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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether continuous glucose monitoring (CGM) can better control blood sugar, reduce the risk of low blood sugar (hypoglycemia), and improve quality of life for people with diabetes on hemodialysis. Participants will either use CGM devices or continue their usual routine of checking blood sugar multiple times a day. Individuals who have been on hemodialysis for at least four weeks and regularly monitor their blood sugar may be suitable candidates. As an unphased trial, this study provides a unique opportunity to advance diabetes care for those on hemodialysis.

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 prior data suggests that continuous glucose monitoring is safe for hemodialysis patients with diabetes?

Research has shown that continuous glucose monitoring (CGM) is generally safe for patients, including those receiving hemodialysis. A review of various studies found no serious safety issues when CGM was used in patients with type 2 diabetes on hemodialysis.

Specialists in kidney and hormone health agree on CGM's safety. Their report emphasizes the absence of major negative effects, making CGM a reliable option. In summary, CGM devices have a strong safety record for people with diabetes, even those undergoing hemodialysis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring (CGM) for diabetes in hemodialysis patients because it offers real-time glucose tracking, unlike traditional methods that require multiple finger pricks a day. CGM devices like Dexcom provide immediate insights into glucose levels, allowing for more precise management. This could be a game-changer for hemodialysis patients who often face complex glucose fluctuations, helping to improve their overall blood sugar control and quality of life.

What evidence suggests that continuous glucose monitoring is effective for diabetes in hemodialysis patients?

This trial will compare continuous glucose monitoring (CGM) with usual care (self-monitored blood glucose) for people with diabetes undergoing hemodialysis. Research has shown that CGM can help manage blood sugar levels by providing real-time information, allowing for more frequent treatment adjustments. This can lead to better overall blood sugar management and may reduce the risk of low blood sugar episodes. Additionally, CGM use has been associated with improved quality of life and reduced stress in managing diabetes. Overall, CGM appears to be a promising tool for improving health outcomes in these patients. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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Efficacy of continuous glucose monitoring in people living ... We conducted a systematic review to examine the current evidence for CGM use and its impact on clinical outcomes in patients with diabetes on dialysis.

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The role of real‐time continuous glucose monitoring in ... This review aims to provide an overview of the role of rtCGM and how best to link rtCGM to iPDM, highlighting its role in enhancing personalized treatment ...

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Consensus Report on the Use of Continuous Glucose ... This report represents the conclusions of 15 experts in nephrology and endocrinology, based on their knowledge of key studies and evidence in the field.

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Continuous glucose monitoring in patients with type 2 ... We conducted a systematic review of published articles on continue glucose monitoring in hemodialysis patients with type 2 diabetes, which included 12 major ...