Continuous Glucose Monitors for Diabetes
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.12345Why 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.16789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are assigned to either Real Time CGM or POC following hospital discharge and monitored for glucose control
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
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.
The Point of Care (POC) group will use "finger sticks" to assess blood glucose values.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
DexCom, Inc.
Industry Sponsor
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
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-monitoringSix-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.
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-6The 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).
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.
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 ...
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-diabetesNew 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 ...
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.
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