Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM) (ICU-TeleCGM)
13 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Geschat)
70
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Parizad Avari, MBBS, PhD
- Telefoonnummer: 020 33133706
- E-mail: p.avari@nhs.net
Studie Contact Back-up
- Naam: Narvada Jugnee, MSc
- Telefoonnummer: 020 33133706
- E-mail: n.jugnee@nhs.net
Studie Locaties
-
-
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London, Verenigd Koninkrijk
- Imperial College Healthcare NHS Trust
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Adults admitted to the intensive care unit with hyperglycaemia
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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®)
|
Continuous glucose monitoring.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Phase 1: Eligible participants that consent to participate.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: From enrollment to the end of intervention at 10 days
|
Time from consent to initiation of CGM
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From enrollment to the end of intervention at 10 days
|
|
Phase 1: Percentage of CGM data availability for each participant
Tijdsspanne: From enrollment to the end of intervention at 10 days
|
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 ®)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
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Phase 1: Proportion of participants completing the study
Tijdsspanne: 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
Tijdsspanne: Throughout Phase 1 study period, up to 6 months
|
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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Phase 1: Safety Outcomes
Tijdsspanne: From enrollment to the end of intervention, up to 10 days
|
- 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 augustus 2026
Primaire voltooiing (Geschat)
1 juni 2028
Studie voltooiing (Geschat)
1 juni 2028
Studieregistratiedata
Eerst ingediend
29 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
13 augustus 2026
Eerst geplaatst (Werkelijk)
17 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
13 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 167867
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Ethics approval does not allow sharing of individual participant data
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
product vervaardigd in en geëxporteerd uit de V.S.
Ja
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