabetes >10 years).
Patients with high-risk foot conditions (e.g., history of ulcer or amputation, deformity, loss of protective sensation, or PAD) should be educated about their risk factors and appropriate management. The selection of appropriate footwear and footwear behaviors at home should also be discussed. This may include well-fitted walking shoes or athletic shoes that cushion the feet and redistribute pressure. People with bony deformities or more advanced disease may require custom-fitted shoes.
Older individuals have a higher risk of premature death, coexisting illnesses, depression, and geriatric syndromes, including neurocognitive impairment. Refer to the ADA consensus report “Diabetes in Older Adults” for details.
The care of older adults with diabetes is complicated by their clinical and functional heterogeneity. Providers caring for older adults with diabetes must take this heterogeneity into consideration when setting and prioritizing treatment goals (Table 10).
There are few long-term studies in older adults demonstrating the benefits of intensive glycemic, blood pressure, and lipid control. Patients who are expected to live long enough to reap the benefits of long-term intensive diabetes management, who have good cognitive and physical function, and who choose to do so via shared decision making may be treated using therapeutic interventions and goals similar to those for younger adults with diabetes. Less intensive management goals may be appropriate for those with life-limiting complications, comorbid conditions, or substantial cognitive or functional impairment. However, glycemic goals at a minimum should avoid acute complications of diabetes, including dehydration, poor wound healing, hyperglycemic hyperosmolar coma, and hypoglycemia. DSME and ongoing DSMS are vital components of diabetes care.
Older adults with diabetes are likely to benefit from control of other cardiovascular risk factors. Evidence is strong for treatment of hypertension. There is less evidence for lipid-lowering and aspirin therapy, although the benefits of these interventions are likely to apply to older adults whose life expectancies equal or exceed the time frames of clinical prevention trials.
Special care is required in prescribing and monitoring pharmacological therapy in older adults. Factors include cost, coexisting conditions (e.g., renal status), and hypoglycemia. The patient’s living situation must be considered because it may affect diabetes management and support. See the complete 2016 Standards for medications and prescribing information specific to older adults.
Management of diabetes is unique in the long-term care (LTC) setting (i.e., nursing homes and skilled nursing facilities). Individualization of health care is important for all patients. However, practical guidance is needed for both medical providers and LTC staff and caregivers. The American Medical Director’s Association guidelines offer a 12-step training program for LTC staff.
Older adults with diabetes in LTC are especially vulnerable to hypoglycemia because of their disproportionately higher number of complications and comorbidities. Alert strategies should be in place for hypoglycemia (blood glucose <70 mg/dL [3.9 mmol/L]) and hyperglycemia (blood glucose >250 mg/dL [13.9 mmol/L]).
For patients in the LTC setting, special attention should be given to nutritional considerations, end of life care, and diabetes management in those with advanced disease. Acknowledging the limited benefit of intensive glycemic control in people with advanced disease can guide A1C goals and determine the use or withdrawal of medications.
See page 5 for screening and diagnostic testing information. The following recommendations were developed for children and adolescents with type 1 diabetes. However, the guidelines are the same for children and adolescents with type 2 diabetes, with the addition of blood pressure measurement, a fasting lipid panel, assessment for albumin excretion, and dilated eye examination at the time of type 2 diabetes diagnosis.
The benefit of A1C control should be balanced against the risk of hypoglycemia and the developmental burden of intensive regimens for children and youth.
Blood pressure measurements should be determined using the appropriate size cuff and with the child seated and relaxed. ACE inhibitors or ARBs should be considered as first-line treatment, following appropriate reproductive counseling due to teratogenic effects.
Lipids should be obtained at diagnosis of type 2 diabetes because of the increased likelihood of comorbid conditions.
Because of the increased frequency of other autoimmune diseases in type 1 diabetes, screening for thyroid dysfunction and celiac disease should be considered.
Due to the complexity of insulin management in pregnancy, referral to a specialized center offering team-based care (including high-risk obstetrician, endocrinologist, dietitian, nurse, and social worker, as needed) is recommended if this resource is available.
All women with diabetes who are of childbearing age should be counseled about the importance of near-normal glycemic control before conception. Observational studies show an increased risk of diabetic embryopathy, especially anencephaly, microcephaly, congenital heart disease, and caudal regression, directly proportional to elevations in A1C during the first 10 weeks of pregnancy.
Preconception counseling visits should address rubella, rapid plasma regain testing, hepatitis B virus, and HIV testing, as well as Pap smear, cervical cultures, blood typing, prescription of prenatal vitamins (with at least 400 μg of folic acid), and smoking cessation counseling, if indicated. Diabetes-specific testing should include A1C, thyroid-stimulating hormone, creatinine, and UACR. The patient’s medication list should be reviewed for potentially teratogenic drugs (e.g., ACE inhibitors or statins), and a referral should be made for a comprehensive eye exam.
Because GDM may represent preexisting undiagnosed type 2 or even type 1 diabetes, women with GDM should be tested for persistent diabetes or prediabetes at 6–12 weeks postpartum with a 75-g OGTT using nonpregnancy criteria as outlined in the screening and diagnostic section on page 5. Because GDM is associated with increased maternal risk for diabetes, women should also be tested every 1–3 years thereafter if 6- to 12-week 75-g OGTT is normal, with frequency of screening depending on other risk factors, including family history, prepregnancy BMI, and need for insulin or oral glucose-lowering medication during pregnancy. Ongoing screening may be performed with any recommended glycemic test (i.e. A1C, FPG, or 75-g OGTT) with nonpregnant thresholds.
Initial orders should state that the patient has type 1 or type 2 diabetes or no previous history of diabetes. Both hyperglycemia and hypoglycemia are associated with adverse outcomes, including death. High-quality care can often be ensured by the use of structured order sets along with quality improvement processes.
Data have shown increased rates of severe hypoglycemia and mortality in tightly versus moderately controlled cohorts in critically ill patients. This evidence established new standards as noted above. Patients with a history of successful tight glycemic control in the outpatient setting who are clinically stable may be maintained with a glucose target <140 mg/dL. Conversely, higher glucose ranges may be acceptable in other appropriate patients.
In most instances in the hospital setting, insulin is the preferred treatment for glycemic control.
IV insulin protocols should be used for critically ill patients. Basal-bolus regimens that include correction doses and account for oral intake may be used for many noncritical-care patients. Scheduled subcutaneous (SQ) insulin injections should align with meals and bedtime or be given every 4–6 hours if no meals are taken or if continuous enteral/parenteral therapy is being used.
SQ insulin should be administered 1–2 hours before IV insulin is discontinued. Converting to basal insulin at 60–80% of the daily infusion dose has been shown to be effective.
Refer to the full Standards for guidance on enteral/parenteral feedings, diabetic ketoacidosis and hyperosmolar hyperglycemic state, and glucocorticoid therapy.
On the morning of surgery or a procedure, hold any oral hypoglycemic agents; give half of the patient’s NPH insulin dose or full doses of long-acting analog or pump basal insulin. Monitor blood glucose every 4–6 hours while a patient is NPO, and dose with short-acting insulin as needed with a target of 80–180 mg/dL (4.4–10.0 mmol/L).
Standardized nurse-driven protocols should be used for hypoglycemia avoidance and treatment. Consider iatrogenic or patient factors that may result in hypoglycemia.
Diabetes self-management in the hospital may be appropriate for select youth and adult patients who successfully conduct comprehensive self-management of diabetes at home, have the cognitive and physical skills needed to successfully self-administer insulin, and perform SMBG.
The goals of MNT are to optimize glycemic control, provide adequate calories to meet metabolic demands, and address personal food preferences. The term “ADA diet” is no longer used. A registered dietitian can serve as an inpatient team member.
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, medications, 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 having 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.
For a list of ADA advocacy position statements, including “Diabetes and Driving” and “Diabetes and Employment,” refer to Section 14 (“Diabetes Advocacy”) of the complete 2016 Standards.
This abridged version of the ADA Position Statement “Standards of Medical Care in Diabetes—2016” was created under the guidance of Sarah Bradley (ADA staff) with invaluable expertise of ADA’s Primary Care Advisory Group, with special thanks to Jay Shubrook, DO, Vallejo, CA, Primary Care Advisory Group Chair; James J. Chamberlain, MD, Salt Lake City, UT; Hope Feldman, CRNP, FNP-BC, Philadelphia, PA; Eric L. Johnson, MD, Grand Forks, ND; Sandra Leal, PharmD, MPH, FAPhA, CDE, Tucson, AZ; Andrew S. Rhinehart, MD, FACP, FACE, CDE, BC-ADM, CDTC, Abingdon, VA; Charles F. Shaefer, Jr., MD, FACP, Augusta, GA; and Neil Skolnik, MD, Jenkintown, PA. Editorial assistance was provided by Annie Neuman, MPA, PA-C, Salt Lake City, UT.
This is an abridged version of the American Diabetes Association Position Statement: Standards of Medical Care in Diabetes—2016. Diabetes Care 2016;39(Suppl. 1):S1–S112.
The complete 2016 Standards supplement, including all supporting references, is available at http://diabetesjournals.org/content/39/Supplement_1.toc.