Using Technology to Address Disparities and Promote Healthcare Equity in Type 1 Diabetes Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in CGM Utilization
研究概览
简要总结
This study is being done to see if using technology, with the help of a Patient Navigator, can help address disparities, improve outcomes, and promote healthcare equity in type 1 diabetes.
详细描述
Patients with T1D require an individualized care plan with ongoing education and support. A recent qualitative study of young adults with T1D and end-stage renal disease revealed that childhood environment, education, socio-economic status, and other determinants contributed to disengagement from treatment regimens and the development of microvascular complications early in life1. Providing participants with real-time CGMS will inform daily decision making.
This is an interventional study using prescribed real-time CGMS together with feedback and support from a Patient Navigator in patients with T1D. The aims of this study include the following.
Aim 1: To incorporate real-time CGMS and patient navigation support into the care of adolescent and adult patients with T1D and one of the following: 1.) two or more hospitalizations for DKA in the last five years or 2.) two or more hemoglobin A1c values over 10% in the last two years.
Aim 2: To collect information from participants regarding health outcomes, experiences with health care, and changes, if any, in diabetes self-management practices, diabetes distress, and diabetes health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 14 to 64 years
- •Clinical diagnosis of type 1 diabetes (T1D)
- •Two or more hospitalizations with diabetic ketoacidosis (DKA) within the past 5 years or hemoglobin A1c greater than 10% on two or more laboratory samples in the last 2 years.
- •Informed Consent
- •Has a CGMS or a prescription for a CGMS as part of their clinical care as part of their clinical care
排除标准
- •Inability or unwillingness to share CGMS data with the study team
研究组 & 干预措施
Patient Navigator
Patient Navigator will provide additional support to participants using their standard of care CGM device.
干预措施: Patient Navigator (Behavioral)
结局指标
主要结局
Change in CGM Utilization
时间窗: Baseline to Month 48
Use of CGMS (Continuous Glucose Monitor) device measured by the percentage of time during a month that a participant is using their CGM.
次要结局
- Change in diabetes health-related quality of life(Baseline to Month 48)
- Diabetes distress changes measured by PAID(Baseline to Month 48)
- Diabetes distress changes measured by PAID-T(Baseline to Month 48)
- Change in diabetes self-management practices(Baseline to Month 48)