Remote Pharmacy Services Plus Continuous Glucose Monitoring in an Underserved Population
The Role of Remote Pharmacy Services With Continuous Glucose Monitoring in an Underserved Population
The purpose of this study is to improve T2DM (type 2 diabetes mellitus) management and health outcomes among underserved patients who receive primary care at a federally qualified health center (FQHC) in Winnebago County, Illinois.
Our aim is to assess the feasibility and preliminary effectiveness of a pilot program combining continuous glucose monitoring (CGM) with monthly telehealth appointments to improve diabetes management in FQHC patients who have uncontrolled T2DM (HbA1c >7%).
Researchers will compare those who receive the intervention (usual in-person care + CGM + 2 telehealth visits with a clinical pharmacist and family medicine resident) with those receiving a CGM in additional to usual care (in-person care + CGM).
Participants will have their HbA1c tested and complete surveys to assess diabetes-related distress and diabetes management self-efficacy at baseline and 3 and 6 months from baseline. This will allow the investigators to raise glucose awareness for all participants utilizing CGM technology while simultaneously determining the necessity of more frequent follow-up than the guideline recommended intervals of 3 months for uncontrolled diabetes in an under-resourced population. This will also allow us to evaluate the feasibility of telehealth in delivering more frequent follow-up care to patients with T2DM.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Illinois
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Rockford、Illinois、美国、61107
- University of Illinois College of Medicine Rockford
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patient receiving primary care from the study clinical site
- Uncontrolled T2DM (HbA1c >7%)
- 18 years of age and older
Exclusion Criteria:
- Patients younger than 18 years of age
- Patients in correctional facilities
- Pregnant or lactating women
- Current Continuous Glucose Monitoring device (CGM) users
- Patients with gestational diabetes mellitus or Type 1 diabetes mellitus
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:CGM + telehealth
In addition to usual care for patients with poorly controlled diabetes, participants will receive a CGM plus education on its use and 2 telehealth appointments, 1 month and 2 months from their initial appointment.
The telehealth appointments will be conducted by a clinical pharmacist and family medicine resident physician and will be used to discuss CGM outcomes and treatment planning.
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Participants will receive CGM supplies for 3 months plus 2 monthly telehealth appointments.
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有源比较器:CGM only
In addition to usual care for patients with poorly controlled diabetes, participants will receive a CGM plus education on its use.
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Participants will receive CGM supplies for 3 months
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HbA1c
大体时间:Enrollment, 3 months, and 6 months
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Hemoglobin A1c
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Enrollment, 3 months, and 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diabetes-related distress
大体时间:Enrollment, 3 months, and 6 months
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Diabetes-related distress as assessed by the TYPE 2 DIABETES DISTRESS ASSESSMENT SYSTEM (T2-DDAS)
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Enrollment, 3 months, and 6 months
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Diabetes Management Self-Efficacy
大体时间:Baseline, 3 months, and 6 months
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Diabetes management self-efficacy as assessed by the Stanford English Diabetes Self-Management study diabetes self-efficacy questionnaire. Stanford English Diabetes Self-Management study. Study reported in Lorig K, Ritter PL, Villa FJ, Armas J. Community-Based Peer-Led Diabetes Self-Management: A Randomized Trial. The Diabetes Educator 2009; Jul-Aug;35(4):641-51. |
Baseline, 3 months, and 6 months
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合作者和调查者
出版物和有用的链接
一般刊物
- Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012 Jan;35(1):32-8. doi: 10.2337/dc11-1438. Epub 2011 Nov 18.
- Patel PM, Thomas D, Liu Z, Aldrich-Renner S, Clemons M, Patel BV. Systematic review of disparities in continuous glucose monitoring and insulin pump utilization in the United States: Key themes and evidentiary gaps. Diabetes Obes Metab. 2024 Oct;26(10):4293-4301. doi: 10.1111/dom.15774. Epub 2024 Jul 15.
- Uhl S, Choure A, Rouse B, Loblack A, Reaven P. Effectiveness of Continuous Glucose Monitoring on Metrics of Glycemic Control in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Clin Endocrinol Metab. 2024 Mar 15;109(4):1119-1131. doi: 10.1210/clinem/dgad652.
- Wallia A, Agarwal S, Owen AL, Lam EL, Davis K, Bailey SC, DeLacey SE, Pack AP, Espinoza J, Bright D, Eggleston A, Walter E, O'Brien MJ. Disparities in Continuous Glucose Monitoring Among Patients Receiving Care in Federally Qualified Health Centers. JAMA Netw Open. 2024 Nov 4;7(11):e2445316. doi: 10.1001/jamanetworkopen.2024.45316.
- Myers A, Presswala L, Bissoonauth A, Gulati N, Zhang M, Izard S, Kozikowski A, Meyers K, Pekmezaris R. Telemedicine for Disparity Patients With Diabetes: The Feasibility of Utilizing Telehealth in the Management of Uncontrolled Type 2 Diabetes in Black and Hispanic Disparity Patients; A Pilot Study. J Diabetes Sci Technol. 2021 Sep;15(5):1034-1041. doi: 10.1177/1932296820951784. Epub 2020 Aug 29.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2264549 - UICOM Rockford
- UIC Diabetes Center Pilot (其他标识符:UIC Diabetes Center)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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