Current trends in diabetes management

Diabetes is chronic, costly, increasingly prevalent, and emerging as an alarming public health challenge because of its burden of microvascular complications and its enormous contribution to cardiovascular disease.

Ali A. Rizvi, MD, FACP

The author is Associate Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism, University of South Carolina School of Medicine, Columbia. He has indicated no relationships to disclose relating to the content of this article.

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Diabetes has assumed epidemic proportions, ranking as the sixth leading cause of death and the costliest chronic disease in the United States.¹ Reduced physical activity among Americans, increased caloric intake, and the resultant elevated rates of overweight and obesity have fueled the dramatic increase in the prevalence of this disease. Worldwide, an estimated 194 million people have diabetes. That number is expected to climb to 221 million by the end of this decade and to 333 million by the year 2025,² posing an enormous global public health and community burden. Clinicians are often ill-prepared to manage diabetes, which contributes to poor outcomes and increased morbidity and mortality.  

Standards of care

Clinical trials Results of multicenter clinical trials have highlighted the relationship between metabolic control of diabetes and its vascular complications. The landmark 1993 Diabetes Control and Complications Trial demonstrated the importance of maintaining tight glycemic control in delaying or preventing microvascular sequelae in type 1 diabetes.³ A 1.3% difference in average glycosylated hemoglobin (A1C) levels between the conventional and intensive treatment groups led to 60% and 54% reductions in neuropathy and albuminuria, respectively, and reduced the adjusted mean risk for the development of retinopathy by 76%. The United Kingdom Prospective Diabetes Study (UKPDS) in 1998 produced similar conclusions for type 2 diabetes.⁴ Patients were treated with sulfonylureas, metformin, and insulin. In addition to a reduction in microvascular complications, improved glycemic control also produced a statistically nonsignificant trend towards decreased macrovascular risk.

The publication of these and other studies gave an unprecedented impetus toward establishing improved glycemic goals. Various organizations proposed guidelines and standards of care for screening, diagnosing, and treating patients with diabetes, among them the World Health Organization, the American Diabetes Association (ADA), and the American College of Endocrinology (ACE).

The ADA recommends that adults be evaluated with a fasting blood glucose level every 3 years starting at age 45 years and sooner if there are risk factors.⁵ ADA recommendations for glycemic, BP, and lipid goals for diabetic patients are listed in Table 1. An A1C value of less than 7% is the optimal value, although it is better to individualize targets. Diabetes was designated a cardiac risk equivalent by the National Cholesterol Education Program (NCEP) 2001 guidelines,⁶ based on evidence that patients with diabetes have the same risk of MI as those without diabetes who have already had an MI. NCEP mandated a target LDL cholesterol level of less than 100 mg/dL in all patients with diabetes.⁷ The 2004 Adult Treatment Panel III update additionally recommends lowering the level of LDL cholesterol to less than 70 mg/dL in patients with both diabetes and cardiovascular disease (CVD) and to consider statin therapy regardless of baseline LDL levels.⁸ Recommendations for screening and treating microvascular complications of diabetes are listed in Table 2. Preconception counseling and care can reduce pregnancy-related morbidity and risk of congenital malformations.

Diabetes outcomes In the United States, there are benchmarks for evaluating quality of care and attaining specific goals and outcomes for chronic conditions such as diabetes. The National Committee for Quality Assurance (NCQA) maintains a list of accredited and certified diabetes disease management programs.⁹ In partnership with the ADA, it has cosponsored the Diabetes Physician Recognition Program, which assesses physician performance on 11 key measures of patient care for adults and 8 measures for pediatric patients. The NCQA also sponsors and supports the Health Plan Employer Data and Information Set (HEDIS), measures of standardized performance designed to ensure that patients have the information they need to compare managed health care plans. The performance measures in HEDIS are related to many significant public health and chronic issues, including diabetes.

The Diabetes Quality Improvement Project (DQIP)⁹ began through a coalition of public and private entities (the ADA, Foundation for Accountability, Health Care Financing Administration, NCQA) and was joined by the American Academy of Family Physicians, the American College of Physicians, and the Veterans Administration. The DQIP’s committee of experts recommended a set of diabetes-specific performance and outcome measures with which plans, clinics, physicians, and other health care providers could be compared for the purposes of accountability. Diabetes-related data for ongoing collection and monitoring include patient characteristics, measures of glycemic control, laboratory values, and screening for complications and comorbidities. Parameters are designed to be tracked over time and used for feedback, quality improvement, and research.  

Barriers to optimal management

In the past decade, the concept of diabetes care has evolved into an aggressive and goal-oriented philosophy, as the result of solid evidence showing that tight glycemic control and intensive risk-factor modification reduce long-term risk and improve health outcomes.^4,5 Unfortunately, translating these principles into clinical practice so patients with diabetes can benefit remains an obstacle, and recent studies show that in spite of the grim statistics, most diabetic patients are not achieving treatment goals.¹⁰ In type 2 diabetes, the management of comorbid conditions such as hypertension and hyperlipidemia is not being aggressively pursued.^3,11 The Third National Health and Nutrition Examination Survey data confirmed that glycemic, BP, and lipid control in patients with diabetes was suboptimal.¹² The current state of diabetes care clearly falls short of commonly accepted standards, and a large gap exists between optimal and actual care.

Obstacles to achieving goals The barriers that prevent evidence-based goals from being achieved can be summarized as follows:

• Clinical inertia—the acceptance of the status quo, so patients and providers are reluctant to escalate and intensify therapy.¹³ This inertia stems from an interplay of related factors: not realizing the seriousness of the disease process and clinician complacency.
• Infrequent follow-up of patients with diabetes. Patients whose medications are being titrated to achieve optimal glycemic control need detailed visits every 2 to 4 weeks and therapy modifications when necessary. Unfortunately, current managed care and time constraints are impediments in this regard.¹⁴
• Health care professionals’ ignorance concerning the use of evidence-based guidelines¹⁵ and lack of awareness of available resources for diabetes education.
• Inability or unwillingness of patients to make lifestyle changes and adhere to complex medication regimens and appointment schedules.¹⁶
• Problems with accessibility, cost of medical care, and insurance coverage.¹⁷

Recent changes in the approach to diabetes, some in response to the above-mentioned barriers, are discussed below.  

Multidisciplinary management

Team care and patient empowerment A patient-centered approach is becoming the most effective way of delivering health care to patients with diabetes¹⁸ because of its three main objectives: 1) multidisciplinary team care; 2) a focus on disease management; and 3) empowering patients to take responsibility for day-to-day self-management through education and a supportive, collaborative relationship with health care providers. Diabetes patient education should cover nutrition, diet, physical activity, medications, and sick-day management.¹⁹ This complex undertaking, a challenge beyond the efforts of the lone clinician, requires longitudinal guidance from a group of professionals who strive for behavior change and realistic goals. The patient must be educated, informed, and empowered through increased awareness and responsibility for self-care.²⁰

The team Members of the diabetes care team include the patient and the provider, the diabetes educator, and the nutritionist. The services of others, such as an ophthalmologist, podiatrist, nephrologist, psychologist, exercise physiologist, and pharmacist, may be needed. The primary goal is to motivate the patient and provide tools for self-care.

Clinicians must also be encouraged to utilize available resources and abandon deep-seated, obsolete practice patterns and attitudes. This entails using guidelines suggestively as an aid in decision making, earning the cooperation of patients in a nonconfrontational manner, and setting rational treatment goals. The involvement of a diabetes educator is also recommended. Many diabetes educators with the required experience can now achieve certification through the certified diabetes educator examination. Established diabetes education programs may also receive ADA recognition. Physicians caring for people with diabetes should make every effort to develop a referral relationship with a diabetes education program in their area. Lists of recognized programs and certified educators for patients, providers, consumers, insurers, payers, and other interested parties are available from the ADA and the American Association of Diabetes Educators. Since these educational services are not uniformly available everywhere, there may be logistical challenges such as access and travel distance, especially in rural areas.

Aggressive diabetes management

Stepped-up care Clinical support is growing for using oral antidiabetic agents, with or without insulin, to provide optimal glycemic control.²¹ The unrelenting progression of glycemic deterioration seen in the UKPDS is thought to be partially due to a prolonged, conservative treatment approach undertaken while the natural progression of the disease takes its toll. Early and aggressive treatment can retard this process by reducing insulin resistance and glucotoxicity, possibly preserving insulin production.

Multiple defects require multiple agents The pathogenesis of type 2 diabetes involves multiple defects, including insulin resistance in muscle and adipose tissue, relative beta-cell failure leading to insulin deficiency, and unrestrained hepatic glucose production—all problems that should be addressed specifically and concurrently. Sequential treatment with individual oral agents is a suboptimal management approach. Simultaneous multiple-agent treatment maintains control and prevents secondary failure. Exogenous insulin does not increase cardiovascular risk, and the benefits of giving insulin early, alone, or in combination with oral agents are well documented.²²

Typically recommended is a regimen of medications with different and complementary actions, such as a sulfonylurea and an insulin sensitizer. The clinician can initiate insulin therapy with a long-acting basal insulin.²³ Pharmacokinetics of the long-acting insulin analog glargine give it a relatively peakless profile independent of time of administration, with a reduced risk of hypoglycemia.²⁴ Escalating treatment requires adding premeal short-acting insulin to cover postprandial glycemic elevations. This proactive and progressive approach to care is termed staged diabetes management.²⁵

Basal-bolus concept In recent years, there has been a change in the delivery of multiple-dose insulin injections for type 1 diabetes or type 2 diabetes that requires insulin. In order to mimic the function of the normal pancreas, therapeutic regimens are designed to treat both fasting and postprandial hyperglycemia. Each component of this regimen comes from a different type of insulin with a specific, predictable pharmacokinetic profile; therefore, a combination of long-acting (eg, isophane insulin [NPH] or insulin glargine) and short-acting (eg, regular insulin, human insulin lispro, or insulin aspart) is usually used. Frequent premeal and postmeal glucose self-monitoring is necessary to identify trends, employ pattern management, and implement the basal-bolus concept, aiming to dovetail insulin dosage to glucose levels.²⁶ This helps to minimize glycemic variations and achieve an individually targeted A1C level.

Insulin pump Basal-bolus therapy is easier to implement when an insulin pump administers continuous short-acting insulin. The pump delivers insulin at a preprogrammed basal rate, while the patient can deliver additional boluses at meal times to cover postprandial hyperglycemia. Pump use improves glycemic control while concurrently decreasing the risk of serious hypoglycemia. Overall cost is cut by the reduction in trips for emergency care and hospitalizations.²⁷ Proper candidate selection is important, and motivated patients with type 1 diabetes comprise the majority of the pump population. However, in recent years this mode of insulin delivery has been used to great advantage in patients with type 2 diabetes as well.²⁸

Inpatient management

Elevated glucose levels promote infection, slow healing, and worsen prognoses in hospitalized patients.²⁹ The current state of inpatient glycemic control leaves much to be desired secondary to factors such as acute illness, routine changes, missed meals, unpredictable oral intake, diagnostic procedures, and medication adjustments. Fear of hypoglycemia among health care professionals also contributes to imperfect glycemic control.

Recent studies of inpatients with various illnesses clearly show that a more aggressive approach to glycemic management improves outcomes. For example, in a European study of post-MI patients, glycemic control utilizing a glucose-insulin-potassium infusion followed by multiple-dose insulin injections significantly improved survival.²² The Leuven trial employed intensive glycemic control (target serum glucose level, 80-110 mg/dL) with continuous insulin infusion in critically ill patients; ICU and hospital mortality rates were reduced by 43% and 34%, respectively.³⁰ Beneficial effects of tight control have been reported in patients undergoing cardiac surgery.³¹ The severity of, and functional recovery after, stroke is linked to ambient glycemia.³²

For critically ill patients, there are titrated protocols of continuous insulin infusion that are easy for nursing personnel to implement.^33,34 Indications for insulin drip recommended by the ACE are listed in Table 3.³⁵ SC insulin may be adequate in less critically ill patients; consider a basal long-acting insulin, together with a short-acting insulin for nutritional and supplemental correction, to effectively control glucose levels. However, do not use sliding scale SC insulin as the sole regimen because it treats hyperglycemia in a retroactive episodic fashion and may lead to hypoglycemia alternating with hyperglycemic spikes. A diabetes team should educate the patient in self-management before discharge to achieve a smooth transition to a stable home regimen.³⁶ 

Multifactorial therapy

Multifactorial treatment is fast becoming a cornerstone of ambulatory care in patients with diabetes, among whom coronary heart disease is the most common cause of death. A multi-targeted, stepped-up regimen addressing body weight, sedentary lifestyle, hypertension, dyslipidemia, tobacco use, and antiplatelet therapy is being increasingly recognized as essential in reducing morbidity and mortality from large vessel atherothrombosis.³⁷ In fact, these risk factors are operative in the related conditions of type 2 diabetes, glucose intolerance or pre-diabetes, and the metabolic syndrome.

The ADA’s specific goals for blood glucose, BP, and lipid levels are summarized in Table 1. An A1C value less than 7% is desirable unless there is frequent hypoglycemia or a shortened life expectancy. A BP lower than 130/80 mm Hg correlates with good clinical outcomes in patients with diabetes. This frequently requires a multiple-drug regimen, including an ACE inhibitor or angiotensin-receptor blocker (ARB).

Lipids Although the primary target is an LDL level that is less than 100 mg/dL (less than 70 mg/dL in patients with CVD), other lipid parameters including HDL and triglyceride levels also merit attention. A combination of diet, regular physical activity, and lipid-lowering medications is usually necessary to achieve these goals. The statins have proven their efficacy in reducing cardiovascular and all-cause mortality in both nondiabetic and diabetic populations, while the fibrates have shown similar benefit by an HDL-raising effect.^38,39 These agents, alone or in combination, are becoming standard therapy as part of the armamentarium for both primary and secondary risk reduction in diabetes.⁴⁰

Finally, aspirin therapy (75-162 mg daily) is recommended for primary prevention in patients with diabetes at increased cardiovascular risk and as a secondary prevention strategy for those with a history of MI, vascular bypass procedure, stroke or transient ischemic attack, peripheral vascular disease, claudication, or angina.⁴¹

Chronic disease management

Disease management is defined as the long-term treatment of a chronic illness through integrated delivery of care in order to improve health outcomes and patient satisfaction and to reduce the cost of care.⁴² In addition to educating patients and empowering them in their own self-care, this approach emphasizes well-designed and innovative clinical information systems and evidence-

based guidelines for clinicians, with feedback and ongoing quality improvement. It is important that providers participate in formulating guidelines, checklists, automated reminders, tracking systems, data profiling, and case management services that are readily accessible at the point of care. Health care organizations with established infrastructure networks have achieved better outcomes and NCQA and quality benchmarks, and they have shown improved provider and patient satisfaction scores.⁴³ Patients thus treated are indeed healthier and consume fewer resources through decreased complications, hospitalizations, and emergency care.⁴⁴ Cost savings and efficiency of care have been demonstrated as well. These strategies work best when provision of services can be coordinated in a well-knit organizational infrastructure. Population-based strategies emphasizing interventions grounded in solid, published evidence, creating diabetes registries, disseminating supporting software, and giving prompt feedback to providers are useful in favorably influencing key measures of health and quality.⁴⁵ It has been easier to emphasize preventive care in such settings.

Diabetes centers, outpatient clinics, and specialty care

Although controversy about the role of generalists and specialists in the treatment of diabetes still exists, the increasing complexity of care and need for expertise requires a critical reevaluation of this arena. Patients with type 1 diabetes do consistently better in the hands of specialists.⁴⁶ Patients with type 2 diabetes, however, do not appear to have a substantial difference in outcomes when cared for by specialists.⁴⁷ However, few studies have considered differences in patient demographics and type. A recent study showed that longitudinal care in a diabetes outpatient clinic (DOC), where patients establish an ongoing relationship with a diabetologist, correlated with improved outcomes.⁴⁸ Overall, DOC care led to better attainment of cholesterol levels and other intermediate targets. A recurrent theme is that the consistent, mutually trusting, comfortable interaction with the same provider yields superior results.⁴⁹ Minimizing variations in quality of care in the specialist setting may therefore be a strategy for improving diabetes management. Other important measures to be incorporated include efficient, coordinated delivery of health care, a hassle-free referral process, identifying and rectifying inappropriate care, utilizing new information systems, improving cost-effectiveness, and employing nonphysician clinicians such as PAs.⁵⁰

Conclusion

Diabetes and its attendant comorbidities pose a significant and increasing health burden, with the potential to become a huge health care crisis in the near future. Type 2 diabetes, obesity, the metabolic syndrome, and cardiovascular problems are closely related, and they are increasing globally. Confronting this epidemic requires concerted attention directed at lifestyle change to promote healthful behaviors and an aggressive, multifaceted treatment approach to minimize complications and disability. Despite the availability of knowledge, treatment options, and technology, there is a significant gap between commonly accepted metabolic goals and the actual care of patients with diabetes. Implementing multitargeted, interdisciplinary interventions through a collaborative approach holds promise and can be adapted to diverse primary care settings. All professionals working in a clinical setting should be in the vanguard of efforts to formulate a viable, long-term strategy to confront diabetes, its devastating complications, and its enormous economic toll.  

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