Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM) (ICU-TeleCGM)
2026년 8월 13일 업데이트: Imperial College Healthcare NHS Trust
The aim of this observational study is to assess safety and implementation of continuous glucose monitors within the Intensive Care Unit.
The Dexcom G7 is a continuous glucose monitoring system that shows blood glucose values in real-time and includes alarms if the glucose is very low or high.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Aim: To assess safety and implementation of networked CGM with ViewsEMR® telemetry within ICU.
The study will be conducted in a two-stage process:
- Phase 1: A single arm (non-randomised) unmasked feasibility study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry. This phase will be conducted at a single site at Imperial College Healthcare NHS Trust (ICHNT).
- Phase 2: A randomised, parallel-group pilot study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry compared to standard of care. This phase will be conducted at three hospitals within the same site: ICHNT (St Mary's Hospital, Charing Cross Hospital and Hammersmith Hospital). The study will be conducted at Imperial College Healthcare NHS Trust in people with hyperglycaemia on admission to ICU requiring insulin.
연구 유형
연구 유형
관찰
등록 (추정된)
등록
70
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Parizad Avari, MBBS, PhD
- 전화번호: 020 33133706
- 이메일: p.avari@nhs.net
연구 연락처 백업
- 이름: Narvada Jugnee, MSc
- 전화번호: 020 33133706
- 이메일: n.jugnee@nhs.net
연구 장소
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London, 영국
- Imperial College Healthcare NHS Trust
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Adults admitted to the intensive care unit with hyperglycaemia
설명
Inclusion Criteria:
- Age >18years inclusive
- Hyperglycaemia requiring insulin therapy (subcutaneous injection or intravenous insulin) during admission on ICU
- Admission to ICU within 48hours
Exclusion Criteria:
- Known significant allergy to tape/ adhesives
- Imminent death or anticipated length of stay <24hours
- Women who are pregnant
- Imminent extracorporeal membrane oxygenation (ECMO)
- Requirement for therapeutic temperature control (i.e. cooling) post cardiac arrest
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
2
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)
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Continuous glucose monitoring.
ViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends
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Usual care + masked Dexcom G7
Use of continuous glucose monitoring (Dexcom G7) without telemetry (ViewsEMR/CampViews®)
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Continuous glucose monitoring.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Phase 1: Eligible participants that consent to participate.
기간: Throughout Phase 1 study period, up to 6 months
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Percentage of eligible participants that consent to participate, including the percentage enrolled through participant informed consent, via personal consultee, and via nominated consultee.
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Throughout Phase 1 study period, up to 6 months
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Phase 1: Time from admission to ICU to initiation of CGM
기간: From admission to ICU to initiation of CGM, up to 48 hours
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Time in minutes from admission to ICU to initiation of CGM
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From admission to ICU to initiation of CGM, up to 48 hours
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Phase 1: Time from consent to initiation of CGM
기간: From enrollment to the end of intervention at 10 days
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Time from consent to initiation of CGM
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From enrollment to the end of intervention at 10 days
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Phase 1: Percentage of CGM data availability for each participant
기간: From enrollment to the end of intervention at 10 days
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Percentage of CGM data availability for each participant
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From enrollment to the end of intervention at 10 days
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Phase 1: Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
기간: From enrollment to the end of intervention at 10 days
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Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
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From enrollment to the end of intervention at 10 days
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Phase 1: Number of premature sensor failures per participant (defined as <70% of anticipated use)
기간: From enrollment to the end of intervention at 10 days
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Number of premature sensor failures per participant (defined as <70% of anticipated use)
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From enrollment to the end of intervention at 10 days
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Phase 1: Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
기간: From enrollment to the end of intervention at 10 days
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Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
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From enrollment to the end of intervention at 10 days
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Phase 1: Proportion of participants completing the study
기간: Throughout Phase 1 study period, up to 6 months
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Proportion of participants completing the study
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Throughout Phase 1 study period, up to 6 months
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Phase 1: Proportion of nursing staff completing study survey
기간: Throughout Phase 1 study period, up to 6 months
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Proportion of nursing staff completing study survey
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Throughout Phase 1 study period, up to 6 months
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Phase 2: Number of episodes of hypoglycaemia per participant
기간: Throughout Phase 2, up to 30 days
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Number of episodes of hypoglycaemia per participant (defined as <3.9mmol/L for 15minutes)
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Throughout Phase 2, up to 30 days
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Phase 1: Safety Outcomes
기간: From enrollment to the end of intervention, up to 10 days
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- Duration of CGM signal loss (units: minutes)
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From enrollment to the end of intervention, up to 10 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
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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 (추정된)
연구 시작
2026년 8월 1일
기본 완료 (추정된)
기본 완료
2028년 6월 1일
연구 완료 (추정된)
연구 완료
2028년 6월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 13일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 17일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 13일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- 167867
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Ethics approval does not allow sharing of individual participant data
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
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예
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예
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. .