318 Participants Needed

Continuous Glucose Monitoring for Type 2 Diabetes

(TEAM-CGM Trial)

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JW
Overseen ByJessica Wijesundara, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of the treatment Community Health Worker, Community Health Worker, CHW, Pharmacist Only for Continuous Glucose Monitoring in Type 2 Diabetes?

Research shows that continuous glucose monitoring (CGM) devices help improve diabetes management by providing detailed glucose trends, which can enhance treatment and safety. Pharmacists are well positioned to support patients in using CGM, as they can offer guidance and collaborate with healthcare providers to help patients achieve their blood sugar goals.12345

Is continuous glucose monitoring safe for humans?

Continuous glucose monitoring (CGM) is generally considered safe for humans, as studies have shown it to be an acceptable tool for managing diabetes, with patients reporting positive experiences.12467

How does the Pharmacist Only treatment for Type 2 Diabetes differ from other treatments?

The Pharmacist Only treatment involves the use of continuous glucose monitoring (CGM) devices managed by pharmacists, which is unique because it allows for real-time glucose tracking and personalized diabetes management in community and ambulatory care settings. This approach leverages pharmacists' expertise to improve patient outcomes by closely monitoring glucose levels and adjusting treatment plans accordingly.14568

What is the purpose of this trial?

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.

Research Team

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Ben Gerber, MD, MPH

Principal Investigator

University of Massachusetts, Worcester

Eligibility Criteria

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.
My A1c level has been 9% or higher in the last 6 months.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Pharmacist + CGM + CHWExperimental Treatment3 Interventions
A second randomization step occurs at 6-months. Participants randomized to this condition receive clinical pharmacist, CHW, and CGM support.
Group II: Pharmacist + CGMExperimental Treatment2 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 OnlyActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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.
Pharmacist-driven continuous glucose monitoring in community and ambulatory care pharmacy practice: A scoping review.Vascimini, A., Saba, Y., Baskharoun, F., et al.[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.
Design and development of a continuous glucose monitoring educational module for students and practicing pharmacists.Sherrill, CH., Lee, S., Bradley, CL.[2022]
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.
Remote Pharmacist-Assisted Flash Continuous Glucose Monitoring Improves Glycemic Outcomes in Patients With Poorly Controlled Diabetes: A Retrospective Case Series.Siemens, R.[2023]

References

Pharmacist-driven continuous glucose monitoring in community and ambulatory care pharmacy practice: A scoping review. [2023]
Patient Satisfaction with Professional Continuous Glucose Monitoring in a Diverse Family Medicine Clinic: A Pilot Study. [2023]
The association between self-monitoring of blood glucose, hemoglobin A1C and testing patterns in community pharmacies: Results of a pilot study. [2020]
Flash Continuous Glucose Monitoring: A Practical Guide and Call to Action for Pharmacists. [2022]
A Cross-Sectional Survey Study Examining the Provision of Continuous Glucose Monitoring Education in U.S. Doctor of Pharmacy Programs. [2022]
Design and development of a continuous glucose monitoring educational module for students and practicing pharmacists. [2022]
The clinical utility of professional continuous glucose monitoring by pharmacists for patients with type 2 diabetes. [2022]
Remote Pharmacist-Assisted Flash Continuous Glucose Monitoring Improves Glycemic Outcomes in Patients With Poorly Controlled Diabetes: A Retrospective Case Series. [2023]
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