Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM) (ICU-TeleCGM)
13. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Odhadovaný)
70
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Parizad Avari, MBBS, PhD
- Telefonní číslo: 020 33133706
- E-mail: p.avari@nhs.net
Studijní záloha kontaktů
- Jméno: Narvada Jugnee, MSc
- Telefonní číslo: 020 33133706
- E-mail: n.jugnee@nhs.net
Studijní místa
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London, Spojené království
- Imperial College Healthcare NHS Trust
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Adults admitted to the intensive care unit with hyperglycaemia
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Phase 1: Eligible participants that consent to participate.
Časové okno: 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.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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 ®)
Časové okno: From enrollment to the end of intervention at 10 days
|
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)
Časové okno: From enrollment to the end of intervention at 10 days
|
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)
Časové okno: 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
Časové okno: Throughout Phase 1 study period, up to 6 months
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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
Časové okno: 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
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Phase 2: Number of episodes of hypoglycaemia per participant
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Phase 1: Safety Outcomes
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. června 2028
Dokončení studie (Odhadovaný)
1. června 2028
Termíny zápisu do studia
První předloženo
29. května 2026
První předloženo, které splnilo kritéria kontroly kvality
13. srpna 2026
První zveřejněno (Aktuální)
17. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
13. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 167867
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Ethics approval does not allow sharing of individual participant data
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
produkt vyrobený a vyvážený z USA
Ano
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