Assessing the Effect of Personalized Diabetes Risk Assessments During Ophthalmologic Visits on Glycemic Control: A Randomized Clinical Trial

Abstract

Importance: Optimization of glycemic control is critical to reduce the number of diabetes mellitus-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 used in ophthalmologic settings.

Objective: To determine whether the point-of-care measurement of hemoglobin A(1c) (HbA(1c)) and personalized diabetes risk assessments performed during retinal ophthalmologic visits improve glycemic control as assessed by HbA(1c) level.

Design, setting, and participants: Ophthalmologist office-based randomized, multicenter clinical trial in which investigators from 42 sites were randomly assigned to provide either a study-prescribed augmented diabetes assessment and education or the usual care. Adults with type 1 or 2 diabetes enrolled into 2 cohorts: those with a more-frequent-than-annual follow-up (502 control participants and 488 intervention participants) and those with an annual follow-up (368 control participants and 388 intervention participants). Enrollment was from April 2011 through January 2013.

Interventions: Point-of-care measurements of HbA1c, blood pressure, and retinopathy severity; an individualized estimate of the risk of retinopathy progression derived from the findings from ophthalmologic visits; structured comparison and review of past and current clinical findings; and structured education with immediate assessment and feedback regarding participant's understanding. These interventions were performed at enrollment and at routine ophthalmic follow-up visits scheduled at least 12 weeks apart.

Main outcomes and measures: Mean change in HbA(1c) level from baseline to 1-year follow-up. Secondary outcomes included body mass index, blood pressure, and responses to diabetes self-management practices and attitudes surveys.

Results: In the cohort with more-frequent-than-annual follow-ups, the mean (SD) change in HbA(1c) level 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% CI, -0.29% to 0.12%]; P = .35). In the cohort with annual follow-ups, the mean (SD) change in HbA(1c) level was 0.0% (1.1%) in the control group and -0.1% (1.6%) in the intervention group (mean difference, -0.05% [95% CI, -0.27% to 0.18%]; P = .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. The addition of personalized education and risk assessment during retinal ophthalmologic visits did not result in a reduction in HbA(1c) level 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 our study.

Trial registration: clinicaltrials.gov Identifier:NCT01323348.

Figure 1. Follow-up Flowchart

Of 42 sites, 34 were randomized on the site level (at 17 sites all investigators were assigned to Intervention, at 17 sites all investigators were assigned to Control) and 8 were randomized on the investigator level.

Figure 2. HbA1c: Central Lab Value versus a) Patient Knowledge at Baseline and b) Point of Care

a) Both cohorts and treatment groups with last known HbA1c within the prior 6 months. B) Both cohorts in the intervention group

Figure 2. HbA1c: Central Lab Value versus a) Patient Knowledge at Baseline and b) Point of Care

a) Both cohorts and treatment groups with last known HbA1c within the prior 6 months. B) Both cohorts in the intervention group