Continuous Glucose Monitoring for Diabetes

Overseen By Angel Morvant, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must be taking: Insulin

Must not be taking: Chemotherapy, Hydroxyurea, Acetaminophen

Disqualifiers: Dialysis, Major surgery, ICU, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: From enrollment until discharge

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to improve patient awareness of the utility of continuous glucose monitoring systems in blood glucose monitoring and to improve patient satisfaction regarding diabetes care, particularly in the matter of blood glucose monitoring, at the transitions of care from the inpatient setting to the ambulatory setting.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants using certain medications like high doses of Vitamin C, hydroxyurea, and acetaminophen. It's best to discuss your specific medications with the trial team.

Is continuous glucose monitoring safe for humans?

Continuous glucose monitors like the Dexcom G7 and Abbott Freestyle have been generally safe for humans, though some users have reported issues like inaccurate readings and allergic skin reactions. No serious adverse events were reported in a study of the Dexcom G7, indicating it is generally safe for use. ^{1 2 3 4 5}

How does the Dexcom G7 Continuous Glucose Monitor differ from other treatments for diabetes?

The Dexcom G7 Continuous Glucose Monitor is unique because it provides real-time glucose readings with high accuracy, having a mean absolute relative difference (MARD) of 8.2% for arm placement, which is lower than many other monitors. It also offers flexibility in sensor placement on the body and does not require a cable connection, making it more convenient for daily use. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment Dexcom G7 Continuous Glucose Monitor and Libre 3 Plus Continuous Glucose Monitor for diabetes?

Research shows that continuous glucose monitors like Dexcom and Libre are effective in managing diabetes by providing accurate glucose readings, which help in better controlling blood sugar levels. Studies have demonstrated that these devices meet certain accuracy standards and perform well, especially during high blood sugar levels. ^{1 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for non-pregnant adults over 18 with Type 1 or Type 2 diabetes, who need daily glucose readings and can use a smartphone app. They should be mentally and physically able to handle the devices, have recent blood sugar levels between 70-350 mg/dL, and require insulin therapy.

Inclusion Criteria

I am an adult over 18, not pregnant, and admitted to VUMC.

I check my blood sugar at least once daily.

Mental status and dexterity adequate to use Libre 3 Plus or Dexcom G7 sensors with Libre 3 or Dexcom G7 application on patient's smartphone

Exclusion Criteria

Currently using Libre 3 Plus or Dexcom G7 CGMS during hospitalization or have used Libre 3 Plus or Dexcom G7 CGMS in the past 3 months

I have received chemotherapy during my current hospital stay.

I am scheduled for major surgery in the next 10-15 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use either the Libre 3 Plus or Dexcom G7 continuous glucose monitor

From enrollment until discharge

Follow-up

Participants are monitored for satisfaction and opinion regarding continuous glucose monitoring systems

2-3 weeks

Follow-up telephone visit

What Are the Treatments Tested in This Trial?

Interventions

• Dexcom G7 Continuous Glucose Monitor
• Libre 3 Plus Continuous Glucose Monitor

Trial Overview The study tests if using Libre 3 Plus or Dexcom G7 Continuous Glucose Monitors helps patients manage their diabetes better after leaving the hospital. It looks at how these monitors affect patient satisfaction and awareness of their blood sugar levels.

How Is the Trial Designed?

Group I: Libre 3 Plus Continuous Glucose Monitor Experimental Treatment 1 Intervention

Subjects in this arm will start using the Libre 3 Plus continuous glucose monitor.

Group II: Dexcom G7 Continuous Glucose Monitor Experimental Treatment 1 Intervention

Subjects in this arm will start using the Dexcom G7 continuous glucose monitor.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

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]

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 11 patients with type 1 diabetes, the Dexcom G5 Mobile (DG5) continuous glucose monitor demonstrated significantly better accuracy than the Eversense (EVS) implantable sensor during controlled clinical conditions, particularly when blood glucose levels were decreasing.

While both devices showed similar accuracy during home monitoring, DG5 had a lower median absolute relative difference (ARD) of 7.91% compared to EVS's 11.4% during glucose excursions in a clinical setting, indicating it may be more reliable for detecting rapid changes in glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor. Boscari, F., Vettoretti, M., Amato, AML., et al.[2021]

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]

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 new continuous glucose monitoring system (CGMS) was well tolerated by 20 children with type 1 diabetes over 7 days, with 90% of sensors still in use at the end of the study, indicating good patient acceptance and safety.

The study found that the CGMS could effectively function beyond the typical 72-hour limit, with 78% of sensors still operational after 7 days, suggesting that the device can provide extended monitoring without significant loss of accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended use of a new continuous glucose monitoring system with wireless data transmission in children with type 1 diabetes mellitus. Wong, LJ., Buckingham, BA., Kunselman, B., et al.[2009]

Citations

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

Comparison of the numerical and clinical accuracy of four continuous glucose monitors. [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. Netherlands pubmed.ncbi.nlm.nih.gov

Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor. [2021]

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]

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

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

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

Extended use of a new continuous glucose monitoring system with wireless data transmission in children with type 1 diabetes mellitus. [2009]