Continuous Glucose Monitoring for Diabetes

Overseen By Eric Cucchi, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must not be taking: Hydroxyurea, High dose acetaminophen

Disqualifiers: Pregnancy, Prisoners, Anasarca, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Dexcom G7 Continuous Glucose Monitor to evaluate its effectiveness in tracking blood sugar levels in critically ill ICU patients. The goal is to ensure the device's accuracy and usefulness in managing diabetes in this setting. Individuals with diabetes or high blood sugar levels (over 200 mg/dL) in the ICU may be suitable candidates for this trial. As an unphased trial, it provides an opportunity to contribute to significant research that could enhance diabetes management for critically ill patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking hydroxyurea or high doses of acetaminophen, as these interfere with the sensor.

What prior data suggests that the Dexcom G7 continuous glucose monitor is safe for use in the ICU?

Research has shown that the Dexcom G7 Continuous Glucose Monitor (CGM) is generally accurate and safe for up to 10.5 days in adults with diabetes, reliably tracking blood sugar levels. However, some users have reported issues with the device's accuracy and safety, leading to serious concerns and even lawsuits.

While the Dexcom G7 has benefited many, awareness of these potential issues is important. Prospective study participants should discuss any concerns with their healthcare provider. This conversation can help clarify expectations and determine if participation is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Dexcom G7 Continuous Glucose Monitor (CGM) is unique because it offers real-time glucose monitoring without the need for fingerstick calibrations, unlike many traditional glucose meters. It is designed to provide continuous, accurate glucose readings, which can help users better manage their diabetes by offering immediate insights into how factors like diet and exercise affect their glucose levels. Researchers are excited about the Dexcom G7 because it has the potential to improve glycemic control and reduce the risk of complications by providing a more comprehensive view of glucose trends over time.

What evidence suggests that the Dexcom G7 is effective for monitoring glucose in critically ill patients?

Studies have shown that the Dexcom G7 continuous glucose monitor (CGM) is accurate and safe for people with diabetes. Research indicates that it can help lower A1C levels, which measure blood sugar control, by about 2.4%. This improvement means the monitor aids in better blood sugar management. It also performs well during surgeries and for pregnant individuals with diabetes, demonstrating reliability in various situations. These findings support the effectiveness of the Dexcom G7 in accurately monitoring glucose levels. ^{2 6 7 8 9}

Who Is on the Research Team?

John P Mordes, MD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for critically ill ICU patients with diabetes. It's to see if the Dexcom G7 Continuous Glucose Monitor works well in this setting.

Inclusion Criteria

I have diabetes.

I can make my own medical decisions or have someone legally able to do so for me.

Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized.

Exclusion Criteria

Anasarca affecting preferred areas for device placement (arm, upper buttocks, or thigh), which may interfere with sensor accuracy.

Persons who are pregnant.

I am able to understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants have a Dexcom G7 CGM placed on the skin and monitored for 10 days or until discharge from the ICU

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexcom G7 Continuous Glucose Monitor

Trial Overview The study tests the accuracy and practicality of using the Dexcom G7 device to monitor blood sugar levels in ICU patients with diabetes.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

All members of the arm will have a CGM place and glucose concentration downloaded.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Citations

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

Accuracy and Safety of Dexcom G7 Continuous Glucose ... 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. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16462

Performance of the DEXCOM G7 CGM system during and ... In conclusion, our results suggest that the Dexcom G7 CGM system exhibits adequate accuracy with no signal losses during surgery. Further ...

3. provider.dexcom.com provider.dexcom.com/dexcom-community-glucose-monitoring-project-six-month-results-using-continuous-glucose-monitoring

Six-Month Results Using Continuous Glucose Monitoring ... Participants using a glucose sensor (n=237) showed clinically meaningful and statistically significant (p<0.001) decrease in A1C of 2.4%+1.9% at 6 months.

4. 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).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11058415/

Performance of the Dexcom G7 Continuous Glucose ... Conclusions. This study demonstrated that the Dexcom G7 CGM system provided accurate readings in pregnant individuals with diabetes. The overall %15/15 and %20 ...

6. dexcom.com dexcom.com/en-is/safety-information

Safety Information The Dexcom G5 Mobile Continuous Glucose Monitoring System is a glucose monitoring system indicated for the management of diabetes in persons age 2 years and ...

7. 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 This device may cause serious injury or death if you continue to use it without correction. Affected Product. Product Names: Dexcom G7 ...

8. dexcom.com dexcom.com/en-us/safety-information

CGM Safety Information Read essential safety information on all of Dexcom's continuous glucose monitoring systems and software.

9. newsweek.com newsweek.com/dexcom-g7-cgm-glucose-monitor-reports-issues-10932888

'It's Life-Threatening'—Dexcom G7 Users Say Glucose ... Dexcom is facing scrutiny and class-action lawsuits over alleged safety and accuracy issues with its G7 monitor.