Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM) (ICU-TeleCGM)
13. august 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
70
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Parizad Avari, MBBS, PhD
- Telefonnummer: 020 33133706
- E-post: p.avari@nhs.net
Studer Kontakt Backup
- Navn: Narvada Jugnee, MSc
- Telefonnummer: 020 33133706
- E-post: n.jugnee@nhs.net
Studiesteder
-
-
-
London, Storbritannia
- Imperial College Healthcare NHS Trust
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adults admitted to the intensive care unit with hyperglycaemia
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase 1: Eligible participants that consent to participate.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 ®)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Throughout Phase 1 study period, up to 6 months
|
Proportion of participants completing the study
|
Throughout Phase 1 study period, up to 6 months
|
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Phase 1: Proportion of nursing staff completing study survey
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase 1: Safety Outcomes
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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- 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.
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- 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.
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- 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.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
1. juni 2028
Studiet fullført (Antatt)
1. juni 2028
Datoer for studieregistrering
Først innsendt
29. mai 2026
Først innsendt som oppfylte QC-kriteriene
13. august 2026
Først lagt ut (Faktiske)
17. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 167867
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Ethics approval does not allow sharing of individual participant data
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Ja
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