JMIR Publications

ABSTRACT

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 is warranted.

Objective:

This study will evaluate the feasibility our federally qualified health center (FQHC) CGM intervention and assess for randomized control trial (RCT) intervention signals and clinically meaningful differences in outcomes.

Methods:

A mixed-methods, pragmatic pilot RCT will be used. A total of 30 Hispanic patients with T1D will be recruited from four 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 an adult family member also consent to study participation. Guided by the Socio-Ecological Model (SEM), our intervention has 3 levels: (1) individual (culturally sensitive CGM information, motivation, and skills acquisition); (2) family/social networks (integration of the core Hispanic values of familismo and collectivismo to leverage family and peer support for CGM uptake); and (3) healthcare 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 (co-attended 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 6 months. Study feasibility will be assessed in terms of recruitment, enrollment, retention, adherence, study procedures and implementation, and acceptability with mixed-methods. We also will collect physiological (e.g., A1C and CGM metrics) and psychosocial (e.g., depression, quality of life, social support, and interpersonal processes of care) outcomes data. Feasibility data will be analyzed using content analysis and univariate/bivariate statistics. Linear and generalized linear mixed modeling will be applied to assess for intervention signals and clinically meaningful differences from baseline to 3-months and 6-months or from 3-months to 6-months (CGM metrics only).

Results:

Funding for this project was secured in September of 2022. At the time of reporting, the study commenced recruitment after completing formative qualitative data collection on SDOH and CGM uptake in Hispanic adults with T1D (N=32). Our community advisory board informed modifications to the study protocol by reviewing and interpreting the qualitative findings, collaborating in related refinement of the intervention, and advising on additional study methods.

Conclusions:

Guided by SEM, our novel FGHC CGM intervention will provide feasibility and outcomes data, along with estimation of variances for outcomes to guide power analyses, to guide a follow-up, full-scale RCT. Our CGM intervention model, incorporating the SDOH, has the unique potential to widen access to and increase CGM uptake in low-income Hispanic adults with T1D while improving outcomes for this vulnerable population.