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

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to test the accuracy of the Dexcom continuous glucose monitoring device during the cardiothoracic surgical procedure and recovery period in the Cardiac Intensive Care Unit. Readings from the device will be compared with the standard of care blood glucose levels that are obtained during your surgery and postoperatively.

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.

Is the Dexcom G7 Continuous Glucose Monitor safe for humans?

The Dexcom G7 Continuous Glucose Monitor has been tested in adults with diabetes and no serious adverse events were reported, indicating it is generally safe for human use. ^{1 2 3 4 5}

How does the Dexcom G7 Continuous Glucose Monitor differ from other treatments for abnormal glucose metabolism?

The Dexcom G7 Continuous Glucose Monitor is unique because it provides real-time glucose readings with high accuracy and a short lag time, allowing for better management of glucose levels. Unlike traditional methods that require finger-prick blood tests, this device continuously monitors glucose levels through a sensor placed on the skin, offering convenience and more comprehensive data for managing abnormal glucose metabolism. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Dexcom G7 Continuous Glucose Monitor 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 matching standard blood glucose measurements. This suggests it could be effective in monitoring and managing abnormal glucose metabolism. ^{1 2 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]

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]

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]

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 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]

Citations

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

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

2. England pubmed.ncbi.nlm.nih.gov

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

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

Comparison of the numerical and clinical accuracy of four continuous glucose monitors. [2022]

4. 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]

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

Predictive Glucose Trends From Continuous Glucose Monitoring: Friend or Foe in Clinical Decision Making? [2020]

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

Regulation Catches Up to Reality. [2019]

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

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