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)
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?
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention Phase 1
Participants use real-time/personal CGM for 4 weeks, followed by a 2-week wash-out period
Intervention Phase 2
Participants cross over to use POC BG for 4 weeks, followed by a 2-week wash-out period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dexcom G6 CGM
- Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)
- POC BG
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator