How do we gauge the success of treatment of diabetes?

Type 2 diabetes is one of the fastest growing epidemics in human history. It comprises a group of related disorders generally thought to be characterized by progressive pancreatic b-cell failure against the backdrop of resistance to insulin action, although there is clearly heterogeneity in this progression. Lifestyle measures of weight loss and exercise should always be considered as major components in treatment, but these measures alone are successful only in a minority of patients. Pharmacological intervention with blood glucose-lowering agents is almost always needed. So, where do we stand with the treatment of type 2 diabetes? The progression of insulin secretory dysfunction requires ongoing assessment of metabolic control and, typically, intensification of therapy with increasing doses of oral hypoglycemic agents and, ultimately, with insulin. Now it seems that we are at the beginning of yet another set of recommendations and guidelines leading to yet another series of type 2 diabetes treatment algorithms. The 2008 American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) ‘‘consensus algorithm for the initiation and adjustment of therapy’’ of type 2 diabetes was, in retrospect, based on a conceptually incorrect hierarchy of supposed glycemic benefits of existing treatment approaches that failed to take into account varying baseline levels of glycemia. It omitted important approaches to treatment and added treatments only after failure of previously used medications. In part as a response, in 2009 the American Association of Clinical Endocrinologists (AACE) published a rather different set of recommendations. Other sets of recommendations include those of the Spanish and Finnish professional organizations. Now, the ADA and EASD have issued a new ‘‘position statement [on the] management of hyperglycemia’’ in type 2 diabetes, giving yet another set of treatment concepts. Is it any wonder there is confusion out there globally? Is the notion of an algorithm, in concept a set of decision-making rules that could be adapted to a computer program, even appropriate? An issue common to all the sets of recommendations is the need to address potentially conflicting goals. For example, in the new ADA ⁄EASD statement, the group’s earlier unitary ‘‘goal’’ of HbA1c <7% has been replaced by ‘‘individualization’’ to meet the needs of the patient. For people with diabetes who are ‘‘younger, healthier’’, the target HbA1c is 6%–6.5%. However, the statement recommends HbA1c 7.5–8% or more for those who are either older, or who have comorbidities, or those who may be prone to hypoglycemia. In fact, seven separate dimensions of patient characteristics are cited to allow the physician to determine that a lesser goal is appropriate. These include what one would think of as psychosocial characteristics, such as the patient’s ‘‘resources and support systems’’ and their ‘‘attitude and expected treatment efforts’’. Also included are longer diabetes duration, shorter life expectancy, established cardiovascular disease complications, and other ‘‘important comorbidities’’, leading the authors of the statement to recommend that achievement of HbA1c <7% not be considered a ‘‘quality indicator’’. We will not be able to turn to randomized controlled trials for ‘‘evidence’’ of who should and who should not be treated. These cannot offer sufficient flexibility of medication and patient characteristic combinations to allow such decision making. In an important sense, we should ask whether the glycemic ‘‘goal’’ does, in fact, change with increasing illness. Rather, to the glycemic goal we should add the goal of avoidance of adverse potential treatment effects, particularly hypoglycemia and weight gain, as well as specific ill-effects of individual agents on the gastrointestinal tract, on bone, on the cardiovascular system, and on the likelihood of malignancy. In addition, one must consider cost and availability, which vary from country to country, as well as within given countries among varying reimbursers. We must not, however, be seen as encouraging professionals treating people with diabetes to default to non-treatment of glycemia, giving so many potential reasons to do less that there is no reason to aim for improvement. Perhaps it is time to return to the days of recommending astute clinical judgment! doi: 10.1111/j.1753-0407.2012. 00218.x Journal of Diabetes 4 (2012) 193–194