Accuracy of the Dexcom G6 Continuous Glucose Monitoring System Following Cardiac Surgery

NCT04569240 | Completed Results FDA Device

• 1 other identifier: 20-698
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Surgery--Complications

Outcome Measures

Primary Outcomes (2)

• 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

  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

  up to 10 days

Other Outcomes (4)

• Blood Volume Waste by Arterial Blood Gas

  Up to 10 days

• Blood Volume Waste by Fingerstick

  Up to 10 days

• Cost Savings:

  Up to 10 days

Study Arms (1)

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

Device: Dexcom G6 continuous glucose monitor

Interventions

Dexcom G6 continuous glucose monitor DEVICE

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.

Dexcom G6 continuous glucose monitor

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (5)

• 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.

  PMID: 17216594 BACKGROUND

• Carrasco 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.

  PMID: 23031487 BACKGROUND

• Bland 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.

  PMID: 7873953 BACKGROUND

• Bakdash JZ, Marusich LR. Repeated Measures Correlation. Front Psychol. 2017 Apr 7;8:456. doi: 10.3389/fpsyg.2017.00456. eCollection 2017.

  PMID: 28439244 BACKGROUND

• Klonoff 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.

  PMID: 25562886 BACKGROUND

Results Point of Contact

• Title: Andrea Parianos
• Organization: Cleveland Clinc

debsa@ccf.org

216-445-8354

Study Officials

• M. Cecilia Lansang, MD, MPH

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Director - Endocrinology Main Campus

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 29, 2020
• Study Start: May 1, 2021
• Primary Completion: January 20, 2024
• Study Completion: July 1, 2024
• Last Updated: November 10, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)