Continuous Glucose Monitoring for Type 2 Diabetes

(TEAM-CGM Trial)

Overseen By Jessica Wijesundara, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must not be taking: Steroids

Disqualifiers: Recent MI, TIA, CVA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how continuous glucose monitoring (CGM) can help manage blood sugar levels in people with type 2 diabetes. It tests various support methods, such as working with pharmacists (healthcare professionals who dispense medications and offer health advice), using telehealth, and involving community health workers, to determine which is most effective. Participants will begin with pharmacist support, and if they do not meet their blood sugar goals, they may receive additional help with CGM and community health workers. Individuals who have had type 2 diabetes for over a year, have a recent A1c level of 8% or higher, and are open to using CGM might be a good fit for this study. As an unphased trial, this study presents a unique opportunity to explore innovative diabetes management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using steroids or planning to use prescription weight loss medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that continuous glucose monitoring (CGM) is generally safe for people with type 2 diabetes. Studies have found that CGM can significantly lower blood sugar levels without major side effects.

When pharmacists manage CGM, patients often see a noticeable drop in their A1c levels, indicating effective and well-tolerated treatment.

Additionally, involving community health workers in the care team has further improved diabetes management, with no strong evidence of increased safety risks. Although having more team members might seem to complicate matters, data does not suggest any additional safety concerns.

Overall, treatment options that include CGM and pharmacist support appear safe according to current research findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for type 2 diabetes because they incorporate continuous glucose monitoring (CGM) and support from clinical pharmacists and community health workers (CHWs), which is a step beyond the traditional approach of medication management and periodic glucose checks. Unlike most current treatments that rely on routine blood sugar testing, CGM offers real-time glucose monitoring, allowing for more immediate and accurate adjustments in diabetes management. The inclusion of CHWs provides an additional layer of support, potentially improving patient outcomes through personalized education and community-based care. This holistic approach could offer more precise control over blood sugar levels and enhance the overall quality of diabetes management.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that continuous glucose monitoring (CGM) can help people with type 2 diabetes control their blood sugar more effectively. In this trial, participants may receive different combinations of support. Some will receive clinical pharmacist management alone, which studies have shown can significantly decrease hemoglobin A1c, a measure of average blood sugar levels over time. Others will receive additional support from CGM and community health workers (CHWs). Including CHWs in these programs may further enhance results, leading to better blood sugar management. These improvements can help people manage their diabetes more effectively. Overall, using CGM, especially with support from healthcare professionals like pharmacists and CHWs, appears promising for achieving better diabetes outcomes. ^{2 3 4 6 7}

Who Is on the Research Team?

Ben Gerber, MD, MPH

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

This trial is for adults aged 25-75 with type 2 diabetes for over a year, who speak English or Spanish. Participants must have an A1c level of at least 9% in the past six months and be willing to use continuous glucose monitoring (CGM) and work with health workers.

Inclusion Criteria

I am between 25 and 75 years old.

I have had type 2 diabetes for more than a year.

eGFR (estimated glomerular filtration rate) > 30.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive clinical pharmacist support and continuous glucose monitoring (CGM) for diabetes management

6 months

Regular visits as per primary care schedule

Re-randomization and Extended Treatment

Participants not meeting HbA1c goals are re-randomized to receive additional community health worker (CHW) support along with pharmacist and CGM support

6 months

Regular visits as per primary care schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker
• Pharmacist Only

Trial Overview

The study tests if having a team of pharmacists and community health workers can help people manage their blood sugar better using CGM technology. It's set up so some patients will get different levels of support to see what works best.

How Is the Trial Designed?

Group I: Pharmacist + CGM + CHW Experimental Treatment 3 Interventions

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

Group II: Pharmacist + CGM Experimental Treatment 2 Interventions

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 III: Pharmacist Only Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Baystate Health

Collaborator

Trials

9

Recruited

54,500+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Family Health Center of Worcester

Collaborator

Trials

2

Recruited

68,300+

Published Research Related to This Trial

A retrospective case series demonstrated that using a flash continuous glucose monitoring (CGM) system in pharmacist-managed diabetes cases effectively improved glycemic control by allowing for real-time monitoring and tailored interventions.

The combination of flash CGM with lifestyle and medication changes not only enhanced diabetes management but also ensured safety by reducing hypoglycemia and stabilizing blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Pharmacist-Assisted Flash Continuous Glucose Monitoring Improves Glycemic Outcomes in Patients With Poorly Controlled Diabetes: A Retrospective Case Series. Siemens, R.[2023]

A 2-week hands-on continuous glucose monitoring (CGM) module significantly improved knowledge and confidence in CGM use among third-year pharmacy students and practicing pharmacists, with 36 students and 5 pharmacists participating in the study.

While students maintained their confidence in CGM tasks long-term, their knowledge showed a slight decline, indicating the need for ongoing education to reinforce learning about CGM technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and development of a continuous glucose monitoring educational module for students and practicing pharmacists. Sherrill, CH., Lee, S., Bradley, CL.[2022]

Pharmacist-driven continuous glucose monitoring (CGM) services show potential benefits in improving glycemic control and quality of life, particularly in ambulatory care settings, based on a review of 11 studies.

Barriers to implementing these services include educational, logistical, workflow, and financial challenges, indicating that while feasible, further exploration is needed to enhance their effectiveness in community pharmacies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist-driven continuous glucose monitoring in community and ambulatory care pharmacy practice: A scoping review. Vascimini, A., Saba, Y., Baskharoun, F., et al.[2023]

Citations

1.

diabetesjournals.org

diabetesjournals.org/clinical/article/43/4/554/162999/Effectiveness-of-Continuous-Glucose-Monitoring-in

Effectiveness of Continuous Glucose Monitoring in a ...

Studies using CGM without a clinical champion such as a clinical pharmacist have shown minimal to modest improvements in glycemic control. For ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2949969025000144

Impact of pharmacist-led continuous glucose monitoring ...

A significant reduction in A1c was observed in patients who participated in a pharmacist-led CGM management program.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12035249/

Evaluating Pharmacotherapy Optimization in Pharmacist ...

The aim of this study was to assess pharmacist impact on the deprescribing of high-risk medications in patients with T2DM utilizing CGM data.

4.

researchprotocols.org

researchprotocols.org/2025/1/e67014

Impact of Pharmacist-Led Continuous Glucose Monitoring ...

Continuous glucose monitoring shared medical appointments improve diabetes self‐efficacy and hemoglobin A1C.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05911256?cond=diabetes&aggFilters=status%3A

A Community Health Worker/Pharmacist Team to Improve ...

Continuous glucose monitoring (CGM) has demonstrable benefits for people living with diabetes, including improvement in diabetes control and reduction in ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40409747/

Impact of Pharmacist-Led Continuous Glucose Monitoring ...

We will also assess changes in CGM-derived glycemic outcomes, health behavior, and safety outcomes among the pharmacist-led CGM cohort.

7.

uspharmacist.com

uspharmacist.com/article/cgm-optimizing-diabetes-outcomes

CGM Optimizing Diabetes Outcomes

The optimization of technology using continuous glucose monitoring (CGM) to improve diabetic outcomes even more.