Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM) (ICU-TeleCGM)
torstai 13. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Arvioitu)
70
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Parizad Avari, MBBS, PhD
- Puhelinnumero: 020 33133706
- Sähköposti: p.avari@nhs.net
Tutki yhteystietojen varmuuskopiointi
- Nimi: Narvada Jugnee, MSc
- Puhelinnumero: 020 33133706
- Sähköposti: n.jugnee@nhs.net
Opiskelupaikat
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London, Yhdistynyt kuningaskunta
- Imperial College Healthcare NHS Trust
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
Adults admitted to the intensive care unit with hyperglycaemia
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Phase 1: Eligible participants that consent to participate.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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 ®)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Phase 1: Safety Outcomes
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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