A Randomized Clinical Trial of a Culturally Tailored Diabetes Education Curriculum With and Without Real-Time Continuous Glucose Monitoring in a Latino Population With Type 2 Diabetes: The CUT-DM With Continuous Glucose Monitoring Study

Background: Data on culturally tailored diabetes education with and without real-time continuous glucose monitoring (RT-CGM) in Latinos with type 2 diabetes, who are not on intensive insulin management, is lacking. Research Design and Methods: This is an open-label randomized control trial of Latinos with uncontrolled (HbA1c > 8.0%) type 2 diabetes conducted in a Federally Qualified Health Center (FQHC). All participants received 12 one-hour culturally tailored education sessions. Patients were randomized (1:1) to education sessions only (blinded CGM) or cyclic (50 days wear: 10 days on, 7 days off) RT-CGM. The primary outcome was a change in HbA1c from baseline to 12 weeks in those with or without CGM. Secondary outcomes included 24-week HbA1c, CGM, and metabolic parameters. Results: Participants (n = 120) were 46 years old on average, 44% female, 98% preferred Spanish language, 30% with income <$25,000, 68% uninsured and 26% using basal insulin only. Mean 1-hour session attendance and RT-CGM wear was 7.0 (±4.4) and 27.9 (±20.5) days, respectively. Mean baseline HbA1c was 10.5% (±1.8). HbA1c reduced by 1.9% (95% confidence interval [CI]: 1.5-2.3) overall ( P < .001). Participants in the RT-CGM group reduced HbA1c at 12 weeks by 2.3% (95% CI: 1.5-3.2) compared to 1.5% (95% CI: 0.6-2.3) in the blinded CGM group ( P =.04). At 24 weeks, overall HbA1c reduction was maintained but between-group differences attenuated. Conclusions: In a Latino type 2 diabetes population that was primarily noninsulin-requiring, virtually delivered, culturally tailored education improved HbA1c, with RT-CGM conferring greater improvement. RT-CGM should be an adjunctive therapy to diabetes education, irrespective of insulin use but continued cyclic CGM use may be needed for sustained effect.