Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM) (ICU-TeleCGM)
13 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
70
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Parizad Avari, MBBS, PhD
- Telefonnummer: 020 33133706
- E-post: p.avari@nhs.net
Studera Kontakt Backup
- Namn: Narvada Jugnee, MSc
- Telefonnummer: 020 33133706
- E-post: n.jugnee@nhs.net
Studieorter
-
-
-
London, Storbritannien
- Imperial College Healthcare NHS Trust
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adults admitted to the intensive care unit with hyperglycaemia
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phase 1: Eligible participants that consent to participate.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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 ®)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phase 1: Safety Outcomes
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
1 juni 2028
Avslutad studie (Beräknad)
1 juni 2028
Studieregistreringsdatum
Först inskickad
29 maj 2026
Först inskickad som uppfyllde QC-kriterierna
13 augusti 2026
Första postat (Faktisk)
17 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 167867
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Ethics approval does not allow sharing of individual participant data
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .