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Effects of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients (GlucoClearIT)

2017년 3월 9일 업데이트: Erasme University Hospital

A Study on the Effects of the Use of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients

After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate treatment cohort will then be consecutively enrolled, followed by the tight glycemic control cohort.

After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory evaluations will be determined.

Subjects enrolled in the standard of care cohort will be treated according to the institution's protocol for measuring glucose and managing insulin. These subjects will be monitored on a GlucoClear System but they will not be managed based on the values or trends of the GlucoClear system.

Subjects enrolled in the treatment cohorts will be monitored and managed with a special version of the GlucoClear continuous monitoring system. This system contains the GlucoClear Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to manage patient glucose within pre-specified target levels. These recommendations are presented on screen for a clinical professional to approve or override.

Subjects in the moderate treatment cohort will have their glucose managed in the range of 120 - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in the range of 80 - 120 mg/dl.

After discharge from the ICU, subjects will followed for adverse events and mortality at 30 days, either by telephone contact or office visit.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Hyperglycemia, hypoglycemia and glycemic variability, the three components of dysglycemia are independently associated with morbidity and mortality of critically ill patients. Blood glucose (BG) control with insulin has the potential to decrease morbidity and mortality of intensive care unit (ICU) patients. Blood glucose control with insulin, however, is associated with an increased risk of hypoglycemia and its effect on glycemic variability is uncertain. BG control with insulin utilizing manual systems for glucose measurement is blood-consuming and time-consuming, since frequent blood draws for glucose measurements are necessary in order to achieve blood glucose control.

Severe hypoglycemia (blood glucose level < 40 mg/dl) is a feared complication of blood glucose control with insulin. Undoubtedly, with implementation of blood glucose with insulin the incidence of hypoglycemia increases. Reported incidences of severe hypoglycemia rise by 5 to 10-fold as compared to conventional glucose control strategies in randomized controlled trials. Several reports showed a significant association between hypoglycemia and patient outcomes. Recently, an association has even been suggested between moderate and mild hypoglycemia (blood glucose level between 40-69 mg/dL) and patient outcomes. Incidences of moderate hypoglycemia are more prevalent than severe hypoglycemia. The risk of developing (severe or moderate) hypoglycemia hampers, at least in part, broad implementation of blood glucose control with insulin, in particular when aiming at normal blood glucose levels [17,18].

Recent studies showed also significant associations between glycemic variability and patient outcomes. BG control algorithms, if properly applied, could decrease glycemic variability. Experimentally, rodent experiment showed that brain damage was not associated with the duration of severe hypoglycemia, but instead with its correction (mainly overcorrection) with intravenous dextrose causing formation of radicals. Hence, a close glucose monitoring to prevent overcorrection is mandatory.

These different arguments strongly support the need for reliable and accurate CGM. The GlucoClearTM Continuous Glucose Monitoring system from Edwards Lifesciences measures blood sugar by Glucose Oxidase Sensing Technology through in-blood measurement. Blood is automatically drawn and analyzed every 5 minutes from a peripheral venous catheter, with real time graphical display. Blood is then returned to the patient and the system automatically self-calibrates. The GlucoClear CGM is designed to be highly accurate. In a recent study performed in critically ill patients, it was shown to comply with the required standards of quality.

The main research question addressed by the present study is: "To which extent a CGM-guided strategy improve the quality of BG control performance"?

연구 유형

중재적

등록 (실제)

100

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Have an anticipated ICU stay of at least 48 hours;
  • Participate or have authorized representative participate in the Informed Consent process and sign/date the approved informed consent form.
  • Have an expected ICU stay of ≥ 24 hours up to 72 hours
  • Have an APACHE II score of ≥ 10, within the first 24 hours of ICU admission.
  • Not be participating in any other investigational interventional study.
  • Have hyperglycemia (BG > 150 mg/dl) up to 6 hours after admission and / or ongoing insulin therapy.
  • Access to a large peripheral vein

Exclusion Criteria:

  • End stage pre-existing medical conditions that would preclude the subject from being able to complete up to 72 hours of glucose monitoring and follow up (14 ± 3 days after Sensor removal); Restricted peripheral venous access, inadequate access for reference sampling or any contraindication to the placement of peripheral IV catheters.
  • Skin conditions or existing (or planned) medical instrumentation and/or dressings that preclude placing the peripheral IV catheters or dressings (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, or surgical dressings).
  • A known history of heparin-induced thrombocytopenia or any contraindication for anti-coagulation therapy.
  • Intolerance to Lactated Ringer's solution ((mEq/liter): Sodium 130; Potassium 4; Calcium 3; Chloride 110; Lactate 28).
  • A positive pregnancy test 72 hours prior to Sensor insertion (for subjects of child bearing potential).
  • Any condition that, in the opinion of the Investigator, would interfere with their participation in the Study.
  • Participated in any other drug, device, or biologic Study within the last 30 days (prior to Sensor insertion) which may clinically interfere with this Study or have not completed the required Protocol follow-up period.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Continuous monitoring-guided therapy
Healthcare providers were allowed to use the blood glucose values displayed on the intravascular continuous monitoring to adapt insulin therapy
장치: Intravascular continuous monitoring
Bedside usual insulin therapy guided by continuous glucose monitoring
다른: Standard of care
Healthcare providers used the usual intermittent method to adapt insulin therapy; the blood glucose values measured by the intravascular continuous monitoring were not displayed but recorded. Usual care involves the adjustment of insulin infusion based on BG values measured with a blood gas analyser 4-6 times per day.
다른: Standard of care
Bedside usual insulin therapy guided by intemittent glucose monitoring

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Time in target
기간: 72 hours
Cumulative time in target band (expressed in percentage) will be calculated from the set of BG values recorded by the CGM in both groups.
72 hours

2차 결과 측정

결과 측정
측정값 설명
기간
SOFA 점수
기간: 72시간
72시간
Hypoglycaemic index
기간: 72 hours
Area under the low limit of the target range
72 hours
Glycemic variability
기간: 72 hours
Coefficient of variation
72 hours
Mortality
기간: 28 days
ICU, hospital and 28-day mortality
28 days
Length of stay
기간: 28 days
28 days
Time to target
기간: 72 hours
Time to achieve the upper limit of target range (hours)
72 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Erasme University Hospital

협력자

Edwards Lifesciences

수사관

  • 연구 책임자: Jean-Louis Vincent, MD PhD, Erasme University Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 5월 1일

기본 완료 (실제)

2014년 5월 1일

연구 완료 (실제)

2015년 6월 1일

연구 등록 날짜

최초 제출

2016년 10월 3일

QC 기준을 충족하는 최초 제출

2017년 2월 8일

처음 게시됨 (추정)

2017년 2월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 3월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 3월 9일

마지막으로 확인됨

2017년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • P2014/162 / B406201420742

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

대사 스트레스 고혈당증에 대한 임상 시험

Intravascular continuous monitoring에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Gambia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다