Continuous Glucose Monitoring, Hyperglycemia, Hypoglycaemia, Intensive Care (ICU), Type 1 Diabetes, Type 2 Diabetes Treated With Insulin
Conditions
Keywords
diabetes, hyperglycaemia, hypoglycaemia, intensive care unit, continuous glucose monitoring
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDexcom G7
Continuous glucose monitoring.
DEVICEViewsEMR telemetry
ViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends
Sponsors
Imperial College Healthcare NHS Trust
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Eligible participants that consent to participate. | 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. |
| Phase 1: Time from admission to ICU to initiation of CGM | From admission to ICU to initiation of CGM, up to 48 hours | Time in minutes from admission to ICU to initiation of CGM |
| Phase 1: Time from consent to initiation of CGM | From enrollment to the end of intervention at 10 days | Time from consent to initiation of CGM |
| Phase 1: Percentage of CGM data availability for each participant | From enrollment to the end of intervention at 10 days | Percentage of CGM data availability for each participant |
| Phase 1: Percentage of participants successfully set-up on telemetry (ViewsEMR ®) | From enrollment to the end of intervention at 10 days | Percentage of participants successfully set-up on telemetry (ViewsEMR ®) |
| Phase 1: Number of premature sensor failures per participant (defined as <70% of anticipated use) | From enrollment to the end of intervention at 10 days | Number of premature sensor failures per participant (defined as \<70% of anticipated use) |
| Phase 1: 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 | Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction) |
| Phase 1: Proportion of participants completing the study | Throughout Phase 1 study period, up to 6 months | Proportion of participants completing the study |
| Phase 1: Proportion of nursing staff completing study survey | Throughout Phase 1 study period, up to 6 months | Proportion of nursing staff completing study survey |
| Phase 2: Number of episodes of hypoglycaemia per participant | Throughout Phase 2, up to 30 days | Number of episodes of hypoglycaemia per participant (defined as \<3.9mmol/L for 15minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Safety Outcomes | From enrollment to the end of intervention, up to 10 days | \- Duration of CGM signal loss (units: minutes) |
Countries
United Kingdom
Contacts
CONTACTParizad Avari, MBBS, PhD
CONTACTNarvada Jugnee, MSc
Outcome results
None listed