How Our Current Medical Care System Fails People With Diabetes

M any randomized controlled intervention trials have demonstrated that lowering glycemia (1,2), LDL cholesterol (3), and blood pressure (4) will markedly benefit the complications from diabetes. Based on these data, the American Diabetes Association has recommended the following targets for glycemic, lipid, and blood pressure outcome measures, A1C 7.0%, LDL cholesterol 100 mg/dl, and blood pressure 130/80 mmHg, respectively (5). Most diabetic patients do not meet these recommended goals. Approximately half of the National Health and Nutrition Examination Survey cohort met the glycemic goal (6). In other larger reported populations, 21–43% of patients had A1C levels 9.5%, only 22–46% of diabetic patients met the LDL cholesterol goal, and 29–33% met the blood pressure goal (7). Far fewer, 2–10%, met the combined American Diabetes Association goals for glycemia, lipids, and blood pressure (7). Many approaches have been tried to improve diabetes care but, with one exception, have been mostly ineffective. These include simply reminding patients about appointments; providing laboratory information on the patient to the physician, even when specific treatment recommendations for the individual patient were included; case management when the case manager could not make independent treatment decisions; education of physicians; and multifaceted quality improvement interventions in the practice setting (7). The small amount of time a physician has to spend with a patient is an important limiting factor. This was amply illustrated in a study (8) in which eight process measures agreed upon by the physician group and whether the patient was due to receive them were displayed on the physicians’ computer screens at the time of the patient visit. The measures due were performed or ordered only onethird of the time. Physicians pinpointed lack of time and other problems that needed attention as primary obstacles to carrying out the agreed-upon recommendations. The one approach that has proven to be effective is using specially trained nurses or pharmacists, under appropriate supervision, with authority to make medication changes without consulting the physician as long as the changes fell within approved treatment algorithms. In randomized clinical trials, A1C levels fell threefold more in 1,969 patients followed by nurses and pharmacists compared with 1,573 patients under usual care (7). Several nonglycemic outcome measures also significantly improved with nurseor pharmacist-directed diabetes care compared with usual care. These included LDL cholesterol, triglycerides, and systolic and diastolic blood pressure (7). These impressive results stand in contrast to case management in which nurses do not have prescriptive authority (7). Perhaps the best evidence for the importance of the nurse or pharmacist to have authority to make independent clinical decisions comes from a direct comparison of programs in the same institution. A diabetes case management program in which medication changes by nurse practitioners required approval by the primary care physician was initially established and compared with usual care. Baseline A1C levels averaging 9.0% did not change over 18 months in either the control or intervention group (9). Subsequently, in the same medical care setting, a clinical pharmacist was allowed to make independent clinical decisions based on an approved protocol. Baseline A1C levels averaging 10% fell by 0.9% in the control group and 2.1% in the intervention group over 12–24 months (10). The results of these two studies within the same institution treating the same population were supported by a recent metaregression analysis on the effects of quality improvement strategies to improve glycemia in type 2 diabetes (11). Interventions in which case managers could adjust medications without awaiting physician approval achieved the most robust improvements, whereas other approaches had minimal effect. The critical factor that underlies the success of specially trained nurses or pharmacists to improve the outcomes of diabetes care is that timely and appropriate clinical decisions are made. The decisions are appropriate because they are based on approved treatment algorithms. However, timeliness of these decisions is also very important. The fact that more time can be spent with the patient, not only in the office dealing specifically with diabetes but also outside of the office via other means of communication, is critical for improved outcomes. For the most part, except for the minority of patients who have polyuria and polydipsia secondary to severe hyperglycemia or those who have diabetes complications, diabetes care is preventive care, i.e., controlling glycemia, lipids, and blood pressure in asymptomatic people. These issues often receive short shrift in the 10 min or so that most patients spend with primary care physicians, who often have other more immediate concerns. Moreover, patients are often seen only every 3 months or so, thus ensuring that glycemia, lipids, and blood pressure could remain out of control for long periods of time. This schedule wastes opportunities to bring these patients under control much more quickly because the maximal responses to changes in medication doses or introduction of new classes of drugs for treating glycemia (except for thiazolidinediones), lipids, and blood pressure all occur within a month. Most treatment decisions involving control of glycemia, lipids, and blood pressure do not require a face-to-face meeting with a provider. Titration of most oral medications for glycemia can be made based on fasting plasma glucose concentrations measured by a laboratory or by a glucose meter at home, with subsequent dose adjustments based on A1C levels (online appendix of ref. 12, available at http://dx.doi.org/10.2337/dc08E d i t o r i a l s