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

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT05911256
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pharmacist Only — 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) — 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) — 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.

Study Details

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.

Key Dates

Start date
Sep 27, 2024
Status verified
Oct 2025
Primary completion
Sep 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
318 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Experimental: 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).
  • Experimental: Pharmacist + CGM + CHW
    A second randomization step occurs at 6-months. Participants randomized to this condition receive clinical pharmacist, CHW, and CGM support.

Primary Outcome Measure

Change in participant HbA1c values [ Time Frame: 0, 3, 6, 9, and 12 months (and additional 18-month collection in first 75% of participants) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MassachusettsWorcesterMassachusetts01605-

Find similar trials in Worcester, MA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Massachusetts· Worcester, MA

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