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Introduction to Basal Insulin Therapy: Clinical Management of Diabetes
Jasmine D. Gonzalvo, PharmD, BCPS, BC-ADM, CDE, LDE
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Introduction to Basal Insulin Therapy: Clinical Management of Diabetes

Jasmine D. Gonzalvo, PharmD, BCPS, BC-ADM, CDE, LDE
Diabetes is a series of metabolic conditions associated with many serious comorbidities, such as heart disease and stroke, peripheral arterial disease and lower-extremity amputations, retinopathy, nephropathy, and peripheral neuropathy. The American Diabetes Association, the American Association of Clinical Endocrinologists, and the International Diabetes Federation recommend that individuals with diabetes be as near to normoglycemic as possible. There are many glycemic management barriers among patients, such as cost, patient perceptions, and clinical inertia. Advancements in the treatment of diabetes with novel pharmacotherapeutic products have changed the therapeutic landscape of diabetes. Newer longer-acting insulin products that closely resemble endogenous insulin secretion patterns are demonstrating some improvements in clinical outcomes.
Am J Manag Care. 2018;24:-S0
 A staggering 30.3 million people in the United States (9.4%) are living with diabetes.1 A recent report from the International Diabetes Federation (IDF) predicted that by 2045, more than 35 million Americans would have diabetes.2,3 An estimated 1.5 million new cases were reported in 2015, but it is highly likely that many people with type 2 diabetes (T2D), formerly known as adult-onset diabetes, or noninsulin-dependent diabetes, go underreported or are unaware they have the disease.1 An estimated 84 million adults—about 33.9%—have prediabetes, based on results of their fasting glucose and glycated hemoglobin levels (A1C).1 What is concerning is that almost 90% of people with prediabetes are unaware of the condition.4 The United States has the highest number of people with diagnosed and undiagnosed diabetes in the world.2 Among those diagnosed, 90% to 95% have T2D, and 5% to 10% have type 1 diabetes (T1D).1 About 2% to 10% of pregnancies are affected by gestational diabetes in the United States annually.5 Along with its associated complications, such as cardiovascular disease, blindness, kidney disease, neuropathy, and lower-extremity amputation, diabetes places a substantial economic burden on the American healthcare system.6

Diabetes is considered to be a series of metabolic conditions associated with high rates of morbidity and mortality; it has been reported as the seventh leading cause of death in the United States.1,6,7 The increasing prevalence of diabetes is a serious health crisis, impacting quality of life, overall health status, direct and indirect healthcare costs, and psychosocial factors.6,8 Based on recent data (2017) collected and reported by the IDF, 176,740 deaths in the United States were related to diabetes.2

The escalating rates of prediabetes among adults 18 years or older in the United States are astounding.1 Based on published data from the National Diabetes Statistics Report, 84.1 million people had prediabetes in 2015, and nearly half of those were 65 years or older.1 As the population ages and the rates of obesity increase, the incidence of diabetes is expected to rise.6 Correspondingly, the economic burden of diabetes will significantly increase among the elderly population, according to the IDF report.2

Childhood obesity and T2D among children and adolescents are rising at alarming rates.6 An estimated 193,000 American children have diabetes and, of those, T1D accounts for approximately 169,000 cases.1,2 Children with T2D are at increased risk of developing associated disease complications by the time they reach adulthood, although efforts can be implemented to prevent or delay the onset of diabetes.2,9

Compared with white individuals, racial minorities are more likely to have higher rates of diabetes and disease-related complications.10 Although there is a higher prevalence of T1D among white children, minority children (10-19 years) are more frequently diagnosed with T2D.1

Pathophysiology of Diabetes

Elevated blood glucose concentrations are the result of the body’s inability to produce insulin or its resistance to the action of insulin, or both. Complications often arise due to years of significant hyperglycemia.6,8,11 A diagnosis of diabetes can be made based on A1C values or plasma glucose levels—either fasting blood glucose (FBG), or following an oral 2-hour glucose tolerance test (2-h PG) (Table 1).7

Although the diagnoses of people with diabetes are commonly categorized as type 1, type 2, or gestational, there are a variety of less-prevalent subtypes that have been recognized in recent years: maturity-onset diabetes of the young, latent autoimmune diabetes in adults, iatrogenic, and glucocorticoid-induced are a few select examples (Table 2).6,12-15

Type 1 Diabetes

Although known to be caused in some cases by an autoimmune response, resulting in pancreatic beta-cell destruction and impaired insulin production, some forms of T1D have no known etiologies.6,7 While clinical presentation can vary and diagnosis can be challenging, symptoms of polyuria, polydipsia, and diabetic ketoacidosis are hallmark signs of T1D.7 The American Diabetes Association (ADA) outlines 3 distinct stages of T1D, from presymptomatic (stage 1) through symptomatic hyperglycemia (stage 3). No strategies to prevent T1D are known.7 Some risk factors include family history, race, and childhood viral infections.7

Type 2 Diabetes

T2D occurs when peripheral tissues, such as muscle and adipose tissue, become progressively resistant to insulin action, and the pancreas is unable to produce enough insulin to overcome resistance.7 Many risk factors for T2D are modifiable including obesity, physical inactivity, poor nutrition, hypertension, smoking, and alcohol abuse.7 However, age, race, low birth weight, gestational diabetes, and family history are examples of nonmodifiable risk factors.7

Gestational Diabetes

Some women who become glucose-intolerant during pregnancy develop gestational diabetes.7 Common risk factors include obesity, gestational diabetes in a previous pregnancy, and having a family history of diabetes.7 Hyperglycemia can result in negative maternal, fetal, and neonatal outcomes, particularly late in the second trimester.7

Diabetes Due to Other Causes

Some factors can precipitate diabetes, such as diseases of the pancreas and specific genetic defects in beta-cell function and insulin action.7 Other causes can include select medications, such as those used in the treatment of HIV/AIDS or organ transplant.7

Complications of Diabetes

Poor glucose management can lead to life-threatening events and hospitalizations.12 The effects of prolonged hyperglycemia, insulin resistance, excessive endogenous levels of insulin, and obesity negatively impact different organ systems in the body (Table 3).6 Data collected as of 2010 from the National Hospital Discharge Survey revealed that more than 5 million hospital admissions in the United States were associated with patients with diabetes.13 Another extensive cohort study reported that severe complications, such as myocardial infarction, are likely to occur in individuals with T2D.14

Heart Disease and Stroke

Cardiovascular (CV) disease accounts for about 65% of all deaths in people with diabetes.6 In fact, people with diabetes have 2 to 4 times greater risk of death due to heart disease, according to Deshpande et al.6 Hypertension is common among patients with T2D, placing them at higher risk for CV and renal diseases.15 Investigators of the United Kingdom Prospective Diabetes Study Group (UKPDS) revealed that maintaining tight control of blood pressure in patients with T2D significantly reduced the risk of fatal CV events, retinopathy, and visual acuity.15 While it has been established that diabetes is a significant risk factor for stroke, diabetes has also been linked to increased mortality and poor poststroke outcomes.16 As demonstrated in the Lausanne Stroke Registry, people with diabetes are at greater risk for cerebral infarction or intracerebral hemorrhage with their first stroke.16

Peripheral Arterial Disease and Lower-Extremity Amputations

Diabetes and smoking are significant risk factors for peripheral arterial disease (PAD), which manifests itself as atherosclerotic occlusive disease and is associated with lower-extremity amputation.17 It is well established that PAD can be asymptomatic in patients with diabetes; often, patients present too late, and amputation is necessary.17 In an effort to avoid serious complications, people with diabetes are advised to inspect their feet daily for signs of injury or infection.17

Retinopathy

In the United States, diabetic retinopathy is responsible for the most new cases of blindness annually.17 Signs of diabetic retinopathy may manifest after 5 years following the onset of hyperglycemia. In addition to length and severity of chronic hyperglycemia, other factors, such as diabetic renal disease, hypertension, and dyslipidemia, are associated with diabetic retinopathy. Optimal glucose management may prevent the development or progression to diabetic retinopathy.17

Nephropathy

In the United States, diabetic nephropathy is the leading cause of end-stage renal disease.17 Signs of diabetic nephropathy can manifest at around 10 years of disease duration. Nephropathy is often referred to as the “silent disease,” because symptoms do not commonly appear until the later stages of chronic kidney disease. Urine albumin-to-creatinine ratio and estimated glomerular filtration rate should be assessed regularly to determine the severity or progression of diabetic nephropathy.17

Peripheral Neuropathy

Symptoms of peripheral neuropathy may present after 5 years of significant hyperglycemia, although as many as 50% of people with diabetes may not experience symptoms and would be at an increased risk for injury and subsequent complications. Optimal glucose management is the only way to prevent progressive nerve damage. Pharmacologic treatment may help with symptoms of significant neuropathy. Baseline and annual assessments with a 10-gram monofilament and a 128-Hz tuning fork are useful to identify individuals at a high risk of injury, infection, and complications.17

Available Therapies and Challenges Associated With Insulin Use

Optimal glycemic management is the cornerstone of reducing the risk of serious complications associated with diabetes.18 The ADA publishes annual Standards of Medical Care in Diabetes, which provide evidence-based clinical guidance to help optimize care for people with diabetes.7 The American Association of Clinical Endocrinologists and the American College of Endocrinology (AACE/ACE) also regularly publish updated approaches to the management of diabetes (Table 4).19

The ADA recommends an A1C goal of less than 7.0%, and target glucose levels 80 to 130 mg/dL (preprandial) and less than 180 mg/dL (postprandial).7 AACE/ACE recommends patients achieve and maintain A1C less than 6.5%, preprandial glucose target less than or equal to 110 mg/dL, and peak postprandial glucose target less than or equal to 140 mg/dL.19 Among clinicians, it is a well-accepted practice to set patient-specific glycemic goals that account for comorbid conditions, or lack thereof.7,19

 
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