Blood GlucoseNCT05255783
The Performance of Dexcom G6 Glucose Monitoring in Critically Ill Patients
A study testing subcutaneous continuous glucose sensor in people with Blood Glucose and Humans, run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Glucose, Humans, Critical Care
- What is being tested?
- subcutaneous continuous glucose sensor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 19 Nov 2021to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Unable to get consent from patient or next-of-kin
- Patients in whom death is considered imminent (within 24 hours)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Blood Glucose, Humans, Critical Care
- Being tested
- subcutaneous continuous glucose sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous continuous glucose sensorDevice
Dexcom G6 continuous glucose monitoring system
| Study group | Role | What they receive |
|---|---|---|
| Critically ill adults requiring insulin | Other | Patients admitted to the intensive care unit requiring insulin infusion to maintain blood glucose within target range Receives: Device: subcutaneous continuous glucose sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute relative difference (MARD)
MARD in percent between subcutaneous sensor glucose values and arterial blood glucose values
Measured: 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)
MAD between subcutaneous sensor glucose values and arterial blood glucose values
Measured: 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
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)
Measured: 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
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
Measured: 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
Clinical accuracy between subcutaneous sensor glucose values and arterial blood glucose values determined by Clarke error grid analysis
Measured: 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
Clinical accuracy between subcutaneous sensor glucose values and arterial blood glucose values determined by surveillance error grid analysis
Measured: 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
Correlation between arterial blood glucose levels and subcutaneous sensor glucose values
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start19 Nov 2021
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Johan Mårtensson, Region Stockholm
- Investigators
- Johan Mårtensson, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255783
- Sponsor's protocol ID
- K 2021-5279
- Other IDs
- FoUI-960993
- Status last verified
- Nov 2024
- First submitted
- 26 Jan 2022
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25233297
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of Dexcom G6 Glucose Monitoring in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05255783
- Acronym / sponsor ID
- K 2021-5279
- Conditions
- Blood Glucose, Humans, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- DexCom, Inc.
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill adults requiring insulin | Other | Device: subcutaneous continuous glucose sensorPatients admitted to the intensive care unit requiring insulin infusion to maintain blood glucose within target range |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Unable to get consent from patient or next-of-kin
- Patients in whom death is considered imminent (within 24 hours)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subcutaneous continuous glucose sensorDexcom G6 continuous glucose monitoring system | Device | Critically ill adults requiring insulin |
Primary outcome
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
6 secondary outcomes
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
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 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
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 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 25233297Matuleviciene 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.
- Individual participant dataSharing planned: No
Related trials for Blood Glucose
RecruitingObservational study
Glucose Levels and Outcomes in Women - Mid Pregnancy
Pregnancy
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruiting
A Nurse-Led Digital Coaching Program to Improve Blood Sugar Control in Adults With Type 2 Diabetes
Type 2 Diabetes Mellitus
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruitingEarly Phase 1
Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome
Metabolic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Mårtensson, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcutaneous continuous glucose sensor in people with Blood Glucose and Humans, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05255783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.