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Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM)

ConditionsType 1 DiabetesType 2 Diabetes Treated With InsulinHyperglycemiaIntensive Care (ICU)Continuous Glucose MonitoringHypoglycaemia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImperial College Healthcare NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18years inclusive

Hyperglycaemia requiring insulin therapy (subcutaneous injection or intravenous insulin) during admission on ICU

Admission to ICU within 48hours

Disqualifiers

Known significant allergy to tape/ adhesives

Imminent death or anticipated length of stay <24hours

Women who are pregnant

Imminent extracorporeal membrane oxygenation (ECMO)

Trial population

Adults admitted to the intensive care unit with hyperglycaemia

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Dexcom G7

    Device

    Continuous glucose monitoring.

  • ViewsEMR telemetry

    Device

    ViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)2 interventions
Group B: Usual care + masked Dexcom G71 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

Phase 1: Safety Outcomes

\- Duration of CGM signal loss (units: minutes)

Time frame
From enrollment to the end of intervention, up to 10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College Healthcare NHS Trust

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: