CGM for Type 2 Diabetes and Kidney Failure

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if real-time continuous glucose monitoring (CGM) can prevent low blood sugar in people with type 2 diabetes who use insulin and undergo dialysis. Participants will either use the Dexcom real-time G6 Continuous Glucose Monitoring System (CGM) or continue with regular blood sugar checks for a few weeks, then switch to evaluate which method is more effective. The trial targets individuals who have been on dialysis for at least 90 days, use insulin, and are willing to wear a CGM device. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance diabetes management for those on dialysis.

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 prior data suggests that the Dexcom real-time G6 Continuous Glucose Monitoring System is safe for patients with type 2 diabetes and end-stage kidney disease?

Research has shown that the Dexcom G6 Continuous Glucose Monitoring (CGM) System is generally safe for people with diabetes. It does not require finger pricks or scanning and provides glucose readings every five minutes.

The FDA has approved the Dexcom G6 for managing diabetes, indicating its safety for this purpose. In studies involving patients on hemodialysis, the Dexcom G6 was used without major safety issues. Some users might experience mild skin irritation at the sensor site, but serious side effects are rare.

Overall, the Dexcom G6 is well-tolerated, making it a promising option for managing blood sugar levels in people with diabetes and severe kidney disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Dexcom real-time G6 Continuous Glucose Monitoring System (CGM) for insulin-treated patients with type 2 diabetes on hemodialysis because it offers a new way to prevent hypoglycemia. Unlike standard care options that rely on point-of-care blood glucose tests, the Dexcom CGM provides continuous, real-time glucose monitoring. This means patients can get immediate alerts about their blood sugar levels, allowing for quicker and potentially more precise insulin adjustments. The real-time data could help reduce the risk of low blood sugar episodes, which is crucial for those also undergoing hemodialysis.

What evidence suggests that the Dexcom real-time G6 Continuous Glucose Monitoring System could be effective in preventing hypoglycemia in patients with type 2 diabetes and end-stage kidney disease?

Research has shown that the Dexcom G6 Continuous Glucose Monitoring (CGM) system can help prevent low blood sugar in people with type 2 diabetes who use insulin and are on dialysis. In this trial, participants will be divided into two groups: one group will use the real-time Dexcom CGM for 4 weeks, followed by a wash-out period, and then switch to Point-Of-Care Blood Glucose (POC BG) monitoring. The other group will start with POC BG monitoring and then switch to the real-time Dexcom CGM. Studies have found that the Dexcom G6 provides accurate, real-time blood sugar readings, enabling patients to adjust their insulin doses more effectively. In trials, the Dexcom G6 reliably tracked blood sugar levels, making it a promising tool for better managing diabetes and reducing the risk of low blood sugar. These findings suggest that the Dexcom G6 can effectively monitor and manage blood sugar levels in people with diabetes on dialysis. ^{1 5 6 7 8}

Who Is on the Research Team?

Guillermo Umpierrez, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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 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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04473430

NCT04473430 | Study to Determine the Efficacy of Real- ... The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia among patients with type 2 diabetes (DM2), treated with ...

2. diabetesjournals.org diabetesjournals.org/care/article/47/11/1922/157170/Accuracy-of-Continuous-Glucose-Monitoring-in

Accuracy of Continuous Glucose Monitoring in Hemodialysis ... We conducted simultaneous protocolized glucose measurements among enrolled patients using CGM measured by Dexcom G6 devices versus blood glucose ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04217161

Dexcom G6 Continuous Glucose Monitoring in Hemodialysis This is a pilot study enrolling adult hemodialysis patients with diabetes recruited from the University of California Irvine Medical Center (UCIMC) who will ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04473430/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

Study to Determine the Efficacy of Real-time CGM in ... The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia in patients with type 2 diabetes and end-stage ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7757524/

Performance of the Dexcom G6 Continuous Glucose ... The aim of this study was to determine the performance of the Dexcom G6 continuous glucose monitoring (CGM) system across three sensor wear sites in pregnant ...

6. dexcom.com dexcom.com/en-us/safety-information

CGM Safety Information Read essential safety information on all of Dexcom's continuous glucose monitoring systems and software.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN170088.pdf

den170088 summary - accessdata.fda.gov The Dexcom G6 System in an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose readings which are updated every 5 minutes ...

8. dexcom.com dexcom.com/en-us/g6-cgm-system

Dexcom G6 CGM System | No Fingersticks, No Scanning The Dexcom G6 Continuous Glucose Monitoring (CGM) System sends real-time glucose readings automatically to a compatible smart device* or Dexcom receiver.