The Performance of Dexcom G6 Glucose Monitoring in Critically Ill Patients

NCT05255783 | Completed FDA Device

• 2 other identifiers: K 2021-5279FoUI-960993
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Glucose; Humans; Critical Care

Outcome Measures

Primary Outcomes (1)

• Mean absolute relative difference (MARD)

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

  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

Secondary Outcomes (6)

• Mean absolute difference (MAD)

  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 according to ISO criteria

  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 according to CLSI standard

  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 determined by Clarke error grid analysis

  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 determined by surveillance error grid analysis

  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

Other Outcomes (3)

• Number of interrupted sensor readings (Feasibility outcome)

  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 (Feasibility outcome)

  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

• Adverse events (safety and tolerability)

  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

Study Arms (1)

Critically ill adults requiring insulin

OTHER

Patients admitted to the intensive care unit requiring insulin infusion to maintain blood glucose within target range

Device: subcutaneous continuous glucose sensor

Interventions

subcutaneous continuous glucose sensor DEVICE

Dexcom G6 continuous glucose monitoring system

Critically ill adults requiring insulin

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Region Stockholm: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

• Matuleviciene V, Joseph JI, Andelin M, Hirsch IB, Attvall S, Pivodic A, Dahlqvist S, Klonoff D, Haraldsson B, Lind M. A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes. Diabetes Technol Ther. 2014 Nov;16(11):759-67. doi: 10.1089/dia.2014.0238. Epub 2014 Sep 18.

  PMID: 25233297 BACKGROUND

Study Officials

• Johan Mårtensson, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 25, 2022
• Study Start: November 19, 2021
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)