Assessing the Effect of Personalized Diabetes Risk Assessments During Ophthalmologic Visits on Glycemic Control

Abstract

Importance: Optimization of glycemic control is critical to reduce diabetes related complications, but long-term success is challenging. Although vision loss is among the greatest fears of individuals with diabetes, comprehensive personalized diabetes education and risk assessments are not consistently employed in ophthalmology settings. Objective: To determine whether point-of-care measurement of HbA1c and personalized diabetes complication risk assessments performed during retinal ophthalmology visits improve glycemic control as assessed by HA1c. Design/Setting: Ophthalmologist office based clinical trial where investigators from 42 sites were randomly assigned to provide either study-prescribed augmented diabetes assessment and education, or usual care. Participants: Adults with type 1 or 2 diabetes enrolled into two cohorts: “more frequent” than annual follow-up (502 control and 488 intervention participants) and “annual” follow-up (368 and 388 participants). Intervention(s): Point-of-care measurement of HbA1c, blood pressure, and retinopathy severity; individualized estimate of retinopathy progression risk derived from the visit findings; structured comparison and review of past and current clinical findings; and structured education with immediate assessment and feedback regarding participant understanding. Intervention was performed at enrollment and routine ophthalmic follow-up visits scheduled at least 12 weeks apart. Main Outcome Measure(s): Mean change in HbA1c from baseline to 1 year. Secondary outcomes included body mass index, blood pressure, and diabetes self-management practices and attitudes surveys. Results: In the “more frequent” cohort, mean (SD) change in HbA1c at 1 year was −0.1% (1.5%) in the control group and −0.3% (1.4%) in the intervention group (adjusted mean difference −0.09%, 95% confidence interval −0.29% to +0.12%, P=0.35). In the “annual” cohort, mean (SD) change in HBA1c was 0.0% (1.1%) and −0.1% (1.6%), respectively (mean difference −0.05%, 95% confidence interval −0.27% to +0.18% P=0.63). Results were similar for all secondary outcomes. Conclusions and Relevance: Long-term optimization of glycemic control is not achieved by a majority of individuals with diabetes. Addition of personalized education and risk assessment during retinal ophthalmology visits, as provided in this study, did not result in HbA1c improvement compared with usual care over 1 year. These data suggest that optimizing glycemic control remains a substantive challenge requiring interventional paradigms other than those examined in this study.