4. Comprehensive Medical Evaluation and Assessment of Comorbidities: Standards of Medical Care in Diabetes—2020

• 4.1 A patient-centered communication style that uses person-centered and strength-based language and active listening; elicits patient preferences and beliefs; and assesses literacy, numeracy, and potential barriers to care should be used to optimize patient health outcomes and health-related quality of life. B

• 4.2 Diabetes care should be managed by a multidisciplinary team that may draw from primary care physicians, subspecialty physicians, nurse practitioners, physician assistants, nurses, dietitians, exercise specialists, pharmacists, dentists, podiatrists, and mental health professionals. E

A successful medical evaluation depends on beneficial interactions between the patient and the care team. The Chronic Care Model (1–3) (see Section 1 “Improving Care and Promoting Health in Populations,” https://doi.org/10.2337/dc20-S001) is a patient-centered approach to care that requires a close working relationship between the patient and clinicians involved in treatment planning. People with diabetes should receive health care from an interdisciplinary team that may include physicians, nurse practitioners, physician assistants, nurses, dietitians, exercise specialists, pharmacists, dentists, podiatrists, and mental health professionals. Individuals with diabetes must assume an active role in their care. The patient, family or support people, physicians, and health care team should together formulate the management plan, which includes lifestyle management (see Section 5 “Facilitating Behavior Change and Well-being to Improve Health Outcomes,” https://doi.org/10.2337/dc20-S005).

The goals of treatment for diabetes are to prevent or delay complications and optimize quality of life (Fig. 4.1). Treatment goals and plans should be created with patients based on their individual preferences, values, and goals. The management plan should take into account the patient’s age, cognitive abilities, school/work schedule and conditions, health beliefs, support systems, eating patterns, physical activity, social situation, financial concerns, cultural factors, literacy and numeracy (mathematical literacy), diabetes complications and duration of disease, comorbidities, health priorities, other medical conditions, preferences for care, and life expectancy. Various strategies and techniques should be used to support patients’ self-management efforts, including providing education on problem-solving skills for all aspects of diabetes management.

Provider communication with patients and families should acknowledge that multiple factors impact glycemic management but also emphasize that collaboratively developed treatment plans and a healthy lifestyle can significantly improve disease outcomes and well-being (4–7). Thus, the goal of provider-patient communication is to establish a collaborative relationship and to assess and address self-management barriers without blaming patients for “noncompliance” or “nonadherence” when the outcomes of self-management are not optimal (8). The familiar terms “noncompliance” and “nonadherence” denote a passive, obedient role for a person with diabetes in “following doctor’s orders” that is at odds with the active role people with diabetes take in directing the day-to-day decision-making, planning, monitoring, evaluation, and problem-solving involved in diabetes self-management. Using a nonjudgmental approach that normalizes periodic lapses in self-management may help minimize patients’ resistance to reporting problems with self-management. Empathizing and using active listening techniques, such as open-ended questions, reflective statements, and summarizing what the patient said, can help facilitate communication. Patients’ perceptions about their own ability, or self-efficacy, to self-manage diabetes are one important psychosocial factor related to improved diabetes self-management and treatment outcomes in diabetes (9–13) and should be a target of ongoing assessment, patient education, and treatment planning.

Language has a strong impact on perceptions and behavior. The use of empowering language in diabetes care and education can help to inform and motivate people, yet language that shames and judges may undermine this effort. The American Diabetes Association (ADA) and the American Association of Diabetes Educators consensus report, “The Use of Language in Diabetes Care and Education,” provides the authors’ expert opinion regarding the use of language by health care professionals when speaking or writing about diabetes for people with diabetes or for professional audiences (14). Although further research is needed to address the impact of language on diabetes outcomes, the report includes five key consensus recommendations for language use:

• Use language that is neutral, nonjudgmental, and based on facts, actions, or physiology/biology.

• Use language free from stigma.

• Use language that is strength based, respectful, and inclusive and that imparts hope.

• Use language that fosters collaboration between patients and providers.

• Use language that is person centered (e.g., “person with diabetes” is preferred over “diabetic”).

• 4.3 A complete medical evaluation should be performed at the initial visit to:

  • Confirm the diagnosis and classify diabetes. B

  • Evaluate for diabetes complications and potential comorbid conditions. B

  • Review previous treatment and risk factor control in patients with established diabetes. B

  • Begin patient engagement in the formulation of a care management plan. B

  • Develop a plan for continuing care. B

• 4.4 A follow-up visit should include most components of the initial comprehensive medical evaluation, including interval medical history, assessment of medication-taking behavior and intolerance/side effects, physical examination, laboratory evaluation as appropriate to assess attainment of A1C and metabolic targets, and assessment of risk for complications, diabetes self-management behaviors, nutrition, psychosocial health, and the need for referrals, immunizations, or other routine health maintenance screening. B

• 4.5 Ongoing management should be guided by the assessment of diabetes complications and shared decision-making to set therapeutic goals. B

• 4.6 The 10-year risk of a first atherosclerotic cardiovascular disease event should be assessed using the race- and sex-specific Pooled Cohort Equations to better stratify atherosclerotic cardiovascular disease risk. B

The comprehensive medical evaluation includes the initial and follow-up evaluations, assessment of complications, psychosocial assessment, management of comorbid conditions, and engagement of the patient throughout the process. While a comprehensive list is provided in Table 4.1, in clinical practice the provider may need to prioritize the components of the medical evaluation given the available resources and time. The goal is to provide the health care team information so it can optimally support a patient. In addition to the medical history, physical examination, and laboratory tests, providers should assess diabetes self-management behaviors, nutrition, and psychosocial health (see Section 5 “Facilitating Behavior Change and Well-being to Improve Health Outcomes,” https://doi.org/10.2337/dc20-S005) and give guidance on routine immunizations. The assessment of sleep pattern and duration should be considered; a recent meta-analysis found that poor sleep quality, short sleep, and long sleep were associated with higher A1C in people with type 2 diabetes (15). Interval follow-up visits should occur at least every 3–6 months, individualized to the patient, and then annually.

Lifestyle management and psychosocial care are the cornerstones of diabetes management. Patients should be referred for diabetes self-management education and support, medical nutrition therapy, and assessment of psychosocial/emotional health concerns if indicated. Patients should receive recommended preventive care services (e.g., immunizations, cancer screening, etc.); smoking cessation counseling; and ophthalmological, dental, and podiatric referrals.

The assessment of risk of acute and chronic diabetes complications and treatment planning are key components of initial and follow-up visits (Table 4.2). The risk of atherosclerotic cardiovascular disease and heart failure (Section 10 “Cardiovascular Disease and Risk Management,” https://doi.org/10.2337/dc20-S010), chronic kidney disease staging (Section 11 “Microvascular Complications and Foot Care,” https://doi.org/10.2337/dc20-S011), and risk of treatment-associated hypoglycemia (Table 4.3) should be used to individualize targets for glycemia (Section 6 “Glycemic Targets,” https://doi.org/10.2337/dc20-S006), blood pressure, and lipids and to select specific glucose-lowering medication (Section 9 “Pharmacologic Approaches to Glycemic Treatment,” https://doi.org/10.2337/dc20-S009), antihypertension medication, and statin treatment intensity.

Additional referrals should be arranged as necessary (Table 4.4). Clinicians should ensure that individuals with diabetes are appropriately screened for complications and comorbidities. Discussing and implementing an approach to glycemic control with the patient is a part, not the sole goal, of the patient encounter.

• 4.7 Provide routinely recommended vaccinations for children and adults with diabetes as indicated by age. C

• 4.8 Annual vaccination against influenza is recommended for all people ≥6 months of age, especially those with diabetes. C

• 4.9 Vaccination against pneumococcal disease, including pneumococcal pneumonia, with 13-valent pneumococcal conjugate vaccine (PCV13) is recommended for children before age 2 years. People with diabetes ages 2 through 64 years should also receive 23-valent pneumococcal polysaccharide vaccine (PPSV23). At age ≥65 years, regardless of vaccination history, additional PPSV23 vaccination is necessary. C

• 4.10 Administer a 2- or 3-dose series of hepatitis B vaccine, depending on the vaccine, to unvaccinated adults with diabetes ages 18 through 59 years. C

• 4.11 Consider administering a 3-dose series of hepatitis B vaccine to unvaccinated adults with diabetes ≥60 years of age. C

Children and adults with diabetes should receive vaccinations according to age-appropriate recommendations (16,17). The Centers for Disease Control and Prevention (CDC) provides vaccination schedules specifically for children, adolescents, and adults with diabetes at cdc.gov/vaccines/schedules/.

People with diabetes are at higher risk for hepatitis B infection and are more likely to develop complications from influenza and pneumococcal disease. The CDC Advisory Committee on Immunization Practices (ACIP) recommends influenza, pneumococcal, and hepatitis B vaccinations specifically for people with diabetes. Vaccinations against tetanus-diphtheria-pertussis, measles-mumps-rubella, human papillomavirus, and shingles are also important for adults with diabetes, as they are for the general population.

Influenza is a common, preventable infectious disease associated with high mortality and morbidity in vulnerable populations, including youth, older adults, and people with chronic diseases. Influenza vaccination in people with diabetes has been found to significantly reduce influenza and diabetes-related hospital admissions (18).

Like influenza, pneumococcal pneumonia is a common, preventable disease. People with diabetes are at increased risk for the bacteremic form of pneumococcal infection and have been reported to have a high risk of nosocomial bacteremia, with a mortality rate as high as 50% (19). The ADA endorses recommendations from the CDC ACIP that adults age ≥65 years, who are at higher risk for pneumococcal disease, receive an additional 23-valent pneumococcal polysaccharide vaccine (PPSV23), regardless of prior pneumococcal vaccination history. See detailed recommendations at www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/pneumo.html.

Compared with the general population, people with type 1 or type 2 diabetes have higher rates of hepatitis B. This may be due to contact with infected blood or through improper equipment use (glucose monitoring devices or infected needles). Because of the higher likelihood of transmission, hepatitis B vaccine is recommended for adults with diabetes age <60 years. For adults age ≥60 years, hepatitis B vaccine may be administered at the discretion of the treating clinician based on the patient’s likelihood of acquiring hepatitis B infection.

Besides assessing diabetes-related complications, clinicians and their patients need to be aware of common comorbidities that affect people with diabetes and may complicate management (20–24). Diabetes comorbidities are conditions that affect people with diabetes more often than age-matched people without diabetes. This section discusses many of the common comorbidities observed in patients with diabetes but is not necessarily inclusive of all the conditions that have been reported.

• 4.12 Patients with type 1 diabetes should be screened for autoimmune thyroid disease soon after diagnosis and periodically thereafter. B

• 4.13 Adult patients with type 1 diabetes should be screened for celiac disease in the presence of gastrointestinal symptoms, signs, or laboratory manifestations suggestive of celiac disease. B

People with type 1 diabetes are at increased risk for other autoimmune diseases, with thyroid disease, celiac disease, and pernicious anemia (vitamin B12 deficiency) being among the most common (25). Other associated conditions include autoimmune hepatitis, primary adrenal insufficiency (Addison disease), dermatomyositis, and myasthenia gravis (26–29). Type 1 diabetes may also occur with other autoimmune diseases in the context of specific genetic disorders or polyglandular autoimmune syndromes (30). Given the high prevalence, nonspecific symptoms, and insidious onset of primary hypothyroidism, routine screening for thyroid dysfunction is recommended for all patients with type 1 diabetes. Screening for celiac disease should be considered in adult patients with suggestive symptoms (e.g., diarrhea, malabsorption, abdominal pain) or signs (e.g., osteoporosis, vitamin deficiencies, iron deficiency anemia) (31,32). Measurement of vitamin B12 levels should be considered for patients with type 1 diabetes and peripheral neuropathy or unexplained anemia.

Diabetes is associated with increased risk of cancers of the liver, pancreas, endometrium, colon/rectum, breast, and bladder (33). The association may result from shared risk factors between type 2 diabetes and cancer (older age, obesity, and physical inactivity) but may also be due to diabetes-related factors (34), such as underlying disease physiology or diabetes treatments, although evidence for these links is scarce. Patients with diabetes should be encouraged to undergo recommended age- and sex-appropriate cancer screenings and to reduce their modifiable cancer risk factors (obesity, physical inactivity, and smoking). New onset of atypical diabetes (lean body habitus, negative family history) in a middle-aged or older patient may precede the diagnosis of pancreatic adenocarcinoma (35). However, in the absence of other symptoms (e.g., weight loss, abdominal pain), routine screening of all such patients is not currently recommended.

• 4.14 In the presence of cognitive impairment, diabetes treatment regimens should be simplified as much as possible and tailored to minimize the risk of hypoglycemia. B

Diabetes is associated with a significantly increased risk and rate of cognitive decline and an increased risk of dementia (36,37). A recent meta-analysis of prospective observational studies in people with diabetes showed 73% increased risk of all types of dementia, 56% increased risk of Alzheimer dementia, and 127% increased risk of vascular dementia compared with individuals without diabetes (38). The reverse is also true: people with Alzheimer dementia are more likely to develop diabetes than people without Alzheimer dementia. In a 15-year prospective study of community-dwelling people >60 years of age, the presence of diabetes at baseline significantly increased the age- and sex-adjusted incidence of all-cause dementia, Alzheimer dementia, and vascular dementia compared with rates in those with normal glucose tolerance (39).

In those with type 2 diabetes, the degree and duration of hyperglycemia are related to dementia. More rapid cognitive decline is associated with both increased A1C and longer duration of diabetes (38). The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study found that each 1% higher A1C level was associated with lower cognitive function in individuals with type 2 diabetes (40). However, the ACCORD study found no difference in cognitive outcomes in participants randomly assigned to intensive and standard glycemic control, supporting the recommendation that intensive glucose control should not be advised for the improvement of cognitive function in individuals with type 2 diabetes (41).

In type 2 diabetes, severe hypoglycemia is associated with reduced cognitive function, and those with poor cognitive function have more severe hypoglycemia. In a long-term study of older patients with type 2 diabetes, individuals with one or more recorded episodes of severe hypoglycemia had a stepwise increase in risk of dementia (42). Likewise, the ACCORD trial found that as cognitive function decreased, the risk of severe hypoglycemia increased (43). Tailoring glycemic therapy may help to prevent hypoglycemia in individuals with cognitive dysfunction.

In one study, adherence to the Mediterranean diet correlated with improved cognitive function (44). However, a recent Cochrane review found insufficient evidence to recommend any dietary change for the prevention or treatment of cognitive dysfunction (45).

A systematic review has reported that data do not support an adverse effect of statins on cognition (46). The U.S. Food and Drug Administration postmarketing surveillance databases have also revealed a low reporting rate for cognitive-related adverse events, including cognitive dysfunction or dementia, with statin therapy, similar to rates seen with other commonly prescribed cardiovascular medications (46). Therefore, fear of cognitive decline should not be a barrier to statin use in individuals with diabetes and a high risk for cardiovascular disease.

• 4.15 Patients with type 2 diabetes or prediabetes and elevated liver enzymes (ALT) or fatty liver on ultrasound should be evaluated for presence of nonalcoholic steatohepatitis and liver fibrosis. C

Diabetes is associated with the development of nonalcoholic fatty liver disease, including its more severe manifestations of nonalcoholic steatohepatitis, liver fibrosis, cirrhosis, and hepatocellular carcinoma (47). Elevations of hepatic transaminase concentrations are associated with higher BMI, waist circumference, and triglyceride levels and lower HDL cholesterol levels. Noninvasive tests, such as elastography or fibrosis biomarkers, may be used to assess risk of fibrosis, but referral to a liver specialist and liver biopsy may be required for definitive diagnosis (48). Interventions that improve metabolic abnormalities in patients with diabetes (weight loss, glycemic control, and treatment with specific drugs for hyperglycemia or dyslipidemia) are also beneficial for fatty liver disease (49,50). Pioglitazone and vitamin E treatment of biopsy-proven nonalcoholic steatohepatitis have been shown to improve liver histology, but effects on longer-term clinical outcomes are not known (51,52). Treatment with liraglutide and with sodium–glucose cotransporter 2 inhibitors (dapagliflozin and empagliflozin) has also shown some promise in preliminary studies, although benefits may be mediated, at least in part, by weight loss (53–55).

Infection with hepatitis C virus (HCV) is associated with a higher prevalence of type 2 diabetes, which is present in up to one-third of individuals with chronic HCV infection. HCV may impair glucose metabolism by several mechanisms, including directly via viral proteins and indirectly by altering proinflammatory cytokine levels (56). The use of newer direct-acting antiviral drugs produces a sustained virological response (cure) in nearly all cases and has been reported to improve glucose metabolism in individuals with diabetes (57). A meta-analysis of mostly observational studies found a mean reduction in A1C levels of 0.45% (95% CI −0.60 to −0.30) and reduced requirement for glucose-lowering medication use following successful eradication of HCV infection (58).

• 4.16 Islet autotransplantation should be considered for patients requiring total pancreatectomy for medically refractory chronic pancreatitis to prevent postsurgical diabetes. C

Diabetes is linked to diseases of the exocrine pancreas such as pancreatitis, which may disrupt the global architecture or physiology of the pancreas, often resulting in both exocrine and endocrine dysfunction. Up to half of patients with diabetes may have some degree of impaired exocrine pancreas function (59). People with diabetes are at an approximately twofold higher risk of developing acute pancreatitis (60).

Conversely, prediabetes and/or diabetes has been found to develop in approximately one-third of patients after an episode of acute pancreatitis (61); thus, the relationship is likely bidirectional. Postpancreatitis diabetes may include either new-onset disease or previously unrecognized diabetes (62). Studies of patients treated with incretin-based therapies for diabetes have also reported that pancreatitis may occur more frequently with these medications, but results have been mixed (63,64).

Islet autotransplantation should be considered for patients requiring total pancreatectomy for medically refractory chronic pancreatitis to prevent postsurgical diabetes. Approximately one-third of patients undergoing total pancreatectomy with islet autotransplantation are insulin free 1 year postoperatively, and observational studies from different centers have demonstrated islet graft function up to a decade after the surgery in some patients (65–69). Both patient and disease factors should be carefully considered when deciding the indications and timing of this surgery. Surgeries should be performed in skilled facilities that have demonstrated expertise in islet autotransplantation.

Age-specific hip fracture risk is significantly increased in both people with type 1 diabetes (relative risk 6.3) and those with type 2 diabetes (relative risk 1.7) in both sexes (70). Type 1 diabetes is associated with osteoporosis, but in type 2 diabetes, an increased risk of hip fracture is seen despite higher bone mineral density (BMD) (71). In three large observational studies of older adults, femoral neck BMD T score and the World Health Organization Fracture Risk Assessment Tool (FRAX) score were associated with hip and nonspine fractures. Fracture risk was higher in participants with diabetes compared with those without diabetes for a given T score and age or for a given FRAX score (72). Providers should assess fracture history and risk factors in older patients with diabetes and recommend measurement of BMD if appropriate for the patient’s age and sex. Fracture prevention strategies for people with diabetes are the same as for the general population and include vitamin D supplementation. For patients with type 2 diabetes with fracture risk factors, thiazolidinediones (73) and sodium–glucose cotransporter 2 inhibitors (74) should be used with caution.

Hearing impairment, both in high-frequency and low- to mid-frequency ranges, is more common in people with diabetes than in those without, perhaps due to neuropathy and/or vascular disease. In a National Health and Nutrition Examination Survey (NHANES) analysis, hearing impairment was about twice as prevalent in people with diabetes compared with those without, after adjusting for age and other risk factors for hearing impairment (75). Low HDL, coronary heart disease, peripheral neuropathy, and general poor health have been reported as risk factors for hearing impairment for people with diabetes, but an association of hearing loss with blood glucose levels has not been consistently observed (76). In the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort, time-weighted mean A1C was associated with increased risk of hearing impairment when tested after long-term (>20 years) follow-up (77). Impairment in smell, but not taste, has also been reported in individuals with diabetes (78).

• 4.17 Patients with HIV should be screened for diabetes and prediabetes with a fasting glucose test before starting antiretroviral therapy, at the time of switching antiretroviral therapy, and 3–6 months after starting or switching antiretroviral therapy. If initial screening results are normal, fasting glucose should be checked annually. E

Diabetes risk is increased with certain protease inhibitors (PIs) and nucleoside reverse transcriptase inhibitors (NRTIs). New-onset diabetes is estimated to occur in more than 5% of patients infected with HIV on PIs, whereas more than 15% may have prediabetes (79). PIs are associated with insulin resistance and may also lead to apoptosis of pancreatic β-cells. NRTIs also affect fat distribution (both lipohypertrophy and lipoatrophy), which is associated with insulin resistance.

Individuals with HIV are at higher risk for developing prediabetes and diabetes on antiretroviral (ARV) therapies, so a screening protocol is recommended (80). The A1C test may underestimate glycemia in people with HIV; it is not recommended for diagnosis and may present challenges for monitoring (81). In those with prediabetes, weight loss through healthy nutrition and physical activity may reduce the progression toward diabetes. Among patients with HIV and diabetes, preventive health care using an approach similar to that used in patients without HIV is critical to reduce the risks of microvascular and macrovascular complications.

For patients with HIV and ARV-associated hyperglycemia, it may be appropriate to consider discontinuing the problematic ARV agents if safe and effective alternatives are available (82). Before making ARV substitutions, carefully consider the possible effect on HIV virological control and the potential adverse effects of new ARV agents. In some cases, antihyperglycemic agents may still be necessary.

• 4.18 In men with diabetes who have symptoms or signs of hypogonadism, such as decreased sexual desire (libido) or activity, or erectile dysfunction, consider screening with a morning serum testosterone level. B

Mean levels of testosterone are lower in men with diabetes compared with age-matched men without diabetes, but obesity is a major confounder (83,84). Treatment in asymptomatic men is controversial. Testosterone replacement in men with symptomatic hypogonadism may have benefits including improved sexual function, well-being, muscle mass and strength, and bone density (85). In men with diabetes who have symptoms or signs of low testosterone (hypogonadism), a morning total testosterone level should be measured using an accurate and reliable assay. In men who have total testosterone levels close to the lower limit, it is reasonable to check sex hormone–binding globulin, as it is often low in diabetes and associated with lower testosterone levels. Further testing (such as luteinizing hormone and follicle-stimulating hormone levels) may be needed to determine if the patient has hypogonadism. Testosterone replacement in older men with hypogonadism has been associated with increased coronary artery plaque volume and, in some studies, an increase in cardiovascular events, which should be considered when assessing the risks and benefits of treatment (86,87).

Age-adjusted rates of obstructive sleep apnea, a risk factor for cardiovascular disease, are significantly higher (4- to 10-fold) with obesity, especially with central obesity (88). The prevalence of obstructive sleep apnea in the population with type 2 diabetes may be as high as 23%, and the prevalence of any sleep-disordered breathing may be as high as 58% (89,90). In obese participants enrolled in the Action for Health in Diabetes (Look AHEAD) trial, it exceeded 80% (91). Patients with symptoms suggestive of obstructive sleep apnea (e.g., excessive daytime sleepiness, snoring, witnessed apnea) should be considered for screening (92). Sleep apnea treatment (lifestyle modification, continuous positive airway pressure, oral appliances, and surgery) significantly improves quality of life and blood pressure control. The evidence for a treatment effect on glycemic control is mixed (93).

Periodontal disease is more severe, and may be more prevalent, in patients with diabetes than in those without and has been associated with higher A1C levels (94–96). Longitudinal studies suggest that people with periodontal disease have higher rates of incident diabetes. Current evidence suggests that periodontal disease adversely affects diabetes outcomes, although evidence for treatment benefits remains controversial (24,97). In a randomized clinical trial, intensive periodontal treatment was associated with better glycemic control (A1C 8.3% vs. 7.8% in control subjects and the intensive-treatment group, respectively) and reduction in inflammatory markers after 12 months of follow-up (98).