Меню
Идёт набор NCT07611721

Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy.

Без фазы С лечением CGM Intensive Care (ICU) Liver Transplant Surgery Solid Organ Transplantation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Continuous glucose monitor.
Кому может быть актуально
Состояния в реестре: CGM, Intensive Care (ICU), Liver Transplant Surgery, Solid Organ Transplantation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Determining the Reliability and Accuracy of the Dexcom G7 Continuous Glucose Monitoring System in the ICU

Обзор

Main objective: The goal is to to determine the accuracy of Dexcom G7 Continuous glucose monitor system in critically ill patients, undergoing major abdominal surgery and solid organ transplantation, in the intensive care unit. On admission to the intensive care unit or at the end of surgery, two Dexcom G7 sensors are placed in the infraclavicular position. Sensor number 1 will be blinded and will only be active when paired with the receiver, without the ability to monitor glucose levels. Sensor number 2 is used for continuous glucose monitoring and can be used to adjust the insulin dose. Patients will wear the continuous glucose monitoring sensor for a maximum of 10 days, including the time spent in the intensive care unit and the immediate care unit. The study will not interfere with any usual care clinical workflows. Calibration is only performed on an unblinded sensor. The reference method for calibration is the glucose from the blood glucose meter. Calibrate on the first day of monitoring: 4 times a day after approximately 6 hours, or if the blood glucose reading from the blood glucose meter is not within the estimated error range of the continuous glucose monitor (difference greater than 1,5mmol/L). Calibration on days 2 and 3 of monitoring: once in the morning, or when the meter's glucose reading is not within the estimated error range of the continuous glucose monitoring (difference greater than 1,5mmol/L) On subsequent days when the blood glucose meter reading is not within the estimated error range of continuous glucose monitoring (difference greater than 1,5mmol/L). Hypothesis: * Ho: No difference in mean absolute relative difference (MARD) between calibrated and non-calibrated sensors. * Ha: Calibrated sensors have lower mean absolute relative difference (δ = 4%, SD = 5%). Further objectives: To evaluate further aspects regarding the Dexcom G7 continuous glucose monitor system's performance in the intensive care unit (ICU), particularly in terms of sensitivity and specificity to detect hypo- and hyperglycaemic events, data availability, device deficiencies and safety. To identify predictive factors of the accuracy of the Dexcom G7 continuous glucose monitor system in critically ill patients in the ICU.

Подробное описание

Design:

* Each intensive care unit patient wears two sensors (calibrated + non-calibrated). * 4 glucose measurements/day × 6 days = 24 measurements/subject. * Sequential Organ Failure Assessment (SOFA) score recorded daily.

Вмешательства

  • Устройство Continuous glucose monitor
    Continuous measurement of glucose from subcutaneous tissue

Первичные конечные точки

  • Calculate overall mean absolute relative difference between arms [Срок оценки: From enrolment to discharge from ICU care or up-to day 10]
Вторичные конечные точки (1)
  • Accuracy metrics [Срок оценки: From enrolment to discharge from ICU care or up-to day 10]

Критерии участия

Критерии включения

  • Age 18 years or over
  • Intensive care unit admission
  • Requiring blood glucose monitoring for insulin therapy

Критерии исключения

  • High-dose ascorbic acid or acetaminophen > 4g/day
  • Physical or mental health condition precluding continuous wear of the continuous glucose monitor, as judged by the physician

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Тройное слепое
Основная цель
Оценка устройства

Центры проведения

Чехия · 1 центр
  • Institute of Clinical and Experimental Medice — Prague

Идентификаторы

NCT: NCT07611721 · G-25-71 · ID Project No. LX22NPO5104

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗