Surgery--ComplicationsNCT04569240
Accuracy of the Dexcom G6 Continuous Glucose Monitoring System Following Cardiac Surgery
A study testing Dexcom G6 continuous glucose monitor in people with Surgery--Complications, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This is a prospective longitudinal study to study the agreement between a novel continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the cardiovascular intensive care unit… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- Dexcom G6 continuous glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and above
- Planned cardiovascular surgery
- Planned admission to Cleveland Clinic Main Campus J5 or J6 or Q5 cardiovascular ICU (CVICU) post-operatively
- With or without known diabetes; if with known diagnosis of diabetes, diabetes can be type 1, type 2, or secondary
Who cannot join
- Allergy to the material of the CGMS or the adhesive to be used
- Skin conditions precluding the use of the CGMS
- Pregnancy
- Other conditions that investigators deem inappropriate for the study
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective longitudinal study to study the agreement between a novel continuous glucose monitoring system (CGMS) versus current blood glucose monitoring.
Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the cardiovascular intensive care unit (CVICU), and by point of care glucose using the Accuchek Inform II on the regular floors, and the CGMS at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors.
Read the detailed description
Maintaining tight blood glucose control following surgery is imperative to reducing infections and neurologic dysfunction. This requires frequent blood sampling while in the intensive care unit, leading to increased waste of blood and utilizing time and resources to collect samples and wait for results. Additionally, when on the regular floors, frequent point of care fingersticks for glucose levels are needed for therapeutic intervention.
Continuous glucose monitoring systems (CGMS) are now available for ambulatory use in patients with diabetes. The potential of using such a system in the hospital, including during the postoperative critical care setting and upon transfer to the regular floor, may reduce personnel burden, produce rapid results, and decrease blood waste. However, these systems have not yet been validated for hospital use.
This is a prospective longitudinal study to study the agreement between a novel continuous glucose monitoring system (CGMS) versus current blood glucose monitoring.
Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the CVICU, and by point of care glucose using the Accuchek Inform II on the regular floors, and the CGMS at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems will be calculated, and error will be classified using the Surveillance Error grid. The proportion of errors of at least moderate risk will be calculated.
Subject characteristics including demographics, comorbidities and baseline disease severity will be summarized using means and standard deviations for continuous measures and frequencies and percentages for categorical factors. To evaluate agreement between methods, concordance correlation coefficients will be calculated, using the method that adjusts for repeated measures as described by King and implemented in software by Carrasco. Analysis will be performed overall, and then stratifying by type of current measure, if the type of measurement varies across settings. Correlations will be calculated using the methods described by Bland and Altman and implemented by Bakdash and Marusich. Differences will also be evaluated for errors according to the Surveillance Error Grid. Rates of moderate or more severe errors will be calculated. For each measure above, 95% confidence intervals will be calculated, accounting for the clustering within subject.. Analyses will be performed using SAS software (version 9.4; Cary, NC) and R software (version 3.5; Vienna Austria).
Glucose readings obtained from the CGMS will be compared with
- blood glucose from the arterial blood gas (ABG) or peripheral/central venous catheter if arterial catheter not in use (standard of care in CVICU) while patients are in the CVICU
- fingerstick point of care (POC) glucose when patients are on the regular floors
- Conditions
- Surgery--Complications
- Being tested
- Dexcom G6 continuous glucose monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6 continuous glucose monitorDevice
Dexcom G6 continuous glucose monitor will be applied to the upper outer arm before cardiovascular surgery. Data will be collected for 10 days or upon discharge from the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Dexcom G6 continuous glucose monitor | Other | All patients will have a Dexcom G6 continuous glucose monitor placed pre-operatively. The glucose readings will be collected for 10 days or upon discharge from the ICU and data will be compared with arterial blood glucose readings or venous Accu-Check Inform II glucose readings Receives: Device: Dexcom G6 continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Matching Glucose Measurements (CGM Versus Blood Glucose Measurements)
Glucose readings from the Dexcom continuous glucose monitor compared with blood glucose from the arterial blood gas (ABG) or peripheral/central venous catheter
Measured: Up to 10 days
Glucose Readings From Continuous Glucose Monitor (CGM) Versus Point of Care Glucose
Glucose readings in mg/dL from the Dexcom continuous glucose monitor (CGM) will be compared with fingerstick point of care glucose levels in mg/dL
Measured: 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 posted29 Sep 2020
- Study start1 May 2021
- Primary completion20 Jan 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, M. Cecilia Lansang, MD, The Cleveland Clinic
- Investigators
- M. Cecilia Lansang, MD, MPH, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569240
- Sponsor's protocol ID
- 20-698
- Status last verified
- Oct 2025
- First submitted
- 8 Sep 2020
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
King TS, Chinchilli VM, Carrasco JL. A repeated measures concordance correlation coefficient. Stat Med. 2007 Jul 20;26(16):3095-113. doi: 10.1002/sim.2778.
PubMed 17216594Carrasco JL, Phillips BR, Puig-Martinez J, King TS, Chinchilli VM. Estimation of the concordance correlation coefficient for repeated measures using SAS and R. Comput Methods Programs Biomed. 2013 Mar;109(3):293-304. doi: 10.1016/j.cmpb.2012.09.002. Epub 2012 Sep 29.
PubMed 23031487Bland JM, Altman DG. Calculating correlation coefficients with repeated observations: Part 1--Correlation within subjects. BMJ. 1995 Feb 18;310(6977):446. doi: 10.1136/bmj.310.6977.446. No abstract available.
PubMed 7873953Bakdash JZ, Marusich LR. Repeated Measures Correlation. Front Psychol. 2017 Apr 7;8:456. doi: 10.3389/fpsyg.2017.00456. eCollection 2017.
PubMed 28439244Klonoff DC, Lias C, Vigersky R, Clarke W, Parkes JL, Sacks DB, Kirkman MS, Kovatchev B; Error Grid Panel. The surveillance error grid. J Diabetes Sci Technol. 2014 Jul;8(4):658-72. doi: 10.1177/1932296814539589. Epub 2014 Jun 13.
PubMed 25562886
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Dexcom G6 Continuous Glucose Monitoring System Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04569240
- Acronym / sponsor ID
- 20-698
- Conditions
- Surgery--Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 1 May 2021 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective longitudinal study to study the agreement between a novel continuous glucose monitoring system (CGMS) versus current blood glucose monitoring.
Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the cardiovascular intensive care unit (CVICU), and by point of care glucose using the Accuchek Inform II on the regular floors, and the CGMS at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors.
Detailed description
Maintaining tight blood glucose control following surgery is imperative to reducing infections and neurologic dysfunction. This requires frequent blood sampling while in the intensive care unit, leading to increased waste of blood and utilizing time and resources to collect samples and wait for results. Additionally, when on the regular floors, frequent point of care fingersticks for glucose levels are needed for therapeutic intervention.
Continuous glucose monitoring systems (CGMS) are now available for ambulatory use in patients with diabetes. The potential of using such a system in the hospital, including during the postoperative critical care setting and upon transfer to the regular floor, may reduce personnel burden, produce rapid results, and decrease blood waste. However, these systems have not yet been validated for hospital use.
This is a prospective longitudinal study to study the agreement between a novel continuous glucose monitoring system (CGMS) versus current blood glucose monitoring.
Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the CVICU, and by point of care glucose using the Accuchek Inform II on the regular floors, and the CGMS at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems will be calculated, and error will be classified using the Surveillance Error grid. The proportion of errors of at least moderate risk will be calculated.
Subject characteristics including demographics, comorbidities and baseline disease severity will be summarized using means and standard deviations for continuous measures and frequencies and percentages for categorical factors. To evaluate agreement between methods, concordance correlation coefficients will be calculated, using the method that adjusts for repeated measures as described by King and implemented in software by Carrasco. Analysis will be performed overall, and then stratifying by type of current measure, if the type of measurement varies across settings. Correlations will be calculated using the methods described by Bland and Altman and implemented by Bakdash and Marusich. Differences will also be evaluated for errors according to the Surveillance Error Grid. Rates of moderate or more severe errors will be calculated. For each measure above, 95% confidence intervals will be calculated, accounting for the clustering within subject.. Analyses will be performed using SAS software (version 9.4; Cary, NC) and R software (version 3.5; Vienna Austria).
Glucose readings obtained from the CGMS will be compared with
- blood glucose from the arterial blood gas (ABG) or peripheral/central venous catheter if arterial catheter not in use (standard of care in CVICU) while patients are in the CVICU
- fingerstick point of care (POC) glucose when patients are on the regular floors
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexcom G6 continuous glucose monitor | Other | Device: Dexcom G6 continuous glucose monitorAll patients will have a Dexcom G6 continuous glucose monitor placed pre-operatively. The glucose readings will be collected for 10 days or upon discharge from the ICU and data will be compared with arterial blood glucose readings or venous Accu-Check Inform II glucose readings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and above
- Planned cardiovascular surgery
- Planned admission to Cleveland Clinic Main Campus J5 or J6 or Q5 cardiovascular ICU (CVICU) post-operatively
- With or without known diabetes; if with known diagnosis of diabetes, diabetes can be type 1, type 2, or secondary
Key exclusion criteria (4 listed)
- Allergy to the material of the CGMS or the adhesive to be used
- Skin conditions precluding the use of the CGMS
- Pregnancy
- Other conditions that investigators deem inappropriate for the study
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 |
|---|---|---|
| Dexcom G6 continuous glucose monitorDexcom G6 continuous glucose monitor will be applied to the upper outer arm before cardiovascular surgery. Data will be collected for 10 days or upon discharge from the ICU. | Device | Dexcom G6 continuous glucose monitor |
Primary outcome
Number of Matching Glucose Measurements (CGM Versus Blood Glucose Measurements)
Time frame: Up to 10 days
Glucose readings from the Dexcom continuous glucose monitor compared with blood glucose from the arterial blood gas (ABG) or peripheral/central venous catheter
Glucose Readings From Continuous Glucose Monitor (CGM) Versus Point of Care Glucose
Time frame: up to 10 days
Glucose readings in mg/dL from the Dexcom continuous glucose monitor (CGM) will be compared with fingerstick point of care glucose levels in mg/dL
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17216594King TS, Chinchilli VM, Carrasco JL. A repeated measures concordance correlation coefficient. Stat Med. 2007 Jul 20;26(16):3095-113. doi: 10.1002/sim.2778.
- Background: PubMed 23031487Carrasco JL, Phillips BR, Puig-Martinez J, King TS, Chinchilli VM. Estimation of the concordance correlation coefficient for repeated measures using SAS and R. Comput Methods Programs Biomed. 2013 Mar;109(3):293-304. doi: 10.1016/j.cmpb.2012.09.002. Epub 2012 Sep 29.
- Background: PubMed 7873953Bland JM, Altman DG. Calculating correlation coefficients with repeated observations: Part 1--Correlation within subjects. BMJ. 1995 Feb 18;310(6977):446. doi: 10.1136/bmj.310.6977.446. No abstract available.
- Background: PubMed 28439244Bakdash JZ, Marusich LR. Repeated Measures Correlation. Front Psychol. 2017 Apr 7;8:456. doi: 10.3389/fpsyg.2017.00456. eCollection 2017.
- Background: PubMed 25562886Klonoff DC, Lias C, Vigersky R, Clarke W, Parkes JL, Sacks DB, Kirkman MS, Kovatchev B; Error Grid Panel. The surveillance error grid. J Diabetes Sci Technol. 2014 Jul;8(4):658-72. doi: 10.1177/1932296814539589. Epub 2014 Jun 13.
- Individual participant dataSharing planned: No
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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.
M. Cecilia Lansang, MD, MPH principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G6 continuous glucose monitor in people with Surgery--Complications, run by The Cleveland Clinic at 1 site in United States.
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 4 inclusion and 4 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 10 Nov 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Matching Glucose Measurements (CGM Versus Blood Glucose Measurements) (time frame: Up to 10 days). The study lists 2 primary outcomes in all. 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 NCT04569240, which also lists 5 linked publications.
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 10 Nov 2025.