Posted Jan 24 , 2018 01:57 AM

Type 2 Diabetes in the Real World: The Elusive Nature of Glycemic Control

Edelman S, and Polonsky WH. Diabetes Care 2017;40:1425

What were the findings (excerpted from the Abstract)?

Despite U.S. Food and Drug Administration (FDA) approval of over 40 new treatment options for type 2 diabetes since 2005, the latest data from the National Health and Nutrition Examination Survey show that the proportion of people with diabetes achieving glycated hemoglobin (A1C) <7.0% remains around 50%, with a negligible decline between the periods 2003–2006 and 2011–2014. The Healthcare Effectiveness Data and Information Set reports even more alarming rates, with only about 40% and 30% of patients achieving A1C <7.0% in the commercially insured (HMO) and Medicaid populations, respectively, again with virtually no change over the past decade. A recent retrospective cohort study using a large U.S. claims database explored why clinical outcomes are not keeping pace with the availability of new treatment options. The study found that A1C reductions fell far short of those reported in randomized clinical trials (RCTs), with poor medication adherence emerging as the key driver behind the disconnect. In this perspective, the authors examine the implications of these findings in conjunction with other data to highlight the discrepancy between RCT findings and the real world, all pointing toward the underrealized promise of FDA-approved therapies and the critical importance of medication adherence. While poor medication adherence is not a new issue, it has yet to be effectively addressed in clinical practice often, we suspect, because it goes unrecognized. To support the busy healthcare professional, innovative approaches are sorely needed.

Why is this important?

RCTs have been the “gold standard” of study design because they tightly control the setting and delivery of interventions, minimize the effect of external factors on outcomes, and lead to a random distribution of unmeasured confounders. Yet the degree to which results obtained under RCT conditions can be extrapolated to real life remains an open question. It is important to be aware of the ways in which clinical trial results might inflate expectations of treatment efficacy. In controlled trials, interventions are often more focused and patients may benefit from more frequent face-to-face visits, convenient access to therapy, closer monitoring, and wider availability of educational resources and support services. Indeed, this focus and attention of control groups has often led to significant improvement in controls leading to the rather common finding of a ‘Hawthorne effect’ in those trials. Patient motivation in these trials is high, and in many cases, there is a financial benefit which incentivizes adherence to the protocol. Our current ability to assess adherence and persistence is based primarily on review of pharmacy records, which may underestimate the extent of the problem as they only track refills. But, an ever-increasing issue is primary nonadherence as adherence and persistence studies typically only include people who have completed a first refill. As co-pays increase and as the cost of newer medications increase, patients frequently cannot afford the first prescription for a new medication. We can do better, but finding a way to interact more frequently with our patients, to incentivize adherence, and to identify when medication prescriptions have never been filled in the first place are some of the challenges we must overcome to achieve better outcomes.

Do you use office staff, other healthcare professionals, community health workers or some other people to increase contact with your patients? Do you incentivize adherence? How? Do you work with local pharmacies to see when medications have been refilled? How do you get compensated for that effort? The answer to these and other questions will help all of us do a better job of helping our patients reach their goals.

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