Dexcom G7 for Abnormal Glucose Metabolism

Overseen By Lynnette Harris, BSN RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 18, Pregnant, Arm contraindication

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Dexcom G7, a device that continuously monitors blood sugar levels, to evaluate its effectiveness during and after heart surgery. Researchers will compare the device's readings to the usual blood sugar tests conducted during surgery and recovery. The study involves patients undergoing heart surgery with a machine that temporarily takes over heart and lung functions at Atrium Health Wake Forest Baptist Medical Center. It aims to ensure the device provides accurate information when needed most. As an unphased trial, this study offers patients the opportunity to contribute to research that could enhance surgical outcomes and patient care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Dexcom G7 device is safe for use during cardiothoracic surgery?

Research has shown that the Dexcom G7 continuous glucose monitor is generally safe for adults. One study tested its safety and accuracy over 10.5 days in people with diabetes and found that the device is easy to use and provides reliable readings. However, some issues have arisen with the device's apps. Dexcom addressed a problem where the apps sometimes failed to alert users when sensors stopped working, potentially leading to missed alerts and delayed treatment.

The Dexcom G7 is already used to help manage diabetes, indicating a good safety record. If the readings do not match expectations or how one feels, it is important to double-check with a fingerstick blood test to ensure accuracy. Overall, the Dexcom G7 monitor is considered safe, but users should remain aware of potential app issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dexcom G7 because it offers continuous glucose monitoring, which is a game-changer for managing abnormal glucose levels during and after cardiothoracic surgery. Unlike traditional methods that rely on periodic blood sugar checks, the Dexcom G7 provides real-time data, helping doctors make timely decisions to keep glucose levels stable. This continuous monitoring can potentially reduce complications and improve recovery times, making it a promising tool in critical care settings.

What evidence suggests that the Dexcom G7 is effective for monitoring glucose levels during cardiothoracic surgery?

Research has shown that the Dexcom G7 Continuous Glucose Monitor effectively provides accurate blood sugar readings for adults with diabetes. In studies, it consistently delivered readings close to standard blood sugar tests. Users of the Dexcom system experienced significant improvements in blood sugar control, with A1C levels dropping by up to 2.4%. This makes the Dexcom G7 a reliable tool for managing blood sugar, crucial for anyone with diabetes. Overall, the device has proven both accurate and helpful in enabling users to better control their blood sugar levels. ^{1 4 6 7 8}

Who Is on the Research Team?

Megan Hicks, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for patients with diabetes or liver metabolic disorders who are undergoing cardiopulmonary bypass surgery. Participants should have abnormal glucose metabolism and will be monitored during and after their heart surgery.

Inclusion Criteria

I am scheduled for heart surgery with a heart-lung machine at Atrium Health Wake Forest Baptist.

Exclusion Criteria

I don't have a rash, missing arm, or a device that would interfere with a new device placement on my arm.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intraoperative Monitoring

Participants undergo continuous glucose monitoring during cardiothoracic surgery using the Dexcom G7 device

Day 1

1 visit (in-person)

Postoperative Monitoring

Continuous glucose monitoring continues in the Cardiovascular Intensive Care Unit to compare device accuracy with standard care

Up to 10 days

Follow-up

Participants are monitored for any device malfunctions and overall glucose control effectiveness

Up to 10 days

What Are the Treatments Tested in This Trial?

Interventions

• Dexcom G7 Continuous Glucose Monitor

Trial Overview

The study is testing the Dexcom G7 Continuous Glucose Monitor's accuracy against standard blood glucose tests during and after cardiac surgery in the intensive care unit.

How Is the Trial Designed?

Group I: Continuous Glucose Monitoring Experimental Treatment 1 Intervention

All participants will wear the Dexcom G7 continuous glucose monitor continuously during their cardiothoracic surgery and throughout their time admitted to the Cardiovascular Intensive Care Unit.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

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 FDA is considering a nonadjunctive label claim for the DEXCOM G5 Mobile continuous glucose monitoring (CGM) system, which would allow users to make insulin dosing decisions based solely on CGM data without needing confirmatory blood glucose tests.

If approved, this change could enhance diabetes management by providing real-time glucose readings every 5 minutes, along with alerts and trending information, potentially reducing the risk of hypoglycemia and improving overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation Catches Up to Reality. Edelman, SV.[2019]

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 34 adults with type 1 diabetes, the Guardian, Navigator, and Glucoday continuous glucose monitors (CGMs) showed comparable numerical accuracy, particularly excelling in hypoglycemic conditions, while the DexCom had significantly larger numerical errors.

Clinical accuracy during euglycemia was high for all CGMs, but the Navigator and Glucoday performed better in detecting hypoglycemia, indicating their potential for better patient safety in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the numerical and clinical accuracy of four continuous glucose monitors. Kovatchev, B., Anderson, S., Heinemann, L., et al.[2022]

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]

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9208857/

Accuracy & Safety of Dexcom G7 CGM in Adults w/ Diabetes

We evaluated the accuracy and safety of a seventh generation (G7) Dexcom continuous glucose monitor (CGM) during 10.5 days of use in adults with diabetes.

2.

diabetesjournals.org

diabetesjournals.org/clinical/article/42/4/540/157065/The-Dexcom-Community-Glucose-Monitoring-Project-6

The Dexcom Community Glucose Monitoring Project: 6-Month ...

After 6 months of program participation, mean A1C decreased by 2.4 ± 1.9% from baseline to 6-month follow-up (from 9.4 ± 1.7 to 7.1 ± 1.2%, P <0.001).

3.

withpower.com

withpower.com/trial/phase-glucose-metabolism-disorders-including-diabetes-mellitus-3-2025-f2450

Dexcom G7 for Abnormal Glucose Metabolism

The Dexcom G7 Continuous Glucose Monitor has been shown to provide accurate glucose readings in adults with diabetes, with a high percentage of readings closely ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04794478

Study Details | NCT04794478 | Evaluation of the Safety ...

The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method. Official Title.

5.

e-enm.org

e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ...

Studies report consistent glycosylated hemoglobin reductions of 0.25%–3.0% and notable time in range improvements of 15%–34%. CGM effectively ...

6.

fda.gov

fda.gov/medical-devices/medical-device-recalls-and-early-alerts/continuous-glucose-monitor-apps-correction-dexcom-inc-issues-correction-g7-apps-and-one-apps-due

Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps

Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of ...

7.

dexcom.com

dexcom.com/en-is/safety-information

Safety Information

If your glucose alerts and readings from G7 do not match your symptoms or expectations, use a fingerstick blood glucose value from your blood glucose meter to ...

8.

dexcom.com

dexcom.com/en-gb/dexcom-g7-cgm-system

Introducing the Dexcom G7 CGM System

The Dexcom G7 will alert you up to 20 minutes before you go low (Urgent Low Soon Alert) or when your glucose is high. You can personalise your alerts. Quiet.