Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)

Recruiting at 1 trial location

Overseen By Rodolfo Galindo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Insulin, Incretin therapy

Must not be taking: Sulfonylureas, Thiazolidinediones

Disqualifiers: Active malignancy, Severe anemia, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

53 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking sulfonylureas or thiazolidinediones if you are using them, as they are not allowed. Other medications are not specifically mentioned, so you may be able to continue them, but it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Dexcom G6 CGM, Dexcom real-time G6 Continuous Glucose Monitoring System (CGM), POC BG?

Research shows that the Dexcom G6 CGM system has improved accuracy and data availability, which can enhance the patient experience and integration into insulin delivery systems. Additionally, the use of its features has been associated with better blood sugar control in people with diabetes. ^{1 2 3 4 5}

What safety data exists for the Dexcom G6 CGM system?

The Dexcom G6 CGM system has been evaluated for safety, including its performance during simulated radiologic procedures and its accuracy compared to glucose meters. Some users have reported inaccurate results, but overall, the system's accuracy and data availability have been improved with algorithm updates, reducing sensor errors and potentially enhancing user experience. ^{1 5 6 7 8}

How is the Dexcom G6 CGM treatment different from other glucose monitoring treatments?

The Dexcom G6 CGM system is unique because it provides real-time continuous glucose monitoring without the need for fingerstick calibration, offering convenience and ease of use compared to traditional glucose monitoring methods. ^{5 7 9 10 11}

What is the purpose of this trial?

This trial uses a device that constantly tracks blood sugar levels to help prevent low blood sugar in patients with type 2 diabetes and end-stage kidney disease who are on insulin and hemodialysis. This technology has been developed to help patients with diabetes manage their blood sugar levels by providing real-time data, which can prevent both low and high blood sugar.

Research Team

Guillermo Umpierrez, MD

Principal Investigator

Emory University

Eligibility Criteria

Inclusion Criteria

You are an adult with type 2 diabetes.

You are currently undergoing hemodialysis treatment for at least 90 days.

currently performing self-monitored blood glucose (at least 2 times daily)

Exclusion Criteria

Use of sulfonylureas or thiazolidinediones alone or in combination with insulin

Significant hypoglycemia (< 40 mg/dL)

Severe hyperglycemia (BG> 400 mg/dL)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Phase 1

Participants use real-time/personal CGM for 4 weeks, followed by a 2-week wash-out period

6 weeks

Intervention Phase 2

Participants cross over to use POC BG for 4 weeks, followed by a 2-week wash-out period

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Dexcom G6 CGM
• Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)
• POC BG

Participant Groups

Group I: Real-time Dexcom CGM during CGM Intervention Experimental Treatment 1 Intervention

Patients with type 2 DM treated with insulin and receiving hemodialysis will use a real-time/personal CGM for 4 weeks (Intervention-Control Group), then 2 weeks of wash-out period, and cross over to use POC BG for 4 weeks, for insulin adjustments.

Group II: Professional Dexcom CGM During Point-Of-Care Blood Glucose Intervention Experimental Treatment 1 Intervention

Patients with type 2 DM treated with insulin and receiving hemodialysis will use POC BG for 4 weeks, then 2 weeks of wash-out period, and cross over to use a real-time/personal CGM for 4 weeks, for insulin adjustments (Control-Intervention Group).

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

The enhanced algorithm for the Dexcom G6 Continuous Glucose Monitoring (CGM) System maintained high accuracy, with a 91.8% accuracy rate, while significantly reducing sensor errors.

The new algorithm led to a 59% decrease in total time spent in sensor error, improving data availability, which could enhance patient experience and integration with insulin delivery systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. Harvey Towers, RA., Zhang, X., Yousefi, R., et al.[2022]

A study of 47,784 users of the Dexcom G6 continuous glucose monitoring system over 6 months found that more than 75% of users across various regions utilized alert features, which significantly improved glycaemic control.

Enabling Low and Urgent Low Soon alerts was linked to less time spent below target glucose levels, while High alerts were associated with more time in the target range and less time above it, indicating that proper use of these alerts can enhance diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

G6 continuous glucose monitoring system feature use and its associations with glycaemia in Europe. Acciaroli, G., Parkin, CG., Thomas, R., et al.[2023]

The Dexcom G4 Platinum Continuous Glucose Monitoring System shows good overall performance in monitoring glucose levels, but newer systems like the G4AP are already available with improved accuracy.

While the G4 system helps reduce time spent in hypoglycemia, its effectiveness in preventing severe hypoglycemia remains questionable, suggesting that conventional systems may not be sufficient for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis: The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System. van Beers, CA., DeVries, JH.[2018]

In a real-world setting, the blinded Dexcom G6 Pro continuous glucose monitor (CGM) demonstrated a mean absolute relative difference (MARD) of 11.0% over a median wear time of 50 hours, indicating reliable accuracy for glucose monitoring in individuals with type 1 diabetes.

The accuracy of the Dexcom G6 Pro improved after the first 12 hours of use, stabilizing at around 10.1% MARD thereafter, which aligns with previous laboratory-based accuracy findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Real-World Accuracy of the Dexcom G6 Pro CGM During the Insulin-Only Bionic Pancreas Pivotal Trial. Marak, MC., Calhoun, P., Damiano, ER., et al.[2023]

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]

The Dexcom G6 continuous glucose monitoring system maintained its functionality and data integrity after exposure to simulated x-ray and MRI procedures, indicating it is safe to use during these medical imaging processes.

During MRI simulations, the devices experienced minimal displacement force, heating of less than 2°C, and low induced currents, suggesting they are unlikely to be dislodged or damaged during standard MRI scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Functional Integrity of Continuous Glucose Monitoring Components After Simulated Radiologic Procedures. Thomas, C., Welsh, JB., Lu, S., et al.[2021]

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 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 FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system showed that 85.5% of its readings from the arm fell within the clinically acceptable range when compared to a standard blood glucose measurement, indicating good efficacy for monitoring glucose levels in patients with diabetes.

However, the FSL-CGM system tended to underestimate glucose levels at lower ranges and overestimate them at higher ranges, particularly after meals, suggesting that users should be cautious and follow optimized instructions for accurate daily management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. Fokkert, MJ., van Dijk, PR., Edens, MA., 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]

References

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

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. [2022]

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

G6 continuous glucose monitoring system feature use and its associations with glycaemia in Europe. [2023]

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

Analysis: The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System. [2018]

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

Testing the Real-World Accuracy of the Dexcom G6 Pro CGM During the Insulin-Only Bionic Pancreas Pivotal Trial. [2023]

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

A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes. [2021]

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

Regulation Catches Up to Reality. [2019]

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

Safety and Functional Integrity of Continuous Glucose Monitoring Components After Simulated Radiologic Procedures. [2021]

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

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. [2022]

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. [2022]

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

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