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.
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.
Study Type
OBSERVATIONAL
Enrollment
70
Continuous glucose monitoring.
ViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends
Imperial College Healthcare NHS Trust
London, United Kingdom
Phase 1: Eligible participants that consent to participate.
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: Throughout Phase 1 study period, up to 6 months
Phase 1: Time from admission to ICU to initiation of CGM
Time in minutes from admission to ICU to initiation of CGM
Time frame: From admission to ICU to initiation of CGM, up to 48 hours
Phase 1: Time from consent to initiation of CGM
Time from consent to initiation of CGM
Time frame: From enrollment to the end of intervention at 10 days
Phase 1: Percentage of CGM data availability for each participant
Percentage of CGM data availability for each participant
Time frame: From enrollment to the end of intervention at 10 days
Phase 1: Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
Time frame: 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)
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
Phase 1: Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
Time frame: From enrollment to the end of intervention at 10 days
Phase 1: Proportion of participants completing the study
Proportion of participants completing the study
Time frame: Throughout Phase 1 study period, up to 6 months
Phase 1: Proportion of nursing staff completing study survey
Proportion of nursing staff completing study survey
Time frame: Throughout Phase 1 study period, up to 6 months
Phase 2: Number of episodes of hypoglycaemia per participant
Number of episodes of hypoglycaemia per participant (defined as \<3.9mmol/L for 15minutes)
Time frame: Throughout Phase 2, up to 30 days
Phase 1: Safety Outcomes
\- Duration of CGM signal loss (units: minutes)
Time frame: From enrollment to the end of intervention, up to 10 days
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