Imperial College Healthcare NHS Trust
London, United Kingdom
NCT Number: NCT07769138
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
London, United Kingdom
Aim: To assess safety and implementation of networked CGM with ViewsEMR® telemetry within ICU.
The study will be conducted in a two-stage process:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous glucose monitoring.
ViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends
Time frame: 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.
Time frame: From admission to ICU to initiation of CGM, up to 48 hours
Time in minutes from admission to ICU to initiation of CGM
Time frame: From enrollment to the end of intervention at 10 days
Time from consent to initiation of CGM
Time frame: From enrollment to the end of intervention at 10 days
Percentage of CGM data availability for each participant
Time frame: From enrollment to the end of intervention at 10 days
Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
Time frame: From enrollment to the end of intervention at 10 days
Number of premature sensor failures per participant (defined as <70% of anticipated use)
Time frame: 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)
Time frame: Throughout Phase 1 study period, up to 6 months
Proportion of participants completing the study
Time frame: Throughout Phase 1 study period, up to 6 months
Proportion of nursing staff completing study survey
Time frame: Throughout Phase 2, up to 30 days
Number of episodes of hypoglycaemia per participant (defined as <3.9mmol/L for 15minutes)
Time frame: From enrollment to the end of intervention, up to 10 days
Contact information is provided by the study sponsor or research team.
Narvada Jugnee, MSc
CONTACT
Parizad Avari, MBBS, PhD
CONTACT
Imperial College Healthcare NHS Trust
Other
Acronym: ICU-TeleCGM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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