Addressing Disparities in Diabetes Care: Integrating Continuous Glucose Monitors and Pharmacist Medication Management for Uninsured Racial Minority Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c
研究概览
简要总结
The purpose of this research is to find out if using a continuous glucose monitor and working with a clinical pharmacist can help improve the health of uninsured minority patients with type 2 diabetes.
详细描述
The objective of this research is to determine the effectiveness of a targeted intervention that integrates continuous glucose monitors and pharmacist-led comprehensive medication management services among uninsured adult patients with poor glycemic control on basal insulin, specifically focusing on Black and Hispanic populations. This pilot study is designed to help justify implementing this intervention on a larger scale within our healthcare system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Hispanic or non-Hispanic Black
- •Diagnosis of Type 2 diabetes
- •HbA1c ≥8% within the past 3 months
- •Active prescription for insulin and injecting at least 1 time daily
排除标准
- •Gestational diabetes
- •Type 1 diabetes
- •Receiving care by endocrinologist
- •Continuous glucose monitor use within the past 6 months
- •Receiving long term, hospice, or palliative care services
- •Malignant cancer
研究组 & 干预措施
Continuous Glucose Monitor
Patients in the intervention arm will receive a continuous glucose monitor in addition to usual care. These patients will be scheduled at least once monthly for clinical pharmacy visits.
干预措施: Continuous Glucose Monitor (Behavioral)
Usual Care
Patients in the usual care arm will have routine physician office visits every 3 months if HbA1c outside goal or every 6 months if HbA1c within goal. Medication regimens will be managed by physicians, nurse practitioners, and physician assistants.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change in Hemoglobin A1c
时间窗: Baseline to Month 6
Change in percentage for Hemoglobin A1c. Normal range for hemoglobin A1c is 4.2%-14%. A low level indicates no diabetes and a high level indicates uncontrolled diabetes.
次要结局
- Change in Medication Adherence(6 Months Post Intervention)
- Diabetes Treatment Satisfaction Questionnaire(Baseline, 1 Month Post Intervention)
- Appraisal of Diabetes Scale(Baseline, 1 Month Post Intervention)
- Change in Medication Adherence(6 Months Post Intervention)
- Number of Hours Glucose Level in Normal Range(Week 1 and 2 of intervention, Last Two Weeks of Intervention)
- Number of Hours Glucose Level Above Normal Range(Week 1 and 2 of intervention, Last Two Weeks of Intervention)
- Number of Hours Glucose Level Below Normal Range(Week 1 and 2 of intervention, Last Two Weeks of Intervention)
- Average Glucose Level(Week 1 and 2 of intervention, Last Two Weeks of Intervention)
- Glucose Management Indicator Percentage(Week 1 and 2 of intervention, Last Two Weeks of Intervention)