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临床试验/NCT07587151
NCT07587151已完成不适用

The Role of Remote Pharmacy Services With Continuous Glucose Monitoring in an Underserved Population

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年3月31日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristine Zimmermann

Assistant Professor

University of Illinois at Chicago

研究点 (1)

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