Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Referrals
研究概览
简要总结
The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 23 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
排除标准
- •Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.
- •Patients with eGFR <30 or ≥ 60 ml/min/1.73m2 without albuminuria.
- •Patients with ESRD or on renal recovery treatments at time of enrollment.
- •Patients who are pregnant at the time of enrollment.
- •Patients who are currently hospitalized.
- •Patients without minimum 6 month pre-baseline KidneyIntelX medical history.
- •Patients who are currently on Enbrel.
结局指标
主要结局
Referrals
时间窗: 6 Months
Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.
HbA1c
时间窗: 6 Months
Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.
Statins and or ACEi/ARB
时间窗: 6 Months
Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
SGLT2/ GLP1
时间窗: 6 Months
Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.
次要结局
未报告次要终点