A Community Health Worker/Pharmacist Team to Improve Blood Sugars in Diabetes Care Using Continuous Glucose Monitoring — TEAM-CGM  

Type 2 Diabetes Clinical Trial

Official title: TEAM Support to Improve Glycemic Control Using CGM in Diverse Populations

Status Not yet recruiting

Clinical Trial Summary

Continuous glucose monitoring (CGM) can help improve blood sugar management in type 2 diabetes. A sequential, multiple assignment, randomized trial will evaluate clinical pharmacists, community health workers, and telehealth in supporting CGM use to improve blood sugar control.

Clinical Trial Description

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 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 the study team's previously studied approach of mobile health (mHealth) diabetes management. The investigators 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 Health, the investigators propose an effectiveness study of team-supported CGM using a Sequential Multiple Assignment Randomized Trial (SMART) study design. The investigators plan to study a diverse population with 318 T2DM patients receiving pharmacist- and CHW-supported CGM delivered through community health centers 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. The investigators 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. The investigators 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. ;

Related Conditions & MeSH terms

• Type 2 Diabetes

• NCT number: NCT05911256
• Study type: Interventional
• Source: University of Massachusetts, Worcester
• Contact: Emmanuella Demosthenes
• Phone: 978-235-3752
• Email: Emmanuella.Demosthenes@umassmed.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Completion date: December 2027