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Completed

NCT Number: NCT05255783

The Performance of Dexcom G6 Glucose Monitoring in Critically Ill Patients

This is an investigator-initiated, prospective, observational accuracy-study. The aim of the study is to test the feasibility, safety, and accuracy of a subcutaneous continuous glucose monitoring system (the Dexcom G6 glucose monitoring system) in critically ill patients. A total of 40 adult patients admitted to the intensive care unit requiring intravenous insulin infusion to maintain blood glucose within target range will be enrolled. Subcutaneous glucose readings will be compared with routine arterial blood glucose measurements to determine accuracy.

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Key information

Conditions

Blood Glucose Critical Care Humans

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

The primary endpoint of the study is the mean absolute relative difference (MARD) in percent between CGM and arterial glucose values. Calculations show that 40 patients are required for a 95% confidence interval for the mean to have a range of ±1.7%, meaning that MARD can be estimated with high precision. Calculations of confidence intervals were done using normal approximation, assuming an SD of 5.5 percentage units.

The following variables will be collected from the electronic medical record (Take Care), from the ICU-specific patient data management system (Clinisoft) and/or from the handheld Dexcom G6 monitor:

Patient-related variables:

  • Age, sex, height and weight
  • Comorbidities (including diabetes status)
  • Chronic medications

Clinical variables:

  • Date and time of ICU admission and discharge
  • Reason for ICU admission
  • Admission source (e.g. emergency department, other hospital, ward)
  • Illness severity scores (e.g. SAPS [Simplified Acute Physiology Score], SOFA [Sequential Organ Failure Assessment])
  • Hemodynamic variables (e.g. heart rate, blood pressure)
  • Blood gas results (including blood glucose concentration)
  • Other routine laboratory results (e.g. serum creatinine, serum albumin, haematocrit)
  • ICU mortality

Treatment variables:

  • Insulin doses (including continuous intravenous infusion rates, intravenous and subcutaneous insulin boluses) and times
  • Doses and administration time for other medications given in the ICU (e.g. Vasopressors, paracetamol)

Continuous Glucose Monitoring (CGM)-related variables:

  • Date and time of sensor insertion
  • Sensor insertion site
  • Number and duration of disconnection episodes
  • Reason for disconnection
  • Date and time of sensor calibrations
  • Sensor glucose values with date and time stamps
  • Date and time of sensor removal
  • Reason for sensor removal
  • Complications at sensor insertion site (redness, swelling, infection, bruising)

Exact date and time of sensor insertion will be manually recorded in a case report form at the bedside. Every time an arterial blood gas is obtained, the arterial blood glucose value and the corresponding CGM glucose value will be manually recorded along with date and time in the case report form. At the end of the study period, after removing the CGM sensor, CGM-data will be downloaded from the handheld Dexcom G6 monitor.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Admitted to ICU at the Karolinska University Hospital Solna
  • Indwelling arterial catheter in situ or expected to be inserted in the next 2 hours
  • Six hours or less since intravenous insulin infusion was commenced or intravenous insulin infusion expected to commence within the next 2 hours
  • Vasopressor infusion ongoing or expected to commence within the next 2 hours
  • Mechanical ventilation ongoing or expected to commence within the next 2 hours
  • Patient expected to stay in the ICU until the day after tomorrow

Exclusion criteria

  • Pregnancy
  • Unable to get consent from patient or next-of-kin
  • Patients in whom death is considered imminent (within 24 hours)

Treatment and study plan

subcutaneous continuous glucose sensor

Device

Dexcom G6 continuous glucose monitoring system

Primary outcomes

  1. Mean absolute relative difference (MARD)

    Time frame: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days

    MARD in percent between subcutaneous sensor glucose values and arterial blood glucose values

Secondary outcomes

  1. Mean absolute difference (MAD)

    Time frame: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days

    MAD between subcutaneous sensor glucose values and arterial blood glucose values

  2. Numerical accuracy according to ISO criteria

    Time frame: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days

    Numerical accuracy between subcutaneous sensor glucose values and arterial blood glucose values determined according to the International Organization for Standardization (ISO) criteria from 2013 (ISO 15197:2013)

  3. Numerical accuracy according to CLSI standard

    Time frame: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days

    Numerical accuracy between subcutaneous sensor glucose values and arterial blood glucose values determined according to the Clinical and Laboratory Standards Institute (CLSI) Point of Care Testing 12-A3 (POCT12-A3) standard

  4. Clinical accuracy determined by Clarke error grid analysis

    Time frame: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days

    Clinical accuracy between subcutaneous sensor glucose values and arterial blood glucose values determined by Clarke error grid analysis

  5. Clinical accuracy determined by surveillance error grid analysis

    Time frame: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days

    Clinical accuracy between subcutaneous sensor glucose values and arterial blood glucose values determined by surveillance error grid analysis

  6. Correlation

    Time frame: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days

    Correlation between arterial blood glucose levels and subcutaneous sensor glucose values

Other outcomes

  1. Number of interrupted sensor readings (Feasibility outcome)

    Time frame: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days

    Number of interrupted sensor readings

  2. Duration of interrupted sensor readings (Feasibility outcome)

    Time frame: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days

    Duration of interrupted sensor readings (hours)

  3. Adverse events (safety and tolerability)

    Time frame: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days

    Local reactions (e.g. allergic skin reactions, bruising) related to sensor insertion/sensor adhesives

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • DexCom, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2022
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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