Continuous Glucose Monitors for Diabetes

Overseen By William H Scott, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Insulin

Must not be taking: Hydroxyurea

Disqualifiers: Pregnancy, Skin disease, Renal disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Continuous Glucose Monitors (CGMs) can help people with diabetes manage their blood sugar more effectively after hospital discharge. It compares two groups: one using CGMs and the other using traditional finger-stick tests. The goal is to determine if CGMs can reduce hospital readmissions by improving blood sugar control. Individuals with diabetes who have high blood sugar levels and use insulin might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative diabetes management methods.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants will be treated with insulin and possibly other non-insulin medications after hospital discharge.

What prior data suggests that Continuous Glucose Monitors are safe for patients with diabetes?

Research shows that the Dexcom G7 Continuous Glucose Monitor (CGM) is generally safe for people with diabetes. Studies have found that this device can be used safely for several days without major problems. For instance, one study reported no serious issues when people used the Dexcom G7 for over 15 days, with no major negative reactions.

Another study confirmed that the CGM is safe and accurate, even for pregnant women with diabetes, indicating that the device works well and is safe for different groups.

A correction was made to the G7 app because it sometimes failed to alert users about sensor issues. This means the app might not always warn if the device isn't working properly, which could delay treatment. However, this issue pertains to the app, not the device itself.

Overall, current evidence considers the Dexcom G7 CGM safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitors (CGMs) for diabetes management because they offer real-time monitoring of blood glucose levels, unlike traditional finger-stick methods. The Dexcom G7 CGM device, used in this study, continuously tracks glucose data and shares it instantly with healthcare providers, allowing for more timely and precise treatment decisions. This real-time feedback can help in more effectively managing blood sugar levels and potentially reducing complications associated with diabetes.

What evidence suggests that Continuous Glucose Monitors are effective for diabetes?

This trial will compare Continuous Glucose Monitors (CGMs) with traditional methods for managing diabetes. Studies have shown that CGMs help people with diabetes control their blood sugar more effectively. One study found that participants using a CGM, such as the Dexcom G7, lowered their A1C levels by about 2.4% over six months. Lower A1C levels indicate better diabetes management. Research also shows that CGMs increase satisfaction with diabetes care. The Dexcom G7 remains accurate and reliable, even during activities like surgery. Overall, CGMs have been proven to support better health outcomes for people managing diabetes. Participants in this trial may use the Dexcom G7 CGM, while others will use traditional "finger sticks" to assess blood glucose values. ^{1 6 7 8 9}

Who Is on the Research Team?

Ilias Spanakis, MD

Principal Investigator

Baltimore VA Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with diabetes who have been recently discharged from the hospital. It aims to see if using Continuous Glucose Monitors (CGMs) can reduce the chance of being readmitted compared to traditional finger stick testing. Participants must be willing to use either a CGM or perform regular finger sticks and be followed for 3 months after leaving the hospital.

Inclusion Criteria

Uncontrolled glycemic control, defined as hyperglycemia with HbA1c ≥8%

I am 18 years old or older.

I have diabetes and will be treated with insulin after leaving the hospital.

Exclusion Criteria

Patients at the time of screening on insulin pumps or CGMs

Pregnant patients

Patients with extensive skin disease or allergies that preclude wearing the CGM sensor

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either Real Time CGM or POC following hospital discharge and monitored for glucose control

12 weeks

Regular monitoring with CGM or POC

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor

Trial Overview The study compares two methods of monitoring blood sugar levels in patients with diabetes post-hospital discharge: Real Time Continuous Glucose Monitoring (CGM) versus Point of Care (POC) finger stick testing. The goal is to determine which method leads to better glucose control and fewer hospital readmissions.

How Is the Trial Designed?

Group I: Real time-CGM Experimental Treatment 1 Intervention

The Real Time-CGM Group will wear the Dexcom G7 CGM device. Their glucose data will be shared in real-time to health care providers for subsequent treatment decisions.

Group II: Point of Care (POC) Experimental Treatment 1 Intervention

The Point of Care (POC) group will use "finger sticks" to assess blood glucose values.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

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

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. 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.

3. 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 ...

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

Advances in Continuous Glucose Monitoring: Clinical ... Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.

6. liebertpub.com liebertpub.com/doi/full/10.1089/dia.2025.0139

Accuracy of the 15.5-Day G7 iCGM in Adults with Diabetes No serious adverse events were reported. Conclusions: The 15-day G7 iCGM was accurate and safe in adults with diabetes throughout the 15.5-day ...

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

8. ca.provider.dexcom.com ca.provider.dexcom.com/articles/new-study-concludes-dexcom-g7-accurate-and-safe-during-pregnancies-complicated-diabetes

New Study Concludes Dexcom G7 is “Accurate and Safe ... Clinical Data Shows Dexcom G7 Provides Accurate Glucose Readings · Dexcom G7 is Safe Throughout Pregnancy · Health Canada Approves Dexcom G7 for ...

9. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-selection-training/dexcom-g7-libre-3-comparison

Dexcom G7 & Libre 3 Comparison Accuracy and safety of Dexcom G7 continuous glucose monitoring in adults with diabetes. Diabetes Technol Ther. 2022;24(6):373-380. doi:10.1089/dia.2022.0011.