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Standards of Medical Care in Diabetes

Abbreviations: ABI, ankle-brachial index • AMI, acute myocardial infarction • ARB, angiotensin receptor blocker • CAD, coronary artery disease • CBG, capillary blood glucose • CHD, coronary heart disease • CHF, congestive heart failure • CSII, continuous subcutaneous insulin injection • CVD, cardiovascular disease • DCCB, dihydropyridine calcium channel blocker • DCCT, Diabetes Control and Complications Trial • DKA, diabetic ketoacidosis • DPP, Diabetes Prevention Program • DSME, diabetes self-management education • DRS, Diabetic Retinopathy Study • ECG, electrocardiogram • eGFR, estimated glomerular filtration rate • ESRD, end-stage renal disease • ETDRS, Early Treatment Diabetic Retinopathy Study • FPG, fasting plasma glucose • GCT, glucose challenge test • GDM, gestational diabetes mellitus • GFR, glomerular filtration rate • HRC, high-risk characteristic • ICU, intensive care unit • IFG, impaired fasting glucose • IGT, impaired glucose tolerance • MNT, medical nutrition therapy • NPDR, nonproliferative diabetic retinopathy • OGTT, oral glucose tolerance test • PAD, peripheral arterial disease • PDR, proliferative diabetic retinopathy • PPG, postprandial plasma glucose • SMBG, self-monitoring of blood glucose • UKPDS, U.K. Prospective Diabetes Study

	CONTENTS

TOP CONTENTS I. CLASSIFICATION AND DIAGNOSIS II. SCREENING FOR DIABETES III. DETECTION AND DIAGNOSIS... IV. PREVENTION/DELAY OF TYPE... V. DIABETES CARE VI. PREVENTION AND MANAGEMENT... VII. DIABETES CARE IN... B. Preconception care Recommendations C. Older individuals VIII. DIABETES CARE IN... IX. HYPOGLYCEMIA AND... X. THIRD-PARTY REIMBURSEMENT FOR... XI. STRATEGIES FOR IMPROVING... References

 

1. CLASSIFICATION AND DIAGNOSIS
   1. Classification
      
   2. Diagnosis
      
   
   
2. SCREENING FOR DIABETES
   
3. DETECTION AND DIAGNOSIS OF GESTATIONAL DIABETES MELLITUS (GDM)
   
4. PREVENTION/DELAY OF TYPE 2 DIABETES
   
5. DIABETES CARE
   1. Initial evaluation
      
   2. Management
      
   3. Glycemic control
      1. Assessment of glycemic control
         1. Self-monitoring of blood glucose
            
         2. A1C
            
         
         
      2. Glycemic goals
         
      
      
   4. Medical nutrition therapy
      
   5. Physical activity
      
   6. Psychosocial assessment and care
      
   7. Referral for diabetes management
      
   8. Intercurrent illness
      
   9. Immunization
      
   
   
6. PREVENTION AND MANAGEMENT OF DIABETES COMPLICATIONS
   1. Cardiovascular disease
      1. Hypertension/blood pressure control
         
      2. Dyslipidemia/lipid management
         
      3. Anti-platelet agents
         
      4. Smoking cessation
         
      5. Coronary heart disease screening and treatment
         
      
      
   2. Nephropathy screening and treatment
      
   3. Retinopathy screening and treatment
      
   4. Foot care
      
   
   
7. DIABETES CARE IN SPECIFIC POPULATIONS
   1. Children and adolescents
      
   2. Preconception care
      
   3. Older individuals
      
   
   
8. DIABETES CARE IN SPECIFIC SETTINGS
   1. Diabetes care in the hospital
      
   2. Diabetes care in the school and day care setting
      
   3. Diabetes care at diabetes camps
      
   4. Diabetes care at correctional institutions
      
   
   
9. HYPOGLYCEMIA AND EMPLOYMENT/LICENSURE
   
10. THIRD-PARTY REIMBURSEMENT FOR DIABETES CARE, SELF-MANAGEMENT EDUCATION, AND SUPPLIES
    
11. STRATEGIES FOR IMPROVING DIABETES CARE
    

Diabetes is a chronic illness that requires continuing medical care and patient self-management education to prevent acute complications and to reduce the risk of long-term complications. Diabetes care is complex and requires that many issues, beyond glycemic control, be addressed. A large body of evidence exists that supports a range of interventions to improve diabetes outcomes.

These standards of care are intended to provide clinicians, patients, researchers, payors, and other interested individuals with the components of diabetes care, treatment goals, and tools to evaluate the quality of care. While individual preferences, comorbidities, and other patient factors may require modification of goals, targets that are desirable for most patients with diabetes are provided. These standards are not intended to preclude more extensive evaluation and management of the patient by other specialists as needed. For more detailed information, refer to Bode (Ed.): Medical Management of Type 1 Diabetes (1), Burant (Ed): Medical Management of Type 2 Diabetes (2), and Klingensmith (Ed): Intensive Diabetes Management (3).

The recommendations included are diagnostic and therapeutic actions that are known or believed to favorably affect health outcomes of patients with diabetes. A grading system (Table 1), developed by the American Diabetes Association (ADA) and modeled after existing methods, was utilized to clarify and codify the evidence that forms the basis for the recommendations. The level of evidence that supports each recommendation is listed after each recommendation using the letters A, B, C, or E.

	I. CLASSIFICATION AND DIAGNOSIS

TOP CONTENTS I. CLASSIFICATION AND DIAGNOSIS II. SCREENING FOR DIABETES III. DETECTION AND DIAGNOSIS... IV. PREVENTION/DELAY OF TYPE... V. DIABETES CARE VI. PREVENTION AND MANAGEMENT... VII. DIABETES CARE IN... B. Preconception care Recommendations C. Older individuals VIII. DIABETES CARE IN... IX. HYPOGLYCEMIA AND... X. THIRD-PARTY REIMBURSEMENT FOR... XI. STRATEGIES FOR IMPROVING... References

• Type 1 diabetes (results from ß-cell destruction, usually leading to absolute insulin deficiency).
  
• Type 2 diabetes (results from a progressive insulin secretory defect on the background of insulin resistance).
  
• Other specific types of diabetes (due to other causes, e.g., genetic defects in ß-cell function, genetic defects in insulin action, diseases of the exocrine pancreas, and drug or chemical induced).
  
• Gestational diabetes mellitus (GDM) (diagnosed during pregnancy).
  

B. Diagnosis
Criteria for the diagnosis of diabetes in nonpregnant adults are shown in Table 2. Three ways to diagnose diabetes are available, and each must be confirmed on a subsequent day unless unequivocal symptoms of hyperglycemia are present. Although the 75-g oral glucose tolerance test (OGTT) is more sensitive and modestly more specific than fasting plasma glucose (FPG) to diagnose diabetes, it is poorly reproducible and rarely performed in practice. Because of ease of use, acceptability to patients, and lower cost, the FPG is the preferred diagnostic test. It should be noted that the vast majority of people who meet diagnostic criteria for diabetes by OGTT, but not by FPG, will have an A1C value <7.0%. The use of the A1C for the diagnosis of diabetes is not recommended at this time.

• IFG = FPG 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l)
  
• IGT = 2-h plasma glucose 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l)
  

Recommendations

• The FPG is the preferred test to diagnose diabetes in children and nonpregnant adults. (E)
  
• The use of the A1C for the diagnosis of diabetes is not recommended at this time. (E)
  

	II. SCREENING FOR DIABETES

TOP CONTENTS I. CLASSIFICATION AND DIAGNOSIS II. SCREENING FOR DIABETES III. DETECTION AND DIAGNOSIS... IV. PREVENTION/DELAY OF TYPE... V. DIABETES CARE VI. PREVENTION AND MANAGEMENT... VII. DIABETES CARE IN... B. Preconception care Recommendations C. Older individuals VIII. DIABETES CARE IN... IX. HYPOGLYCEMIA AND... X. THIRD-PARTY REIMBURSEMENT FOR... XI. STRATEGIES FOR IMPROVING... References

 
There is a major distinction between diagnostic testing and screening. When an individual exhibits symptoms or signs of the disease, diagnostic tests are performed, and such tests do not represent screening. The purpose of screening is to identify asymptomatic individuals who are likely to have diabetes. Separate diagnostic tests using standard criteria are required after positive screening tests to establish a definitive diagnosis as described above.

Type 1 diabetes
Generally, people with type 1 diabetes present with acute symptoms of diabetes and markedly elevated blood glucose levels. Because of the acute onset of symptoms, most cases of type 1 diabetes are detected soon after symptoms develop. Widespread clinical testing of asymptomatic individuals for the presence of autoantibodies related to type 1 diabetes cannot be recommended at this time as a means to identify individuals at risk. Reasons for this include the following: 1) cutoff values for some of the immune marker assays have not been completely established in clinical settings; 2) there is no consensus as to what action should be taken when a positive autoantibody test result is obtained; and 3) because the incidence of type 1 diabetes is low, testing of healthy children will identify only a very small number (<0.5%) who at that moment may be "pre-diabetic." Clinical studies are being conducted to test various methods of preventing type 1 diabetes in high-risk individuals (e.g., siblings of type 1 diabetic patients). These studies may uncover an effective means of preventing type 1 diabetes, in which case targeted screening may be appropriate in the future.

Type 2 diabetes
Type 2 diabetes is frequently not diagnosed until complications appear, and approximately one-third of all people with diabetes may be undiagnosed. Individuals at high risk should be screened for diabetes and pre-diabetes. Criteria for testing for diabetes in asymptomatic, undiagnosed adults are listed in Table 3. The effectiveness of early diagnosis through screening of asymptomatic individuals has not been determined (6).

The incidence of type 2 diabetes in children and adolescents has increased dramatically in the last decade. Consistent with screening recommendations for adults, only children and youth at increased risk for the presence or the development of type 2 diabetes should be tested (8) (Table 4).

On the basis of expert opinion, screening should be considered by health care providers at 3-year intervals beginning at age 45 years, particularly in those with BMI 25 kg/m². The rationale for this interval is that false negatives will be repeated before substantial time elapses, and there is little likelihood of an individual developing any of the complications of diabetes to a significant degree within 3 years of a negative screening test result. Testing should be considered at a younger age or be carried out more frequently in individuals who are overweight and have one or more of the other risk factors for type 2 diabetes.

Recommendations

• Screening to detect pre-diabetes (IFG or IGT) and diabetes should be considered in individuals 45 years of age, particularly in those with a BMI 25 kg/m². Screening should also be considered for people who are <45 years of age and are overweight if they have another risk factor for diabetes (Table 3). Repeat testing should be carried out at 3-year intervals. (E)
  
• Screen for pre-diabetes and diabetes in high-risk, asymptomatic, undiagnosed adults and children within the health care setting. (E)
  
• Either an FPG test or 2-h OGTT (75-g glucose load) is appropriate (B)
  
• The FPG is the preferred test to screen for pre-diabetes and diabetes. The OGTT may also be used to screen for pre-diabetes or diabetes in high-risk adults. (E)
  

	III. DETECTION AND DIAGNOSIS OF GESTATIONAL DIABETES MELLITUS (GDM)

TOP CONTENTS I. CLASSIFICATION AND DIAGNOSIS II. SCREENING FOR DIABETES III. DETECTION AND DIAGNOSIS... IV. PREVENTION/DELAY OF TYPE... V. DIABETES CARE VI. PREVENTION AND MANAGEMENT... VII. DIABETES CARE IN... B. Preconception care Recommendations C. Older individuals VIII. DIABETES CARE IN... IX. HYPOGLYCEMIA AND... X. THIRD-PARTY REIMBURSEMENT FOR... XI. STRATEGIES FOR IMPROVING... References

 
Risk assessment for GDM should be undertaken at the first prenatal visit. Women with clinical characteristics consistent with a high risk for GDM (those with marked obesity, personal history of GDM, glycosuria, or a strong family history of diabetes) should undergo glucose testing as soon as possible (11). An FPG 126 mg/dl or a casual plasma glucose 200 mg/dl meets the threshold for the diagnosis of diabetes and needs to be confirmed on a subsequent day unless unequivocal symptoms of hyperglycemia are present. High-risk women not found to have GDM at the initial screening and average-risk women should be tested between 24 and 28 weeks of gestation. Testing should follow one of two approaches:

• One-step approach: perform a diagnostic 100-g OGTT
  
• Two-step approach: perform an initial screening by measuring the plasma or serum glucose concentration 1 h after a 50-g oral glucose load (glucose challenge test [GCT]) and perform a diagnostic 100-g OGTT on that subset of women exceeding the glucose threshold value on the GCT. When the two-step approach is used, a glucose threshold value 140 mg/dl identifies 80% of women with GDM, and the yield is further increased to 90% by using a cutoff of 130 mg/dl.
  

Low-risk status requires no glucose testing, but this category is limited to those women meeting all of the following characteristics:

• Age <25 years.
  
• Weight normal before pregnancy.
  
• Member of an ethnic group with a low prevalence of GDM.
  
• No known diabetes in first-degree relatives.
  
• No history of abnormal glucose tolerance.
  
• No history of poor obstetric outcome.
  

Recommendations

• Screen for diabetes in pregnancy using risk factor analysis and, if appropriate, use of an OGTT. (C)
  
• Women with gestational diabetes should be screened for diabetes 6 weeks postpartum and should be followed up with subsequent screening for the development of diabetes or pre-diabetes. (E)
  

	IV. PREVENTION/DELAY OF TYPE 2 DIABETES

TOP CONTENTS I. CLASSIFICATION AND DIAGNOSIS II. SCREENING FOR DIABETES III. DETECTION AND DIAGNOSIS... IV. PREVENTION/DELAY OF TYPE... V. DIABETES CARE VI. PREVENTION AND MANAGEMENT... VII. DIABETES CARE IN... B. Preconception care Recommendations C. Older individuals VIII. DIABETES CARE IN... IX. HYPOGLYCEMIA AND... X. THIRD-PARTY REIMBURSEMENT FOR... XI. STRATEGIES FOR IMPROVING... References

 
Studies have been initiated in the last decade to determine the feasibility and benefit of various strategies to prevent or delay the onset of type 2 diabetes. Five well-designed randomized controlled trials have been reported (12–16). The strategies shown to be effective in preventing diabetes relied on lifestyle modification or glucose-lowering drugs that have been approved for treating diabetes.

In the Finnish study (12), middle-aged obese subjects with IGT were randomized to receive either brief diet and exercise counseling (control group) or intensive individualized instruction on weight reduction, food intake, and guidance on increasing physical activity (intervention group). After an average follow-up of 3.2 years, there was a 58% relative reduction in the incidence of diabetes in the intervention group compared with the control subjects.

In the Diabetes Prevention Program (DPP) (13), enrolled subjects were slightly younger and more obese but had nearly identical glucose intolerance compared with subjects in the Finnish study. About 45% of the participants were from minority groups (e.g., African American, Hispanic), and 20% were 60 years of age. Subjects were randomized to one of three intervention groups, which included the intensive nutrition and exercise counseling ("lifestyle") group or either of two masked medication treatment groups: the biguanide metformin group or the placebo group. The latter interventions were combined with standard diet and exercise recommendations. After an average follow-up of 2.8 years, a 58% relative reduction in the progression to diabetes was observed in the lifestyle group, and a 31% relative reduction in the progression of diabetes was observed in the metformin group compared with control subjects. On average, 50% of the lifestyle group achieved the goal of 7% weight reduction, and 74% maintained at least 150 min/week of moderately intense activity.

In the Da Qing Study (16), men and women from health care clinics in the city of Da Qing, China, were screened with OGTT, and those with IGT were randomized by clinic to a control group or to one of three active treatment groups: diet only, exercise only, or diet plus exercise. Subjects were reexamined biannually, and after an average of 6 years follow-up the diet, exercise, and diet-plus-exercise interventions were associated with 31, 46, and 42% reductions in risk of developing type 2 diabetes, respectively.

Two other studies, each using a different class of glucose-lowering agent, have shown a reduction in progression to diabetes with pharmacological intervention. In the Troglitazone in Prevention of Diabetes (TRIPOD) study (14), Hispanic women with previous GDM were randomized to receive either placebo or troglitazone (a drug now withdrawn from commercial sale in the U.S. but belonging to the thiazolidinedione class). After a median follow-up of 30 months, troglitazone treatment was associated with a 56% relative reduction in progression to diabetes. In the STOP-NIDDM trial (15), participants with IGT were randomized in a double-blind fashion to receive either the -glucosidase inhibitor acarbose or a placebo. After a mean follow-up of 3.3 years, a 25% relative risk reduction in progression to diabetes, based on one OGTT, was observed in the acarbose-treated group compared with the placebo group. If this diagnosis was confirmed by a second OGTT, a 36% relative risk reduction was observed in the acarbose group compared with the placebo group.

Our knowledge of the early stages of hyperglycemia that portend the diagnosis of diabetes, and the recent success of major intervention trials, clearly show that individuals at high risk can be identified and diabetes delayed, if not prevented. The cost-effectiveness of intervention strategies is unclear, but the huge burden resulting from the complications of diabetes and the potential ancillary benefits of some of the interventions suggest that an effort to prevent diabetes is worthwhile.

Lifestyle modification
In well-controlled studies that included a lifestyle intervention arm, substantial efforts were necessary to achieve only modest changes in weight and exercise, but those changes were sufficient to achieve an important reduction in the incidence of diabetes. In the Finnish Diabetes Prevention Study, weight loss averaged 9.2 lb at 1 year, 7.7 lb after 2 years, and 4.6 lb after 5 years (12); "moderate exercise," such as brisk walking, for 30 min/day was suggested. In the Finnish study, there was a direct relationship between adherence with the lifestyle intervention and the reduced incidence of diabetes.

In the DPP (13), the lifestyle group lost 12 lb at 2 years and 9 lb at 3 years (mean weight loss for the study duration was 12 lb or 6% of initial body weight). In both of these studies, most of the participants were obese (BMI >30 kg/m²).

A low-fat (<25% fat) intake was recommended; if reducing fat did not produce weight loss to goal, calorie restriction was also recommended. Participants weighing 120–174 lb (54–78 kg) at baseline were instructed to follow a 1,200-kcal/day diet (33 g fat); participants weighing 175–219 lb (79–99 kg) were instructed to follow a 1,500-kcal/day diet (42 g fat); those 220–249 lb (100–113 kg) were instructed to follow an 1,800-kcal/day diet (50 g fat); and those >250 lb (114 kg) were instructed to follow a 2000-kcal/day diet (55 g fat).

Pharmacological interventions
Three diabetes prevention trials used pharmacological therapy, and all have reported a significant lowering of the incidence of diabetes. The biguanide metformin reduced the risk of diabetes by 31% in the DPP (13), the -glucosidase inhibitor acarbose reduced the risk by 32% in the STOP-NIDDM trial (15), and the thiazolidinedione troglitazone reduced the risk by 56% in the TRIPOD study (14).

In the DPP, metformin was about half as effective as diet and exercise in delaying the onset of diabetes overall, but it was nearly ineffective in older individuals (60 years of age) or in those who were less overweight (BMI <30 kg/m²). Conversely, metformin was as effective as lifestyle modification in individuals aged 24–44 years or in those with a BMI 35 kg/m². Thus, the population of people in whom treatment with metformin has equal benefit to that of a lifestyle intervention is only a small subset of those who are likely to have pre-diabetes (IFG or IGT).

There are also data to suggest that blockade of the rennin-angiotensin system (17) may lower the risk of developing diabetes, but more studies are necessary before these drugs can be recommended for preventing diabetes.

Lifestyle or medication?
The DPP is the only study in which a comparison of the two was made, and lifestyle modification was nearly twice as effective in preventing diabetes (58 vs. 31% relative reductions, respectively). The greater benefit of weight loss and physical activity strongly suggests that lifestyle modification should be the first choice to prevent or delay diabetes. Modest weight loss (5–10% of body weight) and modest physical activity (30 min daily) are the recommended goals. Because this intervention not only has been shown to prevent or delay diabetes, but also has a variety of other benefits, health care providers should urge all overweight or sedentary individuals to adopt these changes, and such recommendations should be made at every opportunity.

When all factors are considered, there is insufficient evidence to support the use of drug therapy as a substitute for, or routinely used in addition to, lifestyle modification to prevent diabetes. Public health messages, health care professionals, and health care systems should all encourage behavior changes to achieve a healthy lifestyle. Further research is necessary to understand better how to facilitate effective and efficient programs for the primary prevention of type 2 diabetes.

Recommendations

• Individuals at high risk for developing diabetes need to become aware of the benefits of modest weight loss and participating in regular physical activity. (A)
  
• Patients with IGT should be given counseling on weight loss as well as instruction for increasing physical activity. (A)
  
• Patients with IFG should be given counseling on weight loss as well as instruction for increasing physical activity. (E)
  
• Follow-up counseling appears important for success. (B)
  
• Monitoring for the development of diabetes should be performed every 1–2 years. (E)
  
• Close attention should be given to, and appropriate treatment given for, other CVD risk factors (e.g., tobacco use, hypertension, dyslipidemia). (A)
  
• Drug therapy should not be routinely used to prevent diabetes until more information is known about its cost-effectiveness. (E)
  

	V. DIABETES CARE

TOP CONTENTS I. CLASSIFICATION AND DIAGNOSIS II. SCREENING FOR DIABETES III. DETECTION AND DIAGNOSIS... IV. PREVENTION/DELAY OF TYPE... V. DIABETES CARE VI. PREVENTION AND MANAGEMENT... VII. DIABETES CARE IN... B. Preconception care Recommendations C. Older individuals VIII. DIABETES CARE IN... IX. HYPOGLYCEMIA AND... X. THIRD-PARTY REIMBURSEMENT FOR... XI. STRATEGIES FOR IMPROVING... References

 
A. Initial evaluation
A complete medical evaluation should be performed to classify the patient, detect the presence or absence of diabetes complications, assist in formulating a management plan, and provide a basis for continuing care. If the diagnosis of diabetes has already been made, the evaluation should review the previous treatment and the past and present degrees of glycemic control. Laboratory tests appropriate to the evaluation of each patient’s general medical condition should be performed. A focus on the components of comprehensive care (Table 5) will assist the health care team to ensure optimal management of the patient with diabetes.

The management plan should be formulated as an individualized therapeutic alliance among the patient and family, the physician, and other members of the health care team. Any plan should recognize diabetes self-management education (DSME) as an integral component of care. In developing the plan, consideration should be given to the patient’s age, school or work schedule and conditions, physical activity, eating patterns, social situation and personality, cultural factors, and presence of complications of diabetes or other medical conditions. A variety of strategies and techniques should be used to provide adequate education and development of problem-solving skills in the various aspects of diabetes management. Implementation of the management plan requires that each aspect is understood and agreed on by the patient and the care providers and that the goals and treatment plan are reasonable.

C. Glycemic control
1. Assessment of glycemic control.
Techniques are available for health providers and patients to assess the effectiveness of the management plan on glycemic control.

a. Self-monitoring of blood glucose.
The ADA’s consensus statements on self-monitoring of blood glucose (SMBG) provide a comprehensive review of the subject (18,19). Major clinical trials assessing the impact of glycemic control on diabetes complications have included SMBG as part of multifactorial interventions, suggesting that SMBG is a component of effective therapy. 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, medical nutrition therapy (MNT), and physical activity.

The frequency and timing of SMBG should be dictated by the particular needs and goals of the patients. Daily SMBG is especially important for patients treated with insulin to monitor for and prevent asymptomatic hypoglycemia and hyperglycemia. For most patients with type 1 diabetes and pregnant women taking insulin, SMBG is recommended three or more times daily. The optimal frequency and timing of SMBG for patients with type 2 diabetes on oral agent therapy is not known but should be sufficient to facilitate reaching glucose goals. Patients with type 2 diabetes on insulin typically need to perform SMBG more frequently than those not using insulin. When adding to or modifying therapy, type 1 and type 2 diabetic patients should test more often than usual. The role of SMBG in stable diet-treated patients with type 2 diabetes is not known.

Because the accuracy of SMBG is instrument- and user-dependent (20), it is important for health care providers to evaluate each patient’s monitoring technique, both initially and at regular intervals thereafter. In addition, optimal use of SMBG requires proper interpretation of the data. Patients should be taught how to use the data to adjust food intake, exercise, or pharmacological therapy to achieve specific glycemic goals. Health professionals should evaluate at regular intervals the patient’s ability to use SMBG data to guide treatment.

Recommendations

• Clinical trials using insulin that have demonstrated the value of tight glycemic control have used SMBG as an integral part of the management strategy. (A)
  
• SMBG should be carried out three or more times daily for patients using multiple insulin injections. (A)
  
• For patients using less frequent insulin injections or oral agents or MNT alone, SMBG is useful in achieving glycemic goals. (E)
  
• To achieve postprandial glucose targets, postprandial SMBG may be appropriate. (E)
  
• Instruct the patient in SMBG and routinely evaluate the patient’s technique and ability to use data to adjust therapy. (E)
  

b. A1C.
By performing an A1C test, health providers can measure a patient’s average glycemia over the preceding 2–3 months (20) and, thus, assess treatment efficacy. A1C testing should be performed routinely in all patients with diabetes, first to document the degree of glycemic control at initial assessment and then as part of continuing care. Since the A1C test reflects mean glycemia over the preceding 2–3 months, measurement approximately every 3 months is required to determine whether a patient’s metabolic control has been reached and maintained within the target range. Thus, regular performance of the A1C test permits detection of departures from the target (Table 6) in a timely fashion. For any individual patient, the frequency of A1C testing should be dependent on the clinical situation, the treatment regimen used, and the judgment of the clinician.

• Perform the A1C test at least two times a year in patients who are meeting treatment goals (and who have stable glycemic control). (E)
  
• Perform the A1C test quarterly in patients whose therapy has changed or who are not meeting glycemic goals. (E)
  

2. Glycemic goals.
Glycemic control is fundamental to the management of diabetes. Prospective randomized clinical trials such as the DCCT (22) and the U.K. Prospective Diabetes Study (UKPDS) (23,24) have shown that improved glycemic control is associated with sustained decreased rates of retinopathy, nephropathy, and neuropathy (25). In these trials, treatment regimens that reduced average A1C to 7% (1% above the upper limits of normal) were associated with fewer long-term microvascular complications; however, intensive control was found to increase the risk of severe hypoglycemia and weight gain (26,27). The potential of intensive glycemic control to reduce CVD is supported by epidemiological studies (22–27) and a recent meta-analysis (28), but this potential benefit on CVD events has not yet been demonstrated in a randomized clinical trial.

Recommended glycemic goals for nonpregnant individuals are shown in Table 6. A major limitation to the available data are that they do not identify the optimum level of control for particular patients, as there are individual differences in the risks of hypoglycemia, weight gain, and other adverse effects. Furthermore, with multifactorial interventions, it is unclear how different components (e.g., educational interventions, glycemic targets, lifestyle changes, and pharmacological agents) contribute to the reduction of complications. There are no clinical trial data available for the effects of glycemic control in patients with advanced complications, the elderly (65 years of age), or young children (<13 years of age). Less stringent treatment goals may be appropriate for patients with limited life expectancies, in the very young or older adults, and in individuals with comorbid conditions. Severe or frequent hypoglycemia is an indication for the modification of treatment regimens, including setting higher glycemic goals.

More stringent goals (i.e., a normal A1C, <6%) can be considered in individual patients based on epidemiological analyses that suggest that there is no lower limit of A1C at which further lowering does not reduce the risk of complications, at the risk of increased hypoglycemia (particularly in those with type 1 diabetes). However, the absolute risks and benefits of lower targets are unknown. The risks and benefits of an A1C goal of <6% are currently being tested in an ongoing study (ACCORD [Action to Control Cardiovascular Risk in Diabetes]) in type 2 diabetes.

Elevated postchallenge (2-h OGTT) glucose values have been associated with increased cardiovascular risk independent of FPG in some epidemiological studies. Postprandial plasma glucose (PPG) levels >140 mg/dl are unusual in nondiabetic individuals, although large evening meals can be followed by plasma glucose values up to 180 mg/dl. There are now pharmacological agents that primarily modify PPG and thereby reduce A1C in parallel. Thus, in individuals who have premeal glucose values within target but who are not meeting A1C targets, consideration of monitoring PPG 1–2 h after the start of the meal and treatment aimed at reducing PPG values <180 mg/dl may lower A1C. However, it should be noted that the effect of these approaches on micro- or macrovascular complications has not been studied (29).

For information on glycemic control for women with GDM, refer to the ADA position statement "Gestational Diabetes Mellitus" (11). For information on glycemic control during pregnancy in women with preexisting diabetes, refer to Medical Management of Pregnancy Complicated by Diabetes (3rd ed.) (30).

Recommendations

• Lowering A1C has been associated with a reduction of microvascular and neuropathic complications of diabetes. (A)
  
• Develop or adjust the management plan to achieve normal or near-normal glycemia with an A1C goal of <7%. (B)
  
• More stringent goals (i.e., a normal A1C, <6%) can be considered in individual patients and in pregnancy. (B)
  
• A lower A1C is associated with a lower risk of myocardial infarction and cardiovascular death. (B)
  
• Aggressive glycemic management with insulin may reduce morbidity in patients with severe acute illness, perioperatively, following myocardial infarction and in pregnancy. (B)
  
• Less stringent treatment goals may be appropriate for patients with a history of severe hypoglycemia, patients with limited life expectancies, very young children or older adults, and individuals with comorbid conditions. (E)
  

D. MNT
MNT is an integral component of diabetes management and DSME. A review of the evidence and detailed information can be found in the ADA technical review and position statement in this area (32,33). People with diabetes should receive individualized MNT as needed to achieve treatment goals, preferably provided by a registered dietitian familiar with the components of diabetes MNT. Goals of MNT that apply to all individuals with diabetes are as follows:

• Attain and maintain recommended metabolic outcomes, including glucose and A1C levels, LDL cholesterol, HDL cholesterol, triglyceride levels, blood pressure, and body weight (Table 6).
  
• Prevent and treat the chronic complications and comorbidities of diabetes. Modify nutrient intake and lifestyle as appropriate for the prevention and treatment of obesity, dyslipidemia CVD, hypertension, and nephropathy.
  
• Improve health through healthy food choices and physical activity.
  
• Address individual nutritional needs, taking into consideration personal and cultural preferences and lifestyle, while respecting the individual’s wishes and willingness to change.
  

Goals of MNT that apply to specific situations include the following:

• For youth with type 1 diabetes (34), provide adequate energy to ensure normal growth and development; integrate insulin regimens into usual eating and physical activity habits.
  
• For youth with type 2 diabetes, who are often overweight/obese, facilitate appropriate changes in eating and physical activity habits.
  
• For pregnant and lactating women, provide adequate energy and nutrients needed for optimal outcomes. In pregnancy, counting and recording carbohydrate intake contributes to optimal glycemic control.
  
• For older adults, provide for the nutritional and psychosocial needs of an aging individual.
  
• For individuals treated with insulin or insulin secretagogues, provide self-management education for treatment (and prevention) of hypoglycemia, acute illnesses, and exercise-related blood glucose problems.
  
• For individuals at risk for diabetes, decrease risk by encouraging physical activity and promoting foods choices that facilitate moderate weight loss or at least prevent weight gain.
  

MNT involves a nutrition assessment to evaluate the patient’s food intake, metabolic status, lifestyle and readiness to make changes, goal setting, dietary instruction, and evaluation. To facilitate adherence, the plan should be individualized and take into account cultural, lifestyle, and financial considerations. Monitoring of glucose and A1C, lipids, blood pressure, and renal status is essential to evaluate nutrition-related outcomes. If goals are not met (Table 6), changes must be made in the overall diabetes care and management plan.

Dietary carbohydrate (35).
Regulation of blood glucose to achieve near normal levels is a primary goal in the management of diabetes, and thus, dietary techniques that limit hyperglycemia following a meal are important in limiting the complications of diabetes. Both the amount (grams) of carbohydrate as well as the type of carbohydrate in a food influence blood glucose level. The total amount of carbohydrate consumed is a strong predictor of glycemic response, and thus, monitoring total grams of carbohydrate, whether by use of exchanges or carbohydrate counting, remains a key strategy in achieving glycemic control. A recent analysis of the randomized, controlled trials that have examined the efficacy of the glycemic index (a measure of the effect of type of carbohydrate) on overall blood glucose control indicates that the use of this technique can provide an additional benefit over that observed when total carbohydrate is considered alone.

Low carbohydrate diets are not recommended in the management of diabetes. Although dietary carbohydrate is the major contributor to postprandial glucose concentration, it is an important source of energy, water soluble vitamins and minerals, and fiber. Thus, in agreement with the National Academy of Sciences-Food and Nutrition Board, a recommended range of carbohydrate intake is 45–65% of total calories. In addition, because the brain and central nervous system have an absolute requirement for glucose as an energy source, restricting total carbohydrate to <130 g/day is not recommended.

Weight management (36).
Overweight and obesity are strongly linked to the development of type 2 diabetes and can complicate its management. Obesity is also an independent risk factor for hypertension and dyslipidemia as well as CVD, which is the major cause of death in those with diabetes. Moderate weight loss improves glycemic control, reduces CVD risk, and can prevent the development of type 2 diabetes in those with pre-diabetes. Therefore, weight loss is an important therapeutic strategy in all overweight or obese individuals who have type 2 diabetes or are at risk for developing diabetes. The primary approach for achieving weight loss, in the vast majority of cases, is therapeutic lifestyle change, which includes a reduction in energy intake and an increase in physical activity. A moderate decrease in caloric balance (500–1,000 kcal/day) will result in a slow but progressive weight loss (1–2 lb/week). For most patients, weight loss diets should supply at least 1,000–1,200 kcal/day for women and 1,200–1,600 kcal/day for men.

Physical activity is an important component of a comprehensive weight management program. Regular, moderate intensity, physical activity enhances long-term weight maintenance. Regular activity also improves insulin sensitivity, glycemic control, and selected risk factors for CVD (i.e., hypertension and dyslipidemia), and increased aerobic fitness decreases the risk of coronary heart disease (CHD). Initial physical activity recommendations should be modest, based on the patient’s willingness and ability, gradually increasing the duration and frequency to 30–45 min of moderate aerobic activity 3–5 days per week, when possible. Greater activity levels of at least 1 h/day of moderate (walking) or 30 min/day of vigorous (jogging) activity may be needed to achieve successful long-term weight loss.

Recommendations

• People with diabetes should receive individualized MNT as needed to achieve treatment goals, preferably provided by a registered dietitian familiar with the components of diabetes MNT. (B)
  
• Both the amount (grams) of carbohydrate as well as the type of carbohydrate in a food influence blood glucose level. Monitoring total grams of carbohydrate, whether by use of exchanges or carbohydrate counting, remains a key strategy in achieving glycemic control. The use of the glycemic index/glycemic load can provide an additional benefit over that observed when total carbohydrate is considered alone. (B)
  
• Low carbohydrate diets (restricting total carbohydrate to <130 g/day) are not recommended in the management of diabetes. (E)
  
• Weight loss is recommended for all overweight (BMI 25.0–29.9 kg/m²) or obese (BMI 30.0 kg/m²) adults, who have, or who are at risk for developing, type 2 diabetes. (E)
  
• The primary approach for achieving weight loss is therapeutic lifestyle change, which includes a reduction in energy intake and/or an increase in physical activity. A moderate decrease in caloric balance (500–1,000 kcal/day) will result in a slow but progressive weight loss (1–2 lb/week). For most patients, weight loss diets should supply at least 1,000–1,200 kcal/day for women and 1,200–1,600 kcal/day for men. (E)
  
• Initial physical activity recommendations should be modest, based on the patient’s willingness and ability, gradually increasing the duration and frequency to 30–45 min of moderate aerobic activity 3–5 days per week, when possible. Greater activity levels of at least 1 h/day of moderate (walking) or 30 min/day of vigorous (jogging) activity may be needed to achieve successful long-term weight loss. (E)
  

E. Physical activity
ADA technical reviews on exercise in patients with diabetes have summarized the value of exercise in the diabetes management plan (37,38). Regular exercise has been shown to improve blood glucose control, reduce cardiovascular risk factors, contribute to weight loss, and improve well-being. Furthermore, regular exercise may prevent type 2 diabetes in high-risk individuals (12,13,16).

Before beginning a physical activity program, the patient with diabetes should have a detailed medical evaluation with appropriate diagnostic studies. This examination should screen for the presence of macro- and microvascular complications that may be worsened by the physical activity program (see next section regarding CHD screening). Identification of areas of concern will allow the design of an individualized physical activity plan that can minimize risk to the patient.

All levels of physical activity, including leisure activities, recreational sports, and competitive professional performance, can be performed by people with diabetes who do not have complications and have good glycemic control. The ability to adjust the therapeutic regimen (insulin therapy and MNT) to allow safe participation is an important management strategy.

Recommendations

• A regular physical activity program, adapted to the presence of complications, is recommended for all patients with diabetes who are capable of participating. (B)
  

F. Psychosocial assessment and care
Psychological and social state can impact the patient’s ability to carry out diabetes care tasks (39–44). As a result, health status may be compromised. Family conflict around diabetes care tasks is also common and may interfere with treatment outcomes (45). There are opportunities for the clinician to assess psychosocial status in a timely and efficient manner so that referral for appropriate services can be accomplished (46).

Key opportunities for screening of psychosocial status occur at diagnosis, during regularly scheduled management visits, during hospitalizations, at discovery of complications, or at the discretion of the clinician when problems in glucose control, quality of life, or adherence are identified (47). Patients are likely to exhibit psychological vulnerability at diagnosis and when their medical status changes: the end of the honeymoon period, when the need for intensified treatment is evident and when complications are discovered (42,44).

Psychosocial screening should include but is not limited to: attitudes about the illness, expectations for medical management and outcomes, affect/mood, general and diabetes related quality of life, resources (financial, social, and emotional), (43) and psychiatric history (44,47,48). Particular attention needs to be paid to gross noncompliance with medical regimen (due to self or others) (39,48), depression with the possibility of self-harm (40,41), indications of an eating disorder (49) or a problem that appears to be organic in origin, and cognitive functioning that significantly impairs judgment (41). In these cases, immediate referral for further evaluation by a mental health specialist familiar with diabetes management should occur. Behavioral assessment of management skills is also recommended.

It is preferable to incorporate psychological treatment into routine care rather than waiting for identification of a specific problem or deterioration in psychological status (46). Screening tools can facilitate this goal, and although the clinician may not feel qualified to treat psychological problems, utilizing the patient-provider relationship as a foundation for further treatment can increase the likelihood that the patient will accept referral for other services. It is important to establish that emotional wellbeing is part of diabetes management (47).

Recommendations

• Preliminary assessment of psychological and social status should be included as part of the medical management of diabetes. (E)
  
• Psychosocial screening should include but is not limited to: attitudes about the illness, expectations for medical management and outcomes, affect/mood, general and diabetes related quality of life, resources (financial, social, and emotional) and psychiatric history. (E)
  
• Screening for psychosocial problems such as depression, eating disorders, and cognitive impairment is needed when adherence to the medical regimen is poor. (E)
  
• It is preferable to incorporate psychological treatment into routine care rather than to wait for identification of a specific problem or deterioration in psychological status. (E)
  

G. Referral for diabetes management
For a variety of reasons, some people with diabetes and their health care providers do not achieve the desired goals of treatment (Table 6). Intensification of the treatment regimen is suggested and includes identification (or assessment) of barriers to adherence, culturally appropriate and enhanced DSME, comanagement with a diabetes team, change in pharmacological therapy, initiation of or increase in SMBG, more frequent contact with the patient, and referral to an endocrinologist.

H. Intercurrent illness
The stress of illness, trauma, and/or surgery frequently aggravates glycemic control and may precipitate diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state. Any condition leading to deterioration in glycemic control necessitates more frequent monitoring of blood glucose and urine or blood ketones. A vomiting illness accompanied by ketosis may indicate DKA, a life-threatening condition that requires immediate medical care to prevent complications and death; the possibility of DKA should always be considered (50). Marked hyperglycemia requires temporary adjustment of the treatment program and, if accompanied by ketosis, frequent interaction with the diabetes care team. The patient treated with oral glucose-lowering agents or MNT alone may temporarily require insulin. Adequate fluid and caloric intake must be assured. Infection or dehydration is more likely to necessitate hospitalization of the person with diabetes than the person without diabetes. The hospitalized patient should be treated by a physician with expertise in the management of diabetes, and recent studies suggest that achieving very stringent glycemic control may reduce mortality in the immediate postmyocardial infarction period (51). Aggressive glycemic management with insulin may reduce morbidity in patients with severe acute illness (52).

For information on management of patients in the hospital with DKA or non-ketotic hyperosmolar state, refer to the ADA position statement titled "Hyperglycemic Crises in Diabetes" (50).

I. Immunization
Influenza and pneumonia are common, preventable infectious diseases associated with high mortality and morbidity in the elderly and in people with chronic diseases. There are limited studies reporting the morbidity and mortality of influenza and pneumococcal pneumonia, specifically in people with diabetes. Observational studies of patients with a variety of chronic illnesses, including diabetes, show that these conditions are associated with an increase in hospitalizations for influenza and its complications. Based on a case-control series, influenza vaccine has been shown to reduce diabetes-related hospital admission by as much as 79% during flu epidemics (53). People with diabetes may be at increased risk of the bacteremic form of pneumococcal infection and have been reported to have a high risk of nosocomial bacteremia, which has a mortality rate as high as 50%.

Safe and effective vaccines are available that can greatly reduce the risk of serious complications from these diseases (54,55). There is sufficient evidence to support that people with diabetes have appropriate serologic and clinical responses to these vaccinations. The Centers for Disease Control’s Advisory Committee on Immunization Practices recommends influenza and pneumococcal vaccines for all individuals >65 years of age as well as for all individuals of any age with diabetes.

For a complete discussion on the prevention of influenza and pneumococcal disease in people with diabetes, consult the technical review and position statement on this subject (56,57).

Recommendations

• Annually provide an influenza vaccine to all diabetic patients 6 months of age or older. (C)
  
• Provide at least one lifetime pneumococcal vaccine for adults with diabetes. A one-time revaccination is recommended for individuals >64 years of age previously immunized when they were <65 years of age if the vaccine was administered >5 years ago. Other indications for repeat vaccination include nephrotic syndrome, chronic renal disease, and other immunocompromised states, such as after transplantation. (C)
  

	VI. PREVENTION AND MANAGEMENT OF DIABETES COMPLICATIONS

TOP CONTENTS I. CLASSIFICATION AND DIAGNOSIS II. SCREENING FOR DIABETES III. DETECTION AND DIAGNOSIS... IV. PREVENTION/DELAY OF TYPE... V. DIABETES CARE VI. PREVENTION AND MANAGEMENT... VII. DIABETES CARE IN... B. Preconception care Recommendations C. Older individuals VIII. DIABETES CARE IN... IX. HYPOGLYCEMIA AND... X. THIRD-PARTY REIMBURSEMENT FOR... XI. STRATEGIES FOR IMPROVING... References

 
A. CVD
CVD is the major cause of mortality for individuals with diabetes. It is also a major contributor to morbidity and direct and indirect costs of diabetes. Type 2 diabetes is an independent risk factor for macrovascular disease, and its common coexisting conditions (e.g., hypertension and dyslipidemia) are also risk factors.

Studies have shown the efficacy of reducing cardiovascular risk factors in preventing or slowing CVD. Evidence is summarized in the following sections and reviewed in detail in the ADA technical reviews on hypertension (58), dyslipidemia (59), aspirin therapy (60), and smoking cessation (61) and the consensus statement on CHD in people with diabetes (62). Emphasis should be placed on reducing cardiovascular risk factors, when possible, and clinicians should be alert for signs and symptoms of atherosclerosis.

1. Hypertension/blood pressure control.
Hypertension (HTN) (blood pressure 140/90 mmHg) is a common comorbidity of diabetes, affecting the majority of people with diabetes, depending on type of diabetes, age, obesity, and ethnicity. HTN is also a major risk factor for CVD and microvascular complications such as retinopathy and nephropathy. In type 1 diabetes, HTN is often the result of underlying nephropathy. In type 2 diabetes, HTN may be present as part of the metabolic syndrome (i.e., obesity, hyperglycemia, and dyslipidemia) that is accompanied by high rates of CVD.

Randomized clinical trials have demonstrated the benefit (reduction of CHD events, stroke, and nephropathy) of lowering blood pressure to <130 mmHg systolic and <80 mmHg diastolic in individuals with diabetes (63–66). Epidemiologic analyses show that blood pressure >115/75 mmHg is associated with increased cardiovascular event rates and mortality in individuals with diabetes (63,67,68). Therefore, a target blood pressure goal of <130/80 mmHg is reasonable if it can be safely achieved.

Although there are no well-controlled studies of diet and exercise in the treatment of HTN in individuals with diabetes, reducing sodium intake and body weight (when indicated); increasing consumption of fruits, vegetables, and low-fat dairy products; avoiding excessive alcohol consumption; and increasing activity levels have been shown to be effective in reducing blood pressure in nondiabetic individuals (69). These nonpharmacological strategies may also positively affect glycemia and lipid control. Their effects on cardiovascular events have not been well measured.

Lowering of blood pressure with regimens based on antihypertensive drugs, including ACE inhibitors, angiotensin receptor blockers (ARBs), ß-blockers, diuretics, and calcium channel blockers, has been shown to be effective in lowering cardiovascular events. Several studies suggest that ACE inhibitors may be superior to dihydropyridine calcium channel blockers (DCCBs) in reducing cardiovascular events (70,71). Additionally, in people with diabetic nephropathy indicate that ARBs may be superior to DCCBs for reducing cardiovascular events (72). Conversely, in the recently completed International Verapamil Study (INVEST) of >22,000 people with coronary artery disease (CAD) and hypertension, the non-DCCB, verapamil, demonstrated a similar reduction in cardiovascular mortality to a ß-blocker. Moreover, this relationship held true in the diabetic subgroup (73).

ACE inhibitors have been shown to improve cardiovascular outcomes in high-cardiovascular-risk patients with or without HTN (74,75). In patients with congestive heart failure (CHF), ACE inhibitors are associated with better outcomes when compared with ARBs. In one study an ARB was superior to a ß-blocker as a therapy to improve cardiovascular outcomes in a subset of diabetic patients with HTN and left ventricular hypertrophy (76). The compelling effect of ACE inhibitors or ARBs in patients with albuminuria or renal insufficiency provide additional rationale for use of these agents (see section VI B. below).

The ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial), a large randomized trial of different initial blood pressure pharmacological therapies, found no large differences between initial therapy with a chlorthalidone, amlodipine, and lisinopril. Diuretics appeared slightly more effective than other agents, particularly for reducing heart failure (77). The -blocker arm of the ALLHAT was terminated after interim analysis showed that doxazosin was substantially less effective in reducing CHF than diuretic therapy (78).

Before beginning treatment, patients with elevated blood pressures should have their blood pressure reexamined within 1 month to confirm the presence of HTN. Systolic blood pressure 160 mmHg or diastolic blood pressure 100 mmHg, however, mandates that immediate pharmacological therapy be initiated. Patients with HTN should be seen as often as needed until the recommended blood pressure goal is obtained and then seen as necessary (63). In these patients, other cardiovascular risk factors, including obesity, hyperlipidemia, smoking, presence of microalbuminuria (assessed before initiation of treatment), and glycemic control, should be carefully assessed and treated. Many patients will require three or more drugs to reach target goals.

During pregnancy in diabetic women with chronic HTN, target blood pressure goals of systolic blood pressure 110–129 mmHg and diastolic blood pressure 65–79 mmHg are reasonable as they may contribute to long-term maternal health. Lower blood pressure levels may be associated with impaired fetal growth. During pregnancy treatment with ACE inhibitors and ARBs is contraindicated, since they are likely to cause fetal damage. Antihypertensive drugs known to be effective and safe in pregnancy include methyldopa, labatolol, diltiazem, clonidine, and prazosin. Chronic diuretic use during pregnancy has been associated with restricted maternal plasma volume, which might reduce uteroplacental perfusion.

Recommendations
Screening and diagnosis

• Blood pressure should be measured at every routine diabetes visit. Patients found to have systolic blood pressure 130 mmHg or diastolic blood pressure 80 mmHg should have blood pressure confirmed on a separate day. (C)
  

Goals

• Patients with diabetes should be treated to a systolic blood pressure <130 mmHg. (C)
  
• Patients with diabetes should be treated to a diastolic blood pressure <80 mmHg. (B)
  

Treatment

• Patients with hypertension (systolic blood pressure 140 mmHg or diastolic blood pressure 90 mmHg) should receive drug therapy in addition to lifestyle and behavioral therapy. (A)
  
• Multiple drug therapy (two or more agents at proper doses) is generally required to achieve blood pressure targets. (B)
  
• Patients with a systolic blood pressure of 130–139 mmHg or a diastolic blood pressure of 80–89 mmHg should be given lifestyle and behavioral therapy alone for a maximum of 3 months and then, if targets are not achieved, in addition, be treated with pharmacological agents that block the renin-angiotensin system. (E)
  
• Initial drug therapy should be with a drug class demonstrated to reduce CVD events in patients with diabetes (ACE inhibitors, ARBs, ß-blockers, diuretics, and calcium channel blockers). (A)
  
• All patients with diabetes and hypertension should be treated with a regimen that includes either an ACE inhibitor or an ARB. If one class is not tolerated, the other should be substituted. If needed to achieve blood pressure targets, a thiazide diuretic should be added. (E)
  
• If ACE inhibitors, ARBs, or diuretics are used, monitor renal function and serum potassium levels. (E)
  
• While there are no adequate head-to-head comparisons of ACE inhibitors and ARBs, there is clinical trial support for each of the following statements:
  • In patients with type 1 diabetes, with hypertension and any degree of albuminuria, ACE inhibitors have been shown to delay the progression of nephropathy. (A)
    
  • In patients with type 2 diabetes, hypertension, and microalbuminuria, ACE inhibitors and ARBs have been shown to delay the progression to macroalbuminuria. (A)
    
  • In those with type 2 diabetes, hypertension, macroalbuminuria, and renal insufficiency, ARBs have been shown to delay the progression of nephropathy. (A)
    
  
  
• In pregnant patients with diabetes and chronic hypertension, blood pressure target goals of 110–129/65–79 mmHg are suggested in the interest of long-term maternal health and minimizing impaired fetal growth. ACE inhibitors and ARBs are contraindicated during pregnancy. (E)
  
• In elderly hypertensive patients, blood pressure should be lowered gradually to avoid complications. (E)
  
• Patients not achieving target blood pressure despite multiple drug therapy should be referred to a physician experienced in the care of patients with hypertension. (E)
  
• Orthostatic measurement of blood pressure should be performed in people with diabetes and hypertension when clinically indicated. (E)
  

2. Dyslipidemia/lipid management.
Patients with type 2 diabetes have an increased prevalence of lipid abnormalities that contributes to higher rates of CVD. Lipid management aimed at lowering LDL cholesterol, raising HDL cholesterol, and lowering triglycerides has been shown to reduce macrovascular disease and mortality in patients with type 2 diabetes, particularly those who have had prior cardiovascular events. In studies using HMG (hydroxymethylglutaryl) CoA reductase inhibitors (statins), patients with diabetes achieved significant reductions in coronary and cerebrovascular events (79–82). In two studies using the fibric acid derivative gemfibrozil, reductions in cardiovascular end points were also achieved (83,84).

Target lipid levels are shown in Table 6. Lifestyle intervention including MNT, increased physical activity, weight loss, and smoking cessation should allow some patients to reach these lipid levels. Nutrition intervention should be tailored according to each patient’s age, type of diabetes, pharmacological treatment, lipid levels, and other medical conditions and should focus on the reduction of saturated fat, cholesterol, and transunsaturated fat intake. Glycemic control can also beneficially modify plasma lipid levels. Particularly in patients with very high triglycerides and poor glycemic control, glucose lowering maybe necessary to control hypertriglyceridemia. Pharmacological treatment is indicated if there is an inadequate response to lifestyle modifications and improved glucose control. However, in patients with clinical CVD and LDL >100 mg/dl, pharmacological therapy should be initiated at the same time that lifestyle intervention is started. In patients with diabetes aged <40 years similar consideration for LDL lowering therapy should be given if they have increased cardiovascular risk (e.g., additional cardiovascular risk factors or long duration of diabetes). Very little clinical trial data exists in patients in this age-group.

The first priority of pharmacological therapy is to lower LDL cholesterol to a target goal of <100 mg/dl (2.60 mmol/l) or therapy to achieve a reduction in LDL of 30–40%. For LDL lowering, statins are the drugs of choice. Other drugs that lower LDL include nicotinic acid