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

NCT07769138 | Not Yet Recruiting FDA Device

• 1 other identifier: 167867
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Hyperglycemia; Intensive Care (ICU); Continuous Glucose Monitoring; Hypoglycaemia; Type 2 Diabetes Treated With Insulin

Keywords

diabetes; hyperglycaemia; hypoglycaemia; intensive care unit; continuous glucose monitoring

Outcome Measures

Primary Outcomes (10)

• 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.

  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

  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

  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

  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 ®)

  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)

  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)

  From enrollment to the end of intervention at 10 days

• Phase 1: Proportion of participants completing the study

  Proportion of participants completing the study

  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

  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)

  Throughout Phase 2, up to 30 days

Secondary Outcomes (1)

• Phase 1: Safety Outcomes

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

Study Arms (2)

Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)

Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)

Device: Dexcom G7; Device: ViewsEMR telemetry

Usual care + masked Dexcom G7

Use of continuous glucose monitoring (Dexcom G7) without telemetry (ViewsEMR/CampViews®)

Device: Dexcom G7

Interventions

Dexcom G7 DEVICE

Continuous glucose monitoring.

Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®); Usual care + masked Dexcom G7

ViewsEMR telemetry DEVICE

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

Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults admitted to the intensive care unit with hyperglycaemia

You may qualify if:

• Age \>18years inclusive
• Hyperglycaemia requiring insulin therapy (subcutaneous injection or intravenous insulin) during admission on ICU
• Admission to ICU within 48hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (32)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia; Hypoglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Parizad Avari, MBBS, PhD

CONTACT

020 33133706; p.avari@nhs.net

Narvada Jugnee, MSc

CONTACT

020 33133706; n.jugnee@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: August 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)