Dexcom G7 for Continuous Glucose Monitoring

(DexcomG7 Trial)

Overseen By Kimberly Jenkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Allergy, Skin conditions, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-10 days

28 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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. ^{1 4 8 9 10}

Research Team

Lansang Cecilia, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

All patients will receive the Dexcom G7 continuous glucose monitor (CGM)

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

Approved in United States as Dexcom G7 for:

• Type 1 diabetes
• Type 2 diabetes
• Monitoring glucose levels in adults and children aged 2 years and older

Approved in European Union as Dexcom G7 for:

• Type 1 diabetes
• Type 2 diabetes
• Monitoring glucose levels in adults and children aged 2 years and older

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

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

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The seventh generation (G7) Dexcom continuous glucose monitor (CGM) demonstrated high accuracy in glucose readings, with mean absolute relative differences (MARD) of 8.2% for arm sensors and 9.1% for abdomen sensors, based on data from 316 participants over 10.5 days.

No serious adverse events were reported during the study, indicating that the G7 CGM is safe for use in adults with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. Garg, SK., Kipnes, M., Castorino, K., et al.[2022]

The Dexcom G4 Platinum Continuous Glucose Monitoring System shows good overall performance in monitoring glucose levels, but newer systems like the G4AP are already available with improved accuracy.

While the G4 system helps reduce time spent in hypoglycemia, its effectiveness in preventing severe hypoglycemia remains questionable, suggesting that conventional systems may not be sufficient for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis: The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System. van Beers, CA., DeVries, JH.[2018]

The analysis of adverse events for the Medtronic 670G insulin pump revealed that users experienced more hypoglycemic events when the auto mode was activated compared to when it was turned off.

For the Dexcom continuous glucose monitors, complaints about inaccuracies were most common when the readings fell within the acceptable range (B zone), indicating potential confusion among users regarding the reliability of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. Krouwer, JS.[2022]

In a study of five patients experiencing allergic contact dermatitis (ACD) from the Dexcom G6 glucose monitoring system, all were found to be sensitized to the new adhesive component 2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA), indicating it is a significant cause of skin reactions.

Testing revealed that isobornyl acrylate (IBOA) was not present in the adhesive and did not contribute to the skin issues, confirming that MBPA is the primary allergen responsible for the increased skin problems associated with the updated Dexcom G6 model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact allergy to the Dexcom G6 glucose monitoring system-Role of 2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate in the new adhesive. Oppel, E., Högg, C., Oschmann, A., et al.[2022]

The Dexcom G4 Platinum with Software 505 algorithm (SW505) demonstrated significantly better accuracy and performance compared to the original G4 Platinum system (G4P) in youth with diabetes, with a mean absolute relative difference (MARD) of 10% for SW505 versus 17% for G4P when compared to reference measurements.

Both systems were found to be safe, with no serious adverse events reported, but the improved accuracy of SW505 has the potential to enhance glucose management and glycemic outcomes in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. Laffel, L.[2018]

In a study involving 12 patients with type 1 diabetes, the Abbott FreeStyle Libre glucose monitoring system showed the best sensor performance, meeting ISO criteria 73.2% of the time, compared to 56.1% for Dexcom and 52.0% for Medtronic.

All glucose monitoring systems performed less accurately during hypoglycemia, indicating a potential safety concern for patients when blood sugar levels drop too low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes. Aberer, F., Hajnsek, M., Rumpler, M., et al.[2022]

In a study involving 11 patients with type 1 diabetes, the Dexcom G5 Mobile (DG5) continuous glucose monitor demonstrated significantly better accuracy than the Eversense (EVS) implantable sensor during controlled clinical conditions, particularly when blood glucose levels were decreasing.

While both devices showed similar accuracy during home monitoring, DG5 had a lower median absolute relative difference (ARD) of 7.91% compared to EVS's 11.4% during glucose excursions in a clinical setting, indicating it may be more reliable for detecting rapid changes in glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor. Boscari, F., Vettoretti, M., Amato, AML., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Analysis: The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor. [2021]