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

NCT05911256 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2025-10-17

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

DEVICE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Baystate Health

    collaborator OTHER

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

    collaborator NIH

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Ben Gerber, MD, MPH · University of Massachusetts, Worcester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-27
Primary Completion
2027-09-30
Completion
2028-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05911256 on ClinicalTrials.gov