53 Participants Needed

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
RG
Overseen ByRodolfo Galindo, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
Must be taking: Insulin, Incretin therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.15678

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.5791011

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

GU

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)
See 8 more

Exclusion Criteria

Use of sulfonylureas or thiazolidinediones alone or in combination with insulin
Significant hypoglycemia (< 40 mg/dL)
Severe hyperglycemia (BG> 400 mg/dL)
See 16 more

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
2Treatment groups
Experimental Treatment
Group I: Real-time Dexcom CGM during CGM InterventionExperimental Treatment1 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 InterventionExperimental Treatment1 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).

Find a Clinic Near You

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

References

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. [2022]
G6 continuous glucose monitoring system feature use and its associations with glycaemia in Europe. [2023]
Analysis: The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System. [2018]
Testing the Real-World Accuracy of the Dexcom G6 Pro CGM During the Insulin-Only Bionic Pancreas Pivotal Trial. [2023]
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]
Regulation Catches Up to Reality. [2019]
Safety and Functional Integrity of Continuous Glucose Monitoring Components After Simulated Radiologic Procedures. [2021]
An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. [2022]
New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. [2009]
Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Comparison of the numerical and clinical accuracy of four continuous glucose monitors. [2022]
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