- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05255783
The Performance of Dexcom G6 Glucose Monitoring in Critically Ill Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johan Mårtensson, MD, PhD
- Phone Number: +46 (0)8-12394821
- Email: johan.martensson@regionstockholm.se
Study Contact Backup
- Name: Ola Friman, RN
- Phone Number: +46 (0)8-51775830
- Email: ola.friman@regionstockholm.se
Study Locations
-
-
-
Stockholm, Sweden, 17176
- Recruiting
- Karolinska University Hospital
-
Contact:
- Johan Mårtensson, MD, PhD
- Phone Number: +46 (0)8-12394821
- Email: johan.martensson@regionstockholm.se
-
Contact:
- Ola Friman, RN
- Phone Number: +46 (0)8-51775830
- Email: ola.friman@regionstockholm.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Critically ill adults requiring insulin
Patients admitted to the intensive care unit requiring insulin infusion to maintain blood glucose within target range
|
Dexcom G6 continuous glucose monitoring system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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)
|
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
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
|
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
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
|
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
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
|
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
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
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)
|
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)
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
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Johan Mårtensson, MD, PhD, Karolinska University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K 2021-5279
- FoUI-960993 (Other Grant/Funding Number: Region Stockholm (ALF project))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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