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DOI: 10.1177/0145721705285638 © 2006 American Association of Diabetes Educators; Published by SAGE Publications
Dispelling Myths and Removing Barriers About Insulin in Type 2 DiabetesFrom the Plaza Pharmacy and Wellness Center, Gainesville, Texas. Correspondence to Jerry Meece, RPh, FACA, CDE, Plaza Pharmacy and Wellness Center, 411 N. Grand Avenue, Gainesville, TX 76240. The burden that diabetes has placed on the health care system as a result of increased morbidity, mortality, and economic costs has continued to increase with each new decade. A review of data from the Third National Health and Nutrition Examination Survey (NHANES III; conducted 1988-1994) and the NHANES 1999-2000 shows that there is a smaller percentage of patients with diabetes that are at the American Diabetes Association glycosylated hemoglobin (A1C) goal of 7% than there was 10 years ago (35.8% today vs 44.5% 10 years ago). When looking more broadly at the 3 main outcome measures from NHANES 1999-2000, only 7.3% of the participants surveyed were within target goals for A1C levels, blood pressure levels, and total serum cholesterol levels, despite newer medications, technologies, and knowledge that developed during the past decade.1 Of the 27% of surveyed patients with type 2 diabetes receiving insulin therapy, fewer than one half achieved the recommended A1C level of 7% or less.1 These findings suggest that a concerted effort with all members of the diabetes care team is needed to achieve and maintain the goals that will decrease complications, reduce costs, and increase patient quality of life. Insulin is safe, effective, and the most potent drug available to achieve glycemic targets. Unfortunately, it is not used early enough, often enough, or aggressively enough to cause patients to achieve glycemic goals that have been proven to reduce morbidity and mortality. A major reason for this is the many myths and barriers held by patients and health care providers alike regarding insulin use that can present challenges to starting insulin therapy. Diabetes educators play a major role in helping to dispel these myths by having conversations with patients that allay fears and misconceptions. Conversations about the role of insulin in the successful treatment of type 2 diabetes could be one of the missing elements in allowing a larger number of patients with diabetes to achieve target glycemic goals. An informal survey of diabetes educators conducted prior to the 32nd annual American Association of Diabetes Educators meeting in August 2005 identified the following barriers to starting insulin:
This article will address these barriers, primarily focusing on patient resistance but also on providing insight as to how diabetes educators can enhance communications between patients with type 2 diabetes and health care providers by promoting active self-management and reducing barriers to effective therapy.
Myth: Insulin Is Only for Patients "Failing Oral Therapy" However, it is well known that as time goes on, type 2 diabetes becomes more challenging to manage. Most patients with type 2 diabetes will eventually need to use insulin because of the natural course of the disease, a point that should be explained to patients early on. The fact is that type 2 diabetes is a progressive disease characterized by insulin resistance and insulin deficiency. The United Kingdom Prospective Diabetes Study (UKPDS) showed that by the time an individual is diagnosed with type 2 diabetes, they may have only half the number of ß cells of someone without diabetes (Figure 1).3 Furthermore, by 6 years after diagnosis, more than 50% of patients will require insulin. This increase in the number of patients requiring insulin occurred regardless of which oral antidiabetic drugs (OADs; chloropropamide or glipizide) the patient was currently using.4,5 Even with the availability of newer OADs, diabetes control has not improved substantially. Thus, the use of insulin is both appropriate and necessary in many patients with type 2 diabetes.
Diabetes educators should help patients understand that the failure of therapy is not their fault but is due to the progressive nature of the disease and that the most important thing is to work together to make sure that the treatment matches the pathophysiology of the disease, which may include the use of insulin. Explaining to patients that insulin should be prescribed when it is the most appropriate agent is helpful in getting them to accept the initiation of insulin as a well-thought-out course of action to decrease complications. Such conversations between educator and patient may go a long way toward acceptance of this therapy earlier in the course of this disease.
Needle Phobia
Insulin-delivery systems, such as pens, can also help to minimize needle fear. Insulin pen devices have been developed to offer easier, safer, more accurate, and more discreet insulin injections. The use of insulin delivery systems, available for various types of insulin products, can improve patient acceptance and provide accurate and easier dosing than conventional syringes. The benefits of insulin delivery devices include (1) accurate dosing, (2) faster and easier injection times, (3) increased patient acceptance and adherence, (4) faster and easier ability to change dosage settings, and (5) automatic resetting of the dosing button after drug delivery in some devices.7-9 Pen needles are also sharper than standard insulin needles are because they do not go through the insulin vial stopper prior to injection. An important role of the diabetes educator is to take the time to sit down with the patient and ask open-ended, nonjudgmental questions that help the patient address his or her concerns and aid in decision making in all areas of diabetes management. Considering that most patients will eventually use insulin, the issues concerning insulin should be given special attention. Questions such as, "What are your biggest concerns about starting insulin?" get directly to the issues concerning the patient's fears as opposed to trying to lecture and convince the patient from the viewpoint of an educator. Addressing specific concerns and pointing out the advantages of getting blood glucose levels under control (more energy, less complications, less trips to the bathroom at night, etc) as well as pointing out the advantages of insulin pen devices can greatly reduce the degree of PIR.
Fear of Complications Several major studies have shown that good glycemic control (including the use of insulin) lowers the risk of complications. Results of the Diabetes Control and Complications Trial,10 the Kumamoto study,11 and the UKPDS5 showed that each decrease of 1% in A1C levels results in a 20% to 30% risk reduction in microvascular complications. The results from the Epidemiology and Diabetes Interventions and Complications study suggest that the earlier intensive therapy begins and the longer it is maintained, the better the chances of reducing complications of diabetes.12 Recent studies have shown that tight control, such as that available with insulin therapy, reduced heart attacks and stroke by 57%.13 Put simply, tighter control means fewer complications over time. The best educators not only have the skills to understand complex studies such as these but also have the ability to explain them in terms that can be easily understood by their patients.
Many Options Are Available to Initiate Insulin Therapy in Type 2 Diabetes One of the barriers to the early and aggressive use of insulin is the belief, often held by clinician and patient alike, that starting insulin may be too complicated and too time-consuming. Diabetes educators can ameliorate this by becoming familiar with proven initiation and subsequent titration protocols and procedures for insulin use (see the Pearson and Powers article in this issue). Upon approval by the physician, printed titration schedules can be offered that empower patients to help manage their own insulin regimens. Educators can easily go a step further by working collaboratively with the physician and providing him or her with suggested protocols that the diabetes center can initiate upon referral. Since each state has its own collaborative practice laws, educators should check out the specific laws in their states covering this subject. Delays in starting insulin for patients with type 2 diabetes may be due in part to uncertainty about how best to make the transition from oral therapy to insulin. While there is no one "right" way to initiate insulin therapy, there are several options depending on the patients' preference, needs, and abilities. Recent studies provide evidence-based guidelines that present relatively clear guidance on treatment protocols.14-16 These studies show that when appropriate glycemic targets are chosen and a systematic titration of insulin dosage is agreed on by both the clinician and patient, several methods of initiating insulin may be successful. These guidelines can be customized and modified to suit individual patient needs and, for example, be carried out in an appropriate time frame for the patient. There is no mandate to aggressively titrate insulin therapy as is often done in clinical trial settings; titration can be approached as needed. For patients who are unable to reach or maintain adequate glycemic control using oral medications, insulin is indicated and consideration must be given to which regimen to use. One such regimen that has proven to be effective is starting with once-daily injections of basal insulin, such as insulin glargine.16 The Treat-to-Target Trial provided guidelines for a systematic method of initiation and titration of a basal insulin analog added to oral therapy in patients who had not achieved glycemic goals with oral therapy alone (Table 1). With these straightforward guidelines and the low variability of absorption with basal insulin products, such as insulin glargine and insulin detemir (due to be on the market in the first part of 2006), diabetes educators can work with patients to help them to achieve their glycemic goals with a much lower risk of nocturnal hypoglycemic events. The reported levels of patient adherence to treatment protocols in the Treat-to-Target Trial were greater than 90%, suggesting that this regimen was easy to follow.16
If a patient has satisfactory control while receiving a combination of OADs and basal insulins, such as NPH or insulin glargine, then prandial insulin is not required. Failure to achieve satisfactory control should suggest the need for intensification of therapy, which can be achieved by the addition of prandial insulin. The use of basal insulin alone does not cover prandial or mealtime glucose excursions. When A1C values are high, the first goal of therapy is to reduce fasting plasma glucose (FPG) levels. However, as A1C values are lowered, there is an increasing contribution of postprandial glucose (PPG) levels to A1C values. For instance, in patients with A1C levels <7.3%, postprandial glycemia accounts for approximately 70% of overall glycemia and fasting glucose concentrations account for the remaining 30%.17 Control of PPG has been shown to be important since postprandial hyperglycemia is a more important predictor of macrovascular complications than FPG is (Figure 2).18 Thus, treatment should focus on both FPG and PPG to reach and maintain A1C targets.
The use of premixed insulin analogs, such as insulin lispro 75/25 or insulin aspart 70/30 to initiate insulin therapy, provides a simple way to deliver both mealtime and basal insulin in one formulation. The recent 1-2-3 Study demonstrates how a practitioner can transition a patient to insulin using an analog premix, often starting with a single daily dose with the flexibility to increase the number of doses in patients who require more insulin to achieve glycemic targets. In this study, the use of once-daily insulin aspart 70/30 allowed 41% of the patients to achieve A1C goals of less than 7%, while 77% of the patients achieved an A1C level of less than 7% with 1, 2, or 3 doses a day. Patient doses were titrated upward at 16 and 32 weeks based on A1C levels using a simple, straightforward protocol with little or no increased risk of hypoglycemia.14 Dosing guidelines for this strategy are shown in Figure 3.
The INITiation of Insulin to Reach A1C TargET (INITIATE) study group provides guidelines for twice-daily initiation of a premixed insulin analog, insulin aspart 70/30.15 In this dosing protocol, premixed insulin is started with 6 U twice daily if FPG levels are >180 mg/dL (9.9 mmol/L) or with 5 U twice daily if FPG levels are <180 mg/dL (9.9 mmol/L). Insulin is then titrated in 2-U increments (2 U for self-monitored FPG 111-140 mg/dL [6.1-7.7 mmol/L], 4 U for FPG 141-180 mg/dL [7.8-9.9 mmol/L], and 6 U for FPG >180 mg/dL [9.9 mmol/L]). This proved more effective than a single dose of insulin glargine, perhaps emphasizing the importance of postprandial coverage. Results were similar when twice-daily insulin lispro 75/25 was compared with a single dose of insulin glargine.19
In all the above trials, the use of insulin analogs allow for a systematic methodology for initiating and titrating insulin because of the ability of analog insulin to physiologically mimic the basal and bolus effects of endogenous insulin. Rapid onset of action and low variability from dose to dose allows for adjusting insulin doses with a low risk of hypoglycemia. If patients are using human premix and have issues with hypoglycemia or variability, they can switch unit for unit to a premixed analog. Patients should be reminded, as always is the case when initiating or changing medication regimens, to test their blood glucose levels more often until a clear picture of glycemic levels throughout the day is achieved.
Convenience for the Patient
Rapid-acting insulin analogs or premixed insulin analogs delivered with insulin pens (or in pumps) offer a tremendous advantage to a patient's ability to adhere to insulin regimens, regardless of lifestyle. With insulin pens, having the ability to carry a rapid-acting insulin, such as insulin lispro, insulin aspart, or insulin glulisine, in an injection device that is only slightly larger than an ink pen improves patient adherence. This is because the insulin can be injected immediately before meals, rather than the 30- to 45-minute interval needed with regular human insulin, and because the pen delivery systems are more discrete and easy to carry. Insulin can be administered discreetly at the dinner table, at sporting events, or wherever the patient happens to be. As opposed to the previously mentioned patient on regular insulin, consider that same patient carrying an insulin pen, being able to look over a menu, wait for the meal to arrive, and make an insulin adjustment based on food choices and quantities that he or she feels like eating at the time. Convenience, comfort, and discreetness with insulin pen delivery systems using insulin analogs help patients with diabetes have a greater chance of achieving glycemic goals while maintaining quality of life.
Minimizing Potential Side Effects of Therapy
Hypoglycemia It is often because of hypoglycemia that many patients with type 2 diabetes become frustrated with attempts at treatment intensification. One way for the educator to allay these concerns is to help patients understand that hypoglycemic events occurred more often in the past with some of the older insulin products that have suboptimal physiologic profiles and that a better understanding of the cause and effects of hypoglycemia has helped to reduce both the frequency and severity of these reactions. Insulin analogs, which more closely mirror the actions of endogenous insulin than human insulin products, also help to decrease the incidence and severity of hypoglycemic events. In fact, several studies have shown that insulin analogs are associated with less hypoglycemia than human insulin is, especially at night.16,23-26 Other ways to reduce the number of hypoglycemic events is for educators to take time to gain a better understanding of how insulin fits into the patient's lifestyle, such as exercise regimens, work schedules, and meal times, and to help both the physician and patient decide which regimen and delivery system works best for their individualized needs. Patients should be made aware that although some degree of hypoglycemia may occur in up to 30% of patients receiving insulin, severe hypoglycemia is rare and has been shown to affect only about 0.5% of patients with type 2 diabetes, a rate much lower that that seen in patients with type 1 diabetes.27 Hypoglycemia needs to be addressed as early as possible upon onset, and the role of the educator is integral in helping patients achieve glycemic goals by helping them to understand how to recognize, treat, and avoid this problem. Patients should have a good understanding of not only the general symptoms of hypoglycemia, such as hunger, perspiration, nervousness, and confusion, but also their individual initial symptoms that may help prevent more severe hypoglycemia episodes from occurring. Symptoms and causes of hypoglycemia are summarized in Table 2. Gaining an understanding of the earliest symptoms allows these events to be easily managed with a snack or another glucose source. Patients should also be made aware of the difference between major and minor hypoglycemia and how to manage each. The definition of major hypoglycemia is an episode in which the patient requires assistance or treatment and, if inadequately treated, may be life threatening.28 In contrast, minor hypoglycemia refers to episodes that can be self-treated by consuming fast-acting carbohydrates. It is important to note that major hypoglycemia should be treated as an emergency. Glucagon injection kits are available for the emergency treatment (administered by family members) of major hypoglycemia since patients with major hypoglycemia are usually unconscious or very confused and sleepy. It is important for the educator to positively frame the message as hypoglycemia is discussed. Explaining to them that while it is true that the closer to A1C goals a patient gets the greater the likelihood of minor hypoglycemia, the benefits of lower A1C levels far outweigh concerns about minor episodes of hypoglycemia.
The guiding principle to avoid hypoglycemia when initiating insulin is for both educator and physician to "start low and go slow," titrating upward as both patient and health care provider gain confidence through more frequent blood glucose monitoring about the insulin requirements needed when combined with the individual's lifestyle. The role of education is critical to limit the risk of hypoglycemia. Every patient started on insulin should be referred to a diabetes educator. Additional issues that will need to be discussed include instructing the patient to avoid missing meals, injecting insulin at the right time (30-45 minutes prior to meals for short-acting regular insulin and 10-15 minutes before a meal for rapid-acting analogs and premixed insulin), the impact of physical activity on glucose levels, and being aware of the effects of alcohol consumption.
Weight Gain Weight gain may come from several sources. With improved glycemic control, weight gain may be due to decreased glycosuria, resulting in more glucose absorption and therefore more calories retained. Fluid retention has also been cited as a possible cause. Another factor is patients eating more to treat or prevent hypoglycemia or perceived hypoglycemia that is associated with intensive treatment. The educator should do a thorough review of the patient's blood glucose log to discuss insulin doses if in fact hypoglycemia is occurring. There should also be a discussion to ensure that the patient is not overtreating hypoglycemia by overeating, rather than correctly matching carbohydrate intake to the severity of the reaction. In addition, it can be seen that with improvement in daily blood glucose levels, patients often feel they have the ability to "cheat" on their meal plans more often. The benefits of good glycemic control on reducing the risk of diabetic complications through the appropriate use of intensive therapy should prevail over concerns for weight gain. To minimize this risk, patients starting on insulin should be seen by a dietitian who can help match food choices with insulin dosing as well as explain special efforts they can make regarding diet and exercise to keep weight gain to a minimum. The use of insulin analogs rather than human insulin may reduce weight gain. Patients with type 2 diabetes treated with insulin aspart 70/30 had significantly less weight gain compared with those treated with human premix insulin (0.05 vs 2 kg).23 In the Treat-to-Target Trial, insulin glargine was associated with less weight gain than NPH was.16 The new long-acting insulin analog, insulin detemir, has been shown to be associated with less weight gain than NPH in patients with type 2 diabetes.29 Recently, the combination of metformin and insulin has been shown to be associated with weight loss. This seems to be mostly due to a decrease in food intake (anorexic effect) that was associated with the use of metformin.30,31
Cost A cost analysis over a 9-month period in 1177 patients with type 2 diabetes who were switched from oral medications to insulin found that although insulin initiation increased health care costs by 10% during the initial postinsulin period, subsequent health care expenditures were reduced by 40% over the remainder of the 9-month period following insulin initiation.33 Another recent study compared the cost, efficacy, and safety of metformin and human insulin 70/30 with that of a triple oral regimen in patients who had an inadequate response to 2 OADs (A1C >8%).34 Human insulin 70/30 plus metformin was as effective as 3 OADs in lowering A1C and FPG values. The triple oral regimen was not as cost-effective, and a high percentage of patients did not complete this regimen because of a lack of efficacy or adverse effects. Results showed that human insulin 70/30 and metformin cost $3.20 per day compared with $10.40 per day for 3 OADs. Another factor to consider is that with a large portion of patients with diabetes having prescription cards with various co-pays (depending on the tier or level of co-payment that a drug has in the prescription benefit plan), the amount of co-payment saved by using insulin versus 3 OADs could be significant. A closer look at the oral regimen of every patient who is not achieving control is warranted, depending on the type of oral medication(s) used. Insulin might not only be more cost-effective but also may help achieve better glycemic outcomes.
Diabetes is a complex, progressive, highly individualized disease. To achieve the glycemic control that is required to avoid the serious complications that may occur as a result of chronic hyperglycemia, a comprehensive team effort is required. Patients can achieve glycemic control when the diabetes management team recommends appropriately intensive therapies, provides diabetes self-management training, and assists patients in understanding the value of their individualized therapy. As an integral part of that team, diabetes educators must be vigilant in recognizing patients who are failing to meet glycemic goals on oral medications and be able to transition patients, without the clinical inertia often found in clinical settings, to insulin regimens that are simple and effective. Dispelling myths and removing barriers about insulin therapy is a valuable service that can be provided by educators to ensure the ability to maintain glycemic control over the course of type 2 diabetes. Insulin should now be viewed as a valuable therapeutic tool for early intervention that allows patients to attain and maintain target levels of blood glucose control. There are now published guidelines that provide several options for the initiation of insulin therapy, including a choice of products and a choice of schedules. Furthermore, while there are many ways to implement insulin therapies, the one that the patient understands and agrees to is likely to be the most effective treatment.
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Simplifying Insulin Initiation...
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