Continuous Glucose Monitoring for Diabetes in Hemodialysis Patients
(CONDOR Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Irvine
Disqualifiers: Limited vision, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
15678How 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.
12359Eligibility 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 am 18 years old or older.
I have diabetes.
+3 more
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
Participant Groups
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.
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:
🇺🇸 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, IrvineOrange, CA
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Who Is Running the Clinical Trial?
University of California, IrvineLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Accuracy of a Factory-Calibrated Continuous Glucose Monitor in Individuals With Diabetes on Hemodialysis. [2023]Continuous glucose monitoring (CGM) improves diabetes management, but its reliability in individuals on hemodialysis is poorly understood and potentially affected by interstitial and intravascular volume variations.
Glycaemic control in type 2 diabetic patients on chronic haemodialysis: use of a continuous glucose monitoring system. [2022]The proportion of diabetic patients undergoing haemodialysis is rapidly increasing. Glucose control among such patients is difficult to assess. We aimed to evaluate the clinical performance of a continuous glucose monitoring system (CGMS) in type 2 diabetic patients on chronic haemodialysis.
Continuous glucose monitoring in diabetes patients with chronic kidney disease on dialysis: a meta-analysis. [2022]This review investigates the effectiveness of continuous glucose monitoring (CGM) in diabetes patients who were on routine dialysis.
Blood glucose fluctuations in hemodialysis patients with end stage diabetic nephropathy. [2022]To characterize blood glucose fluctuation during hemodialysis in patients with end stage diabetic nephropathy (ESDN) by a continuous glucose monitoring system (CGMS), and aim to improve blood glucose control in this patient population.
Usefulness of continuous glucose monitoring of blood glucose control in patients with diabetes undergoing hemodialysis: A pilot study. [2023]Blood glucose stability has recently been considered important in the treatment of diabetes. Both hypoglycemia and hyperglycemia can frequently occur in patients with diabetes undergoing hemodialysis. This study aimed to determine the usefulness of continuous glucose monitoring (CGM) for glycemic control and glycemic variability stabilization in patients with diabetes undergoing hemodialysis.
Comparative Accuracy Analysis of a Real-time and an Intermittent-Scanning Continuous Glucose Monitoring System. [2021]Currently, two different types of continuous glucose monitoring (CGM) systems are available: real time (rt) CGM systems that continuously provide glucose values and intermittent-scanning (is) CGM systems. This study compared accuracy of an rtCGM and an isCGM system when worn in parallel.
Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. [2019]Two types of continuous glucose monitoring (CGM) systems are now available: real-time CGM (rtCGM) and intermittently scanned (isCGM). Current rtCGM systems automatically transmit a continuous stream of glucose data to the user, provide alerts and active alarms, and transmit glucose data (trend and numerical) in real time to a receiver, smart watch, or smartphone. The current isCGM system provides the same type of glucose data but requires the user to purposely scan the sensor to obtain information, and it does not have alerts and alarms. Both CGM technologies have significant advantages over self-monitoring of blood glucose; however, differences in the features and capabilities of the two approaches must be considered when guiding patient selection of the system that meets their individual needs.
Pre- and postoperative accuracy and safety of a real-time continuous glucose monitoring system in cardiac surgical patients: a randomized pilot study. [2009]Our objective was to evaluate the accuracy and safety of a real-time (RT) continuous glucose monitoring system (CGMS) in patients before and after cardiothoracic surgery and to investigate whether activation of the alarm function of the RT-CGMS had an effect on glucose control.
An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]Continuous Glucose Monitoring (CGM) is a key tool for insulin-treated people with diabetes (PwD). CGM devices include both real-time CGM (rtCGM) and intermittently scanned CGM (isCGM), which are associated with an improvement of glucose control and less hypoglycemia in clinical trials of people with type 1 and type 2 diabetes.