Cowart Kevin, White Raechel T, Olson Kevin, Carris Nicholas W, Hanna Karim, Zgibor Janice
Department of Pharmacotherapeutics & Clinical Research, Taneja College of Pharmacy, University of South Florida, Tampa, FL, United States.
Department of Family Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, United States.
JMIR Res Protoc. 2025 May 23;14:e67014. doi: 10.2196/67014.
Continuous glucose monitoring (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 in addressing these shortcomings yet have not been rigorously evaluated in the literature.
Herein we present the protocol for a study that seeks to evaluate the change in hemoglobin A (HbA) in people with T2D using CGM under a pharmacist-led approach as compared with a pharmacist-led approach using no CGM (only self-monitoring blood glucose with a glucometer). We will also assess changes in CGM-derived glycemic outcomes, health behavior, and safety outcomes among the pharmacist-led CGM cohort.
This is a 12-week prospective cohort study in an academic family medicine department. We will enroll adults with T2D and a HbA level of ≥8%. Participants in the intervention cohort will wear a CGM sensor (FreeStyle Libre 2) for 12 weeks and receive structured diabetes self-management education and support from a pharmacist. Each participant in the intervention group will have 5 visits with a pharmacist. The primary objective is the between-group difference in change in HbA levels from baseline to 12 weeks between the intervention and historical cohort. Secondary objectives include a change in CGM-derived metrics among the intervention group from baseline to 12 weeks, and a change in health behavior via the Summary of Diabetes Self-Care Activities measure from baseline to 12 weeks in the intervention cohort. A CGM survey will also be administered to participants in the intervention cohort to evaluate changes in diet, physical activity, general lifestyle, and medication adherence. Safety endpoints will also be evaluated. The primary and secondary outcomes will be analyzed within and between groups using descriptive statistics, with a multivariable regression analysis conducted as appropriate to adjust for potential known confounding effects.
This study was funded in July 2023. We began enrolling participants in December 2024. At the time of writing, 3 participants have been enrolled. It is anticipated that we will conclude this study in December 2025 and expect to disseminate results in March 2026.
Results of this study will further elucidate the role of pharmacist-led CGM in primary care.
ClinicalTrials.gov NCT06572306; https://clinicaltrials.gov/study/NCT06572306.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/67014.
持续葡萄糖监测（CGM）越来越被视为 2 型糖尿病（T2D）患者血糖监测的新标准。然而，尽管在治疗方法和技术方面取得了进展，但血糖控制仍未达到最佳状态。涉及药剂师的团队协作方法，尤其是在初级保健中，已被证明在解决这些不足方面是有效的，但尚未在文献中得到严格评估。
在此，我们展示一项研究方案，该研究旨在评估在药剂师主导的方法下，使用 CGM 的 T2D 患者与不使用 CGM（仅使用血糖仪进行自我血糖监测）的药剂师主导方法相比，糖化血红蛋白（HbA）的变化。我们还将评估药剂师主导的 CGM 队列中 CGM 衍生的血糖结果、健康行为和安全结果的变化。
这是一项在学术性家庭医学科进行的为期 12 周的前瞻性队列研究。我们将招募 HbA 水平≥8%的 T2D 成年患者。干预队列的参与者将佩戴 CGM 传感器（FreeStyle Libre 2）12 周，并接受来自药剂师的结构化糖尿病自我管理教育和支持。干预组的每位参与者将与药剂师进行 5 次就诊。主要目标是干预组与历史队列从基线到 12 周 HbA 水平变化的组间差异。次要目标包括干预组从基线到 12 周 CGM 衍生指标的变化，以及干预队列从基线到 12 周通过糖尿病自我护理活动总结测量的健康行为变化。还将对干预队列的参与者进行 CGM 调查，以评估饮食、身体活动、一般生活方式和药物依从性的变化。也将评估安全终点。主要和次要结果将使用描述性统计在组内和组间进行分析，并在适当时进行多变量回归分析以调整潜在的已知混杂效应。
本研究于 2023 年 7 月获得资助。我们于 2024 年 12 月开始招募参与者。在撰写本文时，已招募 3 名参与者。预计我们将在 2025 年 12 月完成本研究，并期望在 2026 年 3 月公布结果。
本研究结果将进一步阐明药剂师主导的 CGM 在初级保健中的作用。
ClinicalTrials.gov NCT06572306；https://clinicaltrials.gov/study/NCT06572306。
国际注册报告标识符（IRRID）：PRR1-10.2196/67014。
