A Community Health Worker/Pharmacist Team to Improve Blood Sugars in Diabetes Care Using Continuous Glucose Monitoring
TEAM-CGM
TEAM Support to Improve Glycemic Control Using CGM in Diverse Populations
2 other identifiers
interventional
318
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Sep 2024
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2023
CompletedFirst Posted
Study publicly available on registry
June 20, 2023
CompletedStudy Start
First participant enrolled
September 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
October 20, 2025
October 1, 2025
2.9 years
June 12, 2023
October 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in participant HbA1c values
Participant HbA1c will be measured and obtained by finger stick using home testing kits.
0, 3, 6, 9, and 12 months (and additional 18-month collection in first 75% of participants)
Secondary Outcomes (9)
Change in glycemic control from baseline using Percent Time in Range
0, 6, and 12 months
Change in Participant self-reported health-related quality of life from baseline
0, 6, and 12 months
Change in participant reported Diabetes Self-Management from baseline
0, 6, and 12 months
Changes in participant reported Diabetes Distress from baseline
0, 6, and 12 months
Change in participant-reported diabetes treatment burden from baseline
0, 6, and 12 months
- +4 more secondary outcomes
Study Arms (3)
Pharmacist Only
ACTIVE COMPARATORParticipants 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.
Pharmacist + CGM
EXPERIMENTALParticipants 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).
Pharmacist + CGM + CHW
EXPERIMENTALA second randomization step occurs at 6-months. Participants randomized to this condition receive clinical pharmacist, CHW, and CGM support.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Massachusetts
Worcester, Massachusetts, 01605, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ben Gerber, MD, MPH
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 12, 2023
First Posted
June 20, 2023
Study Start
September 27, 2024
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- IPD and supporting information will become available at time of primary results publication.
Participant survey data, participant physiologic data, community health worker training and protocol, clinical pharmacist training and protocol, will be shared. This includes a complete, de-identified data set, including survey and clinical/physiologic data (and relevant R or SAS code) through DKnet, the Inter-University Consortium for Political and Social Research, or eScholarship@UMassChan.