Inequity in Racial-Ethnic Representation in Randomized Controlled Trials of Diabetes Technologies in Type 1 Diabetes: Critical Need for New Standards

Racial/ethnic inequity exists in all aspects of health care and does not exclude the field of advanced diabetes technology. Despite the recent increase in technological therapeutic options for diabetes management and mounting evidence of positive effects on glycemic outcomes, emerging reports have highlighted that insulin pump and continuous glucose monitor use remain significantly lower in Black and Hispanic compared with White populations (1,2). Critical needs remain to bridge gaps in technology use. An important issue that we in the scientific and research communities can modify is the inclusion of minorities in clinical trials of diabetes devices. The population prevalence estimates of type 1 diabetes in the U.S. were as follows: non-Hispanic White, 72%; Hispanic, 15.7%; non-Hispanic Black, 9.3%; and Asian, 2.4% (3). Adequate racial/ethnic representation in parallel with the prevalence of type 1 diabetes is needed not only to evaluate widespread efficacy and acceptability of diabetes technology but also to create better dissemination and marketing plans that increase use among underrepresented groups. To evaluate the current state, we investigated racial/ethnic enrollment of participants in published clinical trials of type 1 diabetes technology to estimate whether trial enrollment had adequate representation of racial/ethnic minority groups. We used Medline, Embase, and Cochrane Central databases to systematically search for randomized controlled trials (RCTs) of currently U.S. Food and Drug Administration (FDA)-approved hybrid closed-loop and continuous glucose monitoring devices in the U.S. We included only U.S. studies, as …