PROJECT SUMMARY
Continuous glucose monitoring (CGM) has demonstrable benefits for people living with diabetes, including
improvement in diabetes control and reduction in hypoglycemia. Randomized controlled trials have
demonstrated that CGM can reduce hemoglobin A1c (HbA1c) and increase in the time in range (TIR) metric.
Little is known about CGM use in the broader population with type 2 diabetes (T2DM) in low-income, minority
populations not receiving insulin therapy. This proposed study will rigorously evaluate CGM in a diverse and
vulnerable population with T2DM in the primary care setting. The proposed study will integrate CGM into our
previously studied approach of mobile health (mHealth) diabetes management. Our prior research has
leveraged mHealth tools and a community health worker (CHW)/clinical pharmacist team to manage low-
income, minority populations with T2DM. Clinical pharmacists embedded in the healthcare system review
patient glucose levels, promote medication adherence and collaboratively adjust therapy to help patients reach
HbA1c goals. CHWs augment pharmacist-led efforts and address social determinants of health and provide
individualized, contextual self-management support. In partnership with Baystate Community Health Centers
and UMass Memorial Family Medicine Health Centers, we propose an effectiveness study of team-supported
CGM using a Sequential Multiple Assignment Randomized Trial (SMART) study design. We plan to study a
diverse population with 318 T2DM patients receiving pharmacist- and CHW-supported CGM delivered through
community health centers (CHCs) in Massachusetts. The Specific Aims include: (1) Conduct a randomized,
controlled trial to evaluate the effectiveness of pharmacist-supported CGM in a diverse patient population with
T2DM in the primary care setting. We hypothesize that pharmacist-supported CGM will result in improved
HbA1c, CGM metrics, and other secondary outcomes (e.g., quality of life) at 6 months compared with
pharmacist-only care; (2) Re-randomize patients not at HbA1c goal after 6 months to receive or not receive
CHW support beyond pharmacist-supported CGM. We hypothesize that adding CHWs will result in improved
HbA1c, CGM metrics, and other secondary outcomes at 12 months compared with pharmacist-supported CGM
alone; (3) Evaluate reach, effectiveness, adoption, implementation, and maintenance using the RE-AIM
framework; and (4) Determine total cost and cost-effectiveness of CGM and the supportive components (e.g.,
clinical pharmacist and CHW) from the perspective of the healthcare organization. If this team support model of
diabetes care is found to be cost-effective, such evidence may influence insurance restrictions on ambulatory
CGM coverage in T2DM.
