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

Abstract

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 race/ethnicity categorization is defined differently in other countries. Studies had to be at least 3 months in duration with predefined glycemic outcomes and include children and adults with type 1 diabetes. We included trials published between 1 January 2015 and 22 October 2020 to reflect currently available FDA-approved technologies. In total, 1,118 abstracts were reviewed, and 67 met criteria for detailed review. Out of 67 studies, nine met inclusion criteria. One of the nine studies did not report any race/ethnicity, so it was excluded. In the remaining eight RCTs, out of a total of 1,354 enrolled participants with type 1 diabetes, the great majority were non-Hispanic White (84.5%, n 5 1,144). For racial/ethnic minorities, 6% were Hispanic (n 5 82), 2.2% were non-Hispanic Black (n 5 30), 1% were Asian (n 5 14), and 2% were categorized as “other” racial/ethnic group (Table 1). Approximately 4% of all participants (n 5 56) had no race/ ethnicity reported. None of the trials reported prespecified enrollment targets by race/ethnicity criteria. Our results highlight large disparities in racial/ethnic representation among RCTs of diabetes technologies for type 1 diabetes, including pivotal trials used to gain FDA approval for currently available commercial devices. Moreover, percent enrollment of racial/ethnic minority groups was significantly lower than the current population prevalence estimates of underrepresented groups with type 1 diabetes. Even more concerning is the fact that none of the trials reported a specified recruitment target for different racial/ethnic minority groups, despite recent FDA recommendations for the inclusion of racial and ethnic minorities in clinical trials (4) and given that rates of type 1 diabetes are increasing in underrepresented groups (5). These disheartening findings, coupled with the fact that Black populations with type 1 diabetes, in particular, suffer from the worst medical outcomes in the U.S. (5), demonstrate an urgent need for more inclusive recruitment in clinical