August 2009
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Eliminating Obstacles to Achieve Improved Health Outcomes in Diabetes Patients
When strategies to help patients overcome barriers to tight control are implemented, better outcomes lay ahead.
By Linda M. Siminerio, RN, PhD, CDE
Diabetes has reached epidemic proportions, and it is well documented that many patients do not attain optimal glycemic control. Part of the reason for this is a lapse between treatment failure and subsequent therapy intensification. A better understanding of the diabetes treatment options, realistic goals, and continued follow-up to support treatment adherence are crucial to improving care and outcomes in the setting of diabetes. Diabetes patients confront many barriers that can prevent them from achieving glycemic control. These barriers include medication side effects, psychosocial issues, and access to support services. The following is a summary of an article that appeared in a supplement to The Diabetes Educator (volume 34, supplement 1, Jan/Feb 2008).
Strategies to overcome barriers have been developed. Pramlintide (Symlin, Amylin Pharmaceuticals), an adjunct to insulin therapy, is an antihyperglycemic agent approved for treatment in both type 1 and type 2 diabetes. If patients are educated regarding all aspects of the proper use of this therapy before health care practitioners add it to insulin therapy, patient adherence can be optimized, in turn improving treatment outcomes.
STILL NOT REACHING GOAL
Much work has been done to enhance the understanding of the pathophysiology of diabetes and the efficacy of available therapies; however, The State of Diabetes in America report showed that, from 2003 to 2004, only 33% of adults with type 2 diabetes achieved the American Association of Clinical Endocrinologists target A1C level of 6.5%.1 More concerning, it appears that the rate of failure to meet target A1C is rising. The proportion of type 2 diabetes patients who failed to achieve the American Diabetes Association target of an A1C level of <7% increased from 55.5% during 1988 to 1994 to 64.2% during 1999 to 2000.2
One potential reason patients are not meeting targets is that type 2 diabetes is not always treated sufficiently and aggressively. Type 2 diabetes is a chronic and progressive disorder that requires advancement of therapy,3 but often, there is a lapse between treatment failure and intensification of therapy. Additionally, effective treatments—especially insulin and injectable adjunctive therapies—are often underused. It is likely that both patients and health care providers are reluctant to advance to injectable medications.4,5 Even patients already taking insulin can balk at intensification of treatment due to fears of hypoglycemia and weight gain.3,6-10 To overcome these barriers to enhanced glycemic control, an approach combining diligence by the provider, patient education, and the support of a dedicated management team that includes a certified diabetes educator (CDE), and the use of alternative insulin formulations and adjunctive therapies can be successful.
ANTIHYPERGLYCEMIC THERAPIES
The traditionally available treatments for type 2 diabetes—insulin and oral antihyperglycemic agents (sulfonylureas, meglitinides, biguanides, thiazolidinediones, and a-glucosidase inhibitors)—have been expanded with new therapies such as pramlintide, exenatide (Byetta, Elil Lilly and Amylin), and sitagliptin (Januvia, Merck Inc., & Co). These newer agents are effective in improving glycemic control for appropriate patients. They have many similar biological actions and clinical effects but differ in their mechanism of action, indications, and route of administration (Table 1).11-19
Traditional therapies for type 1 diabetes are injectable insulin, medical nutrition therapy, and physical activity. Numerous types and formulations of injectable insulin (rapid- or short-acting, intermediate- or long-acting, basal, premixed) emerging alternative insulin delivery systems, as well as pramlintide, are available for type 1 diabetes treatment.11
Pramlintide is also indicated as an adjunct to insulin for patients with type 1 or type 2 diabetes who are not sufficiently controlled by optimal insulin therapy. Patients prescribed pramlintide therapy may put up similar barriers to acceptance as with insulin therapy. Some obstacles are injection-related (eg, fear of needles, attitude toward injections, and advancement of therapy) and others are more general and commonly encountered in the treatment of many chronic disorders due to barriers such as adverse effects and limited access to resources and education.4,5,8,20 Many techniques and interventions work for overcoming these barriers and improving glycemic control (Tables 2 through 4).
OVERCOMING PSYCHOSOCIAL BARRIERS TO INJECTABLE MEDICATIONS
Needles. Needle phobia is rare and associated with substantial psychological comorbidity, however, an aversion to injections is common.22,23 Patients frequently are not only anxious about the pain of injections, but they may be embarrassed by the stigma of injecting themselves in public, and apprehensive about self-administering injections.4,5 To overcome these barriers, communication between the health care provider and the patient and education are key.6,20
Attitude. Some physicians are reluctant to initiate injectable therapy. One reason is that they have negative attitudes that they pass on to their patients.4,7,8 It is detrimental for practitioners to use advancement to insulin therapy as a threat to induce patient compliance.4,7 A positive attitude is crucial for patients to embrace any treatment regimen, and the health care provider can reinforce thus and promote the benefits of the treatment.7,24
Adherence. Treatment regimen adherence is a major part of managing any chronic disease. The positive impact of educating patients in self-management on adherence and treatment outcomes has been shown.21 Good communication between the provider and patient involves identifying the patient's attitudes and beliefs in order to determine necessary education. Be sensitive to cultural issues. It is important for practitioners to realize that patients often have health literacy and language problems that should be addressed by avoiding medical jargon, clarifying and restating messages, and regularly assessing recall and comprehension.7
When the patient's concerns and needs are addressed first, this will open the door to a discussion of the larger issues of the importance of glycemic control and the need for adding an injectable therapy.20 When patients are involved in their own care, through goal setting and other behavioral strategies, adherence is improved, and patients are more satisfied with their health care providers. When the patient perceives that the provider cares about his or her emotional well-being, adherence is improved, and better clinical outcomes are seen.4,7
When treatment regimens become more complex, adherence suffers.7 For patients who are having trouble, simplifying the regimen or recommending systems to make things easier can improve adherence. Patient adherence may be improved by the convenience of premixed injectable antihyperglycemic medicines and agents in prefilled pens that allow for injection immediately before a meal, for example.20
OVERCOMING SIDE-EFFECT BARRIERS
Adverse effects can hinder medication adherence. With insulin, the most troublesome of these are hypoglycemia and weight gain.4,20 Pramlintide alone does not cause hypoglycemia, however, the likelihood increases when pramlintide is added to insulin. The most dose-limiting adverse effect associated with pramlintide is nausea, which is usually mild to moderate and decreases over time.11 Perhaps the most important tip for overcoming the side effect barrier is communication. Remind patients that they will feel better once glucose levels are at target, advancement of therapy is necessary to achieve control, and that loss of control is due to the chronic, progressive nature of diabetes, not because they have failed.4
OVERCOMING RESOURCE AND EDUCATION BARRIERS
Another barrier related to injectable drugs is related to limited health care resources and a lack of educational materials.21 There are, however, many educational materials and resources available for education on pramlintide (professional education tools, self-management education programs, and patient education). The involvement of CDEs will ensure successful outcomes with pramlintide.11
Often primary care providers in private practice setting do not have access to team care and support services, putting them at a disadvantage with regard to managing chronic diseases as complex as diabetes.8,28 Optimal diabetes management requires a coordinated multidisciplinary team of health care professionals.28-30
USING PRAMLINTIDE IN DIABETES MANAGEMENT
Education. Patient education begins with the educator performing a thorough assessment of patients' level of understanding and knowledge of their medications. Patients should have a basic understanding of the role of postprandial glycemic control and how medications such as pramlintide help control postprandial glucose. Education about medical nutrition therapy and carbohydrate counting is also important. Self-management education, which includes how to adjust insulin doses in response to blood glucose monitoring of premeal and postmeal glucose levels, is imperative.
Benefits of pramlintide. Pramlintide is indicated for patients who are already taking mealtime insulin. Education about pramlintide should stress that it is not another insulin, but rather that it is a different class of drug with numerous benefits for the patient, including improved postprandial glycemic control and increased satiety, leading to weight loss.11 These are powerful incentives for patients who have struggled with glucose fluctuations, constant hunger, and weight gain.
Adverse effects. Pramlintide alone does not cause hypoglycemia, however, the likelihood of hypoglycemia increases when it is used as an adjunct to insulin. Nausea is the most troublesome dose-limiting adverse effect associated with pramlintide11 (see sidebar).
Injections. Pramlintide should be injected subcutaneously into the abdomen or thigh on a rotating basis. Because mixing pramlintide with insulin alters its pharmacokinetic parameters, pramlintide should be administered separately from the insulin injections. Pramlintide should not be mixed with any type of insulin, different syringes should be used for pramlintide and insulin injections, and the injection sites should be at least 2 incges apart.11
CDEs. Education is an ongoing process, therefore, CDEs working with patients taking pramlintide need to identify and address barriers, provide education about the benefits and risks, and demonstrate the skills necessary for a successful outcome. Once treatment has been initiated, CDEs should continue to work with patients to appropriately and safely adjust their medication doses.
CONCLUSION
The progressive nature of diabetes presents continuous management challenges, especially when it comes to treatment intensification. Even patients who are taking optimal insulin are often frustrated by insulin-induced hypoglycemia and weight gain in their attempts to achieve glycemic control.
Pramlintide is an amylin analogue that works with insulin in a physiological way to reduce postprandial glucose excursions, lessen glucose fluctuations, lower A1C levels, and decrease insulin use. It may help curb appetite and reduce food ingestion, resulting in progressive and sustained weight loss. Although there are many benefits to the inclusion of therapies such as pramlintide, there are several areas to consider. With careful attention to strategies such as self-management education and titration of the pramlintide dose, this therapy can be successfully incorporated. Barriers are most likely to be overcome by a health care provider who has expertise in managing diabetes and is supported by a multidisciplinary health care team that includes a CDE.
Communication and education, along with ongoing support of the patient, are the keys to overcoming the barriers and improving glycemic control.
Linda M. Siminerio, RN, PhD, CDE, is from the Department of Endocrinology and the Diabetes Institute, University of Pittsburgh School of Medicine, Pittsburgh. She disclosed that she is a consultant for Amylin Pharmaceuticals, Inc, and Eli Lilly and Company. She serves on the advisory board Lilly and the speakers' bureau for Sanofi-Aventis.
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