Effect of Continuous Interstitial Glucose Monitoring on Glycaemic Targets and Clinical Outcomes in Critically Ill
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time in range 7,8 - 10,0 mmol/l
研究概览
简要总结
Glucose control is an important part of supportive care for critically ill patients. Achieving optimal glucose control in such situations is challenging due to frequent fluctuations in blood glucose levels. These changes are often difficult to detect because the monitoring procedures are complex and require significant staff involvement, frequent blood draws, and consequent blood loss. Continuous glucose monitoring (CGM) is a simple and minimally invasive technique that has been approved and increasingly used by people with diabetes mellitus. However, its effectiveness in terms of glucose control management and accuracy in conditions with severe organ dysfunction has not been established.
The goal of this study is to assess the performance of CGM-guided glucose control in comparison to the standard glucose monitoring procedure. Additionally, the accuracy of CGM measurements under critical conditions will be evaluated against the standard of care.
详细描述
This study will be an investigator-initiated, non-commercial, prospective, single-center, parallel-group, randomized controlled trial. Critically ill patients with hyperglycemia requiring intravenous insulin therapy will be randomly assigned to two groups: an intervention group that will receive intravenous insulin therapy aided by continuous glucose monitoring (CGM) measurements and a control group that will receive intravenous insulin therapy guided by arterial blood glucose measurements (RadiometerABL800). Patients will be enrolled within 48 hours after ICU admission. Intravenous insulin dosing will be adjusted according to the in-house glycaemic management protocol. After enrollment, patients will be monitored for maximal 10 days (duration of the sensor) or until stopping intravenous insulin therapy, ICU discharge or death, whichever occurs first, if these events happen before the sensor duration ends.
The primary outcome of the study will be the proportion of time spent within the target range of 7.8-10.0 mmol/L. Secondary outcomes will include mean glucose levels and other CGM metrics, daily vasoactive-inotropic score calculation, hospital length of stay, hospital-acquired infections, and acute renal failure.
Additionally, an accuracy analysis in extreme clinical conditions (pH < 7.20, post-resuscitation, ECMO support, severe haemodynamic instability, hypoxia) will be performed by comparing CGM measurements measured by DexcomG7 with arterial blood glucose measurements (RadiometerABL800) from the electronic health record. Satisfaction of health-care personnel will be evaluated. Sensor-related complications will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •age ≥ 18 years
- •admission to the level 3 ICU
- •two consecutive blood glucose measurements > 10.0 mmol/L
- •intravenous insulin therapy
排除标准
- •expected ICU stay < 48 hours
- •pregnancy
- •type 1 diabetes
- •diabetic emergencies (DKA, DAHS)
- •severe skin disease
- •severe neutropenia (< 0.5 × 10^9/L)
- •severe coagulopathy (thrombocytes < 20 × 10^9/L)
- •manufacturer-defined conditions (hydroxyurea use, acetaminophen more than 4 g daily)
研究组 & 干预措施
CGM monitoring
DexcomG7 continuous glucose monitor
干预措施: Continuous glucose monitoring (Device)
Standard of care
Radiometer ABL800 blood glucose measurement
干预措施: Control Arm - standard of care (Diagnostic Test)
结局指标
主要结局
Time in range 7,8 - 10,0 mmol/l
时间窗: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
Percentage of time within recommended glucose range
次要结局
- Mean glucose levels(from the enrollment until completion of the continuous glucose monitoring (up to 10 days))
- Glycemic variability(from the enrollment until completion of the continuous glucose monitoring (up to 10 days))
- Vasopressor inotropic score(from the enrollment until completion of the continuous glucose monitoring (up to 10 days))
- Hospital acquired infections(from the enrollment until hospital discharge, approximately 30 days)
- Acute renal failure(from the enrollment until hospital discharge, approximately 30 days)
研究者
Peter Radsel
Head of Clinical Department of Internal Intensive Care Medicine
University Medical Centre Ljubljana