Key points are not available for this paper at this time.
Background Hispanic adults with type 1 diabetes (T1D) have suboptimal access to continuous glucose monitoring (CGM). Widening access to and increasing uptake of CGM for Hispanic adults with T1D are warranted. Objective This randomized controlled trial (RCT) will evaluate the feasibility of a federally qualified health center (FQHC) CGM intervention and assess for an intervention signal in patient outcomes. Methods A mixed methods, pragmatic pilot RCT will be used. A total of 30 adult Hispanic patients with T1D will be recruited from 4 FQHC sites allocated to provide the intervention (n=2) or control (n=2) conditions. At intervention sites, participants must be willing to use CGM for 3 months and have a willing adult family member participate in the study. Guided by the socioecological model, our intervention has three levels: (1) individual (culturally sensitive CGM information, motivation, and skills acquisition), (2) family or social networks (integration of the core Hispanic values of familismo and collectivismo to leverage family and peer support for CGM uptake), and (3) health care provider levels with CGM training using Project ECHO (Extension for Community Healthcare Outcomes). Intervention participants (n=15) will receive a culturally sensitive CGM intervention with 4 weekly intervention sessions (coattended by a family member), followed by 7 peer support group sessions over 6 months. Control participants will receive a self-monitoring of blood glucose control condition over a 6-month period. Study feasibility will be assessed in terms of recruitment, enrollment, retention, adherence, study procedures and implementation, and acceptability with mixed methods. We will collect physiological (eg, glycated hemoglobin and CGM metrics) and psychosocial (eg, depression, quality of life, social support, and interpersonal processes of care) outcome data. Feasibility data will be analyzed using content analysis and univariate or bivariate statistics. Linear and generalized linear mixed modeling will assess intervention signals and clinically meaningful differences from baseline to 3 and 6 months. Results Funding for this project was secured in September 2022. As of May 2024, recruitment commenced following formative qualitative data collection on the social determinants of health and CGM uptake in Hispanic adults with T1D (N=32). Our community advisory board informed protocol modifications by reviewing qualitative findings, collaborating on related intervention refinement, and advising on cultural sensitivity methods. Conclusions Guided by the socioecological model, our novel FQHC CGM intervention will provide feasibility and outcome data to guide a full-scale RCT. Our intervention model has unique potential to widen CGM access and increase CGM uptake in low-income Hispanic adults with T1D while improving outcomes for this vulnerable population. Trial Registration ClinicalTrials.gov NCT06487962; https://clinicaltrials.gov/study/NCT06487962 International Registered Report Identifier (IRRID) PRR1-10.2196/60583
Newlin-Lew et al. (Tue,) studied this question.