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

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 patients achieving glycated hemoglobin (HbA 1c ) <7.0% (<53 mmol/mol) 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 HbA 1c <7.0% (<53 mmol/mol) 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 HbA 1c 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, we 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 practicedoften, we suspect, because it goes unrecognized. To support the busy health care professional, innovative approaches are sorely needed. ACHIEVEMENT OF HbA 1c GOALS IN THE REAL WORLDLarge randomized controlled trials (RCTs) have clearly demonstrated that achieving and sustaining optimal glycemic control prevents or delays the development of microvascular and macrovascular disease (1-3). Although the risk of developing diabetesrelated complications rises steadily when glycated hemoglobin (HbA 1c ) values are in excess of 6.5% (48 mmol/mol) (4,5), an HbA 1c of ,7% (,53 mmol/mol) is generally considered a target goal for diabetes management (6). In truth, it is now widely recognized that individualizing the HbA 1c goal for each patient is critically important, especially when the presence of comorbidities necessitates less stringent targets (6). However, most government and private insurer reports continue to use 7% as a point of reference; therefore, we focus herein on this marker of glycemic control.Despite our growing understanding of diabetes and the availability of new medications and technologies, a substantial number of individuals are not at their glycemic goal. Of note, recent data indicate that 85.6% of adults with diagnosed diabetes are treated with diabetes medication (7). Results from the National Health and Nutrition Examination Survey (NHANES) indicate that only about 50% of American adults with diabetes are achieving HbA 1c ,7.0% (,53 mmol/mol) (8), and it is estimated that only 64% are reaching individualized glycemic goals (9). These findings are noteworthy

Glycaemic control after treatment intensification in patients with type 2 diabetes uncontrolled on two or more non‐insulin antidiabetic drugs in a real‐world setting

“…Our results are in line with those of a recent metaanalysis of 43 RCTs (overall 16 590 participants) assessing the effects of the addition of a third drug after failure of dual therapy. 23,24 Our results also suggest that the best glycaemic control is achieved in the elderly and in patients with comorbid conditions, whereas the worst control was observed among women. A great number of treatment options show notable efficacy in RCTs, but their impact on glycaemic control in real-world clinical practice is usually less than expected.…”

“…21,22 Conversely, the achievement of the other two goals (HbA1c <7% or < 8%) was inferior with insulin and GLP-1RAs, probably because of the higher preintensification HbA1c levels in these two groups (9.4% for insulin and 9.1% for GLP-1RAs vs. 8.7-9.0%). 23 It has been suggested that poor adherence is the key factor explaining the gap between results from real-world studies and RCTs. 6 The authors concluded that rapid-acting insulin added to metformin and SUs resulted in the largest reduction in HbA1c after 24-36 weeks (1.6% vs. placebo), followed by GLP-1RA (1.0%), basal insulin (0.8%), and SGLT-2i and DPP4i (both 0.7%).…”

Assessing barriers to diabetes medication adherence using the Information-Motivation-Behavioral skills model

“…In a recent cohort study using a large EHR-administrative claims database, poor medication adherence was the primary factor explaining smaller HbA1c reductions among patients receiving usual care in the real-word compared to participants in RCTs [49]. In order to realize HbA1c improvements achieved in RCTs, approaches for improving adherence must be easily implemented in real-world clinical practice and account for multiple adherence barriers [50]. In future research, we plan to improve the efficiency of our barriers assessment, both by reducing the number of items and exploring alternative methods of administration (e.g., via tablet, phone, or kiosks in clinic waiting rooms).…”

Propiedades psicométricas de la escala de locus de control de la salud en Dios en una muestra de mexicanos con diabetes mellitus tipo 2

“…Cifras recientes indican que su prevalencia en adultos de veinte o más años de edad, pasó de 9.2% en el año 2012 a 9.4% en el año 2016 (ENSANUT MC, 2016). Sin embargo, uno de los principales problemas vinculados a la aparición de complicaciones asociadas a la DM2 y a un peor estado de salud es precisamente la falta de adherencia al tratamiento (Edelman & Polonsky, 2017;Jiménez-Corona & Aguilar-Salinas, 2013;Shams, Amjad, Kumar, Ahmed, & Saleem, 2016).…”