Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Average Daily Glucose
研究概览
简要总结
This will be a prospective, randomized, single-blinded controlled trial in which the investigators evaluate post-operative serum glucose control using conventional point-of-care glucose monitoring in the morning and before meals (standard of care) versus continuous glucose monitoring using the Medtronic Guardian™ Sensor 3 continuous glucose monitor. The investigators will compare the average daily glucose level in the post-operative period (through post-operative day five) between the two arms in patients with diabetic nephropathy immediately post-renal transplant. This will serve as a pilot study to in order to power a main study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 years or older
- •Undergoing first-time renal transplantation
- •Have a pre-existing diagnosis of Type 2 diabetes mellitus
排除标准
- •Age less than 18 years
- •Use of insulin pump at time of transplant
- •Insulin infusion requirement during hospitalization
- •Pregnancy or lactation
- •Known allergic reaction to Guardian™ Sensor 3 or adhesives
- •History of hypoglycemia unawareness
研究组 & 干预措施
Intervention Arm
干预措施: Continuous Glucose Monitor Application (Device)
Intervention Arm
干预措施: Finger Stick Glucose Measurement (Diagnostic Test)
Intervention Arm
干预措施: Insulin (Drug)
Control Arm
干预措施: Finger Stick Glucose Measurement (Diagnostic Test)
Control Arm
干预措施: Insulin (Drug)
Control Arm
干预措施: Continuous Glucose Monitor Placebo Applied (Device)
结局指标
主要结局
Average Daily Glucose
时间窗: Postoperative day 1 - 5
The primary outcome of this study is average daily glucose level.
次要结局
- Number of Hyperglycemic Episodes(Postoperative days 1-5)
- Total Insulin Use(Postoperative days 1-5)
- Number of Hypoglycemic Episodes(Postoperative days 1-5)