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

August 13, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Parizad Avari, MBBS, PhD
  • Phone Number: 020 33133706
  • Email: p.avari@nhs.net

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults admitted to the intensive care unit with hyperglycaemia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)
Device: Dexcom G7
Continuous glucose monitoring.
Device: ViewsEMR telemetry
ViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends
Usual care + masked Dexcom G7
Use of continuous glucose monitoring (Dexcom G7) without telemetry (ViewsEMR/CampViews®)
Device: Dexcom G7
Continuous glucose monitoring.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 1: Eligible participants that consent to participate.
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.
Throughout Phase 1 study period, up to 6 months
Phase 1: Time from admission to ICU to initiation of CGM
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
From admission to ICU to initiation of CGM, up to 48 hours
Phase 1: Time from consent to initiation of CGM
Time Frame: From enrollment to the end of intervention at 10 days
Time from consent to initiation of CGM
From enrollment to the end of intervention at 10 days
Phase 1: Percentage of CGM data availability for each participant
Time Frame: From enrollment to the end of intervention at 10 days
Percentage of CGM data availability for each participant
From enrollment to the end of intervention at 10 days
Phase 1: Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
Time Frame: From enrollment to the end of intervention at 10 days
Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
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)
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)
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)
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)
From enrollment to the end of intervention at 10 days
Phase 1: Proportion of participants completing the study
Time Frame: Throughout Phase 1 study period, up to 6 months
Proportion of participants completing the study
Throughout Phase 1 study period, up to 6 months
Phase 1: Proportion of nursing staff completing study survey
Time Frame: 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
Phase 2: Number of episodes of hypoglycaemia per participant
Time Frame: Throughout Phase 2, up to 30 days
Number of episodes of hypoglycaemia per participant (defined as <3.9mmol/L for 15minutes)
Throughout Phase 2, up to 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase 1: Safety Outcomes
Time Frame: From enrollment to the end of intervention, up to 10 days
- Duration of CGM signal loss (units: minutes)
From enrollment to the end of intervention, up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 167867

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethics approval does not allow sharing of individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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