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. (DREAM-ICU)
Determining the Reliability and Accuracy of the Dexcom G7 Continuous Glucose Monitoring System in the ICU
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.
연구 개요
상태
개입 / 치료
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Marek Protus, MD
- 전화번호: +420602278062
- 이메일: marek.protus@ikem.cz
연구 연락처 백업
- 이름: Alexander Macek, MD
- 전화번호: +421910631876
- 이메일: alexander.macek@ikem.cz
연구 장소
-
-
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Prague, 체코
- 모병
- Institute of Clinical and Experimental Medice
-
연락하다:
- Marek Protus, MD
- 전화번호: +420602278062
- 이메일: marek.protus@ikem.cz
-
연락하다:
- Alexander Macek, MD
- 전화번호: +421910631876
- 이메일: alexander.macek@ikem.cz
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 years or over
- Intensive care unit admission
- Requiring blood glucose monitoring for insulin therapy
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Open labeled CGM
Additional calibrations performed on CGM device during monitoring period
|
Continuous measurement of glucose from subcutaneous tissue
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가짜 비교기: Control labeled CGM
No additional calibrations performed on CGM device during monitoring period
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Continuous measurement of glucose from subcutaneous tissue
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Calculate overall mean absolute relative difference between arms
기간: From enrolment to discharge from ICU care or up-to day 10
|
Analyse the difference in mean absolute relative difference (MARD) of Dexcom G7 continuous glucose monitor between calibrated and uncalibrated sensor, in patients undergoing major abdominal surgery and solid organ transplantation.
|
From enrolment to discharge from ICU care or up-to day 10
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Accuracy metrics
기간: From enrolment to discharge from ICU care or up-to day 10
|
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. |
From enrolment to discharge from ICU care or up-to day 10
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- G-25-71
- ID Project No. LX22NPO5104 (기타 보조금/기금 번호: MH CZ-DRO (Institute for Clinical and Experimental Medicine-IKEM, IN 00023001)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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