Table 2 Outcomes and data sources

Clinical Effectiveness

HbA1c

Change from baseline

Proportion of participants with a decrease of at least 1 percentage point

6 and 12 months post enrollment

EMR

Fidelity

Active RGM Usage

Value at intervention completion

Binary value (Y/N: at least one upload of data within a 30-day period and at least 16 blood glucose entries within a 30-day period)

6 months after enrollment or rerandomization^a

Glooko Reports

DSMT attendance

Value at intervention completion

Binary value (Y/N: attended at least three of four sessions)

6 months after enrollment or rerandomization^a

DSMT Attendance Sheets

Adherence to CHW engagement

Value at intervention completion

Binary value (Y/N: completed initial education session, SDoH screener, and at least three meetings with CHW)

6 months after enrollment or rerandomization^a

CHW Log Sheet

Appropriateness

Perceived appropriateness, fit, and compatibility with patient population and organization from the perspectives of Center staff and patients

Qualitative self-reported experiences

N/A

Between 3 and 6 months after enrollment or rerandomization^a

Center Staff Interviews

Patient Focus Group Discussions

Sustainability 

Short Form-Diabetes Empowerment Scale (SF-DES)

Change from baseline

Mean

6 and 12 months post enrollment

RedCAP Study Database

Problem Areas in Diabetes (PAID) Survey

Change from baseline

Mean

6 and 12 months post enrollment

RedCAP Study Database

Patient-Centeredness

Respect for patients’ values, preferences, and expressed needs

Coordinated and integrated

Provide Information, communication, and education

Ensure physical comfort

Provide emotional support

Involve family and friends

Qualitative self-reported experiences

N/A

Between 3 and 6 months after enrollment or rerandomization^a

Patient Focus Group Discussions

Covariates

Race/ethnicity, Age, Sex, Zip code, Insurance status

Value

Distribution across categories

Baseline

EMR

RedCAP Study Database