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临床试验/NCT05571397
NCT05571397已完成1 期

Expanding Use of Continuous Glucose Monitoring Beyond COVID in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes

Ohio State University1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
201
试验地点
1
主要终点
Percentage of Time in Target Glycemic Ranges

研究概览

简要总结

The primary objective of this implementation study is to assess the feasibility of real time continuous glucose monitoring (CGM) implementation using a CGM plus (+) point-of-care (POC) protocol among patients on IV insulin or those with hyperglycemia (>250mg/dl) in the critical care hospital environments.

详细描述

This study analyzes the feasibility of inpatient real time CGM implementation through the use of a CGM + POC protocol as routine care for glycemic monitoring among patients on IV insulin or those with hyperglycemia (>250mg/dl). The investigators will examine the effects on medical intensive care (MICU) patient's (N=100) glycemic control compared to matched historical control patients (N=100) from the MICU who received fingerstick POC.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
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

  • adults >18 years old,
  • admitted to Ohio State University Wexner Medical Center MICU and
  • have hyperglycemia (glucose >250mg/dl) or are currently on IV insulin.

排除标准

  • Current COVID-19 infection,
  • Refractory shock (Levophed dose >0.5 mcg/kg/min or equivalent)
  • Actively being treated for diabetic ketoacidosis (DKA)
  • Actively being treated for hyperosmolar non-ketoacidosis (HONK)
  • Pitting edema, anasarca, blue or purple discoloration to left upper extremity
  • Treated with high dose acetaminophen (>1 gram Q6 hours)
  • Treated with hydroxyurea
  • Are pregnant, patients
  • Using home insulin pump therapy during hospitalization, or
  • Reside in a corrections institution.

研究组 & 干预措施

Dexcom CGM

Experimental

Dexcom G6

干预措施: Dexcom G6 (Device)

Historical Controls

No Intervention

Matched historical controls

结局指标

主要结局

Percentage of Time in Target Glycemic Ranges

时间窗: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient

Percent of time in target glycemic ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d

次要结局

  • Percent of Time in Hypoglycemic Ranges(For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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