In the past two decades, we have acquired an enormous amount of knowledge regarding the epidemiology, diagnosis, pathophysiology and treatment of type 2 diabetes and its comorbidities. In addition to the earlier landmark blood lipid and blood pressure lowering trials, the latest blood glucose lowering megatrials represent the zenith of this global effort to prevent and control diabetes, and its devastating consequences. Although many of these latter trials have yielded negative results and have shown the narrow risk-benefit ratio of intensive treatment in patients with advanced disease, the exceedingly low event rates in these high-risk patients who were carefully monitored and intensively managed made possible in these clinical trial settings have not been emphasized enough. The heterogeneity of the clinical outcomes in these studies further highlight the complexity of diabetes, which is more than managing a disease, but the multiple needs of a patient with multisystem dysfunction. In the final analysis, what transpires from these megatrials is the need to translate the key components of these studies, namely, protocol, team, documentation and monitoring, into our daily clinical practice to enable the care team to stratify risk, define needs, individualize therapy, monitor progress and reinforce compliance in order to achieve positive outcomes. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2010.00063.x, 2010).
Keywords: Diabetes; Disease management; Randomized clinical trials.