Relaxed Glycemic Control and the Risk of Infections in Older Adults with Type 2 Diabetes

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Abstract Professional society guidelines for treatment of type 2 diabetes (T2D) endorse a glycemic goal of hemoglobin A1c (HbA1c) <7% for most nonpregnant adults to reduce the long-term risk of complications. However, for the ~12 million Americans ≥65 years of age who have T2D, current guidelines recommend individualized management and relaxed glycemic control (i.e., HbA1c 7% to <9%) for patients with multiple comorbidities, poor health or limited life expectancy. Recommendations for relaxed glycemic control are based on evidence that intensive therapy has significant risks (e.g., hypoglycemia), treatment burden and cost, and that time to benefit may exceed life expectancy in older patients. However, current guidelines fail to recognize the potential for relaxed glycemic control to increase the risk of infection in older adults. Because a clinical trial of the effect of relaxed vs. intensive glycemic control on infection is not feasible, we propose an observational study to estimate the short-term risk of hospitalization for infection associated with relaxed glycemic control (HbA1c 7% to <9%) compared with intensive glycemic control (HbA1c 6% to <7%). The proposed observational study will use longitudinal data from 116,484 racially and ethnically diverse (62% minority) adults ≥65 years of age with T2D who have HbA1c within the guideline-recommended range of 6% to <9%. The project will identify factors associated with 12-month risk of hospitalization for infection among older adults with T2D (Aim 1); determine rates and hazard ratios of hospitalizations for infection by levels of baseline HbA1c (Aim 2); and estimate the independent (unconfounded) effect of relaxed versus intensive glycemic control on risk of hospitalization for infection using propensity score-based overlap weighting and directed acyclic graph-informed multivariate adjustment to mitigate potential confounding (Aim 3). Throughout the project period, we will work closely with a Stakeholder Advisory Council of key operational and clinical health plan leaders to conduct ongoing review of our research strategy, disseminate our findings and plan future implementation. The proposed research will provide evidence needed to inform recommendations for safe glycemic goals in older patients with T2D and, in particular, to understand the association of relaxed glycemic control and short-term risk of hospitalization for infection.