The Role of Remote Pharmacy Services With Continuous Glucose Monitoring in an Underserved Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient receiving primary care from the study clinical site
- •Uncontrolled T2DM (HbA1c >7%)
- •18 years of age and older
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CGM plus telehealth (Other)
CGM only
In addition to usual care for patients with poorly controlled diabetes, participants will receive a CGM plus education on its use.
干预措施: CGM only (Other)
结局指标
主要结局
HbA1c
时间窗: Enrollment, 3 months, and 6 months
Hemoglobin A1c
次要结局
- Diabetes Management Self-Efficacy(Baseline, 3 months, and 6 months)
- Diabetes-related distress(Enrollment, 3 months, and 6 months)
研究者
Kristine Zimmermann
Assistant Professor
University of Illinois at Chicago
