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临床试验/NCT06190808
NCT06190808已完成不适用

Continuous Glucose Monitoring in the Intensive Care Unit: Validation and Implementation

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Clarke Error Grid

研究概览

简要总结

The aim of the proposed clinical trial is to study the use of the Dexcom G7 continuous glucose monitor (CGM) within the intensive care unit (ICU) environment. The overall goal is to validate the accuracy and practicality of the Dexcom G7 when used to assess glycemia in critically ill patients.

详细描述

The specific goals are 1) to work with intensive care unit (ICU) staff, in a respiratory ICU setting, to determine how best to place and maintain Dexcom G7 continuous glucose monitors (CGMs) on patients and how to place recording devices and chargers in that environment, 2) download CGM readings to the Dexcom Dashboard in an analyzable format, and 3) to compare simultaneous CGM readings with glucose measurements obtained in the course of routine care as recorded in the electronic medical record. The primary analytical goal is the correlation of CGM glucose measurements with those obtained in the course of routine care. A secondary goal is to determine the frequency of device malfunctions that occur either as a result of device failure (e.g. it falls off) or adverse events (e.g. removal due to skin irritation).

Study subjects will be patients admitted to the 6-ICU UMass Memorial Medical Center (UMMMC) University Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized. All enrolled volunteers will have a Dexcom G7 CGM place on the skin according to manufacturer's specifications. The devices will remain in place for 10 days or until discharge from the ICU

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized.
  • Persons with either type 1 or type 2 diabetes.
  • Persons of either sex.
  • Persons of any age over
  • Persons able to give informed consent or cognitively impaired adults whose legally authorized representative (LAR) can give informed consent.
  • English or Spanish speaking adults.

排除标准

  • Persons unable to provide informed consent.
  • Cognitively impaired persons whose LAR declines to provide informed consent.
  • Patients receiving hydroxyurea, which interferes with sensor function.
  • Patients receiving high dose acetaminophen (> 4 gm/day), which interferes with sensor function.
  • Anasarca affecting preferred areas for device placement (arm, upper buttocks, or thigh), which may interfere with sensor accuracy.
  • Severe cachexia with absence of subcutaneous fat at preferred sensor placement sites, which might interfere with sensor accuracy.
  • Persons who are pregnant.
  • Prisoners.

结局指标

主要结局

Clarke Error Grid

时间窗: 6 months

Traditional comparison of glucose concentration results obtained by standard test methods and by newer method

Mean Absolute Relative Difference (MARD).

时间窗: 6 months

Concordance of glucose concentration results obtained by standard test methods with those obtained by a continuous glucose monitoring device

次要结局

  • Unplanned event frequency(6 months)
  • Adverse event nature and frequency(6 months)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

John P Mordes, MD

Professor Emeritus of Medicine

University of Massachusetts, Worcester

研究点 (2)

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