Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 4, 2024
Date Accepted: Apr 10, 2025
Impact of Pharmacist-led Continuous Glucose Monitoring on Clinical Outcomes in Type 2 Diabetes in Primary Care: A Prospective Cohort Study
ABSTRACT
Background:
Continuous glucose monitoring (CGM) provides glycemic metrics beyond hemoglobin A1c (HbA1c) and self-monitoring of blood glucose (SMBG). CGM is increasingly being recognized as the new standard of care for glycemic monitoring in people with type 2 diabetes (T2D). However, despite advances in therapeutics and technology, glycemic control remains suboptimal. Team-based approaches involving pharmacists, particularly in primary care have shown to be effective to address these shortcomings, but have not been rigorously evaluated in the literature.
Objective:
Herein we present the protocol for a study that seeks to evaluate the change in HbA1c in people with T2D using CGM under a pharmacist-led approach as compared to a pharmacist-led approach utilizing no CGM (only self-monitoring blood glucose with a glucometer). We will also assess change in CGM-derived glycemic outcomes among the pharmacist-led CGM cohort and assess change in health behavior among the pharmacist-led CGM cohort.
Methods:
This is a 12-week prospective cohort study in an academic family medicine department. We will enroll adults with T2D and HbA1c ≥ 8%. Subjects in the intervention cohort will wear a CGM (FreeStyle Libre 2) for 12 weeks and receive structured diabetes-self management education and support (DSMES) from a pharmacist. Each subject in the intervention group will have 5 visits with a pharmacist. This study was approved by the USF Institutional Review Board in August 2024.
Results:
This study was funded in June 2024. Recruitment is expected to begin in November 2024, with an expected study completion date of August 2025.
Conclusions:
Results of this study will further elucidate the role of pharmacist-led CGM in primary care, but will also evaluate feasibility and prepare our clinical site to conduct a larger cluster randomized trial to more rigorously test our hypothesis of pharmacist-led CGM as an intervention to overcome diabetes-related clinical inertia. Clinical Trial: ClinicalTrials.gov [NCT06572306]
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