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临床试验/NCT06329297
NCT06329297撤回不适用

Continuous Glucose Monitoring in Medical and Open-Heart Surgical Patients

Parkview Health0 个研究点目标入组 80 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
80
主要终点
CGM vs point of care test (POCT) glucose

研究概览

简要总结

The purpose of this study is to contribute to current research regarding the feasibility and accuracy of CGM in the hospital setting for both the medical and cardiovascular intensive care (ICU) patient populations.

详细描述

The use of continuous glucose monitors (CGM) in the outpatient setting has dramatically increased as these devices continue to improve in both ease of use, accessibility, and accuracy. Federal Drug Administration (FDA) clearance of certain devices has now been granted in both pregnancy and automated insulin delivery systems. As the world has embraced the safety and efficacy of continuous glucose monitors in the outpatient setting, health systems have turned attention to the potential of utilizing these devices to improve glycemic control in the hospital setting. With the announcement of the FDA granting enforcement discretion regarding the use of CGM technology in the hospital setting during the COVID-19 pandemic, the result was an abundance of research evaluating the potential of CGM longevity in the hospital setting.

The Standards of Care in Diabetes: 2023 reported that "preliminary data suggests that CGM can significantly improve glycemic management and other hospital outcomes." Additionally, a systematic review of 32 studies evaluated the accuracy of CGM in the intensive care unit, with a consensus of moderate to good accuracy. CGM in the hospital setting could provide a valuable tool in reducing hypoglycemia, hyperglycemia, and increasing time spent in normoglycemia. Other potential benefits of CGM include a broader view of glucose patterns, capture of asymptomatic hypoglycemia, reduced length of stay, and decreased cost. The Diabetes Technology Society organized the Hospital Consensus Guideline Panel in 2020, with the final report including the recommendation for additional research on the accuracy, data management, and patient-centered outcomes of CGM use in the inpatient setting.

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

  • Admitted patients 18 years of age or older
  • Glucose management per Glucommander and/or receiving POC blood glucose testing
  • Patients admitted to Medical 6 or elective or urgent open-heart surgery patients admitted to the Cardiovascular Intensive Care Unit (CVICU)

排除标准

  • Patients less than 18 years of age
  • Pregnant or currently breastfeeding
  • Prisoners
  • Patients unable to consent in English.
  • Patients with a preexisting insulin pump on admission
  • Active skin infection at the insertion site(s)

研究组 & 干预措施

General medical inpatients

Medical inpatients who have a Glucommander order for management of hyperglycemia will have a CGM monitor placed within 24 hours of admission for up to 7 days or upon discharge.

干预措施: CGM monitor (Device)

Open-heart surgery inpatients

Patients having elective open-heart surgery including coronary artery bypass grafting (CABG), aortic valve repair/replacement (AVR), mitral valve repair/replacement (MVR), or any combination of those will have a CGM monitor placed within one hour of admission for up to 7 days or upon discharge.

干预措施: CGM monitor (Device)

结局指标

主要结局

CGM vs point of care test (POCT) glucose

时间窗: from date of admission up to 7 days

Continuous interstitial glucose monitor readings compared to point of care capillary blood glucose readings

次要结局

  • Slow downward trend arrow on CGM device(from date of admission up to 7 days)

研究者

发起方
Parkview Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Danielle Payne, FNP

Clinical Nurse Researcher & Nursing Research Program Coordinator

Parkview Health

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Continuous Glucose Monitoring in Inpatients | 临床试验