122 Participants Needed

Continuous Glucose Monitoring for Diabetes in Hemodialysis Patients

(CONDOR Trial)

CR
KK
Overseen ByKamyar Kalantar-Zadeh
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.

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.12345

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.13678

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.13789

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous glucose monitoring (CGM) armExperimental Treatment1 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 armActive Control1 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:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Dexcom G6 for:
  • Diabetes management for patients aged 2 years and older
  • Type 1 diabetes
  • Type 2 diabetes
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Continuous Glucose Monitoring Systems for:
  • Diabetes management
  • Type 1 diabetes
  • Type 2 diabetes

Find a Clinic Near You

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

Citations

Accuracy of a Factory-Calibrated Continuous Glucose Monitor in Individuals With Diabetes on Hemodialysis. [2023]
Glycaemic control in type 2 diabetic patients on chronic haemodialysis: use of a continuous glucose monitoring system. [2022]
Continuous glucose monitoring in diabetes patients with chronic kidney disease on dialysis: a meta-analysis. [2022]
Blood glucose fluctuations in hemodialysis patients with end stage diabetic nephropathy. [2022]
Usefulness of continuous glucose monitoring of blood glucose control in patients with diabetes undergoing hemodialysis: A pilot study. [2023]
Comparative Accuracy Analysis of a Real-time and an Intermittent-Scanning Continuous Glucose Monitoring System. [2021]
Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. [2019]
Pre- and postoperative accuracy and safety of a real-time continuous glucose monitoring system in cardiac surgical patients: a randomized pilot study. [2009]
An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]
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