Intermittent Versus Continuous Glucose Monitoring in Intensive Care Unit

Официальное название

Effect of Continuous Interstitial Glucose Monitoring on Glycaemic Targets and Clinical Outcomes in Critically Ill

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Continuous glucose monitoring
  Intravenous insulin therapy will be guided by interstitial glucose measurements using DexcomG7 continuous glucose monitor. Confirmatory blood glucose tests will be performed daily. In extreme clinical conditions (post-resuscitation, pH \< 7.20, severe hypoxia, severe haemodynamic compromise), confirmatory blood tests will be performed in 2 hour intervals until clinical improvement.
• Диагностический тест Control Arm - standard of care
  Intravenous insulin dosing will be guided according to blood glucose measurements using RadiometerABL800 (standard of care). DexcomG7 continuous glucose monitor will be applied in blinded mode for interstitial glucose monitoring for later CGM metrics and comparison analysis.

Первичные конечные точки

• Time in range 7,8 - 10,0 mmol/l [Срок оценки: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)]

Вторичные конечные точки (5)

• Mean glucose levels [Срок оценки: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)]
• Glycemic variability [Срок оценки: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)]
• Vasopressor inotropic score [Срок оценки: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)]
• Hospital acquired infections [Срок оценки: from the enrollment until hospital discharge, approximately 30 days]
• Acute renal failure [Срок оценки: from the enrollment until hospital discharge, approximately 30 days]

Критерии участия

Критерии включения

• age ≥ 18 years
• admission to the level 3 ICU
• two consecutive blood glucose measurements > 10.0 mmol/L
• intravenous insulin therapy

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Словения · 1 центр

• University Medical Center Ljubljana — Ljubljana

Идентификаторы

NCT: NCT07088549 · ICONS-ICU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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