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

NCT ID: NCT05911256

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-27
• Study Completion Date: 2028-03-31

Brief 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.

Detailed 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pharmacist Only

Participants will receive clinical pharmacist management of diabetes. Those participants who meet their HbA1c goal at 6 months will continue with maintenance diabetes management. This includes routine primary care with the primary care provider, routine medication management, and traditional home glucose monitoring. For those not meeting goals in HbA1c they will be randomized again to receive Pharmacist + CGM or receive Pharmacist + CGM + Community Health Worker (CHW) support.

Group Type: ACTIVE_COMPARATOR

Pharmacist Only

Intervention Type: BEHAVIORAL

Clinical pharmacists conduct encounters with patients by videoconferencing or phone. Pharmacists conduct a broad range of activities including ongoing evaluation of medication and lifestyle adherence, setting therapeutic goals, formulating a provider-approved plan of care, and documenting the plan in the electronic health record. Pharmacists propose medication changes based on algorithms and protocols derived from national guidelines under physician guidance.

Pharmacist + CGM

Participants receive clinical pharmacist + CGM support. Those participants who meet their HbA1c goal at 6-months will continue with maintenance diabetes management. This includes routine primary care with the primary care provider, routine medication management, and traditional home glucose monitoring. For those not meeting goals in HbA1c, they will be randomized again to continue with pharmacist + CGM or receive additional CHW support (Pharmacist + CGM + CHW).

Group Type: EXPERIMENTAL

Pharmacist Only

Intervention Type: BEHAVIORAL

Clinical pharmacists conduct encounters with patients by videoconferencing or phone. Pharmacists conduct a broad range of activities including ongoing evaluation of medication and lifestyle adherence, setting therapeutic goals, formulating a provider-approved plan of care, and documenting the plan in the electronic health record. Pharmacists propose medication changes based on algorithms and protocols derived from national guidelines under physician guidance.

Continuous Glucose Monitor (CGM)

Intervention Type: DEVICE

Patients will receive the Continuous Glucose Monitoring (CGM) system. The instruction on use of device is the intervention being tested, not the effectiveness of the device itself. Participants will receive instruction and training on how to use the device and will wear the device for 10 days.

Pharmacist + CGM + CHW

A second randomization step occurs at 6-months. Participants randomized to this condition receive clinical pharmacist, CHW, and CGM support.

Group Type: EXPERIMENTAL

Pharmacist Only

Intervention Type: BEHAVIORAL

Clinical pharmacists conduct encounters with patients by videoconferencing or phone. Pharmacists conduct a broad range of activities including ongoing evaluation of medication and lifestyle adherence, setting therapeutic goals, formulating a provider-approved plan of care, and documenting the plan in the electronic health record. Pharmacists propose medication changes based on algorithms and protocols derived from national guidelines under physician guidance.

Continuous Glucose Monitor (CGM)

Intervention Type: DEVICE

Patients will receive the Continuous Glucose Monitoring (CGM) system. The instruction on use of device is the intervention being tested, not the effectiveness of the device itself. Participants will receive instruction and training on how to use the device and will wear the device for 10 days.

Community Health Worker (CHW)

Intervention Type: BEHAVIORAL

Patients are connected to a community health worker(CHW). CHWs conduct home visits and facilitate 3-way Telehealth visits (Patients, pharmacists, and CHWs) via an iPad with cellular plan. Additional CHW activities include social determinants of health screening, health behavior education, problem solving, goal setting, and medication adherence support.

Interventions

Pharmacist Only

Clinical pharmacists conduct encounters with patients by videoconferencing or phone. Pharmacists conduct a broad range of activities including ongoing evaluation of medication and lifestyle adherence, setting therapeutic goals, formulating a provider-approved plan of care, and documenting the plan in the electronic health record. Pharmacists propose medication changes based on algorithms and protocols derived from national guidelines under physician guidance.

Intervention Type: BEHAVIORAL

Continuous Glucose Monitor (CGM)

Patients will receive the Continuous Glucose Monitoring (CGM) system. The instruction on use of device is the intervention being tested, not the effectiveness of the device itself. Participants will receive instruction and training on how to use the device and will wear the device for 10 days.

Intervention Type: DEVICE

Community Health Worker (CHW)

Patients are connected to a community health worker(CHW). CHWs conduct home visits and facilitate 3-way Telehealth visits (Patients, pharmacists, and CHWs) via an iPad with cellular plan. Additional CHW activities include social determinants of health screening, health behavior education, problem solving, goal setting, and medication adherence support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 25-75.
• History of T2DM > 1 year.
• Speak English or Spanish.
• A1c ≥ 8% (within past 6 months) - with reduction if necessary based on recruitment.
• eGFR (estimated glomerular filtration rate) > 30.
• Willingness to use continuous glucose monitoring (CGM) and work with a community health worker (including home visits) and clinical pharmacist.

Exclusion Criteria

• Plans for weight reduction surgery or prescription weight loss medication (specific for weight loss, not GLP-1).
• Current, recent, or planned use of CGM.
• Current use of steroids.
• Abuse of illicit drugs.
• Pregnancy (or planned pregnancy).
• Specific comorbidities (e.g., recent MI, TIA, CVA, malignancy, hemoglobinopathy, severe hypoglycemia, etc.).
• Psychiatric disorder that may limit ability to perform study tasks
• Skin changes that preclude use of sensor or allergy to adhesive.
• Planning to leave geographic area within 12 months or distance from clinical site > 20 miles.
• Participation in another study.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baystate Health

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Ben Gerber

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ben Gerber, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

University of Massachusetts

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

R01DK133265

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000848

Identifier Type: -

Identifier Source: org_study_id