Comparison of Dexcom G6 Continuous Glucose Monitoring System and Blood Glucose Levels in Adult Hemodialysis Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Blood glucose measurement
研究概览
简要总结
This is a pilot study enrolling adult hemodialysis patients with diabetes recruited from the University of California Irvine Medical Center (UCIMC) who will undergo simultaneous measurement of glucose levels using 1) continuous glucose monitor (CGM) measured by a Dexcom G6 device vs. 2) "gold-standard" blood glucose levels using capillary fingerstick or venous blood glucose measurements obtained on a point of care (POC) blood glucose meter. The study will assess Dexcom G6 accuracy by comparing glucose levels on the CGM device vs. blood glucose measurements in the study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Adult hemodialysis patients age 18 years or older
- •Have a comorbidity of diabetes
- •Receipt of care from the inpatient University of California Irvine Medical Center nephrology consult service
- •Expected hospital stay ≥48 hours
- •Have the ability to directly provide informed consent for participation in the study
排除标准
- •Critically-ill patients receiving care in the intensive care unit (ICU) or cardiac care unit (CCU)
- •Moribund patients expected to die within 48 hours
- •Presence of any condition deemed by PI's judgment that would seriously limit life expectancy (i.e., poor survival)
- •Unwilling or unable to provide informed consent
结局指标
主要结局
Blood glucose measurement
时间窗: 3 to 5 days
Proportion of CGM values within 20% of blood glucose levels \>100 mg/dl or within 20 mg/dl of blood glucose level for levels \<=100 mg/dl. (Will examine different thresholds of CGM values within a certain range of blood glucose levels, i.e., 10%, 15%, 25%.)
次要结局
- Hypoglycemia events(3 to 5 days)
研究者
Connie Rhee
Assistant Professor of Medicine
University of California, Irvine