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临床试验/NCT07271433
NCT07271433已完成不适用

Continuous Glucose Monitoring for Post-kidney Transplantation in Pre-existing Type 2 Diabetes

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月29日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Hospital Readmission

研究概览

简要总结

Use of continuous glucose monitor (CGM) in post kidney transplant patients to better assess changes in glucose levels post kidney transplant

详细描述

This is a non-randomized perspective single arm study with a planned enrollment of 20 patients. The primary objective is to characterize the glucometrics (description of glucose readings in relation to target goals) achieved by a CGM-based insulin titrating protocol for glucocorticoid taper for post kidney transplant patients. The secondary objective is to explore the relationship between the CGM glucometrics and rates of readmission, rejection and delayed graft function in post kidney transplant patients.

A total of 20 patients that are post kidney transplant, will undergo intervention until 3 months post-transplant. Informed consent will be obtained prior to start of study. The final visit will be at 3 months. Patients will be discharged to their local endocrinologist or primary care physician at this 3-month mark. Data will continue to be gathered for 3 more months after exit from intervention. Enrollment will be within the first 2 weeks of hospital discharge. Visits are standard of care (SOC) at the Kidney Transplant Clinic or at the Endocrinology clinic and will be virtual, in-person or telephone encounter.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sex: men and women
  • Ethnicity: all ethnic groups
  • Known type 2 diabetes before kidney transplant
  • Kidney transplant alone
  • On multiple daily insulin injection
  • Standard prednisone taper
  • Smart phone - compatible with the LibreView App

排除标准

  • Simultaneous pancreas-kidney transplant
  • Allergy to Freestyle Libre components including adhesive
  • Use of vitamin C at doses 500 mg or greater
  • Blood dyscrasias that prevent hemoglobin A1c interpretation
  • Lack of mobile app accessibility
  • Rapid prednisone taper

研究组 & 干预措施

Post Kidney Transplant, using CGM

A total of 20 patients that are post kidney transplant, will wear a Continuous Glucose Monitor (CGM) until 3 months post-transplant.

结局指标

主要结局

Hospital Readmission

时间窗: 6 months

Percent of patients who experienced a hospital readmission

Time below range (TBR)

时间窗: 6 months

Percent of patients who achieved Time below range (\<54 mg/dL Glucose) as measured by the Continuous Glucose Monitor

Time above range (TAR)

时间窗: 6 months

Percent of patients who achieved Time above range (181-250mg/dL and \>250 mg/dL Glucose) as measured by the Continuous Glucose Monitor

Rejection

时间窗: 6 months

Percent of patients who experienced a rejection of the transplanted kidney

Time in Range (TIR)

时间窗: 6 months

Percent of patients who achieved Time in Range (55 mg/dL to 180 mg/dL Glucose) as measured by the Continuous Glucose Monitor

Delayed graft function

时间窗: 6 months

Percent of patients who experienced delayed graft function

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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