Evaluation of a Fast Point-of-care Platform for Diabetes Care at Out-patient Clinics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Changes from baseline to the end of study in eGFR
研究概览
简要总结
Using a point-of-care (POC) platform, the investigators will investigate the effects of POC testing for glycated hemoglobin (HbA1c) and cystatin C at out-patient clinics on long-term diabetes outcomes.
详细描述
Laboratory testing for HbA1c and cystatin C is time-consuming, and healthcare providers often do not have update results when they evaluate outpatients with diabetes. A POC testing platform may help address this issue, and the investigators aim to examine its effects on diabetes outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 80 receiving treatment and follow-up for diabetes at outpatient clinics of Taichung Veterans General Hospital, Taichung, Taiwan.
排除标准
- •Past medical history of hemolytic anemia, hemoglobinopathies (sickle cell anemia HbS, fetal hemoglobin HbF), iron deficiency anemia, thalassemia, pernicious anemia, recent blood transfusions, acute bleeding requiring erythropoiesis-stimulating agents.
- •Chronic liver disease, cirrhosis, hyperbilirubinemia, asplenia (splenomegaly, splenectomy).
- •Hypertriglyceridemia (over 500 mg/dl), or alcoholism.
- •Thyroid dysfunction, active malignant tumors under treatment, HIV infection.
- •Long-term use (over three months) of steroids or cyclosporine.
- •Severe proteinuria (e.g., nephrotic syndrome), or a baseline eGFR <60 ml/min/1.73 m².
研究组 & 干预措施
Outpatients with diabetes who provide consent to POC testing
Intervention: POC testing for HbA1c and cystatin C. Observational follow up: data on fasting glucose, HbA1c, serum creatinine, urine albumin to creatinine ratio (UACR), lipids profile, ...etc.
干预措施: POC testing (Other)
Outpatients with diabetes who decline to POC testing, but consent to observational follow up
This group will serve as the controls. Follow up data on fasting glucose, HbA1c, serum creatinine, urine albumin to creatinine ratio (UACR), lipids profile, ...etc.
结局指标
主要结局
Changes from baseline to the end of study in eGFR
时间窗: Observational follow up period of 3 years
Estimated glomerular filtration rate (eGFR) will be determined using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey AS, et al. Ann Intern Med. 2009; 150: 604-12).
次要结局
- Changes from baseline to the end of study in UACR(Observational follow up period of 3 years)
研究者
Jun-Sing Wang, MD, PhD
Director, Division of Endocrinology and Metabolism
Taichung Veterans General Hospital