28 Participants Needed

Dexcom G7 for Continuous Glucose Monitoring

(DexcomG7 Trial)

KJ
KJ
Overseen ByKimberly Jenkins
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective longitudinal study to study the agreement between a 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 (POC) fingerstick glucose using the Accucheck Inform II on the regular floors, and the CGMS reading 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, as well as errors, will be calculated.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring blood glucose levels, so it's best to ask the study team for guidance.

Is the Dexcom G7 Continuous Glucose Monitoring System safe for use in humans?

The Dexcom G7 Continuous Glucose Monitoring System has been evaluated for safety in adults with diabetes, and no serious adverse events were reported during a study involving 316 participants. However, previous models like the Dexcom G6 have been associated with skin reactions due to certain adhesive components.12345

What makes the Dexcom G7 Continuous Glucose Monitoring System unique compared to other treatments for diabetes?

The Dexcom G7 Continuous Glucose Monitoring System is unique because it provides highly accurate glucose readings with a single-digit mean absolute relative difference (MARD) and can be worn on the arm or abdomen for up to 10.5 days, offering flexibility and convenience for users.14567

What data supports the effectiveness of the Dexcom G7 Continuous Glucose Monitoring System treatment?

The Dexcom G7 Continuous Glucose Monitoring System has been shown to provide accurate glucose readings in adults with diabetes, with a mean absolute relative difference (MARD) of 8.2% for sensors placed on the arm and 9.1% for those on the abdomen. This means the system is reliable in tracking blood sugar levels, which can help people with diabetes manage their condition more effectively.148910

Who Is on the Research Team?

LC

Lansang Cecilia, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients who have undergone cardiac surgery and are being monitored in the Cardiovascular Intensive Care Unit (CVICU) or on regular floors. Participants must be eligible for regular blood glucose monitoring. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I am scheduled for heart or chest surgery.
With or without known diabetes (as 75% of patients entering the CVICU have hyperglycemia requiring intravenous insulin infusion)
I am scheduled for admission to specific units at Cleveland Clinic for heart care.
See 1 more

Exclusion Criteria

Patients receiving mechanical circulatory assist devices
Allergy to the material of the continuous glucose monitoring systems (CGMS) or the adhesive to be used
Pregnancy
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Dexcom G7 continuous glucose monitor and have their blood glucose measured regularly every 1-3 hours in the CVICU and on regular floors

1-10 days
Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dexcom G7
Trial Overview The study is testing the accuracy of the Dexcom G7, a new continuous glucose monitor (CGM), by comparing its readings with standard blood glucose measurements taken every 1-3 hours post-cardiac surgery.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention

Dexcom G7 is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Dexcom G7 for:
🇪🇺
Approved in European Union as Dexcom G7 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

DexCom, Inc.

Industry Sponsor

Trials
151
Recruited
35,700+
Kevin Sayer profile image

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane profile image

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Published Research Related to This Trial

The SEVEN PLUS System, a new continuous glucose monitoring device, demonstrated a median absolute relative difference of 13.0% compared to laboratory reference measurements, indicating good accuracy in glucose tracking for the 53 participants, mostly with type 1 diabetes.
The device showed improved sensor life, with 89% of sensors lasting the full 7 days, and no serious adverse events were reported, highlighting its safety and reliability for users.
New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time.Bailey, T., Zisser, H., Chang, A.[2009]
The enhanced algorithm for the Dexcom G6 Continuous Glucose Monitoring (CGM) System maintained high accuracy, with a 91.8% accuracy rate, while significantly reducing sensor errors.
The new algorithm led to a 59% decrease in total time spent in sensor error, improving data availability, which could enhance patient experience and integration with insulin delivery systems.
A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance.Harvey Towers, RA., Zhang, X., Yousefi, R., et al.[2022]
The Dexcom G6 continuous glucose monitoring (CGM) system demonstrated a mean absolute relative difference (MARD) of 7.7% in accuracy when compared to laboratory blood glucose measurements, indicating high reliability for monitoring glucose levels in children and adolescents with type 1 diabetes.
With 96.2% of estimated glucose values falling within 20% of the reference values, the G6 system's accuracy supports its potential to enhance glycemic control and encourage consistent use among young patients.
Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes.Welsh, JB., Zhang, X., Puhr, SA., et al.[2020]

Citations

New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. [2009]
A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. [2022]
Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. [2020]
Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. [2022]
Analysis: The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System. [2018]
An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. [2022]
Contact allergy to the Dexcom G6 glucose monitoring system-Role of 2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate in the new adhesive. [2022]
Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. [2018]
Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes. [2022]
Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security