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
아직 모집하지 않음
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
관찰
등록 (추정된)
70
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
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
-
-
-
London, 영국
- Imperial College Healthcare NHS Trust
-
-
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
- 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
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)
|
Continuous glucose monitoring.
ViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends
|
|
Usual care + masked Dexcom G7
Use of continuous glucose monitoring (Dexcom G7) without telemetry (ViewsEMR/CampViews®)
|
Continuous glucose monitoring.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase 1: Eligible participants that consent to participate.
기간: Throughout Phase 1 study period, up to 6 months
|
Percentage of eligible participants that consent to participate, including the percentage enrolled through participant informed consent, via personal consultee, and via nominated consultee.
|
Throughout Phase 1 study period, up to 6 months
|
|
Phase 1: Time from admission to ICU to initiation of CGM
기간: From admission to ICU to initiation of CGM, up to 48 hours
|
Time in minutes from admission to ICU to initiation of CGM
|
From admission to ICU to initiation of CGM, up to 48 hours
|
|
Phase 1: Time from consent to initiation of CGM
기간: From enrollment to the end of intervention at 10 days
|
Time from consent to initiation of CGM
|
From enrollment to the end of intervention at 10 days
|
|
Phase 1: Percentage of CGM data availability for each participant
기간: From enrollment to the end of intervention at 10 days
|
Percentage of CGM data availability for each participant
|
From enrollment to the end of intervention at 10 days
|
|
Phase 1: Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
기간: From enrollment to the end of intervention at 10 days
|
Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
|
From enrollment to the end of intervention at 10 days
|
|
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
|
Number of premature sensor failures per participant (defined as <70% of anticipated use)
|
From enrollment to the end of intervention at 10 days
|
|
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
|
Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
|
From enrollment to the end of intervention at 10 days
|
|
Phase 1: Proportion of participants completing the study
기간: Throughout Phase 1 study period, up to 6 months
|
Proportion of participants completing the study
|
Throughout Phase 1 study period, up to 6 months
|
|
Phase 1: Proportion of nursing staff completing study survey
기간: Throughout Phase 1 study period, up to 6 months
|
Proportion of nursing staff completing study survey
|
Throughout Phase 1 study period, up to 6 months
|
|
Phase 2: Number of episodes of hypoglycaemia per participant
기간: Throughout Phase 2, up to 30 days
|
Number of episodes of hypoglycaemia per participant (defined as <3.9mmol/L for 15minutes)
|
Throughout Phase 2, up to 30 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase 1: Safety Outcomes
기간: From enrollment to the end of intervention, up to 10 days
|
- Duration of CGM signal loss (units: minutes)
|
From enrollment to the end of intervention, up to 10 days
|
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
- Saunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, Burroughs H, Jinks C. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893-1907. doi: 10.1007/s11135-017-0574-8. Epub 2017 Sep 14.
- Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
- Deshmukh H, Wilmot EG, Gregory R, Barnes D, Narendran P, Saunders S, Furlong N, Kamaruddin S, Banatwalla R, Herring R, Kilvert A, Patmore J, Walton C, Ryder REJ, Sathyapalan T. Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Diabetes Care. 2020 Sep;43(9):2153-2160. doi: 10.2337/dc20-0738. Epub 2020 Jul 15.
- Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.
- Agarwal S, Mathew J, Davis GM, Shephardson A, Levine A, Louard R, Urrutia A, Perez-Guzman C, Umpierrez GE, Peng L, Pasquel FJ. Continuous Glucose Monitoring in the Intensive Care Unit During the COVID-19 Pandemic. Diabetes Care. 2021 Mar;44(3):847-849. doi: 10.2337/dc20-2219. Epub 2020 Dec 23.
- Sadhu AR, Serrano IA, Xu J, Nisar T, Lucier J, Pandya AR, Patham B. Continuous Glucose Monitoring in Critically Ill Patients With COVID-19: Results of an Emergent Pilot Study. J Diabetes Sci Technol. 2020 Nov;14(6):1065-1073. doi: 10.1177/1932296820964264. Epub 2020 Oct 16.
- Curkendall SM, Natoli JL, Alexander CM, Nathanson BH, Haidar T, Dubois RW. Economic and clinical impact of inpatient diabetic hypoglycemia. Endocr Pract. 2009 May-Jun;15(4):302-12. doi: 10.4158/EP08343.OR.
- Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341.
- Holzinger U, Warszawska J, Kitzberger R, Wewalka M, Miehsler W, Herkner H, Madl C. Real-time continuous glucose monitoring in critically ill patients: a prospective randomized trial. Diabetes Care. 2010 Mar;33(3):467-72. doi: 10.2337/dc09-1352. Epub 2009 Dec 10.
- Turchin A, Matheny ME, Shubina M, Scanlon JV, Greenwood B, Pendergrass ML. Hypoglycemia and clinical outcomes in patients with diabetes hospitalized in the general ward. Diabetes Care. 2009 Jul;32(7):1153-7. doi: 10.2337/dc08-2127.
- Baker EH, Janaway CH, Philips BJ, Brennan AL, Baines DL, Wood DM, Jones PW. Hyperglycaemia is associated with poor outcomes in patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease. Thorax. 2006 Apr;61(4):284-9. doi: 10.1136/thx.2005.051029. Epub 2006 Jan 31.
- Dhatariya KK, Umpierrez G. Gaps in our knowledge of managing inpatient dysglycaemia and diabetes in non-critically ill adults: A call for further research. Diabet Med. 2023 Mar;40(3):e14980. doi: 10.1111/dme.14980. Epub 2022 Nov 16.
- Avari P, Lumb A, Flanagan D, Rayman G, Misra S, Dhatariya K, Choudhary P. Continuous Glucose Monitoring Within Hospital: A Scoping Review and Summary of Guidelines From the Joint British Diabetes Societies for Inpatient Care. J Diabetes Sci Technol. 2023 May;17(3):611-624. doi: 10.1177/19322968221137338. Epub 2022 Nov 28.
- Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care. 2017 Jun;40(6):736-741. doi: 10.2337/dc17-0133. Epub 2017 Apr 7.
- Zelada H, Perez-Guzman MC, Chernavvsky DR, Galindo RJ. Continuous glucose monitoring for inpatient diabetes management: an update on current evidence and practice. Endocr Connect. 2023 Sep 25;12(10):e230180. doi: 10.1530/EC-23-0180. Print 2023 Oct 1.
- Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Olafsdottir AF, Frid A, Wedel H, Ahlen E, Nystrom T, Hellman J. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):379-387. doi: 10.1001/jama.2016.19976.
- Faulds ER, Boutsicaris A, Sumner L, Jones L, McNett M, Smetana KS, May CC, Buschur E, Exline MC, Ringel MD, Dungan K. Use of Continuous Glucose Monitor in Critically Ill COVID-19 Patients Requiring Insulin Infusion: An Observational Study. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4007-e4016. doi: 10.1210/clinem/dgab409.
- Heinemann L, Deiss D, Hermanns N, Graham C, Kaltheuner M, Liebl A, Price D. HypoDE: Research Design and Methods of a Randomized Controlled Study Evaluating the Impact of Real-Time CGM Usage on the Frequency of CGM Glucose Values <55 mg/dl in Patients With Type 1 Diabetes and Problematic Hypoglycemia Treated With Multiple Daily Injections. J Diabetes Sci Technol. 2015 May;9(3):651-62. doi: 10.1177/1932296815575999. Epub 2015 Mar 9.
- Wexler DJ, Meigs JB, Cagliero E, Nathan DM, Grant RW. Prevalence of hyper- and hypoglycemia among inpatients with diabetes: a national survey of 44 U.S. hospitals. Diabetes Care. 2007 Feb;30(2):367-9. doi: 10.2337/dc06-1715. No abstract available.
- Tomlin AM, Tilyard MW, Dovey SM, Dawson AG. Hospital admissions in diabetic and non-diabetic patients: a case-control study. Diabetes Res Clin Pract. 2006 Sep;73(3):260-7. doi: 10.1016/j.diabres.2006.01.008. Epub 2006 Feb 28.
- Sarkisian S, Fenton TR, Shaheen AA, Raman M. Parenteral nutrition-associated hyperglycemia in noncritically ill inpatients is associated with higher mortality. Can J Gastroenterol. 2010 Jul;24(7):453-7. doi: 10.1155/2010/718526.
- Hulkower RD, Pollack RM, Zonszein J. Understanding hypoglycemia in hospitalized patients. Diabetes Manag (Lond). 2014 Mar;4(2):165-176. doi: 10.2217/DMT.13.73.
- Cook CB, Kongable GL, Potter DJ, Abad VJ, Leija DE, Anderson M. Inpatient glucose control: a glycemic survey of 126 U.S. hospitals. J Hosp Med. 2009 Nov;4(9):E7-E14. doi: 10.1002/jhm.533.
- Litchman ML, Allen NA. Real-Time Continuous Glucose Monitoring Facilitates Feelings of Safety in Older Adults With Type 1 Diabetes: A Qualitative Study. J Diabetes Sci Technol. 2017 Sep;11(5):988-995. doi: 10.1177/1932296817702657. Epub 2017 Apr 5.
- Roussel R, Riveline JP, Vicaut E, de Pouvourville G, Detournay B, Emery C, Levrat-Guillen F, Guerci B. Important Drop in Rate of Acute Diabetes Complications in People With Type 1 or Type 2 Diabetes After Initiation of Flash Glucose Monitoring in France: The RELIEF Study. Diabetes Care. 2021 Jun;44(6):1368-1376. doi: 10.2337/dc20-1690. Epub 2021 Apr 20.
- Parkin CG, Graham C, Smolskis J. Continuous Glucose Monitoring Use in Type 1 Diabetes: Longitudinal Analysis Demonstrates Meaningful Improvements in HbA1c and Reductions in Health Care Utilization. J Diabetes Sci Technol. 2017 May;11(3):522-528. doi: 10.1177/1932296817693253. Epub 2017 Feb 1.
- Davis GM, Faulds E, Walker T, Vigliotti D, Rabinovich M, Hester J, Peng L, McLean B, Hannon P, Poindexter N, Saunders P, Perez-Guzman C, Tekwani SS, Martin GS, Umpierrez G, Agarwal S, Dungan K, Pasquel FJ. Remote Continuous Glucose Monitoring With a Computerized Insulin Infusion Protocol for Critically Ill Patients in a COVID-19 Medical ICU: Proof of Concept. Diabetes Care. 2021 Apr;44(4):1055-1058. doi: 10.2337/dc20-2085. Epub 2021 Feb 9.
- Friman O, Soltani N, Lind M, Zetterqvist P, Balintescu A, Perner A, Oldner A, Rooyackers O, Martensson J. Performance of Subcutaneous Continuous Glucose Monitoring in Adult Critically Ill Patients Receiving Vasopressor Therapy. Diabetes Technol Ther. 2024 Oct;26(10):763-772. doi: 10.1089/dia.2024.0035. Epub 2024 May 31.
- Lumb A, Misra S, Rayman G, Avari P, Flanagan D, Choudhary P, Dhatariya K. Variation in the Current Use of Technology to Support Diabetes Management in UK Hospitals: Results of a Survey of Health Care Professionals. J Diabetes Sci Technol. 2023 May;17(3):733-741. doi: 10.1177/19322968231161076. Epub 2023 Mar 22.
- American Diabetes Association Professional Practice Committee. 16. Diabetes Care in the Hospital: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S295-S306. doi: 10.2337/dc24-S016.
- Avari P, Choudhary P, Lumb A, Misra S, Rayman G, Flanagan D, Dhatariya K; Joint British Diabetes Societies for Inpatient Care (JBDS-IP) group. Using technology to support diabetes care in hospital: Guidelines from the Joint British Diabetes Societies for Inpatient Care (JBDS-IP) group and Diabetes Technology Network (DTN) UK. Diabet Med. 2025 Mar;42(3):e15452. doi: 10.1111/dme.15452. Epub 2024 Oct 21.
- Bengtsson M. How to plan and perform a qualitative study using content analysis. NursingPlus Open. 2016;2:8-14. doi:10.1016/J.NPLS.2016.01.001
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)
2026년 8월 1일
기본 완료 (추정된)
2028년 6월 1일
연구 완료 (추정된)
2028년 6월 1일
연구 등록 날짜
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
2026년 8월 13일
처음 게시됨 (실제)
2026년 8월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 13일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
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
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
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. .