Continuous Glucose Monitoring for Diabetes in Hemodialysis Patients

(CONDOR Trial)

Overseen By Kamyar Kalantar-Zadeh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Limited vision, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

122 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of continuous glucose monitoring (CGM) for diabetes in hemodialysis patients?

Research shows that continuous glucose monitoring (CGM) can help improve blood sugar control in diabetes patients undergoing hemodialysis by providing more stable glucose levels and reducing fluctuations, which are common in this group. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

Research indicates that continuous glucose monitoring (CGM) systems are generally safe for humans, including those undergoing procedures like cardiothoracic surgery. While the accuracy and reliability of CGM in specific conditions like hemodialysis need further study, no significant safety concerns have been reported in the available research. ^{1 5 6 7 8}

How is continuous glucose monitoring (CGM) unique for diabetes patients on hemodialysis?

Continuous glucose monitoring (CGM) is unique for diabetes patients on hemodialysis because it provides real-time tracking of blood sugar levels, helping to manage the frequent blood sugar fluctuations that occur in these patients. Unlike traditional methods, CGM offers continuous data, which can improve glucose control and reduce episodes of low or high blood sugar. ^{1 2 3 5 9}

What is the purpose of this trial?

This randomized controlled trial will investigate whether use of continuous glucose monitoring (CGM) vs. usual care with self-monitored blood glucose 1) enhances glycemic control, 2) reduces hypoglycemia risk, and 3) improves quality of life, diabetes distress, and fear of hypoglycemia in hemodialysis patients with diabetes mellitus.

Eligibility Criteria

This trial is for adults over 18 with end-stage kidney disease on hemodialysis and diabetes, who have been checking their blood sugar themselves for at least 4 weeks. They must be willing to wear a continuous glucose monitoring device and have done so with good compliance in the pre-trial period.

Inclusion Criteria

I have been on in-center hemodialysis for at least 4 weeks due to end-stage kidney disease.

I have diabetes.

You have to wear a continuous glucose monitoring (CGM) device at least 70% of the time before the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo continuous glucose monitoring using Dexcom devices or self-monitored blood glucose for 12 weeks

12 weeks

Weekly monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Continuous glucose monitoring (CGM)
• Usual care (Self-monitored blood glucose)

Trial Overview The study compares two ways of monitoring blood sugar in dialysis patients with diabetes: one group will use continuous glucose monitors (CGM), while the other will stick to self-monitoring. The goal is to see if CGMs can better control blood sugar levels, reduce low blood sugar episodes, and improve overall well-being.

Participant Groups

Group I: Continuous glucose monitoring (CGM) arm Experimental Treatment 1 Intervention

During the intervention period, patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.

Group II: Usual care arm Active Control 1 Intervention

During the intervention period, patients in the usual care arm will conduct self-monitored blood glucose (SMBG) at least 4 times/day. At Weeks 6 and 12 of the intervention period, usual care arm patients will also undergo 10-days of blinded CGM data collection.

Continuous glucose monitoring (CGM) is already approved in United States, European Union for the following indications:

Approved in United States as Dexcom G6 for:

• Diabetes management for patients aged 2 years and older
• Type 1 diabetes
• Type 2 diabetes

Approved in European Union as Continuous Glucose Monitoring Systems for:

• Diabetes management
• Type 1 diabetes
• Type 2 diabetes

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

A study involving 20 participants on hemodialysis showed that a factory-calibrated continuous glucose monitoring (CGM) system has a mean absolute relative difference of about 13.8% to 14.4% compared to standard blood glucose measurements, indicating reasonable accuracy.

The CGM demonstrated clinical relevance, with 98.7% of readings falling within acceptable error zones, suggesting it can effectively aid diabetes management for individuals undergoing hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a Factory-Calibrated Continuous Glucose Monitor in Individuals With Diabetes on Hemodialysis. Villard, O., Breton, MD., Rao, S., et al.[2023]

Continuous glucose monitoring (CGM) is an effective tool for assessing glycemic control in type 2 diabetic patients undergoing chronic hemodialysis, showing a strong correlation with traditional glucose meter readings (r = 0.90).

Markers like glycated hemoglobin (A1c) and fructosamine, which are reliable indicators of glucose control in non-hemodialysis diabetic patients, do not correlate well with glucose levels in hemodialysis patients, indicating the need for alternative monitoring methods in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycaemic control in type 2 diabetic patients on chronic haemodialysis: use of a continuous glucose monitoring system. Riveline, JP., Teynie, J., Belmouaz, S., et al.[2022]

Continuous glucose monitoring (CGM) is an effective method for tracking blood sugar levels in diabetes patients undergoing routine dialysis, showing a strong correlation with self-monitoring blood glucose values (r=0.837).

During dialysis, CGM values and mean amplitude of glucose excursions (MAGE) were significantly lower compared to pre-dialysis levels, indicating that CGM can effectively capture changes in glucose levels related to dialysis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in diabetes patients with chronic kidney disease on dialysis: a meta-analysis. Wang, F., Wang, D., Lu, XL., et al.[2022]

Patients with end stage diabetic nephropathy (ESDN) experience significantly greater blood glucose fluctuations during hemodialysis compared to those with end stage renal disease (ESRD) without diabetes, indicating a need for improved glucose management in this population.

The study found that the HbA1c levels in ESDN patients do not accurately reflect their actual blood glucose levels as measured by continuous glucose monitoring, suggesting that relying on HbA1c could lead to misleading assessments of glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood glucose fluctuations in hemodialysis patients with end stage diabetic nephropathy. Jin, YP., Su, XF., Yin, GP., et al.[2022]

In a study of 18 patients with diabetes undergoing hemodialysis, continuous glucose monitoring (CGM) significantly improved glycemic control and reduced variability after treatment adjustments were made based on initial CGM data.

By the follow-up period, CGM helped equalize glucose levels on dialysis and non-dialysis days, indicating its potential to personalize diabetes management in patients undergoing hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of continuous glucose monitoring of blood glucose control in patients with diabetes undergoing hemodialysis: A pilot study. Lee, S., Lee, S., Kim, KM., et al.[2023]

In a study involving 27 subjects over 14 days, the Dexcom G5 Mobile (rtCGM) demonstrated higher accuracy than the FreeStyle Libre (isCGM), with 91.5% of its readings within ±20% of laboratory results compared to 82.5% for FreeStyle Libre.

The mean absolute relative difference (MARD) was lower for the Dexcom G5 at 9.5%, indicating it provided more precise glucose readings than the FreeStyle Libre, which had a MARD of 13.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Accuracy Analysis of a Real-time and an Intermittent-Scanning Continuous Glucose Monitoring System. Link, M., Kamecke, U., Waldenmaier, D., et al.[2021]

Real-time continuous glucose monitoring (rtCGM) systems provide automatic glucose data transmission, alerts, and alarms, making them more user-friendly and responsive compared to intermittently scanned (isCGM) systems, which require manual scanning for data retrieval.

Both rtCGM and isCGM offer significant advantages over traditional blood glucose self-monitoring, but the choice between them should be based on individual patient needs and preferences due to their differing features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. Edelman, SV., Argento, NB., Pettus, J., et al.[2019]

The real-time continuous glucose monitoring system (RT-CGMS) was found to be safe and accurate in monitoring glucose levels in patients undergoing cardiothoracic surgery, with 96.6% of sensor values aligning with accepted accuracy standards.

The activation of the alarm function on the RT-CGMS did not significantly impact glucose control, indicating that further research is needed to understand its potential benefits in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre- and postoperative accuracy and safety of a real-time continuous glucose monitoring system in cardiac surgical patients: a randomized pilot study. Logtenberg, SJ., Kleefstra, N., Snellen, FT., et al.[2009]

Continuous Glucose Monitoring (CGM) devices, including real-time (rtCGM) and intermittently scanned (isCGM), significantly improve glucose control and reduce hypoglycemia in insulin-treated individuals with diabetes, based on recent clinical evidence.

An updated algorithm was developed to help healthcare providers choose the most suitable CGM device for different clinical scenarios, such as type 1 and type 2 diabetes, pregnancy, and frailty, ensuring a personalized approach to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. Maiorino, MI., Buzzetti, R., Irace, C., et al.[2023]

References

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

Accuracy of a Factory-Calibrated Continuous Glucose Monitor in Individuals With Diabetes on Hemodialysis. [2023]

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

Glycaemic control in type 2 diabetic patients on chronic haemodialysis: use of a continuous glucose monitoring system. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in diabetes patients with chronic kidney disease on dialysis: a meta-analysis. [2022]

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

Blood glucose fluctuations in hemodialysis patients with end stage diabetic nephropathy. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Usefulness of continuous glucose monitoring of blood glucose control in patients with diabetes undergoing hemodialysis: A pilot study. [2023]

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

Comparative Accuracy Analysis of a Real-time and an Intermittent-Scanning Continuous Glucose Monitoring System. [2021]

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

Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. [2019]

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

Pre- and postoperative accuracy and safety of a real-time continuous glucose monitoring system in cardiac surgical patients: a randomized pilot study. [2009]

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

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]