Testing patient-informed approaches for visually depicting the hemoglobin A1c value to patients with poorly controlled diabetes: a randomized, controlled trial.

Background: Patients' understanding of the hemoglobin A1c (HbA1c) has been linked to better diabetes care outcomes (glycemic control, self-care). This is concerning given low documented rates of HbA1c understanding. In this non-blinded, randomized trial, we compared two formats for communicating the HbA1c, selected based on input from people with diabetes, to standard presentation to assess their impact on participants' glycemic control and diabetes-related perceptions.

Methods: To design the tested formats, we interviewed 25 patients with diabetes and reviewed a range of possible formats, including color-based scales and graphs. The interviews were recorded, transcribed, and subjected to thematic analysis. Synthesizing interviewees' feedback, we selected two formats, one using a combination of words and colors (Words) and one using a color-coded graph (Graph), for further evaluation. We then randomized adults with poorly controlled diabetes to receive mailed information on their current diabetes control in one of three ways: 1) standard lab report (control), 2) Words format, or 3) Graph format. The primary outcome was HbA1c change at 6 months. Also examined were changes in participants' diabetes-related perceptions and choice of participation incentive.

Results: Of the 234 enrolled participants, 76.9% were Black, and their median baseline HbA1c was 9.1% (interquartile range 8.4-10.4). There were no between-arm differences in HbA1c change (- 1.04% [SD 2.2] Control vs. -0.59% [SD 2.0] Words vs. -0.54% [SD 2.1] Graph, p > 0.05 for all comparisons). Participants in the Words arm had an increase in the accuracy of their perceptions of diabetes seriousness (p = 0.04) and in the number of participants reporting a diabetes management goal (p = 0.01).

Conclusions: The two patient-informed communication formats did not differentially impact glycemic control among adults with inadequately controlled diabetes. However, a significant proportion of participants in the Words arm had an increase in the accuracy of their perception of diabetes seriousness, a potential mediating factor in positive diabetes-related behavioral changes. With increasing use of patient-facing online portals, thoughtfully designed approaches for visually communicating essential, but poorly understood, information like the HbA1c to patients have the potential to facilitate interpretation and support self-management.

Clinical Trial Registration: Prospectively registered as NCT01886170.