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

University of Massachusetts, Worcester

Status: Invitation-only

Conditions: Type 2 Diabetes

Treatments: Device: Continuous Glucose Monitor (CGM); Behavioral: Community Health Worker (CHW); Behavioral: Pharmacist Only

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05911256

R01DK133265 (U.S. NIH Grant/Contract)

STUDY00000848

Details and patient eligibility

About

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.

Full 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.

Enrollment: 318 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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318 participants in 3 patient groups

Pharmacist Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Pharmacist Only

Pharmacist + CGM

Experimental group

Description:

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).

Treatment:

Device: Continuous Glucose Monitor (CGM)

Behavioral: Pharmacist Only

Pharmacist + CGM + CHW

Experimental group

Description:

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

Treatment:

Device: Continuous Glucose Monitor (CGM)

Behavioral: Pharmacist Only

Behavioral: Community Health Worker (CHW)